Efficacy of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP) Primary Version

ERIC Educational Resources Information Center

DiPerna, James Clyde; Lei, Puiwa; Bellinger, Jillian; Cheng, Weiyi

2015-01-01

A multisite cluster randomized trial was conducted to examine the effects of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP; Elliott & Gresham, 2007) on students' classroom social behavior. The final sample included 432 students across 38 second grade classrooms. Social skills and problem behaviors were measured…

Site matters: multisite randomized trial of motivational enhancement therapy in community drug abuse clinics.

PubMed

Ball, Samuel A; Martino, Steve; Nich, Charla; Frankforter, Tami L; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E; Obert, Jeanne L; Farentinos, Christiane; Carroll, Kathleen M

2007-08-01

The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention differences between the 2 brief intervention conditions. Although both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. This finding was complicated by program site main effects and higher level interactions. MET resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites.

Recruiting a Diverse Group of Middle School Girls into the Trial of Activity for Adolescent Girls

ERIC Educational Resources Information Center

Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

2008-01-01

Background: School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among…

Multisite Randomized Trial of Behavioral Interventions for Women with Co-Occurring PTSD and Substance Use Disorders

ERIC Educational Resources Information Center

Hien, Denise A.; Wells, Elizabeth A.; Jiang, Huiping; Suarez-Morales, Lourdes; Campbell, Aimee N. C.; Cohen, Lisa R.; Miele, Gloria M.; Killeen, Therese; Brigham, Gregory S.; Zhang, Yulei; Hansen, Cheri; Hodgkins, Candace; Hatch-Maillette, Mary; Brown, Chanda; Kulaga, Agatha; Kristman-Valente, Allison; Chu, Melissa; Sage, Robert; Robinson, James A.; Liu, David; Nunes, Edward V.

2009-01-01

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353…

African American Veterans Storytelling: A Multisite Randomized Trial to Improve Hypertension.

PubMed

Houston, Thomas K; Fix, Gemmae M; Shimada, Stephanie L; Long, Judith A; Gordon, Howard S; Pope, Charlene; Volkman, Julie; Allison, Jeroan J; DeLaughter, Kathryn; Orner, Michelle; Bokhour, Barbara G

2017-09-01

Disparities in hypertension control persist for African American Veterans. To enhance cultural relevance of hypertension control self-management education, in a multisite, stratified randomized trial, we tested an interactive Veteran-to-Veteran storytelling digital video disk (DVD) intervention created with Veteran partners, versus an education-only DVD comparison. At 3 VA facilities, African American Veterans with uncontrolled hypertension were randomized to storytelling DVD intervention or didactic comparison DVD and followed for 6 months. We hypothesized that follow-up blood pressure (BP) would be lower among Veterans in the intervention group. African American Veterans (N=619) were 92% male, 39% over age 65, most had a high-school education, over 50% of both the intervention and comparison group reported a household income of <$20,000, and 40% had less than adequate health literacy. At baseline, mean intervention and comparison group BPs were 138/80 and 139/81 mm Hg, respectively; at 6 months, mean systolic BP (SBP) increased by 0.1 in the intervention group and by 1.9 for the comparison group; diastolic BP fell by 0.1 in the intervention group and rose by 0.2 in the comparison group. No differences between the intervention and control groups were statistically significant (all P>0.3). Site differences were large; at one, the intervention group improved while the comparison groups deteriorated, resulting in 6.3 and 3.9 mm Hg more improvement for the intervention group in SBP and diastolic BP (P=0.06 and 0.04), respectively; at the other 2 sites, there were positive and negative changes, all small, in the 2 measures, with minimal differences-one site favored the comparison group and the other, the intervention (these comparisons did not approach statistical significance (all P>0.20). In a secondary analysis stratified by baseline BP, there was no intervention effect among those with uncontrolled BP, but intervention patients who were in control at baseline were more likely to stay in control, compared with comparison [SBP increase by 6.3 mm Hg (SD=14.4) among intervention, and by 10.9 mm Hg (SD=16.9) in comparison, P=0.02]. In this multisite trial, we did not find a significant overall storytelling intervention effect (Clinicaltrials.gov Reg. #NCT01276197).

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial

PubMed Central

Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-01-01

Background Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. Objective The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. Methods A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association–recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators’ monitoring of patients’ adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A1c levels, weight, and the usability of the connected system. Results An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. Conclusions If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. Trial Registration ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5) PMID:29610111

The role of economics in the QUERI program: QUERI Series

PubMed Central

Smith, Mark W; Barnett, Paul G

2008-01-01

Background The United States (U.S.) Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) has implemented economic analyses in single-site and multi-site clinical trials. To date, no one has reviewed whether the QUERI Centers are taking an optimal approach to doing so. Consistent with the continuous learning culture of the QUERI Program, this paper provides such a reflection. Methods We present a case study of QUERI as an example of how economic considerations can and should be integrated into implementation research within both single and multi-site studies. We review theoretical and applied cost research in implementation studies outside and within VA. We also present a critique of the use of economic research within the QUERI program. Results Economic evaluation is a key element of implementation research. QUERI has contributed many developments in the field of implementation but has only recently begun multi-site implementation trials across multiple regions within the national VA healthcare system. These trials are unusual in their emphasis on developing detailed costs of implementation, as well as in the use of business case analyses (budget impact analyses). Conclusion Economics appears to play an important role in QUERI implementation studies, only after implementation has reached the stage of multi-site trials. Economic analysis could better inform the choice of which clinical best practices to implement and the choice of implementation interventions to employ. QUERI economics also would benefit from research on costing methods and development of widely accepted international standards for implementation economics. PMID:18430199

The role of economics in the QUERI program: QUERI Series.

PubMed

Smith, Mark W; Barnett, Paul G

2008-04-22

The United States (U.S.) Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) has implemented economic analyses in single-site and multi-site clinical trials. To date, no one has reviewed whether the QUERI Centers are taking an optimal approach to doing so. Consistent with the continuous learning culture of the QUERI Program, this paper provides such a reflection. We present a case study of QUERI as an example of how economic considerations can and should be integrated into implementation research within both single and multi-site studies. We review theoretical and applied cost research in implementation studies outside and within VA. We also present a critique of the use of economic research within the QUERI program. Economic evaluation is a key element of implementation research. QUERI has contributed many developments in the field of implementation but has only recently begun multi-site implementation trials across multiple regions within the national VA healthcare system. These trials are unusual in their emphasis on developing detailed costs of implementation, as well as in the use of business case analyses (budget impact analyses). Economics appears to play an important role in QUERI implementation studies, only after implementation has reached the stage of multi-site trials. Economic analysis could better inform the choice of which clinical best practices to implement and the choice of implementation interventions to employ. QUERI economics also would benefit from research on costing methods and development of widely accepted international standards for implementation economics.

The Impact of Parent-Delivered Intervention on Parents of Very Young Children with Autism

ERIC Educational Resources Information Center

Estes, Annette; Vismara, Laurie; Mercado, Carla; Fitzpatrick, Annette; Elder, Lauren; Greenson, Jessica; Lord, Catherine; Munson, Jeffrey; Winter, Jamie; Young, Gregory; Dawson, Geraldine; Rogers, Sally

2014-01-01

This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model (P-ESDM) on parenting-related stress and sense of competence. This was part of a multisite, randomized trial comparing P-ESDM (n = 49) with community intervention (n = 49) for children aged 12 and 24 months. The P-ESDM group reported no…

The Ecological Effects of Universal and Selective Violence Prevention Programs for Middle School Students: A Randomized Trial

ERIC Educational Resources Information Center

Simon, Thomas R.; Ikeda, Robin M.; Smith, Emilie Phillips; Reese, Le'Roy E.; Rabiner, David L.; Miller, Shari; Winn, Donna-Marie; Dodge, Kenneth A.; Asher, Steven R.; Horne, Arthur M.; Orpinas, Pamela; Martin, Roy; Quinn, William H.; Tolan, Patrick H.; Gorman-Smith, Deborah; Henry, David B.; Gay, Franklin N.; Schoeny, Michael; Farrell, Albert D.; Meyer, Aleta L.; Sullivan, Terri N.; Allison, Kevin W.

2009-01-01

This study reports the findings of a multisite randomized trial evaluating the separate and combined effects of 2 school-based approaches to reduce violence among early adolescents. A total of 37 schools at 4 sites were randomized to 4 conditions: (1) a universal intervention that involved implementing a student curriculum and teacher training…

Site Matters: Multisite Randomized Trial of Motivational Enhancement Therapy in Community Drug Abuse Clinics

PubMed Central

Ball, Samuel A.; Martino, Steve; Nich, Charla; Frankforter, Tami L.; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E.; Obert, Jeanne L.; Farentinos, Christiane; Carroll, Kathleen M.

2007-01-01

The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention differences between the 2 brief intervention conditions. Although both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. This finding was complicated by program site main effects and higher level interactions. MET resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites. PMID:17663610

Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.

PubMed

Frank, Fabian; Wilk, Juliette; Kriston, Levente; Meister, Ramona; Shimodera, Shinji; Hesse, Klaus; Bitzer, Eva-Maria; Berger, Mathias; Hölzel, Lars P

2015-10-23

Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear. The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient's discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated. Our study will provide evidence on the incremental effect of a brief psychoeducational intervention for relatives as a maintenance treatment after inpatient depression treatment. Positive results may have a major impact on health care for depression. German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391.

Coherent Power Analysis in Multilevel Studies Using Parameters from Surveys

ERIC Educational Resources Information Center

Rhoads, Christopher

2017-01-01

Researchers designing multisite and cluster randomized trials of educational interventions will usually conduct a power analysis in the planning stage of the study. To conduct the power analysis, researchers often use estimates of intracluster correlation coefficients and effect sizes derived from an analysis of survey data. When there is…

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial.

PubMed

Wang, Jing; Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-04-02

Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association-recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators' monitoring of patients' adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A 1c levels, weight, and the usability of the connected system. An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5). ©Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.04.2018.

Lessons learned from a practice-based, multi-site intervention study with nurse participants

PubMed Central

Friese, Christopher R.; Mendelsohn-Victor, Kari; Ginex, Pamela; McMahon, Carol M.; Fauer, Alex J.; McCullagh, Marjorie C.

2016-01-01

Purpose To identify challenges and solutions to the efficient conduct of a multi-site, practice-based randomized controlled trial to improve nurses’ adherence to personal protective equipment use in ambulatory oncology settings. Design The Drug Exposure Feedback and Education for Nurses’ Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to web-based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a web-based continuing education video. Approach The study principal investigator, the study coordinator, and two site leaders identified challenges to study implementation and potential solutions, plus potential methods to prevent logistical challenges in future studies. Findings Noteworthy challenges included variation in human subjects protection policies, grants and contracts budgeting, infrastructure for nursing-led research, and information technology variation. Successful strategies included scheduled web conferences, site-based study champions, site visits by the principal investigator, and centrally-based document preparation. Strategies to improve efficiency in future studies include early and continued engagement with contract personnel in sites, and proposed changes to the common rule concerning human subjects. The DEFENS study successfully recruited 393 nurses across 12 sites. To date, 369 have completed surveys and 174 nurses have viewed educational materials. Conclusions Multi-site studies of nursing personnel are rare and challenging to existing infrastructure. These barriers can be overcome with strong engagement and planning. Clinical Relevance Leadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplace-based randomized, controlled behavioral trial. PMID:28098951

Methodological challenges in conducting a multi-site randomized clinical trial of massage therapy in hospice.

PubMed

Kutner, Jean; Smith, Marlaine; Mellis, Karen; Felton, Sue; Yamashita, Traci; Corbin, Lisa

2010-06-01

Researchers conducting multi-site studies of interventions for end-of-life symptom management face significant challenges with respect to obtaining an adequate sample and training and retaining on-site study teams. The purpose of this paper is to describe the strategies and responses to these challenges in a multi-site randomized clinical trial (RCT) of the efficacy of massage therapy for decreasing pain among patients with advanced cancer in palliative care/hospice settings. Over a period of 36 months, we enrolled 380 participants across 15 sites; 27% of whom withdrew prior to study completion (less than the anticipated 30% rate). We saw an average of 68% turnover amongst study staff. Three key qualities characterized successful on-site study teams: (1) organizational commitment; (2) strong leadership from on-site study coordinators; and (3) effective lines of communication between the on-site study coordinators and both their teams and the university-based research team. Issues of recruitment, retention and training should be accounted for in hospice-based research study design and budgeting.

Challenges and lessons learned in conducting comparative-effectiveness trials.

PubMed

Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

2012-05-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

Challenges and Lessons Learned in Conducting Comparative-Effectiveness Trials

PubMed Central

Herrick, Linda M.; Locke, G. Richard; Zinsmeister, Alan R.; Talley, Nicholas J.

2014-01-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication. PMID:22552235

Toward evidence-based interventions for diverse populations: The San Francisco General Hospital prevention and treatment manuals.

PubMed

Muñoz, Ricardo F; Mendelson, Tamar

2005-10-01

Clinical trials have seldom included adequate samples of people of color. Therefore, practitioners serving ethnic minorities often do not have access to readily available evidence-based interventions. This article summarizes the development and empirical evaluation of prevention and treatment manuals designed for low-income ethnic minority populations at San Francisco General Hospital. The manuals were often designed by people of color familiar with the communities for which they were developed. Independent research teams in multi-site national and international clinical trials have evaluated many of these manuals with encouraging results. ((c) 2005 APA, all rights reserved).

Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors.

PubMed

Carlson, Linda E; Zelinski, Erin L; Speca, Michael; Balneaves, Lynda G; Jones, Jennifer M; Santa Mina, Daniel; Wayne, Peter M; Campbell, Tavis S; Giese-Davis, Janine; Faris, Peter; Zwicker, Jennifer; Patel, Kamala; Beattie, Tara L; Cole, Steve; Toivonen, Kirsti; Nation, Jill; Peng, Philip; Thong, Bruce; Wong, Raimond; Vohra, Sunita

2017-08-01

A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics. The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system. Copyright © 2017 Elsevier Inc. All rights reserved.

Treatment of Adolescent Marijuana Abuse: A Randomized Clinical Trial. Presentation 1: Structure of the Cannabis Youth Treatment Study.

ERIC Educational Resources Information Center

Titus, Janet C.; Dennis, Michael L.; Diamond, Guy; Godley, Susan H.; Babor, Thomas; Donaldson, Jean; Herrell, James; Tims, Frank; Webb, Charles

The Cannabis Youth Treatment (CYT) study is a multi-site randomized field experiment examining five outpatient treatment protocols for adolescents who abuse or are dependent on marijuana. The purpose of the CYT project is twofold: (a) to test the relative clinical effectiveness and cost-effectiveness of five promising interventions targeted at…

The Effects of Collaborative Strategic Reading Instruction on the Reading Comprehension of Middle School Students: Year 2 Replication

ERIC Educational Resources Information Center

Swanson, Elizabeth; Mohammed, Sarojani S.; Boardman, Alison Gould; Vaughn, Sharon; Klingner, Janette; Roberts, Greg; Leroux, Audrey; Solis, Michael

2011-01-01

The current study is the second in a series of multi-site, multi-year randomized control trials designed to test the efficacy of a fully developed intervention, Collaborative Strategic Reading (CSR), with adolescent readers. In year 1, the research questions were: (1) Does CSR improve reading comprehension for adolescent readers attending…

Examining the Impact of ABRACADABRA on Early Literacy in Northern Australia: An Implementation Fidelity Analysis

ERIC Educational Resources Information Center

Wolgemuth, Jennifer R.; Abrami, Philip C.; Helmer, Janet; Savage, Robert; Harper, Helen; Lea, Tess

2014-01-01

To address students' poor literacy outcomes, an intervention using a computer-based literacy tool, ABRACADABRA, was implemented in 6 Northern Australia primary schools. A pretest, posttest parallel group, single blind multisite randomized controlled trial was conducted with 308 students between the ages of 4 and 8 years old (M age = 5.8 years, SD…

Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders.

PubMed

Harbourne, Regina T; Dusing, Stacey C; Lobo, Michele A; Westcott-McCoy, Sarah; Bovaird, James; Sheridan, Susan; Galloway, James C; Chang, Hui-Ju; Hsu, Lin-Ya; Koziol, Natalie; Marcinowski, Emily C; Babik, Iryna

2018-06-01

There is limited research examining the efficacy of early physical therapy on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the clear association between motor activity and cognition during infancy. The aim of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to advance global development in infants with motor delays or neuromotor dysfunction. This study is a longitudinal multisite randomized controlled trial. Infants in the START-Play group are compared to infants receiving usual care in early intervention (EI). The research takes place in homes in Pennsylvania, Delaware, Washington, and Virginia. There will be 140 infants with neuromotor dysfunction participating, beginning between 7 to 16 months of age. Infants will have motor delays and emerging sitting skill. START-Play provides individualized twice-weekly home intervention for 12 weeks with families to enhance cognition through sitting, reaching, and problem-solving activities for infants. Ten interventionists provide the intervention, with each child assigned 1 therapist. The primary outcome measure is the Bayley III Scales of Infant Development. Secondary measures include change in the Early Problem Solving Indicator, change in the Gross Motor Function Measure, and change in the type and duration of toy contacts during reaching. Additional measures include sitting posture control and parent-child interaction. Limitations include variability in usual EI care and the lack of blinding for interventionists and families. This study describes usual care in EI across 4 US regions and compares outcomes of the START-Play intervention to usual care.

STRATEGIES FOR OVERCOMING SITE AND RECRUITMENT CHALLENGES IN RESEARCH STUDIES BASED IN INTENSIVE CARE UNITS

PubMed Central

Chlan, Linda; Guttormson, Jill; Tracy, Mary Fran; Bremer, Karin Lindstrom

2009-01-01

Although enrolling a sufficient number of participants is a challenge for any multisite clinical trial, recruiting patients who are critically ill and receiving mechanical ventilatory support presents additional challenges because of the severity of the patients’ illness and the impediments to their communication. Recruitment challenges related to the research sites, nursing staff, and research participants faced in the first 2 years of a 4-year multisite clinical trial of a patient-directed music intervention for managing anxiety in the intensive care unit were determined. Strategies to overcome these challenges, and thereby increase enrollment, were devised. Individual strategies, such as timing of screening on a unit, were tailored to each participating site to enhance recruitment for this trial. Other strategies, such as obtaining a waiver for a participant’s signature, were instituted across all participating sites. Through implementation of these various strategies, the mean monthly enrollment of participants increased by 50%. Investigators are advised to plan well in advance of starting recruitment for a clinical trial based in an intensive care unit, anticipate peaks and valleys in recruitment, and be proactive in addressing issues creatively as the issues arise. PMID:19723861

Concordance of Race or Ethnicity of Interventionists and Caregivers of Dementia Patients: Relationship to Attrition and Treatment Outcomes in the REACH Study

ERIC Educational Resources Information Center

McGinnis, Kathleen A.; Schulz, Richard; Stone, Roslyn A.; Klinger, Julie; Mercurio, Rocco

2006-01-01

Purpose: We assess the effects of racial or ethnic concordance between caregivers and interventionists on caregiver attrition, change in depression, and change in burden in a multisite randomized clinical trial. Design and Methods: Family caregivers of patients with Alzheimer's disease were randomized to intervention or control groups at six sites…

Transporting Clinical Research to Community Settings: Designing and Conducting a Multisite Trial of Brief Strategic Family Therapy

PubMed Central

Robbins, Michael S.; Alonso, Elizabeth; Horigian, Viviana E.; Bachrach, Ken; Burlew, Kathy; Carrión, Ibis S.; Hodgkins, Candace C.; Miller, Michael; Schindler, Eric; VanDeMark, Nancy; Henderson, Craig; Szapocznik, José

2010-01-01

This paper describes the development and implementation of a trial of Brief Strategic Family Therapy (BSFT), an evidence-based drug intervention for adolescents, in eight community substance abuse treatment programs. Researchers and treatment programs collaborated closely to identify and overcome challenges, many of them related to achieving results that were both scientifically rigorous and applicable to the widest possible variety of adolescent substance abuse treatment programs. To meet these challenges, the collaborative team drew on lessons and practices from efficacy, effectiveness, and implementation research. PMID:22002455

Using School-Level Interviews to Develop a Multisite PE Intervention Program

PubMed Central

Moe, Stacey G.; Pickrel, Julie; McKenzie, Thomas L.; Strikmiller, Patricia K.; Coombs, Derek; Murrie, Dale

2008-01-01

The Trial of Activity for Adolescent Girls (TAAG) is a randomized, multicenter field trial in middle schools that aims to reduce the decline of physical activity in adolescent girls. To inform the development of the TAAG intervention, two phases of formative research are conducted to gain information on school structure and environment and on the conduct of physical education classes. Principals and designated staff at 64 eligible middle schools were interviewed using the School Survey during Phase 1. The following year (Phase 2), physical education department heads of the 36 schools selected into TAAG were interviewed. Responses were examined to design a standardized, multicomponent physical activity intervention for six regions of the United States. This article describes the contribution of formative research to the development of the physical education intervention component and summarizes the alignment of current school policies and practices with national and state standards. PMID:16397159

Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

ERIC Educational Resources Information Center

Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

2016-01-01

Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

PubMed

Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

2014-11-01

Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may suggest new methods for enhancing outcomes. Australia and New Zealand Clinical Trial Registry: ACTRN12611000136909. Copyright © 2014. Published by Elsevier Ltd.

Rationale, design and methods for process evaluation in the HEALTHY study.

PubMed

Schneider, M; Hall, W J; Hernandez, A E; Hindes, K; Montez, G; Pham, T; Rosen, L; Sleigh, A; Thompson, D; Volpe, S L; Zeveloff, A; Steckler, A

2009-08-01

The HEALTHY study was a multi-site randomized trial designed to determine whether a 3-year school-based intervention targeting nutrition and physical activity behaviors could effectively reduce risk factors associated with type 2 diabetes in middle school children. Pilot and formative studies were conducted to inform the development of the intervention components and the process evaluation methods for the main trial. During the main trial, both qualitative and quantitative assessments monitored the fidelity of the intervention and motivated modifications to improve intervention delivery. Structured observations of physical education classes, total school food environments, classroom-based educational modules, and communications and promotional campaigns provided verification that the intervention was delivered as intended. Interviews and focus groups yielded a multidimensional assessment of how the intervention was delivered and received, as well as identifying the barriers to and facilitators of the intervention across and within participating schools. Interim summaries of process evaluation data were presented to the study group as a means of ensuring standardization and quality of the intervention across the seven participating centers. Process evaluation methods and procedures documented the fidelity with which the HEALTHY study was implemented across 21 intervention schools and identified ways in which the intervention delivery might be enhanced throughout the study.

What Works in Gifted Education Mathematics Study: Impact of Pre-Differentiated and Enriched Curricula on General Education Teachers and Their Students. Research Monograph Series. RM13242

ERIC Educational Resources Information Center

Gubbins, E. Jean; McCoach, D. Betsy; Foreman, Jennifer L.; Gilson, Cindy M.; Bruce-Davis, Micah N.; Rubenstein, Lisa DaVia; Savino, Jennifer; Rambo, Karen; Waterman, Craig

2013-01-01

The present study seeks to determine how exposure to pre-differentiated and enriched curricula incorporating educative curriculum materials affects students' achievement as well as teacher and administrator responses to the intervention. A 2-year multi-site cluster randomized control trial study recruited a national sample of 4,530 grade 3…

Implementation Considerations for Multisite Clinical Trials with Cognitive Neuroscience Tasks

PubMed Central

Keefe, Richard S. E.; Harvey, Philip D.

2008-01-01

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered. PMID:18495645

Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions

PubMed Central

Taylor, Lauren J; Rathouz, Paul J; Berlin, Ana; Brasel, Karen J; Mosenthal, Anne C; Finlayson, Emily; Cooper, Zara; Steffens, Nicole M; Jacobson, Nora; Buffington, Anne; Tucholka, Jennifer L; Zhao, Qianqian; Schwarze, Margaret L

2017-01-01

Introduction Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. Methods and analysis This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. Ethics and dissemination Approvals have been granted by the Institutional Review Board at the University of Wisconsin and at each participating site, and a Certificate of Confidentiality has been obtained. Results will be reported in peer-reviewed publications and presented at national meetings. Trial registration number NCT02623335. PMID:28554911

The utility of a composite biological endpoint in HIV/STI prevention trials.

PubMed

Hartwell, Tyler D; Pequegnat, Willo; Moore, Janet L; Parker, Corette B; Strader, Lisa C; Green, Annette M; Quinn, Thomas C; Wasserheit, Judith N; Klausner, Jeffrey D

2013-11-01

A human immunodeficiency virus (HIV) as a biological endpoint in HIV prevention trials may not be feasible, so investigators have used surrogate biological outcomes. In a multisite trial, the epidemiology of STIs may be different across sites and preclude using one STI as the outcome. This study explored using a composite STI outcome to address that problem. The combined biological endpoint was the incidence of any of six new STIs (chlamydia, gonorrhea, trichomonas (women only), syphilis, herpes simplex virus type 2 infection and HIV) during a 24-month follow up period. We investigated how a composite STI outcome would perform compared to single and dual STI outcomes under various conditions. We simulated outcomes for four populations that represented a wide range of sex and age distributions, and STI prevalences. The simulations demonstrated that a combined biologic outcome was superior to single and dual STI outcomes in assessing intervention effects in 82 % of the cases. A composite biological outcome was effective in detecting intervention effects and might allow more investigations to incorporate multiple biological outcomes in the assessment of behavioral intervention trials for HIV prevention.

Acculturation level and caregiver outcomes from a randomized intervention trial to enhance caregivers' health: evidence from REACH II.

PubMed

Meyer, Oanh L; Liu, Xiaoyan Lucia; Tancredi, Daniel; Ramirez, A Susana; Schulz, Richard; Hinton, Ladson

2018-06-01

Latinos comprise a growing segment of the caregiver population and vary widely in acculturation, yet little is known regarding how acculturation might affect caregiver stress or intervention outcomes. This study examined the relationship between acculturation and burden, bother, and depression in Latino dementia caregivers at baseline and following an intervention. This was a secondary data analysis of 211 Latino caregivers of older adults with dementia from Resources for Enhancing Alzheimer's Caregiver Health (REACH) II, a multisite randomized trial of caregiver interventions. Baseline and follow-up data were used to run mixed-effects models examining the main and moderating effect of acculturation on caregiver stress. No significant main effect of acculturation was found for any of the outcome measures, controlling for demographic covariates. Acculturation moderated the effect of the intervention on caregiver burden: those who were more acculturated benefited more from the intervention. Differential acculturation for Latino caregivers was not directly associated with caregiver burden, bother, or depression, but was associated with reducing burden from the intervention. Future research should explore by what mechanism acculturation influences caregiver burden following an intervention.

Process evaluation in a multisite, primary obesity-prevention trial in American Indian schoolchildren.

PubMed

Helitzer, D L; Davis, S M; Gittelsohn, J; Going, S B; Murray, D M; Snyder, P; Steckler, A B

1999-04-01

We describe the development, implementation, and use of the process evaluation component of a multisite, primary obesity prevention trial for American Indian schoolchildren. We describe the development and pilot testing of the instruments, provide some examples of the criteria for instrument selection, and provide examples of how process evaluation results were used to document and refine intervention components. The theoretical and applied framework of the process evaluation was based on diffusion theory, social learning theory, and the desire for triangulation of multiple modes of data collection. The primary objectives of the process evaluation were to systematically document the training process, content, and implementation of 4 components of the intervention. The process evaluation was developed and implemented collaboratively so that it met the needs of both the evaluators and those who would be implementing the intervention components. Process evaluation results revealed that observation and structured interviews provided the most informative data; however, these methods were the most expensive and time consuming and required the highest level of skill to undertake. Although the literature is full of idealism regarding the uses of process evaluation for formative and summative purposes, in reality, many persons are sensitive to having their work evaluated in such an in-depth, context-based manner as is described. For this reason, use of structured, quantitative, highly objective tools may be more effective than qualitative methods, which appear to be more dependent on the skills and biases of the researcher and the context in which they are used.

From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

PubMed Central

Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

2011-01-01

Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

The study designed by a committee: design of the Multisite Violence Prevention Project.

PubMed

Henry, David B; Farrell, Albert D

2004-01-01

This article describes the research design of the Multisite Violence Prevention Project (MVPP), organized and funded by the National Center for Injury Prevention and Control (NCIPC) at the Centers for Disease Control and Prevention (CDC). CDC's objectives, refined in the course of collaboration among investigators, were to evaluate the efficacy of universal and targeted interventions designed to produce change at the school level. The project's design was developed collaboratively, and is a 2 x 2 cluster-randomized true experimental design in which schools within four separate sites were assigned randomly to four conditions: (1) no-intervention control group, (2) universal intervention, (3) targeted intervention, and (4) combined universal and targeted interventions. A total of 37 schools are participating in this study with 8-12 schools per site. The impact of the interventions on two successive cohorts of sixth-grade students will be assessed based on multiple waves of data from multiple sources of information, including teachers, students, parents, and archival data. The nesting of students within teachers, families, schools and sites created a number of challenges for designing and implementing the study. The final design represents both resolution and compromise on a number of creative tensions existing in large-scale prevention trials, including tensions between cost and statistical power, and between internal and external validity. Strengths and limitations of the final design are discussed.

Effectiveness of information and communication technologies interventions to increase mental health literacy: A systematic review.

PubMed

Tay, Jing Ling; Tay, Yi Fen; Klainin-Yobas, Piyanee

2018-06-13

Most mental health conditions affect adolescent and young adults. The onset of many mental disorders occurs in the young age. This is a critical period to implement interventions to enhance mental health literacy (MHL) and to prevent the occurrence of mental health problems. This systematic review examined the effectiveness of information and communication technologies interventions on MHL (recognition of conditions, stigma and help-seeking). The authors searched for both published and unpublished studies. Nineteen studies were included with 9 randomized controlled trials and 10 quasi-experimental studies. Informational interventions were useful to enhance MHL of less-known disorders such as anxiety disorder and anorexia, but not depression. Interventions that were effective in enhancing depression MHL comprised active component such as videos or quizzes. Interventions that successfully elevated MHL also reduced stigma. Elevated MHL levels did not improve help-seeking, and reduction in stigma levels did not enhance help-seeking behaviours. Future good quality, large-scale, multi-sites randomized controlled trials are necessary to evaluate MHL interventions. © 2018 John Wiley & Sons Australia, Ltd.

Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

PubMed

Natale, Joanne E; Lebet, Ruth; Joseph, Jill G; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A Q

2017-05-01

To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P < .001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001). Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. ClinicalTrials.gov: NCT00814099. Copyright © 2017 Elsevier Inc. All rights reserved.

Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial.

PubMed

Bekelman, David B; Plomondon, Mary E; Carey, Evan P; Sullivan, Mark D; Nelson, Karin M; Hattler, Brack; McBryde, Connor F; Lehmann, Kenneth G; Gianola, Katherine; Heidenreich, Paul A; Rumsfeld, John S

2015-05-01

Heart failure (HF) has a major effect on patients' health status, including their symptom burden, functional status, and health-related quality of life. To determine the effectiveness of a collaborative care patient-centered disease management (PCDM) intervention to improve the health status of patients with HF. The Patient-Centered Disease Management (PCDM) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF. A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 60 (heavy symptom burden and impaired functional status and quality of life) were enrolled between May 2009 and June 2011. The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator, cardiologist, psychiatrist, and primary care physician; home telemonitoring and patient self-management support; and screening and treatment for comorbid depression. The primary outcome was change in the KCCQ overall summary score at 1 year (a 5-point change is clinically significant). Mortality, hospitalization, and depressive symptoms (Patient Health Questionnaire 9) were secondary outcomes. There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention (n=187) vs usual care (n=197); baseline mean KCCQ overall summary scores were 37.9 vs 36.9 (P=.48). There was significant improvement in the KCCQ overall summary scores in both groups after 1 year (mean change, 13.5 points in each group), with no significant difference between groups (P=.97). The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month, 6-month, and 12-month data (P=.74). Among secondary outcomes, there were significantly fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) (P = .04). Among those who screened positive for depression, there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm (2.1 points lower, P=.01). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P=.87). This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care. clinicaltrials.gov Identifier: NCT00461513.

What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

PubMed

Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

2015-11-01

Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

Impact of a two-city community cancer prevention intervention on African Americans.

PubMed Central

Blumenthal, Daniel S.; Fort, Jane G.; Ahmed, Nasar U.; Semenya, Kofi A.; Schreiber, George B.; Perry, Shelley; Guillory, Joyce

2005-01-01

We report the first multisite, multicomponent community intervention trial to focus on cancer prevention in African Americans. The project explored the potential of historically black medical schools to deliver health information to their local communities and used a community-based participatory research approach. The intervention consisted of culturally sensitive messages at appropriate educational levels delivered over an 18-month period and tested in predominantly black census tracts in Nashville, TN and Atlanta, GA. Chattanooga, TN and Decatur, GA served as comparison cities. Results were evaluated by pre- and postintervention random-digit dial telephone surveys. The intervention cities showed an increase in reported contact with or knowledge of the project. There was little or no effect on knowledge or attitudes in the intervention cities. Compared to Chattanooga, Nashville showed an increase in percentage of women receiving Pap smears. Compared to Decatur, Atlanta showed an increase in percentage of age-appropriate populations receiving digital rectal exams, colorectal cancer screenings and mammograms. The results of this community intervention trial demonstrated modest success and are encouraging for future efforts of longer duration. PMID:16334495

Effects of an Organizational Linkage Intervention on Inter-Organizational Service Coordination Between Probation/Parole Agencies and Community Treatment Providers.

PubMed

Welsh, Wayne N; Knudsen, Hannah K; Knight, Kevin; Ducharme, Lori; Pankow, Jennifer; Urbine, Terry; Lindsey, Adrienne; Abdel-Salam, Sami; Wood, Jennifer; Monico, Laura; Link, Nathan; Albizu-Garcia, Carmen; Friedmann, Peter D

2016-01-01

Weak coordination between community correctional agencies and community-based treatment providers is a major barrier to diffusion of medication-assisted treatment (MAT)--the inclusion of medications (e.g., methadone and buprenorphine) in combination with traditional counseling and behavioral therapies to treat substance use disorders. In a multisite cluster randomized trial, experimental sites (j = 10) received a 3-h MAT training plus a 12-month linkage intervention; control sites (j = 10) received the 3-h training alone. Hierarchical linear models showed that the intervention resulted in significant improvements in perceptions of interagency coordination among treatment providers, but not probation/parole agents. Implications for policy and practice are discussed.

Intraclass Correlations for Three-Level Multi-Site Cluster-Randomized Trials of Science Achievement

ERIC Educational Resources Information Center

Westine, Carl D.

2015-01-01

A cluster-randomized trial (CRT) relies on random assignment of intact clusters to treatment conditions, such as classrooms or schools (Raudenbush & Bryk, 2002). One specific type of CRT, a multi-site CRT (MSCRT), is commonly employed in educational research and evaluation studies (Spybrook & Raudenbush, 2009; Spybrook, 2014; Bloom,…

Learning "about" and "from" Variation in Program Impacts Using Multisite Trials. MDRC Working Papers on Research Methodology

ERIC Educational Resources Information Center

Raudenbush, Stephen W.; Bloom, Howard S.

2015-01-01

The present paper, which is intended for a diverse audience of evaluation researchers, applied social scientists, and research funders, provides a broad overview of the conceptual and statistical issues involved in using multisite randomized trials to learn "about" and "from" variation in program effects across…

Learning about and from a Distribution of Program Impacts Using Multisite Trials

ERIC Educational Resources Information Center

Raudenbush, Stephen W.; Bloom, Howard S.

2015-01-01

The present article provides a synthesis of the conceptual and statistical issues involved in using multisite randomized trials to learn about and from a distribution of heterogeneous program impacts across individuals and/or program sites. Learning "about" such a distribution involves estimating its mean value, detecting and quantifying…

Statistical Analysis for Multisite Trials Using Instrumental Variables with Random Coefficients

ERIC Educational Resources Information Center

Raudenbush, Stephen W.; Reardon, Sean F.; Nomi, Takako

2012-01-01

Multisite trials can clarify the average impact of a new program and the heterogeneity of impacts across sites. Unfortunately, in many applications, compliance with treatment assignment is imperfect. For these applications, we propose an instrumental variable (IV) model with person-specific and site-specific random coefficients. Site-specific IV…

Site Matters: Multisite Randomized Trial of Motivational Enhancement Therapy in Community Drug Abuse Clinics

ERIC Educational Resources Information Center

Ball, Samuel A.; Martino, Steve; Nich, Charla; Frankforter, Tami L.; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E.; Obert, Jeanne L.; Farentinos, Christiane; Carroll, Kathleen M.

2007-01-01

The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention…

A Multisite Psychotherapy and Medication Trial for Depressed Adolescents: Background and Benefits

ERIC Educational Resources Information Center

Kratochvil, Christopher J.; Simons, Anne; Vitiello, Benedetto; Walkup, John; Emslie, Graham; Rosenberg, David; March, John S.

2005-01-01

The Treatment for Adolescents With Depression Study (TADS) is an NIMH-supported multisite clinical trial that compares the effectiveness of a depression-specific cognitive behavioral therapy (CBT), medication management with fluoxetine (FLX), the combination of CBT and FLX (COMB), and medical management with pill placebo (PBO). TADS was…

Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial.

PubMed

Metcalfe, Kelly A; Dennis, Cindy-Lee; Poll, Aletta; Armel, Susan; Demsky, Rochelle; Carlsson, Lindsay; Nanda, Sonia; Kiss, Alexander; Narod, Steven A

2017-03-01

Women with a BRCA1 or BRCA2 mutation are at high risk for breast cancer and must make important decisions about breast cancer prevention and screening. In the current study, we report a multisite, randomized, controlled trial evaluating the effectiveness of a decision aid for breast cancer prevention in women with a BRCA mutation with no previous diagnosis of cancer. Within 1 month of receiving a positive BRCA result, women were randomized to receive either usual care (control group) or decision aid (intervention group). Participants were followed at 3, 6, and 12 months; were asked about preventive measures; and completed standardized questionnaires assessing decision making and psychosocial functioning. One hundred fifty women were randomized. Mean cancer-related distress scores were significantly lower in the intervention group compared with the control group at 6 months (P = 0.01) and at 12 months postrandomization (P = 0.05). Decisional conflict scores declined over time for both groups and at no time were there statistical differences between the two groups. The decision aid for breast cancer prevention in women with a BRCA1 or BRCA2 mutation is effective in significantly decreasing cancer-related distress within the year following receipt of positive genetic test results.Genet Med 19 3, 330-336.

Process evaluation of the Hunter Illawarra Kids Challenge Using Parent Support study: a multisite randomized controlled trial for the management of child obesity.

PubMed

Jones, Rachel A; Warren, Janet M; Okely, Anthony D; Collins, Clare E; Morgan, Philip J; Cliff, Dylan P; Burrows, Tracy; Cleary, Jane; Baur, Louise A

2010-11-01

The purposes of this article are to (a) outline findings from secondary or process outcome data of the Hunter Illawarra Kids Challenge Using Parent Support (HIKCUPS) study and (b) inform the design and development of future research interventions and practice in the management of child obesity. Data were collected by means of facilitator evaluations, independent session observation, attendance records, and parent questionnaires. Internal validity and reliability of the program delivery were high. All parents reported positive changes in their children as a result of the physical activity program, the dietary modification program, or both. Most participants completed the home activities, but more than half reported that finding time to do them was problematic. Facilitator review indicated that future programs should specifically cater to children of similar age or same sex, allow adequate time for explanation of complex nutritional concepts, and use intrinsic motivators for participants. Recommendations for future interventions, specifically the implementation of subsequent HIKCUPS or other multisite effectiveness studies, are detailed.

Randomized Multi-site Trial of the Job Seekers’ Workshop in Patients with Substance Use Disorders

PubMed Central

Svikis, Dace S.; Keyser-Marcus, Lori; Stitzer, Maxine; Rieckmann, Traci; Safford, Lauretta; Loeb, Peter; Allen, Tim; Luna-Anderson, Carol; Back, Sudie E.; Cohen, Judith; DeBernardi, Michael A.; Dillard, Bruce; Forcehimes, Alyssa; Jaffee, William; Killeen, Therese; Kolodner, Ken; Levy, Michael; Pallas, Diane; Perl, Harold I.; Potter, Jennifer Sharpe; Provost, Scott; Reese, Karen; Sampson, Royce R.; Sepulveda, Allison; Snead, Ned; Wong, Conrad J.; Zweben, Joan

2012-01-01

Background Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial was to evaluate the Job Seekers’ Workshop (JSW), a three session, manualized program designed to train patients in the skills needed to find and secure a job. Method Study participants were recruited through the NIDA Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-hr small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring. Results JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program), Specifically, one-fifth of participants at 12 weeks (20.1 – 24.3%) and nearly one-third at 24 weeks (31.4–31.9%) had positive outcomes, with “obtaining a new taxed job” accounting for the majority of cases. Conclusion JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well. PMID:21802222

CHERISH (collaboration for hospitalised elders reducing the impact of stays in hospital): protocol for a multi-site improvement program to reduce geriatric syndromes in older inpatients.

PubMed

Mudge, Alison M; Banks, Merrilyn D; Barnett, Adrian G; Blackberry, Irene; Graves, Nicholas; Green, Theresa; Harvey, Gillian; Hubbard, Ruth E; Inouye, Sharon K; Kurrle, Sue; Lim, Kwang; McRae, Prue; Peel, Nancye M; Suna, Jessica; Young, Adrienne M

2017-01-09

Older inpatients are at risk of hospital-associated geriatric syndromes including delirium, functional decline, incontinence, falls and pressure injuries. These contribute to longer hospital stays, loss of independence, and death. Effective interventions to reduce geriatric syndromes remain poorly implemented due to their complexity, and require an organised approach to change care practices and systems. Eat Walk Engage is a complex multi-component intervention with structured implementation, which has shown reduced geriatric syndromes and length of stay in pilot studies at one hospital. This study will test effectiveness of implementing Eat Walk Engage using a multi-site cluster randomised trial to inform transferability of this intervention. A hybrid study design will evaluate the effectiveness and implementation strategy of Eat Walk Engage in a real-world setting. A multisite cluster randomised study will be conducted in 8 medical and surgical wards in 4 hospitals, with one ward in each site randomised to implement Eat Walk Engage (intervention) and one to continue usual care (control). Intervention wards will be supported to develop and implement locally tailored strategies to enhance early mobility, nutrition, and meaningful activities. Resources will include a trained, mentored facilitator, audit support, a trained healthcare assistant, and support by an expert facilitator team using the i-PARIHS implementation framework. Patient outcomes and process measures before and after intervention will be compared between intervention and control wards. Primary outcomes are any hospital-associated geriatric syndrome (delirium, functional decline, falls, pressure injuries, new incontinence) and length of stay. Secondary outcomes include discharge destination; 30-day mortality, function and quality of life; 6 month readmissions; and cost-effectiveness. Process measures including patient interviews, activity mapping and mealtime audits will inform interventions in each site and measure improvement progress. Factors influencing the trajectory of implementation success will be monitored on implementation wards. Using a hybrid design and guided by an explicit implementation framework, the CHERISH study will establish the effectiveness, cost-effectiveness and transferability of a successful pilot program for improving care of older inpatients, and identify features that support successful implementation. ACTRN12615000879561 registered prospectively 21/8/2015.

A Multisite Cluster Randomized Field Trial of Open Court Reading

ERIC Educational Resources Information Center

Borman, Geoffrey D.; Dowling, N. Maritza; Schneck, Carrie

2008-01-01

In this article, the authors report achievement outcomes of a multisite cluster randomized field trial of Open Court Reading 2005 (OCR), a K-6 literacy curriculum published by SRA/McGraw-Hill. The participants are 49 first-grade through fifth-grade classrooms from predominantly minority and poor contexts across the nation. Blocking by grade level…

An Open, Multisite Pilot Study of Cognitive Therapy for Depressed Adolescents

PubMed Central

BELSHER, GAYLE; WILKES, T. C. R.; RUSH, A. J.

1995-01-01

In a 12-session open trial of cognitive therapy, depressed adolescent outpatients showed significant decreases in depressive symptomatology, although there was less improvement in a subgroup with comorbid attention-deficit hyperactivity or schizoid personality disorder. Decreases on measures of depressive symptoms and depressotypic cognition were maintained up to 5 months after acute-phase treatment. Outcome was not associated with age, gender, other comorbid diagnoses, concurrent use of antidepressants, duration of acute-phase therapy, or participation in subsequent booster sessions. Data suggest that cognitive therapy is a promising intervention for depressed adolescents and provide a rationale for pursuit of controlled cognitive therapy trials with this population. PMID:22700213

Process evaluation in a multisite, primary obesity-prevention trial in American Indian schoolchildren1–3

PubMed Central

Helitzer, Deborah L; Davis, Sally M; Gittelsohn, Joel; Going, Scott B; Murray, David M; Snyder, Patricia; Steckler, Allan B

2016-01-01

We describe the development, implementation, and use of the process evaluation component of a multisite, primary obesity prevention trial for American Indian schoolchildren. We describe the development and pilot testing of the instruments, provide some examples of the criteria for instrument selection, and provide examples of how process evaluation results were used to document and refine intervention components. The theoretical and applied framework of the process evaluation was based on diffusion theory, social learning theory, and the desire for triangulation of multiple modes of data collection. The primary objectives of the process evaluation were to systematically document the training process, content, and implementation of 4 components of the intervention. The process evaluation was developed and implemented collaboratively so that it met the needs of both the evaluators and those who would be implementing the intervention components. Process evaluation results revealed that observation and structured interviews provided the most informative data; however, these methods were the most expensive and time consuming and required the highest level of skill to undertake. Although the literature is full of idealism regarding the uses of process evaluation for formative and summative purposes, in reality, many persons are sensitive to having their work evaluated in such an in-depth, context-based manner as is described. For this reason, use of structured, quantitative, highly objective tools may be more effective than qualitative methods, which appear to be more dependent on the skills and biases of the researcher and the context in which they are used. PMID:10195608

A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization.

PubMed

Brown, Alexandra R; Gajewski, Byron J; Aaronson, Lauren S; Mudaranthakam, Dinesh Pal; Hunt, Suzanne L; Berry, Scott M; Quintana, Melanie; Pasnoor, Mamatha; Dimachkie, Mazen M; Jawdat, Omar; Herbelin, Laura; Barohn, Richard J

2016-08-31

In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.

Tobacco dependence counseling in a randomized multisite clinical trial

PubMed Central

Croghan, Ivana T.; Trautman, Judith A.; Winhusen, Theresa; Ebbert, Jon O.; Kropp, Frankie; Schroeder, Darrell R.; Hurt, Richard D.

2012-01-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a “train-the-trainer” model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3 ± 2.8 sessions (mean ± SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and “meeting expectations” on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. PMID:22406192

Tobacco dependence counseling in a randomized multisite clinical trial.

PubMed

Croghan, Ivana T; Trautman, Judith A; Winhusen, Theresa; Ebbert, Jon O; Kropp, Frankie B; Schroeder, Darrell R; Hurt, Richard D

2012-07-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. Copyright © 2012 Elsevier Inc. All rights reserved.

The impact of parent-delivered intervention on parents of very young children with autism.

PubMed

Estes, Annette; Vismara, Laurie; Mercado, Carla; Fitzpatrick, Annette; Elder, Lauren; Greenson, Jessica; Lord, Catherine; Munson, Jeffrey; Winter, Jamie; Young, Gregory; Dawson, Geraldine; Rogers, Sally

2014-02-01

This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model (P-ESDM) on parenting-related stress and sense of competence. This was part of a multisite, randomized trial comparing P-ESDM (n = 49) with community intervention (n = 49) for children aged 12 and 24 months. The P-ESDM group reported no increase in parenting stress, whereas the Community group experienced an increase over the same 3-month period. Parental sense of competence did not differ. Number of negative life events was a significant predictor of parenting stress and sense of competence across both groups. This suggests that a parent-coaching intervention may help maintain parental adjustment directly after a child is diagnosed with ASD.

The impact of parent-delivered intervention on parents of very young children with autism

PubMed Central

Estes, Annette; Vismara, Laurie; Mercado, Carla; Fitzpatrick, Annette; Elder, Lauren; Greenson, Jessica; Lord, Catherine; Munson, Jeffrey; Winter, Jamie; Young, Gregory; Dawson, Geraldine; Rogers, Sally

2013-01-01

This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model (P-ESDM) on parenting-related stress and sense of competence. This was part of a multisite, randomized trial comparing P-ESDM (n=49) with community intervention (n=49) for children aged 12 and 24 months. The P-ESDM group reported no increase in parenting stress, whereas the Community group experienced an increase over the same 3-month period. Parental sense of competence did not differ. Number of negative life events was a significant predictor of parenting stress and sense of competence across both groups. This suggests that a parent-coaching intervention may help maintain parental adjustment directly after a child is diagnosed with ASD. PMID:23838727

How Much Do the Effects of Education and Training Programs Vary across Sites? Evidence from Past Multisite Randomized Trials

ERIC Educational Resources Information Center

Weiss, Michael J.; Bloom, Howard S.; Verbitsky-Savitz, Natalya; Gupta, Himani; Vigil, Alma E.; Cullinan, Daniel N.

2017-01-01

Multisite trials, in which individuals are randomly assigned to alternative treatment arms within sites, offer an excellent opportunity to estimate the cross-site average effect of treatment assignment (intent to treat or ITT) "and" the amount by which this impact varies across sites. Although both of these statistics are substantively…

Sensitivity of the Modified Children's Yale-Brown Obsessive Compulsive Scale to Detect Change: Results from Two Multi-Site Trials

ERIC Educational Resources Information Center

Scahill, Lawrence; Sukhodolsky, Denis G.; Anderberg, Emily; Dimitropoulos, Anastasia; Dziura, James; Aman, Michael G.; McCracken, James; Tierney, Elaine; Hallett, Victoria; Katz, Karol; Vitiello, Benedetto; McDougle, Christopher

2016-01-01

Repetitive behavior is a core feature of autism spectrum disorder. We used 8-week data from two federally funded, multi-site, randomized trials with risperidone conducted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate the sensitivity of the Children's Yale-Brown Obsessive Compulsive Scale modified for autism…

Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial

PubMed Central

2011-01-01

Background Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional psycho- and pharmacological interventions are not as effective as in acute, episodic depression. Current medications are no more effective than those introduced 50 years ago whereas the only psychotherapy developed specifically for the subgroup of chronic depression, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP), faired well in one large trial. However, CBASP has never been directly compared to a non-specific control treatment. Methods/Design The present article describes the study protocol of a multisite parallel-group randomized controlled trial in Germany. The purpose of the study is to estimate the efficacy of CBASP compared to supportive psychotherapy in 268 non-medicated early-onset chronically depressed outpatients. The intervention includes 20 weeks of acute treatment with 24 individual sessions followed by 28 weeks of continuation treatment with another 8 sessions. Depressive symptoms are evaluated 20 weeks after randomisation by means of the 24-item Hamilton Rating Scale of Depression (HRSD). Secondary endpoints are depressive symptoms after 12 and 48 weeks, and remission after 12, 20, and 48 weeks. Primary outcome will be analysed using analysis of covariance (ANCOVA) controlled for pre-treatment scores and site. Analyses of continuous secondary variables will be performed using linear mixed models. For remission rates, chi-squared tests and logistic regression will be applied. Discussion The study evaluates the comparative effects of a disorder-specific psychotherapy and a well designed non-specific psychological approach in the acute and continuation treatment phase in a large sample of early-onset chronically depressed patients. Trial registration ClinicalTrials.gov (NCT00970437). PMID:21849054

A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students.

PubMed

Turrisi, Rob; Larimer, Mary E; Mallett, Kimberly A; Kilmer, Jason R; Ray, Anne E; Mastroleo, Nadine R; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W; Montoya, Heidi

2009-07-01

The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session.

A Randomized Clinical Trial Evaluating a Combined Alcohol Intervention for High-Risk College Students*

PubMed Central

Turrisi, Rob; Larimer, Mary E.; Mallett, Kimberly A.; Kilmer, Jason R.; Ray, Anne E.; Mastroleo, Nadine R.; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W.; Montoya, Heidi

2009-01-01

Objective: The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Method: Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. Results: The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. Conclusions: The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session. PMID:19515296

Methodological Overview of an African American Couple-Based HIV/STD Prevention Trial

PubMed Central

2010-01-01

Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history). Conclusions The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples based clinical trials in HIV/STD risk reduction and can be generalized to other couples based behavioral interventions. PMID:18724188

Sources of Site Differences in the Efficacy of a Multisite Clinical Trial: The Treatment of SSRI-Resistant Depression in Adolescents

ERIC Educational Resources Information Center

Spirito, Anthony; Abebe, Kaleab Z.; Iyengar, Satish; Brent, David; Vitiello, Benedetto; Clarke, Gregory; Wagner, Karen Dineen; Asarnow, Joan; Emslie, Graham; Keller, Martin

2009-01-01

Site differences in treatment outcomes are not often highlighted when the results of multisite randomized clinical trials (MRCTs) are reported. The primary analyses of a 6-site MRCT, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, showed substantial variation by site in the performance of a medication-only condition and a…

Stimulant abuser groups to engage in 12-step: a multisite trial in the National Institute on Drug Abuse Clinical Trials Network.

PubMed

Donovan, Dennis M; Daley, Dennis C; Brigham, Gregory S; Hodgkins, Candace C; Perl, Harold I; Garrett, Sharon B; Doyle, Suzanne R; Floyd, Anthony S; Knox, Patricia C; Botero, Christopher; Kelly, Thomas M; Killeen, Therese K; Hayes, Carole; Kau'i Baumhofer, Nicole; Kau'ibaumhofer, Nicole; Seamans, Cindy; Zammarelli, Lucy

2013-01-01

The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service. Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs). Intensive outpatient substance treatment programs. Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated. Urinalysis and self-reports of substance use and 12-step attendance and activities. Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers. Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU. The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU. Copyright © 2013 Elsevier Inc. All rights reserved.

Helping Alliance, Retention, and Treatment Outcomes: A Secondary Analysis From the NIDA Clinical Trials Network Women and Trauma Study

PubMed Central

Ruglass, Lesia M.; Miele, Gloria M.; Hien, Denise A.; Campbell, Aimee N. C.; Hu, Mei-Chen; Caldeira, Nathilee; Jiang, Huiping; Litt, Lisa; Killeen, Therese; Hatch-Maillette, Mary; Najavits, Lisa; Brown, Chanda; Robinson, James A.; Brigham, Gregory S.; Nunes, Edward V.

2013-01-01

We examined the association between the therapeutic alliance and treatment outcomes among 223 women with posttraumatic stress disorder (PTSD) and substance use disorders who participated in a multisite clinical trial of group treatments for trauma and addictions in the United States throughout 2004 and 2005. General linear models indicated that women who received Seeking Safety, a cognitive-behavioral treatment, had significantly higher alliance ratings than those in Women's Health Education, a control group. Alliance was related to significant decreases in PTSD symptoms and higher attendance in both interventions. Alliance was not related to substance use outcomes. Implications and limitations of the findings are discussed. PMID:22475068

The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants.

PubMed

Standley, Jayne M; Cassidy, Jane; Grant, Roy; Cevasco, Andrea; Szuch, Catherine; Nguyen, Judy; Walworth, Darcy; Procelli, Danielle; Jarred, Jennifer; Adams, Kristen

2010-01-01

In this randomized, controlled multi-site study, the pacifier-activated-lullaby system (PAL) was used with 68 premature infants. Dependent variables were (a) total number of days prior to nipple feeding, (b) days of nipple feeding, (c) discharge weight, and (d) overall weight gain. Independent variables included contingent music reinforcement for non-nutritive sucking for PAL intervention at 32 vs. 34 vs. 36 weeks adjusted gestational age (AGA), with each age group subdivided into three trial conditions: control consisting of no PAL used vs. one 15-minute PAL trial vs. three 15-minute PAL trials. At 34 weeks, PAL trials significantly shortened gavage feeding length, and three trials were significantly better than one trial. At 32 weeks, PAL trials lengthened gavage feeding. Female infants learned to nipple feed significantly faster than male infants. It was noted that PAL babies went home sooner after beginning to nipple feed, a trend that was not statistically significant.

Association between physical pain and alcohol treatment outcomes: The mediating role of negative affect.

PubMed

Witkiewitz, Katie; McCallion, Elizabeth; Vowles, Kevin E; Kirouac, Megan; Frohe, Tessa; Maisto, Stephen A; Hodgson, Ray; Heather, Nick

2015-12-01

Physical pain and negative affect have been described as risk factors for alcohol use following alcohol treatment. The current study was a secondary analysis of 2 clinical trials for alcohol use disorder (AUD) to examine the associations between pain, negative affect and AUD treatment outcomes. Participants included 1,383 individuals from the COMBINE Study (COMBINE Pharmacotherapies and Behavioral Interventions for Alcohol Dependence; COMBINE Study Research Group, 2003; 31% female, 23% ethnic minorities, average age = 44.4 [SD = 10.2]), a multisite combination pharmacotherapy and behavioral intervention study for AUD in the United States, and 742 individuals from the United Kingdom Alcohol Treatment Trial (UKATT Research Team, 2001; 25.9% female, 4.4% ethnic minorities, average age = 41.6 [SD = 10.1]) a multisite behavioral intervention study for AUD in the United Kingdom. The Form-90 was used to collect alcohol use data, the Short Form Health Survey and Quality of Life measures were used to assess pain, and negative affect was assessed using the Brief Symptom Inventory (COMBINE) and the General Health Questionnaire (UKATT). Pain scores were significantly associated with drinking outcomes in both datasets. Greater pain scores were associated with greater negative affect and increases in pain were associated with increases in negative affect. Negative affect significantly mediated the association between pain and drinking outcomes and this effect was moderated by social behavior network therapy (SBNT) in the UKATT study, with SBNT attenuating the association between pain and drinking. Findings suggest pain and negative affect are associated among individuals in AUD treatment and that negative affect mediated pain may be a risk factor for alcohol relapse. (c) 2015 APA, all rights reserved).

Benefit-cost analysis of SBIRT interventions for substance using patients in emergency departments.

PubMed

Horn, Brady P; Crandall, Cameron; Forcehimes, Alyssa; French, Michael T; Bogenschutz, Michael

2017-08-01

Screening, brief intervention, and referral to treatment (SBIRT) has been widely implemented as a method to address substance use disorders in general medical settings, and some evidence suggests that its use is associated with decreased societal costs. In this paper, we investigated the economic impact of SBIRT using data from Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED), a multisite, randomized controlled trial. Utilizing self-reported information on medical status, health services utilization, employment, and crime, we conduct a benefit-cost analysis. Findings indicate that neither of the SMART-ED interventions resulted in any significant changes to the main economic outcomes, nor had any significant impact on total economic benefit. Thus, while SBIRT interventions for substance abuse in Emergency Departments may be appealing from a clinical perspective, evidence from this economic study suggests resources could be better utilized supporting other health interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

Strategies to Support Recruitment of Patients with Life-limiting illness for Research: The Palliative Care Research Cooperative Group

PubMed Central

Hanson, Laura C.; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E.; Kutner, Jean S.; Aziz, Noreen M.; Abernethy, Amy

2014-01-01

Context The Palliative Care Research Cooperative group (PCRC) is the first clinical trials cooperative for palliative care in the United States. Objectives To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. Methods The parent study was a multi-site randomized controlled trial enrolling adults with life expectancy anticipated to be 1–6 months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semi-structured interviews with 18 site Principal Investigators (PI) and Clinical Research Coordinators (CRC), and reviewed recruitment rates. Interviews covered 3 topics – 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. Results All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of n=381 patients. Site enrollment ranged from 1–109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients’ needs, support from clinical champions, and the additional resources of a trials cooperative group. Conclusion The recruitment experience from the multi-site PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. PMID:24863152

Physical Activity Self-Management and Coaching Compared to Social Interaction in Huntington Disease: Results From the ENGAGE-HD Randomized, Controlled Pilot Feasibility Trial

PubMed Central

Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; Rosser, Anne; Hood, Kerenza

2017-01-01

Abstract Background. Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective. This study assessed feasibility and outcomes of a 14-week physical activity self-management and coaching intervention compared with social contact in Huntington disease (HD) to inform the design of a future full-scale trial. Design. Assessor blind, multisite, randomized pilot feasibility trial. Setting. Participants were recruited and assessed at baseline, 16 weeks following randomization, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention. People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements. Eligibility, recruitment, retention, and intervention participation were determined at 16 weeks. Other outcomes of interest included measures of mobility, self-efficacy, physical activity, and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results. Forty percent (n = 46) of eligible patients were enrolled; 22 were randomized to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92%, respectively. Minimum participation criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between-group treatment effects on function; however, increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lend support to our predefined intervention logic model. Limitations. The use of self-report measures may have introduced bias. Conclusions. An HD physical activity self-management and coaching intervention is feasible and worthy of further investigation. PMID:28371942

Measuring the Effects of an Animal-Assisted Intervention for Pediatric Oncology Patients and Their Parents: A Multisite Randomized Controlled Trial [Formula: see text].

PubMed

McCullough, Amy; Ruehrdanz, Ashleigh; Jenkins, Molly A; Gilmer, Mary Jo; Olson, Janice; Pawar, Anjali; Holley, Leslie; Sierra-Rivera, Shirley; Linder, Deborah E; Pichette, Danielle; Grossman, Neil J; Hellman, Cynthia; Guérin, Noémi A; O'Haire, Marguerite E

2018-05-01

This multicenter, parallel-group, randomized trial examined the effects of an animal-assisted intervention on the stress, anxiety, and health-related quality of life for children diagnosed with cancer and their parents. Newly diagnosed patients, aged 3 to 17 years (n = 106), were randomized to receive either standard care plus regular visits from a therapy dog (intervention group), or standard care only (control group). Data were collected at set points over 4 months of the child's treatment. Measures included the State-Trait Anxiety Inventory™, Pediatric Quality of Life Inventory, Pediatric Inventory for Parents, and child blood pressure and heart rate. All instruments were completed by the child and/or his/her parent(s). Children in both groups experienced a significant reduction in state anxiety ( P < .001). Parents in the intervention group showed significantly decreased parenting stress ( P = .008), with no changes in stress among parents in the control group. However, no significant differences between groups over time on any measures were observed. Animal-assisted interventions may provide certain benefits for parents and families during the initial stages of pediatric cancer treatment.

A model for rigorously applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework in the design and measurement of a large scale collaborative multi-site study.

PubMed

Becan, Jennifer E; Bartkowski, John P; Knight, Danica K; Wiley, Tisha R A; DiClemente, Ralph; Ducharme, Lori; Welsh, Wayne N; Bowser, Diana; McCollister, Kathryn; Hiller, Matthew; Spaulding, Anne C; Flynn, Patrick M; Swartzendruber, Andrea; Dickson, Megan F; Fisher, Jacqueline Horan; Aarons, Gregory A

2018-04-13

This paper describes the means by which a United States National Institute on Drug Abuse (NIDA)-funded cooperative, Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS), utilized an established implementation science framework in conducting a multi-site, multi-research center implementation intervention initiative. The initiative aimed to bolster the ability of juvenile justice agencies to address unmet client needs related to substance use while enhancing inter-organizational relationships between juvenile justice and local behavioral health partners. The EPIS (Exploration, Preparation, Implementation, Sustainment) framework was selected and utilized as the guiding model from inception through project completion; including the mapping of implementation strategies to EPIS stages, articulation of research questions, and selection, content, and timing of measurement protocols. Among other key developments, the project led to a reconceptualization of its governing implementation science framework into cyclical form as the EPIS Wheel. The EPIS Wheel is more consistent with rapid-cycle testing principles and permits researchers to track both progressive and recursive movement through EPIS. Moreover, because this randomized controlled trial was predicated on a bundled strategy method, JJ-TRIALS was designed to rigorously test progress through the EPIS stages as promoted by facilitation of data-driven decision making principles. The project extended EPIS by (1) elucidating the role and nature of recursive activity in promoting change (yielding the circular EPIS Wheel), (2) by expanding the applicability of the EPIS framework beyond a single evidence-based practice (EBP) to address varying process improvement efforts (representing varying EBPs), and (3) by disentangling outcome measures of progression through EPIS stages from the a priori established study timeline. The utilization of EPIS in JJ-TRIALS provides a model for practical and applied use of implementation frameworks in real-world settings that span outer service system and inner organizational contexts in improving care for vulnerable populations. NCT02672150 . Retrospectively registered on 22 January 2016.

Fidelity considerations in translational research: Eating As Treatment - a stepped wedge, randomised controlled trial of a dietitian delivered behaviour change counselling intervention for head and neck cancer patients undergoing radiotherapy.

PubMed

Beck, Alison Kate; Baker, Amanda; Britton, Ben; Wratten, Chris; Bauer, Judith; Wolfenden, Luke; Carter, Gregory

2015-10-15

The confidence with which researchers can comment on intervention efficacy relies on evaluation and consideration of intervention fidelity. Accordingly, there have been calls to increase the transparency with which fidelity methodology is reported. Despite this, consideration and/or reporting of fidelity methods remains poor. We seek to address this gap by describing the methodology for promoting and facilitating the evaluation of intervention fidelity in The EAT (Eating As Treatment) project: a multi-site stepped wedge randomised controlled trial of a dietitian delivered behaviour change counselling intervention to improve nutrition (primary outcome) in head and neck cancer patients undergoing radiotherapy. In accordance with recommendations from the National Institutes of Health Behaviour Change Consortium Treatment Fidelity Workgroup, we sought to maximise fidelity in this stepped wedge randomised controlled trial via strategies implemented from study design through to provider training, intervention delivery and receipt. As the EAT intervention is designed to be incorporated into standard dietetic consultations, we also address unique challenges for translational research. We offer a strong model for improving the quality of translational findings via real world application of National Institutes of Health Behaviour Change Consortium recommendations. Greater transparency in the reporting of behaviour change research is an important step in improving the progress and quality of behaviour change research. ACTRN12613000320752 (Date of registration 21 March 2013).

A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey.

PubMed

Modi, Riddhi A; Mugavero, Michael J; Amico, Rivet K; Keruly, Jeanne; Quinlivan, Evelyn Byrd; Crane, Heidi M; Guzman, Alfredo; Zinski, Anne; Montue, Solange; Roytburd, Katya; Church, Anna; Willig, James H

2017-06-16

Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features. The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices. Clinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v). ©Riddhi A Modi, Michael J Mugavero, Rivet K Amico, Jeanne Keruly, Evelyn Byrd Quinlivan, Heidi M Crane, Alfredo Guzman, Anne Zinski, Solange Montue, Katya Roytburd, Anna Church, James H Willig. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.06.2017.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. Methods/Design The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. Discussion The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. Trial registration Trial registration reference: ISRCTN45433299 PMID:23356861

Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions.

PubMed

Taylor, Lauren J; Rathouz, Paul J; Berlin, Ana; Brasel, Karen J; Mosenthal, Anne C; Finlayson, Emily; Cooper, Zara; Steffens, Nicole M; Jacobson, Nora; Buffington, Anne; Tucholka, Jennifer L; Zhao, Qianqian; Schwarze, Margaret L

2017-05-29

Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. Approvals have been granted by the Institutional Review Board at the University of Wisconsin and at each participating site, and a Certificate of Confidentiality has been obtained. Results will be reported in peer-reviewed publications and presented at national meetings. NCT02623335. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Do Parents Know Best? Examining the Relationship Between Parenting Profiles, Prevention Efforts, and Peak Drinking in College Students1

PubMed Central

Mallett, Kimberly A.; Turrisi, Rob; Ray, Anne E.; Stapleton, Jerod; Abar, Caitlin; Mastroleo, Nadine R.; Tollison, Sean; Grossbard, Joel; Larimer, Mary E.

2013-01-01

The study examined parent profiles among high school athletes transitioning to college and their association with high-risk drinking in a multi-site, randomized trial. Students (n = 587) were randomized to a control or combined parent-based and brief motivational intervention condition and completed measures at baseline and at 5- and 10-month follow-ups. Four parent profiles (authoritative, authoritarian, permissive, indifferent) were observed among participants. Findings indicated control participants with authoritarian parenting were at the greatest risk for heavy drinking. Alternately, students exposed to permissive or authoritarian parenting reported lower peak drinking when administered the combined intervention, compared to controls. Findings suggest the combined intervention was efficacious in reducing peak alcohol consumption among high-risk students based on athlete status and parenting profiles. PMID:24109150

Initial Impact of the Fast Track Prevention Trial for Conduct Problems: I. The High-Risk Sample

PubMed Central

2009-01-01

Fast Track is a multisite, multicomponent preventive intervention for young children at high risk for long-term antisocial behavior. Based on a comprehensive developmental model intervention included a universal-level classroom program plus social skills training, academic tutoring, parent training, and home visiting to improve competencies and reduce problems in a high-risk group of children selected in kindergarten. At the end of Grade 1, there were moderate positive effects on children's social, emotional, and academic skills; peer interactions and social status; and conduct problems and special-education use. Parents reported less-physical discipline and greater parenting satisfaction/ease of parenting and engaged in more appropriate/consistent discipline, warmth/positive involvement, and involvement with the school. Evidence of differential intervention effects across child gender, race, site, and cohort was minimal. PMID:10535230

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Clinical Trials NCT01740635.

Methodology of the Stroke Self-Management Rehabilitation Trial: an international, multisite pilot trial.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Theadom, Alice; Barker-Collo, Suzanne; Thrift, Amanda; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Sanya, Emmanuel; Feigin, Valery L

2015-02-01

Stroke is a major cause of long-term adult disability with many survivors living in the community relying on family members for on-going support. However, reports of inadequate understanding of rehabilitation techniques are common. A self-management DVD-based observational learning tool may help improve functional outcomes for survivors of stroke and reduce caregivers' burden. This article describes the methodology of the stroke self-management rehabilitation trial. The overall aim of this pilot trial is to assess the feasibility and preliminary efficacy of a DVD-based intervention for improving functional outcomes of survivors of stroke 2 months postrandomization to inform the design of a full-scale randomized clinical trial. Recruitment of a minimum of 20 survivors of stroke and their informal caregivers (where available) in each of the participating centers will occur across multiple international sites. After baseline assessments, participants will be randomly assigned to an intervention or standard care group. The intervention comprises a structured DVD observation and practice schedule over 8 weeks. All participants will complete follow-up assessments. The outcome measures will include a global shift in the Rankin Scale scores and dichotomized scores, changes in quality of life, general health, depression, and caregiver burden at 2 months postrandomization. A qualitative analysis of the effects of the intervention will also be undertaken. The results of the pilot study will provide knowledge of whether observational learning techniques delivered via DVD can effectively improve recovery after stroke and reduce caregiver burden. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Strategies to support recruitment of patients with life-limiting illness for research: the Palliative Care Research Cooperative Group.

PubMed

Hanson, Laura C; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E; Kutner, Jean S; Aziz, Noreen M; Abernethy, Amy

2014-12-01

The Palliative Care Research Cooperative Group (PCRC) is the first clinical trials cooperative for palliative care in the U.S. To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. The parent study was a multisite randomized controlled trial enrolling adults with life expectancy anticipated to be one to six months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semistructured interviews with 18 site principal investigators (PIs) and clinical research coordinators (CRCs) and reviewed recruitment rates. Interviews covered three topics: 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of 381 patients. Site enrollment ranged from 1 to 109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients' needs, support from clinical champions, and the additional resources of a trials cooperative group. The recruitment experience from the multisite PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. Methods/Design We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. Discussion This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. Clinical trial registration ClinicalTrials.gov NCT02054598. PMID:25004983

Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial

PubMed Central

2014-01-01

Background Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. Methods/design The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months’ intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning, attachment, capacity for mentalizing and quality of life. Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year. Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles. Discussion Severe borderline personality disorder is a serious psychological disorder that is associated with high burden. This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients. Trial registration NTR2175 PMID:24886402

Development of the REFOCUS intervention to increase mental health team support for personal recovery.

PubMed

Slade, Mike; Bird, Victoria; Le Boutillier, Clair; Farkas, Marianne; Grey, Barbara; Larsen, John; Leamy, Mary; Oades, Lindsay; Williams, Julie

2015-12-01

There is an emerging evidence base about best practice in supporting recovery. This is usually framed in relation to general principles, and specific pro-recovery interventions are lacking. To develop a theoretically based and empirically defensible new pro-recovery manualised intervention--called the REFOCUS intervention. Seven systematic and two narrative reviews were undertaken. Identified evidence gaps were addressed in three qualitative studies. The findings were synthesised to produce the REFOCUS intervention, manual and model. The REFOCUS intervention comprises two components: recovery-promoting relationships and working practices. Approaches to supporting relationships comprise coaching skills training for staff, developing a shared team understanding of recovery, exploring staff values, a Partnership Project with people who use the service and raising patient expectations. Working practices comprise the following: understanding values and treatment preferences; assessing strengths; and supporting goal-striving. The REFOCUS model describes the causal pathway from the REFOCUS intervention to improved recovery. The REFOCUS intervention is an empirically supported pro-recovery intervention for use in mental health services. It will be evaluated in a multisite cluster randomised controlled trial (ISRCTN02507940). © The Royal College of Psychiatrists 2015.

Mediation Analysis of the Efficacy of the Eban HIV/STD Risk-Reduction Intervention for African American HIV Serodiscordant Couples.

PubMed

El-Bassel, Nabila; Jemmott, John B; Bellamy, Scarlett L; Pequegnat, Willo; Wingood, Gina M; Wyatt, Gail E; Landis, J Richard; Remien, Robert H

2016-06-01

Targeting couples is a promising behavioral HIV risk-reduction strategy, but the mechanisms underlying the effects of such interventions are unknown. We report secondary analyses testing whether Social-Cognitive-Theory variables mediated the Eban HIV-risk-reduction intervention's effects on condom-use outcomes. In a multisite randomized controlled trial conducted in four US cities, 535 African American HIV-serodiscordant couples were randomized to the Eban HIV risk-reduction intervention or attention-matched control intervention. Outcomes were proportion condom-protected sex, consistent condom use, and frequency of unprotected sex measured pre-, immediately post-, and 6 and 12 months post-intervention. Potential mediators included Social-Cognitive-Theory variables: outcome expectancies and self-efficacy. Mediation analyses using the product-of-coefficients approach in a generalized-estimating-equations framework revealed that condom-use outcome expectancy, partner-reaction outcome expectancy, intention, self-efficacy, and safer-sex communication improved post-intervention and mediated intervention-induced improvements in condom-use outcomes. These findings underscore the importance of targeting outcome expectancies, self-efficacy, and safer-sex communication in couples-level HIV risk-reduction interventions.

Adapting Social Neuroscience Measures for Schizophrenia Clinical Trials, Part 1: Ferrying Paradigms Across Perilous Waters

PubMed Central

Green, Michael F.

2013-01-01

Social cognitive impairment is prominent in schizophrenia, and it is closely related to functional outcome. Partly for these reasons, it has rapidly become a target for both training and psychopharmacological interventions. However, there is a paucity of reliable and valid social cognitive endpoints that can be used to evaluate treatment response in clinical trials. Also, clinical studies in schizophrenia have benefited rather little from the surge of activity and knowledge in nonclinical social neuroscience. The National Institute of Mental Health-sponsored study, “Social Cognition and Functioning in Schizophrenia” (SCAF), attempted to address this translational challenge by selecting paradigms from social neuroscience that could be adapted for use in schizophrenia. The project also evaluated the psychometric properties and external validity of the tasks to determine their suitability for multisite clinical trials. This first article in the theme section presents the goals, conceptual background, and rationale for the SCAF project. PMID:24072811

Building capacity for rigorous controlled trials in autism: the importance of measuring treatment adherence.

PubMed

McConachie, H; Fletcher-Watson, S

2015-03-01

Research groups across Europe have been networking to share information and ideas about research on preschool children with autism. The paper describes preliminary work to develop capacity for future multi-site randomized controlled trials of early intervention, with a specific focus on the need to measure treatment adherence where parents deliver therapy. The paper includes a review of randomized and controlled studies of parent-mediated early intervention from two sources, a recent Cochrane Collaboration review and a mapping of European early intervention studies in autism published since 2002. The data extracted focused on methods for describing parent adherence, that is, how and to what extent parents carry out the strategies taught them by therapists. Less than half of the 32 studies reviewed included any measure of parent adherence. Only seven included a direct assessment method. The challenges of developing pan-European early intervention evaluation studies are discussed, including choice of intervention model and of important outcomes, the need for translation of measurement tools and achievement of joint training to reliability of assessors. Measurement of parent-child interaction style and of adherence to strategies taught need further study. © 2014 The Authors. Child: Care, Health and Development published by John Wiley & Sons Ltd.

A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer.

PubMed

Robb, Sheri L; Clair, Alicia A; Watanabe, Masayo; Monahan, Patrick O; Azzouz, Faouzi; Stouffer, Janice W; Ebberts, Allison; Darsie, Emily; Whitmer, Courtney; Walker, Joey; Nelson, Kirsten; Hanson-Abromeit, Deanna; Lane, Deforia; Hannan, Ann

2008-07-01

Coping theorists argue that environmental factors affect how children perceive and respond to stressful events such as cancer. However, few studies have investigated how particular interventions can change coping behaviors. The active music engagement (AME) intervention was designed to counter stressful qualities of the in-patient hospital environment by introducing three forms of environmental support. The purpose of this multi-site randomized controlled trial was to determine the efficacy of the AME intervention on three coping-related behaviors (i.e. positive facial affect, active engagement, and initiation). Eighty-three participants, ages 4-7, were randomly assigned to one of three conditions: AME (n = 27), music listening (ML; n = 28), or audio storybooks (ASB; n = 28). Conditions were videotaped to facilitate behavioral data collection using time-sampling procedures. After adjusting for baseline differences, repeated measure analyses indicated that AME participants had a significantly higher frequency of coping-related behaviors compared with ML or ASB. Positive facial affect and active engagement were significantly higher during AME compared with ML and ASB (p<0.0001). Initiation was significantly higher during AME than ASB (p<0.05). This study supports the use of the AME intervention to encourage coping-related behaviors in hospitalized children aged 4-7 receiving cancer treatment. (c) 2007 John Wiley & Sons, Ltd.

An Effectiveness Trial of a New Enhanced Dissonance Eating Disorder Prevention Program among Female College Students

PubMed Central

Stice, Eric; Butryn, Meghan L.; Rohde, Paul; Shaw, Heather; Marti, C. Nathan

2014-01-01

Objective Efficacy trials indicate that a dissonance-based prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced risk factors, eating disorder symptoms, and future eating disorder onset, but weaker effects emerged from an effectiveness trial wherein high school clinicians recruited students and delivered the program under real-world conditions. The present effectiveness trial tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruited students and delivered the intervention using improved procedures to select, train, and supervise clinicians. Method Young women recruited from seven universities across the US (N = 408, M age = 21.6, SD = 5.64) were randomized to the dissonance intervention or an educational brochure control condition. Results Dissonance participants showed significantly greater decreases in risk factors (thin-ideal internalization, body dissatisfaction, dieting, negative affect) and eating disorder symptoms versus controls at posttest and 1-year follow-up, resulting in medium average effect size (d = .60). Dissonance participants also reported significant improvements in psychosocial functioning, but not reduced healthcare utilization or unhealthy weight gain. Conclusions This novel multisite effectiveness trial with college clinicians found that the enhanced dissonance version of this program and the improved facilitator selection/training procedures produced average effects that were 83% larger than effects observed in the high school effectiveness trial. PMID:24189570

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

PubMed

Brenner, Alison T; Getrich, Christina M; Pignone, Michael; Rhyne, Robert L; Hoffman, Richard M; McWilliams, Andrew; de Hernandez, Brisa Urquieta; Weaver, Mark A; Tapp, Hazel; Harbi, Khalil; Reuland, Daniel

2014-07-08

Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. ClinicalTrials.gov NCT02054598.

Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial.

PubMed

Laurenssen, Elisabeth M P; Westra, Dieuwertje; Kikkert, Martijn J; Noom, Marc J; Eeren, Hester V; van Broekhuyzen, Anna J; Peen, Jaap; Luyten, Patrick; Busschbach, Jan J V; Dekker, Jack J M

2014-05-22

Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months' intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning, attachment, capacity for mentalizing and quality of life. Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year. Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles. Severe borderline personality disorder is a serious psychological disorder that is associated with high burden. This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients. NTR2175.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. Methods A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. Discussion The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Trial registration Clinical Trials NCT01740635. PMID:24156396

Efficacy of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP) primary version.

PubMed

DiPerna, James Clyde; Lei, Puiwa; Bellinger, Jillian; Cheng, Weiyi

2015-03-01

A multisite cluster randomized trial was conducted to examine the effects of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP; Elliott & Gresham, 2007) on students' classroom social behavior. The final sample included 432 students across 38 second grade classrooms. Social skills and problem behaviors were measured via the SSIS rating scale for all participants, and direct observations were completed for a subsample of participants within each classroom. Results indicated that the SSIS-CIP demonstrated positive effects on teacher ratings of participants' social skills and internalizing behaviors, with the greatest changes occurring in classrooms with students who exhibited lower skill proficiency prior to implementation. Statistically significant differences were not observed between treatment and control participants on teacher ratings of externalizing problem behaviors or direct observation.

Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial.

PubMed

Dennis, C-L; Hodnett, E; Kenton, L; Weston, J; Zupancic, J; Stewart, D E; Kiss, A

2009-01-15

To evaluate the effectiveness of telephone based peer support in the prevention of postnatal depression. Multisite randomised controlled trial. Seven health regions across Ontario, Canada. 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service. Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session. Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services. After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (chi(2)=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend. Telephone based peer support can be effective in preventing postnatal depression among women at high risk. ISRCTN 68337727.

Gender research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: a summary of findings.

PubMed

Greenfield, Shelly F; Rosa, Carmen; Putnins, Susan I; Green, Carla A; Brooks, Audrey J; Calsyn, Donald A; Cohen, Lisa R; Erickson, Sarah; Gordon, Susan M; Haynes, Louise; Killeen, Therese; Miele, Gloria; Tross, Susan; Winhusen, Theresa

2011-09-01

The National Institute of Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable subgroups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes. To review gender-related findings from published CTN clinical trials and related studies from January 2000 to March 2010. CTN studies were selected for review if they focused on treatment outcomes or services for special populations of women with substance use disorders (SUDs) including those with trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors; or implemented gender-specific protocols. The CTN has randomized 11,500 participants (41% women) across 200 clinics in 24 randomized controlled trials in community settings, of which 4 have been gender-specific. This article summarizes gender-related findings from CTN clinical trials and related studies, focusing on trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors. These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance-using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are adequate to support more nuanced analytic methods.

Structure to utilize interventionists' implementation experiences of a family-based behavioral weight management program to enhance the dissemination of the standardized intervention: The TODAY study.

PubMed

Chadwick, Jennifer Q; Van Buren, Dorothy J; Morales, Elisa; Timpson, Alexandra; Abrams, Ericka L; Syme, Amy; Preske, Jeff; Mireles, Gerardo; Anderson, Barbara; Grover, Nisha; Laffel, Lori

2017-08-01

Background For a 2- to 6-year period, interventionists for the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) randomized clinical trial delivered a family-based, behavioral weight-loss program (the TODAY Lifestyle Program) to 234 youth with type 2 diabetes. Interventionists held at least a bachelor's degree in psychology, social work, education, or health-related field and had experience working with children and families, especially from diverse ethnic and socioeconomic backgrounds. This article describes the administrative and organizational structure of the lifestyle program and how the structure facilitated collaboration among study leadership and lifestyle interventionists on the tailoring of the program to best suit the needs of the trial's diverse patient population. Methods During the pilot phase and throughout the duration of the trial, the interventionists' experiences in delivering the intervention were collected in a variety of ways including membership on study committees, survey responses, session audio recordings, and feedback during in-person trainings. Results The experiences of interventionists conveyed to study leadership through these channels resulted in decisions to tailor the lifestyle intervention's delivery location and ways to supplement the standardized educational materials to better address the needs of a diverse patient population. Conclusion The methods used within the TODAY study to encourage and utilize interventionists' experiences while implementing the lifestyle program may be useful to the design of future multi-site, clinical trials seeking to tailor behavioral interventions in a standardized, and culturally and developmentally sensitive manner.

Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial.

PubMed

Syrjala, Karen L; Abrams, Janet R; Polissar, Nayak L; Hansberry, Jennifer; Robison, Jeanne; DuPen, Stuart; Stillman, Mark; Fredrickson, Marvin; Rivkin, Saul; Feldman, Eric; Gralow, Julie; Rieke, John W; Raish, Robert J; Lee, Douglas J; Cleeland, Charles S; DuPen, Anna

2008-03-01

Standard guidelines for cancer pain treatment routinely recommend training patients to reduce barriers to pain relief, use medications appropriately, and communicate their pain-related needs. Methods are needed to reduce professional time required while achieving sustained intervention effectiveness. In a multisite, randomized controlled trial, this study tested a pain training method versus a nutrition control. At six oncology clinics, physicians (N=22) and nurses (N=23) enrolled patients (N=93) who were over 18 years of age, with cancer diagnoses, pain, and a life expectancy of at least 6 months. Pain training and control interventions were matched for materials and method. Patients watched a video followed by about 20 min of manual-standardized training with an oncology nurse focused on reviewing the printed material and adapted to individual concerns of patients. A follow-up phone call after 72 h addressed individualized treatment content and pain communication. Assessments at baseline, one, three, and 6 months included barriers, the Brief Pain Inventory, opioid use, and physician and nurse ratings of their patients' pain. Trained versus control patients reported reduced barriers to pain relief (P<.001), lower usual pain (P=.03), and greater opioid use (P<.001). No pain training patients reported severe pain (>6 on a 0-10 scale) at 1-month outcomes (P=.03). Physician and nurse ratings were closer to patients' ratings of pain for trained versus nutrition groups (P=.04 and <.001, respectively). Training efficacy was not modified by patient characteristics. Using video and print materials, with brief individualized training, effectively improved pain management over time for cancer patients of varying diagnostic and demographic groups.

Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.

PubMed

Sandroff, Brian M; Bollaert, Rachel E; Pilutti, Lara A; Peterson, Melissa L; Baynard, Tracy; Fernhall, Bo; McAuley, Edward; Motl, Robert W

2017-10-01

Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability. 83 participants with substantial MS-related mobility disability underwent initial mobility, gait, fitness, and cognitive processing speed assessments and were randomly assigned to 6-months of supervised multimodal (progressive aerobic, resistance, and balance) exercise training (intervention condition) or stretching-and-toning activities (control condition). Participants completed the same outcome assessments halfway through and immediately following the 6-month study period. There were statistically significant improvements in six-minute walk performance (F(2158)=3.12, p=0.05, η p 2 =0.04), peak power output (F(2150)=8.16, p<0.01, η p 2 =0.10), and Paced Auditory Serial Addition Test performance (F(2162)=4.67, p=0.01, η p 2 =0.05), but not gait outcomes, for those who underwent the intervention compared with those who underwent the control condition. This RCT provides novel, preliminary evidence that multimodal exercise training may improve endurance walking performance and cognitive processing speed, perhaps based on improvements in cardiorespiratory capacity, in persons with MS with substantial mobility disability. This is critical for informing the development of multi-site exercise rehabilitation programs in larger samples of persons with MS-related mobility disability. Copyright © 2017 Elsevier Inc. All rights reserved.

Cost-Effectiveness of an Internet-Delivered Treatment for Substance Abuse: Data from a Multisite Randomized Controlled Trial

PubMed Central

Murphy, Sean M.; Campbell, Aimee N. C.; Ghitza, Udi E.; Kyle, Tiffany L.; Bailey, Genie L.; Nunes, Edward V.; Polsky, Daniel

2016-01-01

Background Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES). Methods Economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry). Results From the provider’s perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU has at least a 95% chance of being considered cost-effective for providers and payers with willingness-to-pay thresholds as low as $20,000 per abstinent year. Findings for the subgroup not abstinent at study entry are slightly more favorable. Conclusions With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy. Clinical trial registration NCT01104805. PMID:26880594

Effectiveness trial of a selective dissonance-based eating disorder prevention program with female college students: Effects at 2- and 3-year follow-up.

PubMed

Stice, Eric; Rohde, Paul; Butryn, Meghan L; Shaw, Heather; Marti, C Nathan

2015-08-01

An efficacy trial found that a dissonance-based prevention program reduced risk factors, eating disorder symptoms, and future eating disorder onset, but smaller effects emerged when high school clinicians recruited students and delivered the program under real-world conditions in an effectiveness trial. The current report describes results at 2- and 3-year follow-up from an effectiveness trial that tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruit students and deliver the intervention using improved train and supervision procedures. Young women from eight universities (N = 408, M age = 21.6, SD = 5.64) were randomized to the prevention program or an educational brochure control condition. Dissonance participants showed greater decreases in risk factors, eating disorder symptoms, and psychosocial impairment by 3-year follow-up than controls, but not healthcare utilization, BMI, or eating disorder onset. This novel multisite effectiveness trial found that the enhanced dissonance intervention and improved training and supervision procedures produced an average effect size at 3-year follow-up that was 290% and 160% larger than effects observed in the high school effectiveness trial and efficacy trial respectively. Yet, the lack of eating disorder onset effects may imply that factors beyond pursuit of the thin ideal now contribute to eating disorder onset. Copyright © 2015 Elsevier Ltd. All rights reserved.

Finding Efficiency in the Design of Large Multisite Evaluations: Estimating Variances for Science Achievement Studies

ERIC Educational Resources Information Center

Westine, Carl D.

2016-01-01

Little is known empirically about intraclass correlations (ICCs) for multisite cluster randomized trial (MSCRT) designs, particularly in science education. In this study, ICCs suitable for science achievement studies using a three-level (students in schools in districts) MSCRT design that block on district are estimated and examined. Estimates of…

Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial.

PubMed

Bekelman, David B; Allen, Larry A; McBryde, Connor F; Hattler, Brack; Fairclough, Diane L; Havranek, Edward P; Turvey, Carolyn; Meek, Paula M

2018-04-01

Many patients with chronic heart failure experience reduced health status despite receiving conventional therapy. To determine whether a symptom and psychosocial collaborative care intervention improves heart failure-specific health status, depression, and symptom burden in patients with heart failure. A single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach. Patients were randomized 1:1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients' primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician. The primary outcome was patient-reported heart failure-specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality. Of 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control arm (difference, 2.6; 95% CI, -1.3 to 6.6; P = .19). Among secondary outcomes, depressive symptoms and fatigue improved at 6 months with CASA (effect size of -0.29 [95% CI, -0.53 to -0.04] for depressive symptoms and -0.30 [95% CI, -0.55 to -0.06] for fatigue; P = .02 for both). There were no significant changes in overall symptom distress, pain, shortness of breath, or number of hospitalizations. Mortality at 12 months was similar in both arms (10 patients died receiving CASA, and 13 patients died receiving usual care; P = .52). This multisite randomized clinical trial of the CASA intervention did not demonstrate improved heart failure-specific health status. Secondary outcomes of depression and fatigue, both difficult symptoms to treat in heart failure, improved. clinicaltrials.gov Identifier: NCT01739686.

Optimized probability sampling of study sites to improve generalizability in a multisite intervention trial.

PubMed

Kraschnewski, Jennifer L; Keyserling, Thomas C; Bangdiwala, Shrikant I; Gizlice, Ziya; Garcia, Beverly A; Johnston, Larry F; Gustafson, Alison; Petrovic, Lindsay; Glasgow, Russell E; Samuel-Hodge, Carmen D

2010-01-01

Studies of type 2 translation, the adaption of evidence-based interventions to real-world settings, should include representative study sites and staff to improve external validity. Sites for such studies are, however, often selected by convenience sampling, which limits generalizability. We used an optimized probability sampling protocol to select an unbiased, representative sample of study sites to prepare for a randomized trial of a weight loss intervention. We invited North Carolina health departments within 200 miles of the research center to participate (N = 81). Of the 43 health departments that were eligible, 30 were interested in participating. To select a representative and feasible sample of 6 health departments that met inclusion criteria, we generated all combinations of 6 from the 30 health departments that were eligible and interested. From the subset of combinations that met inclusion criteria, we selected 1 at random. Of 593,775 possible combinations of 6 counties, 15,177 (3%) met inclusion criteria. Sites in the selected subset were similar to all eligible sites in terms of health department characteristics and county demographics. Optimized probability sampling improved generalizability by ensuring an unbiased and representative sample of study sites.

Evaluation of a nurse practitioner disease management model for chronic heart failure: a multi-site implementation study.

PubMed

Lowery, Julie; Hopp, Faith; Subramanian, Usha; Wiitala, Wyndy; Welsh, Deborah E; Larkin, Angela; Stemmer, Karen; Zak, Cassandra; Vaitkevicius, Peter

2012-01-01

While disease management appears to be effective in selected, small groups of CHF patients from randomized controlled trials, its effectiveness in a broader CHF patient population is not known. This prospective, quasi-experimental study compared patient outcomes under a nurse practitioner-led disease management model (intervention group) with outcomes under usual care (control group) in both primary and tertiary medical centers. The study included 969 veterans (458 intervention, 511 control) treated for CHF at six VA medical centers. Intervention patients had significantly fewer (p<0.05) CHF and all-cause admissions at one-year follow-up, and lower mortality at both one- and two-year follow-up. These data provide support for the potential effectiveness of the intervention, and suggest that the evidence from RCTs of disease management models for CHF can be translated into clinical practice, even without the benefits of a selected patient population and dedicated resources often found in RCTs. © 2011 Wiley Periodicals, Inc.

Randomized feasibility trial to improve hydroxyurea adherence in youth ages 10-18 years through community health workers: The HABIT study.

PubMed

Green, Nancy S; Manwani, Deepa; Matos, Sergio; Hicks, April; Soto, Luisa; Castillo, Yina; Ireland, Karen; Stennett, Yvonne; Findley, Sally; Jia, Haomiao; Smaldone, Arlene

2017-12-01

The main therapeutic intervention for sickle cell disease (SCD) is hydroxyurea (HU). The effect of HU is largely through dose-dependent induction of fetal hemoglobin (HbF). Poor HU adherence is common among adolescents. Our 6-month, two-site pilot intervention trial, "HABIT," was led by culturally aligned community health workers (CHWs). CHWs performed support primarily through home visits, augmented by tailored text message reminders. Dyads of youth with SCD ages 10-18 years and a parent were enrolled. A customized HbF biomarker, the percentage decrease from each patients' highest historical HU-induced HbF, "Personal best," was used to qualify for enrollment and assess HU adherence. Two primary outcomes were as follows: (1) intervention feasibility and acceptability and (2) HU adherence measured in three ways: monthly percentage improvement toward HbF Personal best, proportion of days covered (PDC) by HU, and self-report. Twenty-eight dyads were enrolled, of which 89% were retained. Feasibility and acceptability were excellent. Controlling for group assignment and month of intervention, the intervention group improved percentage decrease from Personal best by 2.3% per month during months 0-4 (P = 0.30), with similar improvement in adherence demonstrated using pharmacy records. Self-reported adherence did not correlate. Dyads viewed CHWs as supportive for learning about SCD and HU, living with SCD and making progress in coordinated self-management responsibility to support a daily HU habit. Most parents and youth appreciated text message HU reminders. The HABIT pilot intervention demonstrated feasibility and acceptability with promising effect toward improved medication adherence. Testing in a larger multisite intervention trial is warranted. © 2017 Wiley Periodicals, Inc.

Involving Community Stakeholders to Increase Park Use and Physical Activity

PubMed Central

Marsh, Terry; Mariscal, Mark; Pina-Cortez, Sophia; Cohen, Deborah A.

2014-01-01

Objective To describe implementation of a randomized controlled trial of community-based participatory research (CBPR) approaches to increase park use and physical activity across 33 diverse neighborhoods in Los Angeles. Methods Fifty parks were randomly assigned based on park size, facilities and programs, and neighborhood socio-demographic characteristics to: park director (PD, 17 parks); PD and park advisory board of interested community members (PD+PAB, 16 parks); and no-intervention control (17 parks) arms. Between 2007 and 2012, PDs and PABs from the 33 intervention parks participated in community engagement, baseline assessment, marketing training, intervention design and implementation, and follow-up assessment. Results Intervention parks (PD and PD+PAB) invested in new and diversified signage, promotional items, outreach or support for group activities like fitness classes and walking clubs, and various marketing strategies. Scaling up CBPR methods across parks in 33 diverse neighborhoods was challenging. Working with departmental management and established structures for community input (PABs) and park policy (PDs) facilitated implementation and sustainability. Conclusion Scaling up CBPR methods across diverse communities involved tradeoffs. CBPR is useful for tailoring research and enhancing community impact and sustainability, but more work is needed to understand how to conduct multi-site trials across diverse settings using CBPR. PMID:24674853

Involving community stakeholders to increase park use and physical activity.

PubMed

Derose, Kathryn Pitkin; Marsh, Terry; Mariscal, Mark; Pina-Cortez, Sophia; Cohen, Deborah A

2014-07-01

The aim of this study is to describe implementation of a randomized controlled trial of community-based participatory research (CBPR) approaches to increase park use and physical activity across 33 diverse neighborhoods in Los Angeles. Fifty parks were randomly assigned based on park size, facilities and programs, and neighborhood socio-demographic characteristics to: park director (PD, 17 parks); PD and park advisory board of interested community members (PD+PAB, 16 parks); and no-intervention control (17 parks) arms. Between 2007 and 2012, PDs and PABs from the 33 intervention parks participated in community engagement, baseline assessment, marketing training, intervention design and implementation, and follow-up assessment. Intervention parks (PD and PD+PAB) invested in new and diversified signage, promotional items, outreach or support for group activities like fitness classes and walking clubs, and various marketing strategies. Scaling up CBPR methods across parks in 33 diverse neighborhoods was challenging. Working with departmental management and established structures for community input (PABs) and park policy (PDs) facilitated implementation and sustainability. Scaling up CBPR methods across diverse communities involved tradeoffs. CBPR is useful for tailoring research and enhancing community impact and sustainability, but more work is needed to understand how to conduct multi-site trials across diverse settings using CBPR. Copyright © 2014 Elsevier Inc. All rights reserved.

CliniProteus: A flexible clinical trials information management system

PubMed Central

Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael

2007-01-01

Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

PubMed

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial.

PubMed

Marsch, Lisa A; Guarino, Honoria; Grabinski, Michael J; Syckes, Cassandra; Dillingham, Elaine T; Xie, Haiyi; Crosier, Benjamin S

2015-12-01

Young people who engage in substance use are at risk for becoming infected with HIV and diseases with similar transmission dynamics. Effective disease prevention programs delivered by prevention specialists exist but are rarely provided in systems of care due to staffing/resource constraints and operational barriers-and are thus of limited reach. Web-based prevention interventions could possibly offer an effective alternative to prevention specialist-delivered interventions and may enable widespread, cost-effective access to evidence-based prevention programming. Previous research has shown the HIV/disease prevention program within the Web-based therapeutic education system (TES) to be an effective adjunct to a prevention specialist-delivered intervention. The present study was the first randomized, clinical trial to evaluate the comparative effectiveness of this Web-based intervention as a standalone intervention relative to a traditional, prevention specialist-delivered intervention. Adolescents entering outpatient treatment for substance use participated in this multi-site trial. Participants were randomly assigned to either a traditional intervention delivered by a prevention specialist (n=72) or the Web-delivered TES intervention (n=69). Intervention effectiveness was assessed by evaluating changes in participants' knowledge about HIV, hepatitis, and sexually transmitted infections, intentions to engage in safer sex, sex-related risk behavior, self-efficacy to use condoms, and condom use skills. Participants in the TES intervention achieved significant and comparable increases in HIV/disease-related knowledge, condom use self-efficacy, and condom use skills and comparable decreases in HIV risk behavior relative to participants who received the intervention delivered by a prevention specialist. Participants rated TES as easier to understand. This study indicates that TES is as effective as HIV/disease prevention delivered by a prevention specialist. Because technology-based interventions such as TES have high fidelity, are inexpensive and scalable, and can be implemented in a wide variety of settings, they have the potential to greatly increase access to effective prevention programming. Copyright © 2015 Elsevier Inc. All rights reserved.

Construct, Concurrent and Predictive Validity of the URICA: Data from Two Multi-site Clinical Trials

PubMed Central

Field, Craig A.; Adinoff, Bryon; Harris, T. Robert; Ball, Samuel A.; Carroll, Kathleen M.

2011-01-01

Background A better understanding of how to measure motivation to change and how it relates to behavior change in patients with drug and alcohol dependence would broaden our understanding of the role of motivation in addiction treatment. Methods Two multi-site, randomized clinical trials comparing brief motivational interventions with standard care were conducted in the National Institute on Drug Abuse Clinical Trials Network. Patients with primary drug dependence and alcohol dependence entering outpatient treatment participated in a study of either Motivational Enhancement Therapy (n=431) or Motivational Interviewing (n=423). The construct, concurrent, and predictive validity of two composite measures of motivation to change derived from the University of Rhode Island Change Assessment (URICA): Readiness to Change (RTC) and Committed Action (CA) were evaluated. Results Confirmatory factor analysis confirmed the a priori factor structure of the URICA. RTC was significantly associated with measures of addiction severity at baseline (r=.12-.52, p<.05). Although statistically significant (p<.01), the correlations between treatment outcomes and RTC were low (r=-.15 and -18). Additional analyses did not support a moderating or mediating effect of motivation on treatment retention or substance use. Conclusions The construct validity of the URICA was confirmed separately in a large sample of drug- and alcohol-dependent patients. However, evidence for the predictive validity of composite scores was very limited and there were no moderating or mediating effects of either measure on treatment outcome. Thus, increased motivation to change, as measured by the composite scores of motivation derived from the URICA, does not appear to influence treatment outcome. PMID:19157723

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial.

PubMed

Spoelstra, Sandra L; Given, Charles W; Sikorskii, Alla; Coursaris, Constantinos K; Majumder, Atreyee; DeKoekkoek, Tracy; Schueller, Monica; Given, Barbara A

2016-06-01

This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Measures were administered at baseline, weekly (Weeks 1-8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n = 38) were satisfied. The differences between experimental and control groups' ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04; ES = 0.54) in the experimental group. Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice.

Randomized Trial of a Peer-Led, Telephone-Based Empowerment Intervention for Persons With Chronic Spinal Cord Injury Improves Health Self-Management.

PubMed

Houlihan, Bethlyn Vergo; Brody, Miriam; Everhart-Skeels, Sarah; Pernigotti, Diana; Burnett, Sam; Zazula, Judi; Green, Christa; Hasiotis, Stathis; Belliveau, Timothy; Seetharama, Subramani; Rosenblum, David; Jette, Alan

2017-06-01

To evaluate the impact of "My Care My Call" (MCMC), a peer-led, telephone-based health self-management intervention in adults with chronic spinal cord injury (SCI). Single-blinded randomized controlled trial. General community. Convenience sample of adults with SCI (N=84; mean time post-SCI, 9.9y; mean age, 46y; 73.8% men; 44% with paraplegia; 58% white). Trained peer health coaches applied the person-centered health self-management intervention with 42 experimental subjects over 6 months on a tapered call schedule. The 42 control subjects received usual care. Both groups received the MCMC Resource Guide. Primary outcome-health self-management as measured by the Patient Activation Measure (PAM). Secondary outcomes-global ratings of service/resource use, health-related quality of life, and quality of primary care. Intervention participants averaged 12 calls over 6 months (averaging 21.8min each), with distinct variation. At 6 months, intervention participants reported a significantly greater change in PAM scores (6mo: estimate, 7.029; 95% confidence interval, .1018-13.956; P=.0468) compared with controls, with a trend toward significance at 4 months. At 6 months, intervention participants reported a significantly greater decrease in social/role activity limitations (estimate, -.443; P=.0389), greater life satisfaction (estimate, 1.0091; P=.0522), greater services/resources awareness (estimate, 1.678; P=.0253), greater overall service use (estimate, 1.069; P=.0240), and a greater number of services used (estimate, 1.542; P=.0077). Subgroups most impacted by MCMC on PAM change scores included the following: high social support, white persons, men, 1 to 6 years postinjury, and tetraplegic. This trial demonstrates that the MCMC peer-led, health self-management intervention achieved a positive impact on self-management to prevent secondary conditions in adults with SCI. These results warrant a larger, multisite trial of its efficacy and cost-effectiveness. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Bias and Bias Correction in Multi-Site Instrumental Variables Analysis of Heterogeneous Mediator Effects

ERIC Educational Resources Information Center

Reardon, Sean F.; Unlu, Faith; Zhu, Pei; Bloom, Howard

2013-01-01

We explore the use of instrumental variables (IV) analysis with a multi-site randomized trial to estimate the effect of a mediating variable on an outcome in cases where it can be assumed that the observed mediator is the only mechanism linking treatment assignment to outcomes, as assumption known in the instrumental variables literature as the…

Bias and Bias Correction in Multisite Instrumental Variables Analysis of Heterogeneous Mediator Effects

ERIC Educational Resources Information Center

Reardon, Sean F.; Unlu, Fatih; Zhu, Pei; Bloom, Howard S.

2014-01-01

We explore the use of instrumental variables (IV) analysis with a multisite randomized trial to estimate the effect of a mediating variable on an outcome in cases where it can be assumed that the observed mediator is the only mechanism linking treatment assignment to outcomes, an assumption known in the IV literature as the exclusion restriction.…

Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.

PubMed

Campbell, Aimee N C; Nunes, Edward V; Miele, Gloria M; Matthews, Abigail; Polsky, Daniel; Ghitza, Udi E; Turrigiano, Eva; Bailey, Genie L; VanVeldhuisen, Paul; Chapdelaine, Rita; Froias, Autumn; Stitzer, Maxine L; Carroll, Kathleen M; Winhusen, Theresa; Clingerman, Sara; Perez, Livangelie; McClure, Erin; Goldman, Bruce; Crowell, A Rebecca

2012-03-01

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings. Copyright © 2011 Elsevier Inc. All rights reserved.

Design and Methodological Considerations of an Effectiveness Trial of a Computer-assisted Intervention: An Example from the NIDA Clinical Trials Network

PubMed Central

Campbell, Aimee N. C.; Nunes, Edward V.; Miele, Gloria M.; Matthews, Abigail; Polsky, Daniel; Ghitza, Udi E.; Turrigiano, Eva; Bailey, Genie L.; VanVeldhuisen, Paul; Chapdelaine, Rita; Froias, Autumn; Stitzer, Maxine L.; Carroll, Kathleen M.; Winhusen, Theresa; Clingerman, Sara; Perez, Livangelie; McClure, Erin; Goldman, Bruce; Crowell, A. Rebecca

2011-01-01

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings. PMID:22085803

Classroom Promotion of Oral Language (CPOL): protocol for a cluster randomised controlled trial of a school-based intervention to improve children’s literacy outcomes at grade 3, oral language and mental health

PubMed Central

Goldfeld, Sharon; Snow, Pamela; Eadie, Patricia; Munro, John; Gold, Lisa; Le, Ha N D; Orsini, Francesca; Shingles, Beth; Lee, Katherine; Connell, Judy; Watts, Amy

2017-01-01

Introduction Oral language and literacy competence are major influences on children’s developmental pathways and life success. Children who do not develop the necessary language and literacy skills in the early years of school then go on to face long-term difficulties. Improving teacher effectiveness may be a critical step in lifting oral language and literacy outcomes. The Classroom Promotion of Oral Language trial aims to determine whether a specifically designed teacher professional learning programme focusing on promoting oral language can lead to improved teacher knowledge and practice, and advance outcomes in oral language and literacy for early years school children, compared with usual practice. Methods and analysis This is a two-arm cluster multisite randomised controlled trial conducted within Catholic and Government primary schools across Victoria, Australia. The intervention comprises 4 days of face-to-face professional learning for teachers and ongoing implementation support via a specific worker. The primary outcome is reading ability of the students at grade 3, and the secondary outcomes are teacher knowledge and practice, student mental health, reading comprehension and language ability at grade 1; and literacy, writing and numeracy at grade 3. Economic evaluation will compare the incremental costs of the intervention to the measured primary and secondary outcomes. Ethics and dissemination This trial was approved by the Monash University Human Research Ethics Committee #CF13/2634-2013001403 and later transferred to the University of Melbourne #1545540. The investigators (including Government and Catholic partners) will communicate trial results to stakeholders, collaborators and participating schools and teachers via appropriate presentations and publications. Trial registration number ISRCTN77681972; Pre-results. PMID:29162571

Issues in the design of multisite clinical trials of psychotherapy: VA Cooperative Study No. 494 as an example.

PubMed

Schnurr, Paula P; Friedman, Matthew J; Engel, Charles C; Foa, Edna B; Shea, M Tracie; Resick, Patricia M; James, Kenneth E; Chow, Bruce K

2005-12-01

This article describes issues in the design of an ongoing multisite randomized clinical trial of psychotherapy for treating posttraumatic stress disorder (PTSD) in female veterans and active duty personnel. Research aimed at testing treatments for PTSD in women who have served in the military is especially important due to the high prevalence of PTSD in this population. VA Cooperative Study 494 was designed to enroll 384 participants across 12 sites. Participants are randomly assigned to receive 10 weekly sessions of individual psychotherapy: Prolonged Exposure, a specific cognitive-behavioral therapy protocol for PTSD, or present-centered therapy, a comparison treatment that addresses current interpersonal problems but avoids a trauma focus. PTSD is the primary outcome. Additional outcomes are comorbid problems such as depression and anxiety; psychosocial function and quality of life; physical health status; satisfaction with treatment; and service utilization. Follow-up assessments are conducted at the end of treatment and then 3 and 6 months after treatment. Both treatments are delivered according to a manual. Videotapes of therapy sessions are viewed by experts who provide feedback to therapists throughout the trial to ensure adherence to the treatment manual. Discussion includes issues encountered in multisite psychotherapy trials along with the rationale for our decisions about how we addressed these issues in CSP #494.

An effectiveness trial of a new enhanced dissonance eating disorder prevention program among female college students.

PubMed

Stice, Eric; Butryn, Meghan L; Rohde, Paul; Shaw, Heather; Marti, C Nathan

2013-12-01

Efficacy trials indicate that a dissonance-based prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced risk factors, eating disorder symptoms, and future eating disorder onset, but weaker effects emerged from an effectiveness trial wherein high school clinicians recruited students and delivered the program under real-world conditions. The present effectiveness trial tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruited students and delivered the intervention using improved procedures to select, train, and supervise clinicians. Young women recruited from seven universities across the US (N = 408, M age = 21.6, SD = 5.64) were randomized to the dissonance intervention or an educational brochure control condition. Dissonance participants showed significantly greater decreases in risk factors (thin-ideal internalization, body dissatisfaction, dieting, negative affect) and eating disorder symptoms versus controls at posttest and 1-year follow-up, resulting in medium average effect size (d = .60). Dissonance participants also reported significant improvements in psychosocial functioning, but not reduced health care utilization or unhealthy weight gain. This novel multisite effectiveness trial with college clinicians found that the enhanced dissonance version of this program and the improved facilitator selection/training procedures produced average effects that were 83% larger than effects observed in the high school effectiveness trial. Copyright © 2013 Elsevier Ltd. All rights reserved.

Real-Time Enrollment Dashboard For Multisite Clinical Trials.

PubMed

Mattingly, William A; Kelley, Robert R; Wiemken, Timothy L; Chariker, Julia H; Peyrani, Paula; Guinn, Brian E; Binford, Laura E; Buckner, Kimberley; Ramirez, Julio

2015-10-30

Achieving patient recruitment goals are critical for the successful completion of a clinical trial. We designed and developed a web-based dashboard for assisting in the management of clinical trial screening and enrollment. We use the dashboard to assist in the management of two observational studies of community-acquired pneumonia. Clinical research associates and managers using the dashboard were surveyed to determine its effectiveness as compared with traditional direct communication. The dashboard has been in use since it was first introduced in May of 2014. Of the 23 staff responding to the survey, 77% felt that it was easier or much easier to use the dashboard for communication than to use direct communication. We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are a useful tool for clinical trial management. They can be used as a standalone trial information tool or included into a larger management system.

Association of Implementation of Practice Standards for Electrocardiographic Monitoring With Nurses' Knowledge, Quality of Care, and Patient Outcomes: Findings From the Practical Use of the Latest Standards of Electrocardiography (PULSE) Trial.

PubMed

Funk, Marjorie; Fennie, Kristopher P; Stephens, Kimberly E; May, Jeanine L; Winkler, Catherine G; Drew, Barbara J

2017-02-01

Although continuous electrocardiographic (ECG) monitoring is ubiquitous in hospitals, monitoring practices are inconsistent. We evaluated implementation of American Heart Association practice standards for ECG monitoring on nurses' knowledge, quality of care, and patient outcomes. The PULSE (Practical Use of the Latest Standards of Electrocardiography) Trial was a 6-year multisite randomized clinical trial with crossover that took place in 65 cardiac units in 17 hospitals. We measured outcomes at baseline, time 2 after group 1 hospitals received the intervention, and time 3 after group 2 hospitals received the intervention. Measurement periods were 15 months apart. The 2-part intervention consisted of an online ECG monitoring education program and strategies to implement and sustain change in practice. Nurses' knowledge (N=3013 nurses) was measured by a validated 20-item online test, quality of care related to ECG monitoring (N=4587 patients) by on-site observation, and patient outcomes (mortality, in-hospital myocardial infarction, and not surviving a cardiac arrest; N=95 884 hospital admissions) by review of administrative, laboratory, and medical record data. Nurses' knowledge improved significantly immediately after the intervention in both groups but was not sustained 15 months later. For most measures of quality of care (accurate electrode placement, accurate rhythm interpretation, appropriate monitoring, and ST-segment monitoring when indicated), the intervention was associated with significant improvement, which was sustained 15 months later. Of the 3 patient outcomes, only in-hospital myocardial infarction declined significantly after the intervention and was sustained. Online ECG monitoring education and strategies to change practice can lead to improved nurses' knowledge, quality of care, and patient outcomes. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01269736. © 2017 American Heart Association, Inc.

Association of Implementation of Practice Standards for Electrocardiographic Monitoring with Nurses’ Knowledge, Quality of Care, and Patient Outcomes: Findings from the Practical Use of the Latest Standards of Electrocardiography (PULSE) Trial

PubMed Central

Funk, Marjorie; Fennie, Kristopher P.; Stephens, Kimberly E.; May, Jeanine L.; Winkler, Catherine G.; Drew, Barbara J.

2017-01-01

Background Although continuous electrocardiographic (ECG) monitoring is ubiquitous in hospitals, monitoring practices are inconsistent. We evaluated implementation of American Heart Association practice standards for ECG monitoring on nurses’ knowledge, quality of care, and patient outcomes. Methods and Results The PULSE Trial was a 6-year multi-site randomized clinical trial with crossover that took place in 65 cardiac units in 17 hospitals. We measured outcomes at baseline, Time 2 after Group 1 hospitals received the intervention, and Time 3 after Group 2 hospitals received the intervention. Measurement periods were 15 months apart. The 2-part intervention consisted of an online ECG monitoring education program and strategies to implement and sustain change in practice. Nurses’ knowledge (N=3,013 nurses) was measured by a validated 20-item online test, quality of care related to ECG monitoring (N=4,587 patients) by on-site observation, and patient outcomes (mortality, in-hospital myocardial infarction, and not surviving a cardiac arrest) (N=95,884 hospital admissions) by review of administrative, laboratory, and medical record data. Nurses’ knowledge improved significantly immediately following the intervention in both groups, but was not sustained 15 months later. For most measures of quality of care (accurate electrode placement, accurate rhythm interpretation, appropriate monitoring, and ST-segment monitoring when indicated), the intervention was associated with significant improvement, which was sustained 15 months later. Of the 3 patient outcomes, only in-hospital myocardial infarction declined significantly after the intervention, and was sustained. Conclusions Online ECG monitoring education and strategies to change practice can lead to improved nurses’ knowledge, quality of care, and patient outcomes. PMID:28174175

Validity of Teacher Ratings in Selecting Influential Aggressive Adolescents for a Targeted Preventive Intervention

PubMed Central

Henry, David B.; Miller-Johnson, Shari; Simon, Thomas R.; Schoeny, Michael E.

2009-01-01

This study describes a method for using teacher nominations and ratings to identify socially influential, aggressive middle school students for participation in a targeted violence prevention intervention. The teacher nomination method is compared with peer nominations of aggression and influence to obtain validity evidence. Participants were urban, predominantly African American and Latino sixth-grade students who were involved in a pilot study for a large multi-site violence prevention project. Convergent validity was suggested by the high correlation of teacher ratings of peer influence and peer nominations of social influence. The teacher ratings of influence demonstrated acceptable sensitivity and specificity when predicting peer nominations of influence among the most aggressive children. Results are discussed m terms of the application of teacher nominations and ratings in large trials and full implementation of targeted prevention programs. PMID:16378226

Efficacy of a Process Improvement Intervention on Delivery of HIV Services to Offenders: A Multisite Trial

PubMed Central

Shafer, Michael S.; Dembo, Richard; del Mar Vega-Debién, Graciela; Pankow, Jennifer; Duvall, Jamieson L.; Belenko, Steven; Frisman, Linda K.; Visher, Christy A.; Pich, Michele; Patterson, Yvonne

2014-01-01

Objectives. We tested a modified Network for the Improvement of Addiction Treatment (NIATx) process improvement model to implement improved HIV services (prevention, testing, and linkage to treatment) for offenders under correctional supervision. Methods. As part of the Criminal Justice Drug Abuse Treatment Studies, Phase 2, the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites, where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training. The outcome measure was the odds of successful delivery of an HIV service. Results. The results were significant at the .05 level, and the point estimate for the odds ratio was 2.14. Although overall the results were heterogeneous, the experiments that focused on implementing HIV prevention interventions had a 95% confidence interval that exceeded the no-difference point. Conclusions. Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments. PMID:25322311

Efficacy of a process improvement intervention on delivery of HIV services to offenders: a multisite trial.

PubMed

Pearson, Frank S; Shafer, Michael S; Dembo, Richard; Del Mar Vega-Debién, Graciela; Pankow, Jennifer; Duvall, Jamieson L; Belenko, Steven; Frisman, Linda K; Visher, Christy A; Pich, Michele; Patterson, Yvonne

2014-12-01

We tested a modified Network for the Improvement of Addiction Treatment (NIATx) process improvement model to implement improved HIV services (prevention, testing, and linkage to treatment) for offenders under correctional supervision. As part of the Criminal Justice Drug Abuse Treatment Studies, Phase 2, the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites, where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training. The outcome measure was the odds of successful delivery of an HIV service. The results were significant at the .05 level, and the point estimate for the odds ratio was 2.14. Although overall the results were heterogeneous, the experiments that focused on implementing HIV prevention interventions had a 95% confidence interval that exceeded the no-difference point. Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments.

Contextual Factors Related to Implementation and Reach of a Pragmatic Multisite Trial– The My Own Health Report (MOHR) Study

PubMed Central

Balasubramanian, Bijal A.; Heurtin-Roberts, Suzanne; Krasny, Sarah; Rohweder, Catherine; Fair, Kayla; Olmos, Tanya; Stange, Kurt C.; Gorin, Sherri Sheinfeld

2018-01-01

Background Contextual factors relevant to health care improvement studies are important for translating findings to other settings; however, these are rarely collected systematically and reported. This study articulates a prospective method for assessing contextual factors and describes factors related to implementation and patient reach of a pragmatic multisite trial conducted in nine primary care practices. Methods In a qualitative case-series, contextual factors were assessed from the My Own Health Report (MOHR) study, focused on systematically conducting health risk assessments and goal setting for unhealthy behaviors and behavioral health in primary care. Data were collected prospectively at baseline, mid-point, and end of intervention using a template that guided conduct of interviews and observations at practice sites. A multidisciplinary team used an iterative process to summarize themes describing contextual factors related to intervention implementation and patient reach, calculated by dividing the number of patients who completed the MOHR assessment by the number of patients offered MOHR. Results Contextual factors operational both within and external to the practice environment influenced implementation and patient reach over time. These included practice members’ motivations towards the MOHR intervention, practice staff capacity to take on additional responsibilities for implementation, practice information system capacity, external resources to support quality improvement, linkages with community resources, and fit of implementation strategy to patient populations. Conclusions Systematic assessment of contextual factors throughout implementation of quality improvement initiatives is needed to meaningfully interpret findings and translate lessons learned to other health care settings. Thus, knowledge of contextual factors is essential for scaling up of effective improvement strategies. PMID:28484066

Preconception maternal nutrition: a multi-site randomized controlled trial

PubMed Central

2014-01-01

Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age. Trial registration ClinicalTrials.gov NCT01883193. PMID:24650219

A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia

PubMed Central

2013-01-01

Background People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population. Methods A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant’s individual cognitive levels and implemented as a carer-supported intervention. Feasibility of recruitment, retention and implementation of intervention were recorded through observation and documented in field notes. Adherence, carer burden and use of task simplification strategies were also monitored. Outcome measures, collected at 12 weeks included physiological, fear of falling, cognitive and functional measures. Results Recruitment was achievable but may be more challenging in a multisite trial. Twenty two dyads of persons with mild dementia and their carers were randomised to intervention or usual care control group. Of 38 dyads referred to the study, there was a high rate of willingness to participate, with 6 (16%) declining and 10 (26%) not meeting inclusion criteria. The intervention was well received by participants and carers and adherence to both program components was very good. All participants implemented some home safety recommendations (range 19-80%) with half implementing 50% or more. At the end of 12 weeks, 72% of the intervention group were exercising. Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant (RR= 0.50 (95% CI 0.11-2.19). There were no differences in physiological outcome measures between the control and intervention groups. However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up. Conclusions The pilot study was feasible and acceptable to people with mild dementia and their carers. The lessons learnt included: recruitment for a larger trial will require multiple approaches; home safety recommendations should provide a greater emphasis on environmental use compared with behavioural change; strategies to ensure an adequate dosage of exercise should be further explored. We recommend that intervention delivery incorporate an integrated occupational therapy and physiotherapy approach and that carers be provided with an individualised session to enhance dementia-specific skills in management and communication. A refined intervention should be tested in a randomised trial with an adequately powered sample size. Trial registration Australia and New Zealand Clinical Trials Registry 126100001049066 PMID:24004682

A Paradox-based data collection and management system for multi-center randomized clinical trials.

PubMed

Abdellatif, Mazen; Reda, Domenic J

2004-02-01

We have developed a Paradox-based data collection and management system for large-scale multi-site randomized clinical trials. The system runs under Windows operating system and integrates Symantec pcAnywhere32 telecommunications software for data transmission and remote control sessions, PKZIP utility for the compression/decompression of transmitted data, and Stat/Transfer for exporting the centralized Paradox database for analyses. We initially developed this system for VA Cooperative Study #399 'The Effect of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation', which collects over 1000 variables on 706 patients at 20 sites. Patient intake for this 5-year study began in March of 1998. We have also developed an enhanced version of this system, which is being used in the NIH-funded 'Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)' that collects over 1200 variables on 1588 patients at 13 sites. Patient intake for this 4-year study began in October of 2000.

Distortions in Distributions of Impact Estimates in Multi-Site Trials: The Central Limit Theorem Is Not Your Friend

ERIC Educational Resources Information Center

May, Henry

2014-01-01

Interest in variation in program impacts--How big is it? What might explain it?--has inspired recent work on the analysis of data from multi-site experiments. One critical aspect of this problem involves the use of random or fixed effect estimates to visualize the distribution of impact estimates across a sample of sites. Unfortunately, unless the…

Lessons Learned in Evaluating a Multisite, Comprehensive Teen Dating Violence Prevention Strategy: Design and Challenges of the Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships.

PubMed

Niolon, Phyllis Holditch; Taylor, Bruce G; Latzman, Natasha E; Vivolo-Kantor, Alana M; Valle, Linda Anne; Tharp, Andra T

2016-03-01

This paper describes the multisite, longitudinal cluster randomized controlled trial (RCT) design of the evaluation of the Dating Matters: Strategies to Promote Healthy Relationships initiative, and discusses challenges faced in conducting this evaluation. Health departments in 4 communities are partnering with middle schools in high-risk, urban communities to implement 2 models of teen dating violence (TDV) prevention over 4 years. Schools were randomized to receive either the Dating Matters comprehensive strategy or the "standard of care" strategy (an existing, evidence-based TDV prevention curriculum). Our design permits comparison of the relative effectiveness of the comprehensive and standard of care strategies. Multiple cohorts of students from 46 middle schools are surveyed in middle school and high school, and parents and educators from participating schools are also surveyed. Challenges discussed in conducting a multisite RCT include site variability, separation of implementation and evaluation responsibilities, school retention, parent engagement in research activities, and working within the context of high-risk urban schools and communities. We discuss the strengths and weaknesses of our approaches to these challenges in the hopes of informing future research. Despite multiple challenges, the design of the Dating Matters evaluation remains strong. We hope this paper provides researchers who are conducting complex evaluations of behavioral interventions with thoughtful discussion of the challenges we have faced and potential solutions to such challenges.

Lessons Learned in Evaluating a Multisite, Comprehensive Teen Dating Violence Prevention Strategy: Design and Challenges of the Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships

PubMed Central

Niolon, Phyllis Holditch; Taylor, Bruce G.; Latzman, Natasha E.; Vivolo-Kantor, Alana M.; Valle, Linda Anne; Tharp, Andra T.

2018-01-01

Objective This paper describes the multisite, longitudinal cluster randomized controlled trial (RCT) design of the evaluation of the Dating Matters: Strategies to Promote Healthy Relationships initiative, and discusses challenges faced in conducting this evaluation. Method Health departments in 4 communities are partnering with middle schools in high-risk, urban communities to implement 2 models of teen dating violence (TDV) prevention over 4 years. Schools were randomized to receive either the Dating Matters comprehensive strategy or the “standard of care” strategy (an existing, evidence-based TDV prevention curriculum). Our design permits comparison of the relative effectiveness of the comprehensive and standard of care strategies. Multiple cohorts of students from 46 middle schools are surveyed in middle school and high school, and parents and educators from participating schools are also surveyed. Results Challenges discussed in conducting a multisite RCT include site variability, separation of implementation and evaluation responsibilities, school retention, parent engagement in research activities, and working within the context of high-risk urban schools and communities. We discuss the strengths and weaknesses of our approaches to these challenges in the hopes of informing future research. Conclusions Despite multiple challenges, the design of the Dating Matters evaluation remains strong. We hope this paper provides researchers who are conducting complex evaluations of behavioral interventions with thoughtful discussion of the challenges we have faced and potential solutions to such challenges. PMID:29607239

Eban HIV/STD risk reduction intervention: conceptual basis and procedures.

PubMed

2008-09-01

To describe the Eban HIV/STD Risk Reduction Intervention being evaluated in the NIMH Multisite HIV/STD Prevention trial for heterosexual African American couples, including the integrated theoretical framework, the structure, core elements and procedures of the intervention, and how the content was shaped by culturally congruent concepts to address the needs of the study target population. The Eban HIV/STD Risk Reduction Intervention is designed to address multilevel individual-, interpersonal-, and community-level factors that contribute to HIV/STD transmission risk behaviors among heterosexual African American couples who are HIV serodiscordant. The Eban HIV/STD Risk Reduction Intervention employs a mixed modality, couple-based approach that is based on an integrated ecological framework incorporating social cognitive theory and uses an Afrocentric paradigm that is informed by previous evidence-based couples HIV prevention interventions. For this randomized controlled trial, African American serodiscordant couples were recruited from 4 urban sites (Atlanta, Los Angeles, New York, and Philadelphia) and were randomized to either the Eban HIV/STD Risk Reduction Intervention (treatment condition) or a Health Promotion Intervention that served as an attentional control condition. Both interventions had 4 individual couple sessions and 4 group sessions, but only the treatment condition was focused on reducing HIV/STD risk behaviors. Behavioral and biological data were collected at baseline, immediately after the intervention, and at 6 and 12 months. The theoretical framework, core elements, and content of each session are described and lessons learned from this intervention trial are discussed. An HIV prevention intervention combining couple and group sessions can be feasibly implemented with African American HIV-serodiscordant couples who remain at high risk of HIV/STD transmission. The lessons learned from the trial suggest that the participants responded very well to both the couple and the group sessions. Participant feedback suggests that the cultural congruence of the intervention and use of African American cofacilitators made them feel comfortable disclosing risky behaviors. Participant feedback also suggests that the intervention's couple-based focus on enhancing dyadic communication and decision-making skills was key to helping the couples work together to overcome barriers to using condoms. Participant and facilitator evaluations of the Eban Risk Reduction Intervention suggest that couples responded well to the Afrocentric content and mixed modalities of the intervention sessions. Couple sessions were optimal for enhancing interpersonal and microlevel factors, including communication, problem solving, and decision making.

Do Psychosocial Interventions Improve Quality of Life and Wellbeing in Adults with Neuromuscular Disorders? A Systematic Review and Narrative Synthesis.

PubMed

Walklet, Elaine; Muse, Kate; Meyrick, Jane; Moss, Tim

2016-08-30

Quality of life and well-being are frequently restricted in adults with neuromuscular disorders. As such, identification of appropriate interventions is imperative. The objective of this paper was to systematically review and critically appraise quantitative studies (RCTs, controlled trials and cohort studies) of psychosocial interventions designed to improve quality of life and well-being in adults with neuromuscular disorders. A systematic review of the published and unpublished literature was conducted. Studies meeting inclusion criteria were appraised using a validated quality assessment tool and results presented in a narrative synthesis. Out of 3,136 studies identified, ten studies met criteria for inclusion within the review. Included studies comprised a range of interventions including: cognitive behavioural therapy, dignity therapy, hypnosis, expressive disclosure, gratitude lists, group psychoeducation and psychologically informed rehabilitation. Five of the interventions were for patients with Amyotrophic Lateral Sclerosis (ALS). The remainder were for patients with post-polio syndrome, muscular dystrophies and mixed disorders, such as Charcot-Marie-Tooth disease, myasthenia gravis and myotonic dystrophy. Across varied interventions and neuromuscular disorders, seven studies reported a short-term beneficial effect of intervention on quality of life and well-being. Whilst such findings are encouraging, widespread issues with the methodological quality of these studies significantly compromised the results. There is no strong evidence that psychosocial interventions improve quality of life and well-being in adults with neuromuscular disorders, due to a paucity of high quality research in this field. Multi-site, randomised controlled trials with active controls, standardised outcome measurement and longer term follow-ups are urgently required.

Do Psychosocial Interventions Improve Quality of Life and Wellbeing in Adults with Neuromuscular Disorders? A Systematic Review and Narrative Synthesis

PubMed Central

Walklet, Elaine; Muse, Kate; Meyrick, Jane; Moss, Tim

2016-01-01

Quality of life and well-being are frequently restricted in adults with neuromuscular disorders. As such, identification of appropriate interventions is imperative. The objective of this paper was to systematically review and critically appraise quantitative studies (RCTs, controlled trials and cohort studies) of psychosocial interventions designed to improve quality of life and well-being in adults with neuromuscular disorders. A systematic review of the published and unpublished literature was conducted. Studies meeting inclusion criteria were appraised using a validated quality assessment tool and results presented in a narrative synthesis. Out of 3,136 studies identified, ten studies met criteria for inclusion within the review. Included studies comprised a range of interventions including: cognitive behavioural therapy, dignity therapy, hypnosis, expressive disclosure, gratitude lists, group psychoeducation and psychologically informed rehabilitation. Five of the interventions were for patients with Amyotrophic Lateral Sclerosis (ALS). The remainder were for patients with post-polio syndrome, muscular dystrophies and mixed disorders, such as Charcot-Marie-Tooth disease, myasthenia gravis and myotonic dystrophy. Across varied interventions and neuromuscular disorders, seven studies reported a short-term beneficial effect of intervention on quality of life and well-being. Whilst such findings are encouraging, widespread issues with the methodological quality of these studies significantly compromised the results. There is no strong evidence that psychosocial interventions improve quality of life and well-being in adults with neuromuscular disorders, due to a paucity of high quality research in this field. Multi-site, randomised controlled trials with active controls, standardised outcome measurement and longer term follow-ups are urgently required. PMID:27854227

Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial.

PubMed

Patterson, P Daniel; Moore, Charity G; Guyette, Frank X; Doman, Jack M; Sequeira, Denisse; Werman, Howard A; Swanson, Doug; Hostler, David; Lynch, Joshua; Russo, Lindsey; Hines, Linda; Swecker, Karen; Runyon, Michael S; Buysse, Daniel J

2017-06-05

Most air medical Emergency Medical Services (EMS) clinicians work extended duration shifts, and more than 50% report inadequate sleep, poor sleep quality, and/or poor recovery between shifts. The SleepTrackTXT pilot trial (ClinicalTrials.gov, NCT02063737) showed that use of mobile phone text messages could impact EMS clinician self-reported fatigue and sleepiness during long duration shifts. The purpose of the SleepTrackTXT2 trial is to leverage lessons learned from the first SleepTrackTXT study and test an enhanced intervention targeting air medical EMS clinicians. We will conduct a multi-site randomized trial with a sample of adult EMS clinicians recruited from four air medical EMS systems located in the midwest, northeastern, and southern USA. Participants will be allocated to one of two possible arms for a 4-month (120-day) study period. The intervention arm will involve text-message assessments of sleepiness, fatigue, and difficulty concentrating at the beginning, every 4 hours during, and at the end of scheduled shifts. Participants reporting high levels of sleepiness, fatigue, or difficulty with concentration will receive one of nine randomly selected intervention messages to promote behavior change during shift work to improve alertness. Intervention participants will receive a text-message report on Friday of each week that shows their sleep debt over the previous 7 days followed by a text message to promote paying back sleep debt recovery when feasible. Participants in the control group receive text messages that only include assessments. Both arms will receive text-message assessments of perceived recovery since last shift, sleepiness, fatigue, or difficulty with concentration at noon (1200 hours) on days between scheduled shifts (off-duty days). We have two aims for this study: (1) to determine the short-term impact of the enhanced SleepTrackTXT2 intervention on air medical clinician fatigue reported in real time during and at the end of shift work, and (2) to determine the long-term impact of the SleepTrackTXT2 intervention on sleep quality and sleep health indicators including hours of sleep and recovery between shift work. The SleepTrackTXT2 trial may provide evidence of real-world effectiveness that would support widespread expansion of fatigue mitigation interventions in emergency care clinician shift workers. The trial may specifically support use of real-time assessments and interventions delivered via mobile technology such as text messaging. ClinicalTrials.gov, NCT02783027 . Registered on 23 May 2016.

Gender-transformative Bandebereho couples’ intervention to promote male engagement in reproductive and maternal health and violence prevention in Rwanda: Findings from a randomized controlled trial

PubMed Central

Barker, Gary; Bastian, Gautam G.; Bingenheimer, Jeffrey B.; Kazimbaya, Shamsi; Nzabonimpa, Anicet; Pulerwitz, Julie; Sayinzoga, Felix; Sharma, Vandana; Shattuck, Dominick

2018-01-01

Background Rigorous evidence of the effectiveness of male engagement interventions, particularly on how these interventions impact relationship power dynamics and women’s decision-making, remains limited. This study assessed the impact of the Bandebereho gender-transformative couples’ intervention on impact on multiple behavioral and health-related outcomes influenced by gender norms and power relations. Methods We conducted a multi-site randomised controlled trial in four Rwandan districts with expectant/current fathers and their partners, who were randomised to the intervention (n = 575 couples) or control group (n = 624 couples). Primary outcomes include women’s experience of physical and sexual IPV, women’s attendance and men’s accompaniment at ANC, modern contraceptive use, and partner support during pregnancy. At 21-months post-baseline, 1123 men and 1162 partners were included in intention to treat analysis. Generalized estimating equations with robust standard errors were used to fit the models. Findings The Bandebereho intervention led to substantial improvements in multiple reported outcomes. Compared to the control group, women in the intervention group reported: less past-year physical (OR 0.37, p<0.001) and sexual IPV (OR 0.34, p<0.001); and greater attendance (IRR 1.09, p<0.001) and male accompaniment at antenatal care (IRR 1.50, p<0.001); and women and men in the intervention group reported: less child physical punishment (women: OR 0.56, p = 0.001; men: OR 0.66, p = 0.005); greater modern contraceptive use (women: OR 1.53, p = 0.004; men: OR 1.65, p = 0.001); higher levels of men’s participation in childcare and household tasks (women: beta 0.39, p<0.001; men: beta 0.33, p<0.001); and less dominance of men in decision-making. Conclusions Our study strengthens the existing evidence on male engagement approaches; together with earlier studies our findings suggest that culturally adapted gender-transformative interventions with men and couples can be effective at changing deeply entrenched gender inequalities and a range of health-related behavioral outcomes. Trial registration ClinicalTrials.gov NCT02694627 PMID:29617375

The Childhood Obesity Research Demonstration project: a team approach for supporting a multisite, multisector intervention.

PubMed

Williams, Nancy; Dooyema, Carrie A; Foltz, Jennifer L; Belay, Brook; Blanck, Heidi M

2015-02-01

Comprehensive multisector, multilevel approaches are needed to address childhood obesity. This article introduces the structure of a multidisciplinary team approach used to support and guide the multisite, multisector interventions implemented as part of the Childhood Obesity Research Demonstration (CORD) project. This article will describe the function, roles, and lessons learned from the CDC-CORD approach to project management. The CORD project works across multisectors and multilevels in three demonstration communities. Working with principal investigators and their research teams who are engaging multiple stakeholder groups, including community organizations, schools and child care centers, health departments, and healthcare providers, can be a complex endeavor. To best support the community-based research project, scientific and programmatic expertise in a wide range of areas was required. The team was configured based on the skill sets needed to interact with the various levels of staff working with the project. By thoughtful development of the team and processes, an efficient system for supporting the multisite, multisector intervention project sites was developed. The team approach will be formally evaluated at the end of the project period.

Rationale for Using Exercise in the Treatment of Stimulant Use Disorders

PubMed Central

Greer, Tracy L.; Ring, Kolette M.; Warden, Diane; Grannemann, Bruce D.; Church, Timothy S.; Somoza, Eugene; Blair, Steven N.; Szapocznik, Jose; Stoutenberg, Mark; Rethorst, Chad; Walker, Robrina; Morris, David W.; Kosinski, Andrzej S.; Kyle, Tiffany; Marcus, Bess; Crowell, Becca; Oden, Neal; Nunes, Edward; Trivedi, Madhukar H.

2013-01-01

Novel approaches to the treatment of stimulant abuse and dependence are needed. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse. In addition, exercise has been associated with improvements in many other health-related areas that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight, quality of life, and anhedonia. Neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes in stimulant abuse. The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. If effective, exercise may provide an additional approach to the treatment of stimulant use disorders. PMID:25364477

A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D)

PubMed Central

Weissberg-Benchell, Jill; Rausch, Joseph; Iturralde, Esti; Jedraszko, Aneta; Hood, Korey

2016-01-01

Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future. PMID:27267154

The physical therapy clinical research network (PTClinResNet): methods, efficacy, and benefits of a rehabilitation research network.

PubMed

Winstein, Carolee; Pate, Patricia; Ge, Tingting; Ervin, Carolyn; Baurley, James; Sullivan, Katherine J; Underwood, Samantha J; Fowler, Eileen G; Mulroy, Sara; Brown, David A; Kulig, Kornelia; Gordon, James; Azen, Stanley P

2008-11-01

This article describes the vision, methods, and implementation strategies used in building the infrastructure for PTClinResNet, a clinical research network designed to assess outcomes for health-related mobility associated with evidence-based physical therapy interventions across and within four different disability groups. Specific aims were to (1) create the infrastructure necessary to develop and sustain clinical trials research in rehabilitation, (2) generate evidence to evaluate the efficacy of resistance exercise-based physical interventions designed to improve muscle performance and movement skills, and (3) provide education and training opportunities for present and future clinician-researchers and for the rehabilitation community at-large in its support of evidence-based practice. We present the network's infrastructure, development, and several examples that highlight the benefits of a clinical research network. We suggest that the network structure is ideal for building research capacity and fostering multisite, multiinvestigator clinical research projects designed to generate evidence for the efficacy of rehabilitation interventions.

Cost-effectiveness of an internet-delivered treatment for substance abuse: Data from a multisite randomized controlled trial.

PubMed

Murphy, Sean M; Campbell, Aimee N C; Ghitza, Udi E; Kyle, Tiffany L; Bailey, Genie L; Nunes, Edward V; Polsky, Daniel

2016-04-01

Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES). Economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry). From the provider's perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU has at least a 95% chance of being considered cost-effective for providers and payers with willingness-to-pay thresholds as low as $20,000 per abstinent year. Findings for the subgroup not abstinent at study entry are slightly more favorable. With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.

PubMed

Montero-Odasso, Manuel; Almeida, Quincy J; Burhan, Amer M; Camicioli, Richard; Doyon, Julien; Fraser, Sarah; Li, Karen; Liu-Ambrose, Teresa; Middleton, Laura; Muir-Hunter, Susan; McIlroy, William; Morais, José A; Pieruccini-Faria, Frederico; Shoemaker, Kevin; Speechley, Mark; Vasudev, Akshya; Zou, G Y; Berryman, Nicolas; Lussier, Maxime; Vanderhaeghe, Leanne; Bherer, Louis

2018-04-16

Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .

Predictors of medication adherence in high risk youth of color living with HIV.

PubMed

Macdonell, Karen E; Naar-King, Sylvie; Murphy, Debra A; Parsons, Jeffrey T; Harper, Gary W

2010-07-01

To test predictors of medication adherence in high-risk racial or ethnic minority youth living with HIV (YLH) using a conceptual model of social cognitive predictors including a continuous measure of motivational readiness. Youth were participants in a multi-site clinical trial examining the efficacy of a motivational intervention. Racial-minority YLH (primarily African American) who were prescribed antiretroviral medication were included (N = 104). Data were collected using computer-assisted personal interviewing method via an Internet-based application and questionnaires. Using path analysis with bootstrapping, most youth reported suboptimal adherence, which predicted higher viral load. Higher motivational readiness predicted optimal adherence, and higher social support predicted readiness. Decisional balance was indirectly related to adherence. The model provided a plausible framework for understanding adherence in this population. Culturally competent interventions focused on readiness and social support may be helpful for improving adherence in YLH.

A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia.

PubMed

Wesson, Jacqueline; Clemson, Lindy; Brodaty, Henry; Lord, Stephen; Taylor, Morag; Gitlin, Laura; Close, Jacqueline

2013-09-03

People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes, yet there is currently no evidence to guide falls prevention in this population. A randomised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program. The program was tailored to participant's individual cognitive levels and implemented as a carer-supported intervention. Feasibility of recruitment, retention and implementation of intervention were recorded through observation and documented in field notes. Adherence, carer burden and use of task simplification strategies were also monitored. Outcome measures, collected at 12 weeks included physiological, fear of falling, cognitive and functional measures. Recruitment was achievable but may be more challenging in a multisite trial. Twenty two dyads of persons with mild dementia and their carers were randomised to intervention or usual care control group. Of 38 dyads referred to the study, there was a high rate of willingness to participate, with 6 (16%) declining and 10 (26%) not meeting inclusion criteria. The intervention was well received by participants and carers and adherence to both program components was very good. All participants implemented some home safety recommendations (range 19-80%) with half implementing 50% or more. At the end of 12 weeks, 72% of the intervention group were exercising. Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant (RR= 0.50 (95% CI 0.11-2.19). There were no differences in physiological outcome measures between the control and intervention groups. However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up. The pilot study was feasible and acceptable to people with mild dementia and their carers. The lessons learnt included: recruitment for a larger trial will require multiple approaches; home safety recommendations should provide a greater emphasis on environmental use compared with behavioural change; strategies to ensure an adequate dosage of exercise should be further explored. We recommend that intervention delivery incorporate an integrated occupational therapy and physiotherapy approach and that carers be provided with an individualised session to enhance dementia-specific skills in management and communication. A refined intervention should be tested in a randomised trial with an adequately powered sample size. Australia and New Zealand Clinical Trials Registry 126100001049066.

Gender Research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: A Summary of Findings

PubMed Central

Greenfield, Shelly F.; Rosa, Carmen; Putnins, Susan I.; Green, Carla A.; Brooks, Audrey J.; Calsyn, Donald A.; Cohen, Lisa R.; Erickson, Sarah; Gordon, Susan M.; Haynes, Louise; Killeen, Therese; Miele, Gloria; Tross, Susan; Winhusen, Theresa

2011-01-01

Background The NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable sub-groups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes. Objectives To review gender-related findings from published CTN clinical trials and related studies from January, 2000 through March, 2010. Methods CTN studies were selected for review if they focused on treatment outcomes or services for special populations of women with substance use disorders (SUDs) including those with trauma histories, pregnancy, co-occurring eating and other psychiatric disorders and HIV risk behaviors; or implemented gender-specific protocols. Results The CTN has randomized 11,500 participants (41% women) across 200 clinics in 24 randomized clinical trials in community settings, of which 4 have been gender-specific. This paper summarizes gender-related findings from CTN clinical trials and related studies, focusing on trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors. Conclusions These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. Scientific Relevance To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are adequate to support more nuanced analytic methods. PMID:21854272

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial

PubMed Central

2013-01-01

Background Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. Methods/Design In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. Discussion The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Trial registration Current Controlled Trials ISRCTN84216587 PMID:23317474

Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics.

PubMed

Robinson, Thomas N; Kraemer, Helena C; Matheson, Donna M; Obarzanek, Eva; Wilson, Darrell M; Haskell, William L; Pruitt, Leslie A; Thompson, Nikko S; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; McCarthy, Sally; Watanabe, Connie; Killen, Joel D

2008-01-01

African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income, pre-adolescent African-American girls. Randomized controlled trial with measurements scheduled in girls' homes at baseline, 6, 12, 18 and 24 month post-randomization. Low-income areas of Oakland, CA. Eight, nine and ten year old African-American girls and their parents/caregivers. Girls are randomized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention. Interventions last for 2 years for each participant. Change in body mass index over the two-year study. Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. Two-hundred sixty one (261) families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74 th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 h per day of screen media use, and diets high in energy from fat. The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income, pre-adolescent African-American girls.

Clinical Trials in Your Community

Cancer.gov

The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.

A Hybrid Web-Based and In-Person Self-Management Intervention to Prevent Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): Protocol for a Pilot Single-Blind Randomized Controlled Trial

PubMed Central

2017-01-01

Background Acute pain frequently transitions to chronic pain after major lower extremity trauma (ET). Several modifiable psychological risk and protective factors have been found to contribute to, or prevent, chronic pain development. Some empirical evidence has shown that interventions, including cognitive and behavioral strategies that promote pain self-management, could prevent chronic pain. However, the efficacy of such interventions has never been demonstrated in ET patients. We have designed a self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). Objective This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and research methods of the intervention, as well as the potential effects of iPACT-E-Trauma, on pain intensity and pain interference with daily activities. Methods A 2-arm single-blind pilot RCT will be conducted. Participants will receive the iPACT-E-Trauma intervention (experimental group) or an educational pamphlet (control group) combined with usual care. Data will be collected at baseline, during iPACT-E-Trauma delivery, as well as at 3 and 6 months post-injury. Primary outcomes are pain intensity and pain interference with daily living activities at 6 months post-injury. Secondary outcomes are pain self-efficacy, pain acceptance, pain catastrophizing, pain-related fear, anxiety and depression symptoms, health care service utilization, and return to work. Results Fifty-three patients were recruited at the time of manuscript preparation. Comprehensive data analyses will be initiated in July 2017. Study results are expected to be available in 2018. Conclusions Chronic pain is an important problem after major lower ET. However, no preventive intervention has yet been successfully proven in these patients. This study will focus on developing a feasible intervention to prevent acute to chronic pain transition in the context of ET. Findings will allow for the refinement of iPACT-E-Trauma and methodological parameters in prevision of a full-scale multi-site RCT. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs) PMID:28652226

Rhythm experience and Africana culture trial (REACT!): A culturally salient intervention to promote neurocognitive health, mood, and well-being in older African Americans.

PubMed

Lukach, Alexis J; Jedrziewski, M Kathryn; Grove, George A; Mechanic-Hamilton, Dawn J; Williams, Shardae S; Wollam, Mariegold E; Erickson, Kirk I

2016-05-01

The Rhythm Experience and Africana Culture Trial (REACT!) is a multi-site randomized controlled intervention study designed to examine the efficacy of using African Dance as a form of moderate-intensity physical activity to improve cognitive function in older African Americans. African Americans are almost two times more likely than Caucasians to experience cognitive impairment in late adulthood. This increased risk may be attributed to lower level and quality of education, lower socioeconomic status, and higher prevalence of vascular diseases, type 2 diabetes, hypertension, and obesity, all of which are recognized as risk factors for dementia. Fortunately, interventions targeting cardiovascular health (i.e., physical activity) are associated with improved neurocognitive function and a reduced risk for dementia, so African Americans may be particularly suited for interventions targeting cardiovascular health and cognitive function. Here, we describe a randomized intervention protocol for increasing physical activity in older (65-75years) African Americans. Participants (n=80) at two study locations will be randomized into one of two groups. The treatment group will participate in African Dance three times per week for six months and the control group will receive educational training on Africana history and culture, as well as information about health behaviors, three times per week for six months. If successful, the REACT! study may transform community interventions and serve as a platform and model for testing other populations, age groups, and health outcomes, potentially identifying novel and creative methods for reducing or eliminating health disparities. Copyright © 2016 Elsevier Inc. All rights reserved.

Rhythm experience and Africana culture trial (REACT!): A culturally salient intervention to promote neurocognitive health, mood, and well-being in older African Americans

PubMed Central

Lukach, Alexis J.; Jedrziewski, M. Kathryn; Grove, George A.; Mechanic-Hamilton, Dawn J.; Williams, Shardae S.; Wollam, Mariegold E.; Erickson, Kirk I.

2017-01-01

The Rhythm Experience and Africana Culture Trial (REACT!) is a multi-site randomized controlled intervention study designed to examine the efficacy of using African Dance as a form of moderate-intensity physical activity to improve cognitive function in older African Americans. African Americans are almost two times more likely than Caucasians to experience cognitive impairment in late adulthood. This increased risk may be attributed to lower level and quality of education, lower socioeconomic status, and higher prevalence of vascular diseases, type 2 diabetes, hypertension, and obesity, all of which are recognized as risk factors for dementia. Fortunately, interventions targeting cardiovascular health (i.e., physical activity) are associated with improved neurocognitive function and a reduced risk for dementia, so African Americans may be particularly suited for interventions targeting cardiovascular health and cognitive function. Here, we describe a randomized intervention protocol for increasing physical activity in older (65–75 years) African Americans. Participants (n = 80) at two study locations will be randomized into one of two groups. The treatment group will participate in African Dance three times per week for six months and the control group will receive educational training on Africana history and culture, as well as information about health behaviors, three times per week for six months. If successful, the REACT! study may transform community interventions and serve as a platform and model for testing other populations, age groups, and health outcomes, potentially identifying novel and creative methods for reducing or eliminating health disparities. PMID:27033674

Promising strategies for advancement in knowledge of suicide risk factors and prevention.

PubMed

Sareen, Jitender; Isaak, Corinne; Katz, Laurence Y; Bolton, James; Enns, Murray W; Stein, Murray B

2014-09-01

Suicide is an important public health problem. Although there have been advances in our knowledge of suicide, gaps remain in knowledge about suicide risk factors and prevention. Here, we discuss research pathways that have the potential to rapidly advance knowledge in suicide risk assessment and reduction of suicide deaths over the next decade. We provide a concise overview of the methodologic approaches that have the capacity to rapidly increase knowledge and change practice, which have been successful in past work in psychiatry and other areas of medicine. We suggest three specific pathways to advance knowledge of suicide risk factors and prevention. First, analysis of large-scale epidemiologic surveys and administrative data sets can advance the understanding of suicide. Second, given the low base rate of suicide, there is a need for networks/consortia of investigators in the field of suicide prevention. Such consortia have the capacity to analyze existing epidemiologic data sets, create multi-site cohort studies of high-risk groups to increase knowledge of biological and other risk factors, and create a platform for multi-site clinical trials. Third, partnerships with policymakers and researchers would facilitate careful scientific evaluation of policies and programs aimed at reducing suicide. Suicide intervention policies are often multifaceted, expensive, and rarely evaluated. Using quasi-experimental methods or sophisticated analytic strategies such as propensity score-matching techniques, the impact of large-scale interventions on suicide can be evaluated. Furthermore, such partnerships between policymakers and researchers can lead to the design and support of prospective RCTs (e.g., cluster randomized trials, stepped wedge designs, waiting list designs) in high-risk groups (e.g., people with a history of suicide attempts, multi-axial comorbidity, and offspring of people who have died by suicide). These research pathways could lead to rapid knowledge uptake between communities and have the strong potential to reduce suicide. Copyright © 2014 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Teen Online Problem Solving for Teens With Traumatic Brain Injury: Rationale, Methods, and Preliminary Feasibility of a Teen Only Intervention

PubMed Central

Wade, Shari L.; Narad, Megan E.; Kingery, Kathleen M.; Taylor, H. Gerry; Stancin, Terry; Kirkwood, Michael W.; Yeates, Keith O.

2017-01-01

Purpose/Objective To describe the Teen Online Problem Solving—Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving—Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11–18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Results Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). Conclusions/Implications TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. PMID:28836809

Implementation of Treat-to-Target in Rheumatoid Arthritis Through a Learning Collaborative: Results of a Randomized Controlled Trial.

PubMed

Solomon, Daniel H; Losina, Elena; Lu, Bing; Zak, Agnes; Corrigan, Cassandra; Lee, Sara B; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie R; Pincus, Theodore; Radner, Helga; Yu, Zhi; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N

2017-07-01

Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. © 2017, American College of Rheumatology.

Teen online problem solving for teens with traumatic brain injury: Rationale, methods, and preliminary feasibility of a teen only intervention.

PubMed

Wade, Shari L; Narad, Megan E; Kingery, Kathleen M; Taylor, H Gerry; Stancin, Terry; Kirkwood, Michael W; Yeates, Keith O

2017-08-01

To describe the Teen Online Problem Solving-Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving-Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design: This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11-18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The impact of gender on treatment effectiveness of body psychotherapy for negative symptoms of schizophrenia: a secondary analysis of the NESS trial data

PubMed Central

Savill, Mark; Orfanos, Stavros; Bentall, Richard; Reininghaus, Ulrich; Wykes, Til; Priebe, Stefan

2016-01-01

Despite promising findings from small-scale studies suggesting that body psychotherapy may be an effective treatment for negative symptoms, these results were not replicated in a recent multisite trial. In this trial a far smaller proportion of women were recruited relative to earlier studies, which may be an issue given the gender mix of the sample evaluated has been found to affect trial outcomes in schizophrenia. Using data from our multisite trial, the interaction between gender and treatment allocation as a predictor of outcomes was examined in 275 participants (72 women and 203 men) randomised to either a body psychotherapy or Pilates group. Negative symptoms were found to significantly reduce in women randomised to the body psychotherapy condition in comparison to Pilates, while no such effect was detected in men. Consistent with the smaller trials, this improvement was found to relate predominantly to expressive deficits. These findings suggest that body psychotherapy may be an effective treatment for negative symptoms in women. These findings emphasise the importance of sample characteristics in determining trial outcome in psychological treatment studies. PMID:27871030

Brief Strategic Family Therapy versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

ERIC Educational Resources Information Center

Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, Jose

2011-01-01

Objective: To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method: A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to…

The feasibility and efficacy of tobacco use prevention in orthodontics.

PubMed

Hovell, M F; Jones, J A; Adams, M A

2001-04-01

SMILES PLUS was the first study to extend the clinician-delivered logic model to prevention of tobacco use among adolescents. This multi-site trial with 154 participating offices, based on social learning theory and a behavioral ecological model, was designed to test whether orthodontists can prevent preteens from initiating smoking. The study found that orthodontists do not automatically adhere to anti-tobacco prevention services. Social learning variables can enhance both adherence to counseling guidelines and content of counseling to increase prevention effects. Providing financial incentives, tracking prescriptions, prompting positive feedback from patients, and adopting anti-tobacco counseling models in the office are likely to enhance anti-tobacco preventive services. Training orthodontists to be comfortable when advising nonsmoking youth not to start and to use social consequences to justify youth avoidance of tobacco might increase adherence to protocols and make their counseling more powerful. Adolescent smokers prior to intervention were more likely to start other risky behaviors later. Preventing tobacco use may halt additional risk behaviors and thereby reduce morbidity/mortality even more than expected from tobacco control alone. New and refined clinical trials should be conducted to determine the most effective interventions for adolescent tobacco control by clinicians.

Relationship power and sexual risk among women in community-based substance abuse treatment.

PubMed

Campbell, Aimee N C; Tross, Susan; Dworkin, Shari L; Hu, Mei-Chen; Manuel, Jennifer; Pavlicova, Martina; Nunes, Edward V

2009-11-01

Relationship power has been highlighted as a major factor influencing women's safer sex practices. Little research, however, has specifically examined relationship power in drug-involved women, a population with increased risk for HIV transmission. Using baseline data from a National Institute on Drug Abuse Clinical Trials Network multisite trial of a women's HIV prevention intervention in community-based drug treatment programs, this paper examined the association between sexual relationship power and unprotected vaginal or anal sex. The Sexual Relationship Power Scale, a measure of relationship control and decision-making dominance, was used to assess the association between power and unprotected sex in relationships with primary male partners. It was hypothesized that increased relationship power would be associated with decreased unprotected sexual occasions, after controlling for relevant empirical and theoretical covariates. Findings show a more complex picture of the association between power and sexual risk in this population, with a main effect in the hypothesized direction for decision-making dominance but not for relationship control. Possible explanations for these findings are discussed, and future research directions for examining power constructs and developing interventions targeting relationship power among drug-involved women are suggested.

Assessing intervention fidelity in a multi-level, multi-component, multi-site program: the Children's Healthy Living (CHL) program.

PubMed

Butel, Jean; Braun, Kathryn L; Novotny, Rachel; Acosta, Mark; Castro, Rose; Fleming, Travis; Powers, Julianne; Nigg, Claudio R

2015-12-01

Addressing complex chronic disease prevention, like childhood obesity, requires a multi-level, multi-component culturally relevant approach with broad reach. Models are lacking to guide fidelity monitoring across multiple levels, components, and sites engaged in such interventions. The aim of this study is to describe the fidelity-monitoring approach of The Children's Healthy Living (CHL) Program, a multi-level multi-component intervention in five Pacific jurisdictions. A fidelity-monitoring rubric was developed. About halfway during the intervention, community partners were randomly selected and interviewed independently by local CHL staff and by Coordinating Center representatives to assess treatment fidelity. Ratings were compared and discussed by local and Coordinating Center staff. There was good agreement between the teams (Kappa = 0.50, p < 0.001), and intervention improvement opportunities were identified through data review and group discussion. Fidelity for the multi-level, multi-component, multi-site CHL intervention was successfully assessed, identifying adaptations as well as ways to improve intervention delivery prior to the end of the intervention.

Dental Attendance Among Low-Income Women and Their Children Following a Brief Motivational Counseling Intervention: A Community Randomized Trial

PubMed Central

Weinstein, Philip; Mancl, Lloyd; Garson, Gayle; Huebner, Colleen E; Milgrom, Peter; Grembowski, David; Shepherd-Banigan, Megan; Smolen, Darlene; Sutherland, Marilynn

2015-01-01

This study tested a behavioral intervention to increase dental attendance among rural Oregonian low-income women and their children. It utilized a multi-site, single-blind, randomized trial design. Four hundred women were randomized into one of four conditions to receive prenatal or postpartum motivational interviewing/counseling (MI) or prenatal or postpartum health education (HE). Counselors also functioned as patient navigators. Primary outcomes were dental attendance during pregnancy for the mother and for the child by age 18 months. Attendance was obtained from the Oregon Division of Medical Assistance Programs and participant self-report. Statewide self-reported utilization data were obtained from the Oregon Pregnancy Risk Assessment Monitoring System (PRAMS). Maternal attendance was 92% in the prenatal MI group and 94% in the prenatal HE group (RR = 0.98; 95% CI = 0.93–1.04). Children’s attendance was 54% in postpartum MI group and 52% in the postpartum HE group (RR = 1.03; 95% CI = 0.82–1.28). Compared to statewide PRAMS, attendance was higher during pregnancy for study mothers (45% statewide; 95% CI = 40–50%) and for their children by 24 months (36% statewide; 95% CI = 27–44%). MI did not lead to greater attendance when compared to HE alone and cost more to implement. High attendance may be attributable to the counselors’ patient navigator function. Trial Registration: ClinicalTrials.gov Identifier NCT01120041 PMID:26372934

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia--a multi-centre randomised controlled trial.

PubMed

Priebe, Stefan; Savill, Mark; Reininghaus, Ulrich; Wykes, Til; Bentall, Richard; Lauber, Christoph; McCrone, Paul; Röhricht, Frank; Eldridge, Sandra

2013-01-14

Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Current Controlled Trials ISRCTN84216587.

Researching effective approaches to cleaning in hospitals: protocol of the REACH study, a multi-site stepped-wedge randomised trial.

PubMed

Hall, Lisa; Farrington, Alison; Mitchell, Brett G; Barnett, Adrian G; Halton, Kate; Allen, Michelle; Page, Katie; Gardner, Anne; Havers, Sally; Bailey, Emily; Dancer, Stephanie J; Riley, Thomas V; Gericke, Christian A; Paterson, David L; Graves, Nicholas

2016-03-24

The Researching Effective Approaches to Cleaning in Hospitals (REACH) study will generate evidence about the effectiveness and cost-effectiveness of a novel cleaning initiative that aims to improve the environmental cleanliness of hospitals. The initiative is an environmental cleaning bundle, with five interdependent, evidence-based components (training, technique, product, audit and communication) implemented with environmental services staff to enhance hospital cleaning practices. The REACH study will use a stepped-wedge randomised controlled design to test the study intervention, an environmental cleaning bundle, in 11 Australian hospitals. All trial hospitals will receive the intervention and act as their own control, with analysis undertaken of the change within each hospital based on data collected in the control and intervention periods. Each site will be randomised to one of the 11 intervention timings with staggered commencement dates in 2016 and an intervention period between 20 and 50 weeks. All sites complete the trial at the same time in 2017. The inclusion criteria allow for a purposive sample of both public and private hospitals that have higher-risk patient populations for healthcare-associated infections (HAIs). The primary outcome (objective one) is the monthly number of Staphylococcus aureus bacteraemias (SABs), Clostridium difficile infections (CDIs) and vancomycin resistant enterococci (VRE) infections, per 10,000 bed days. Secondary outcomes for objective one include the thoroughness of hospital cleaning assessed using fluorescent marker technology, the bio-burden of frequent touch surfaces post cleaning and changes in staff knowledge and attitudes about environmental cleaning. A cost-effectiveness analysis will determine the second key outcome (objective two): the incremental cost-effectiveness ratio from implementation of the cleaning bundle. The study uses the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework to support the tailored implementation of the environmental cleaning bundle in each hospital. Evidence from the REACH trial will contribute to future policy and practice guidelines about hospital environmental cleaning. It will be used by healthcare leaders and clinicians to inform decision-making and implementation of best-practice infection prevention strategies to reduce HAIs in hospitals. Australia New Zealand Clinical Trial Registry ACTRN12615000325505.

A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

PubMed

Lifson, Alan R; Workneh, Sale; Hailemichael, Abera; MacLehose, Richard F; Horvath, Keith J; Hilk, Rose; Fabian, Lindsey; Sites, Anne; Shenie, Tibebe

2018-06-01

Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm 3 , and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.

Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01]--study protocol and baseline practice and provider characteristics.

PubMed

Persell, Stephen D; Friedberg, Mark W; Meeker, Daniella; Linder, Jeffrey A; Fox, Craig R; Goldstein, Noah J; Shah, Parth D; Knight, Tara K; Doctor, Jason N

2013-06-27

Inappropriate antibiotic prescribing for nonbacterial infections leads to increases in the costs of care, antibiotic resistance among bacteria, and adverse drug events. Acute respiratory infections (ARIs) are the most common reason for inappropriate antibiotic use. Most prior efforts to decrease inappropriate antibiotic prescribing for ARIs (e.g., educational or informational interventions) have relied on the implicit assumption that clinicians inappropriately prescribe antibiotics because they are unaware of guideline recommendations for ARIs. If lack of guideline awareness is not the reason for inappropriate prescribing, educational interventions may have limited impact on prescribing rates. Instead, interventions that apply social psychological and behavioral economic principles may be more effective in deterring inappropriate antibiotic prescribing for ARIs by well-informed clinicians. The Application of Behavioral Economics to Improve the Treatment of Acute Respiratory Infections (BEARI) Trial is a multisite, cluster-randomized controlled trial with practice as the unit of randomization. The primary aim is to test the ability of three interventions based on behavioral economic principles to reduce the rate of inappropriate antibiotic prescribing for ARIs. We randomized practices in a 2 × 2 × 2 factorial design to receive up to three interventions for non-antibiotic-appropriate diagnoses: 1) Accountable Justifications: When prescribing an antibiotic for an ARI, clinicians are prompted to record an explicit justification that appears in the patient electronic health record; 2) Suggested Alternatives: Through computerized clinical decision support, clinicians prescribing an antibiotic for an ARI receive a list of non-antibiotic treatment choices (including prescription options) prior to completing the antibiotic prescription; and 3) Peer Comparison: Each provider's rate of inappropriate antibiotic prescribing relative to top-performing peers is reported back to the provider periodically by email. We enrolled 269 clinicians (practicing attending physicians or advanced practice nurses) in 49 participating clinic sites and collected baseline data. The primary outcome is the antibiotic prescribing rate for office visits with non-antibiotic-appropriate ARI diagnoses. Secondary outcomes will examine antibiotic prescribing more broadly. The 18-month intervention period will be followed by a one year follow-up period to measure persistence of effects after interventions cease. The ongoing BEARI Trial will evaluate the effectiveness of behavioral economic strategies in reducing inappropriate prescribing of antibiotics. ClinicalTrials.gov: NCT01454947.

An Experimental Study of Procedures to Enhance Ratings of Fidelity to an Evidence-Based Family Intervention.

PubMed

Smith, Justin D; Dishion, Thomas J; Brown, Kimbree; Ramos, Karina; Knoble, Naomi B; Shaw, Daniel S; Wilson, Melvin N

2016-01-01

The valid and reliable assessment of fidelity is critical at all stages of intervention research and is particularly germane to interpreting the results of efficacy and implementation trials. Ratings of protocol adherence typically are reliable, but ratings of therapist competence are plagued by low reliability. Because family context and case conceptualization guide the therapist's delivery of interventions, the reliability of fidelity ratings might be improved if the coder is privy to client context in the form of an ecological assessment. We conducted a randomized experiment to test this hypothesis. A subsample of 46 families with 5-year-old children from a multisite randomized trial who participated in the feedback session of the Family Check-Up (FCU) intervention were selected. We randomly assigned FCU feedback sessions to be rated for fidelity to the protocol using the COACH rating system either after the coder reviewed the results of a recent ecological assessment or had not. Inter-rater reliability estimates of fidelity ratings were meaningfully higher for the assessment information condition compared to the no-information condition. Importantly, the reliability of the COACH mean score was found to be statistically significantly higher in the information condition. These findings suggest that the reliability of observational ratings of fidelity, particularly when the competence or quality of delivery is considered, could be improved by providing assessment data to the coders. Our findings might be most applicable to assessment-driven interventions, where assessment data explicitly guides therapist's selection of intervention strategies tailored to the family's context and needs, but they could also apply to other intervention programs and observational coding of context-dependent therapy processes, such as the working alliance.

An Experimental Study of Procedures to Enhance Ratings of Fidelity to an Evidence-Based Family Intervention

PubMed Central

Smith, Justin D.; Dishion, Thomas J.; Brown, Kimbree; Ramos, Karina; Knoble, Naomi B.; Shaw, Daniel S.; Wilson, Melvin N.

2015-01-01

The valid and reliable assessment of fidelity is critical at all stages of intervention research and is particularly germane to interpreting the results of efficacy and implementation trials. Ratings of protocol adherence typically are reliable, but ratings of therapist competence are plagued by low reliability. Because family context and case conceptualization guide the therapist's delivery of interventions, the reliability of fidelity ratings might be improved if the coder is privy to client context in the form of an ecological assessment. We conducted a randomized experiment to test this hypothesis. A subsample of 46 families with 5-year-old children from a multisite randomized trial who participated in the feedback session of the Family Check-Up (FCU) intervention were selected. We randomly assigned FCU feedback sessions to be rated for fidelity to the protocol using the COACH rating system either after the coder reviewed the results of a recent ecological assessment or had not. Inter-rater reliability estimates of fidelity ratings were meaningfully higher for the assessment information condition compared to the no-information condition. Importantly, the reliability of the COACH mean score was found to be statistically significantly higher in the information condition. These findings suggest that the reliability of observational ratings of fidelity, particularly when the competence or quality of delivery is considered, could be improved by providing assessment data to the coders. Our findings might be most applicable to assessment-driven interventions, where assessment data explicitly guides therapist's selection of intervention strategies tailored to the family's context and needs, but they could also apply to other intervention programs and observational coding of context-dependent therapy processes, such as the working alliance. PMID:26271300

Study design and protocol for a culturally adapted cognitive behavioral stress and self-management intervention for localized prostate cancer: The Encuentros de Salud study.

PubMed

Penedo, Frank J; Antoni, Michael H; Moreno, Patricia I; Traeger, Lara; Perdomo, Dolores; Dahn, Jason; Miller, Gregory E; Cole, Steve; Orjuela, Julian; Pizarro, Edgar; Yanez, Betina

2018-06-14

Almost 2.8 million men in the U.S. are living with prostate cancer (PC), accounting for 40% of all male cancer survivors. Men diagnosed with prostate cancer may experience chronic and debilitating treatment side effects, including sexual and urinary dysfunction, pain and fatigue. Side effects can be stressful and can also lead to poor psychosocial functioning. Prior trials reveal that group-based cognitive behavioral stress and self-management (CBSM) is effective in reducing stress and mitigating some of these symptoms, yet little is known about the effects of culturally-translated CBSM among Spanish-speaking men with PC. This manuscript describes the rationale and study design of a multi-site, randomized controlled trial to determine whether participation in a culturally adapted cognitive behavioral stress management (C-CBSM) intervention leads to significantly greater reductions in symptom burden and improvements in health-related quality of life relative to participation in a non-culturally adapted cognitive behavioral stress management (CBSM) intervention. Participants (N = 260) will be Spanish-speaking Hispanic/Latino men randomized to the standard, non-culturally adapted CBSM intervention (e.g., cognitive behavioral strategies, stress management, and health maintenance) or the culturally adapted C-CBSM intervention (e.g., content adapted to be compatible with Hispanic/Latino cultural patterns and belief systems, meanings, values and social context) for 10 weeks. Primary outcomes (i.e., disease-specific symptom burden and health-related quality of life) will be assessed across time. We hypothesize that a culturally adapted C-CBSM intervention will be more efficacious in reducing symptom burden and improving health-related quality of life among Hispanic/Latino men when compared to a non-culturally adapted CBSM intervention. Copyright © 2017. Published by Elsevier Inc.

Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial.

PubMed

Williams, Grant R; Nyrop, Kirsten A; Deal, Allison M; Muss, Hyman B; Sanoff, Hanna K

2015-05-01

Colorectal cancer (CRC) diagnosis and treatment can have substantial detrimental impacts on health related quality of life (HRQOL) and physical function. This is especially true for older CRC patients and is of paramount concern in chemotherapy treatment decision making; yet, few studies to date have focused on understanding and managing fatigue in older CRC patients. We present the design of a study to evaluate the feasibility and impact of a home-based, self-directed physical activity intervention on fatigue in older CRC patients receiving adjuvant chemotherapy treatment. Secondary aims pertain to intervention impact on HRQOL, physical function, and self-efficacy for managing fatigue. Multi-site, randomized controlled trial of physical activity intervention compared to usual care in a sample of older adults undergoing adjuvant chemotherapy for CRC. Forty CRC patients will be recruited and study questionnaires/assessments will be performed at baseline, 3 months, and after completion of adjuvant chemotherapy. The primary outcome is a comparison of the change in fatigue from baseline to 3 months between Intervention and Control arms. We will also compare changes in engagement in physical activity, HRQOL, physical function, and self-efficacy. Exploratory analyses will compare Intervention and Control arms with regard to changes in muscle mass and a biomarker aging that is known to increase during chemotherapy (p16(INK4a)). If positive, findings from this pilot study would suggest the potential for improving the care of older persons with CRC undergoing adjuvant chemotherapy through a home-based physical activity intervention to manage fatigue, HRQOL, and physical function. NCT02191969. Copyright © 2015 Elsevier Inc. All rights reserved.

Improving health outcomes for youth living with the human immunodeficiency virus: a multisite randomized trial of a motivational intervention targeting multiple risk behaviors.

PubMed

Naar-King, Sylvie; Parsons, Jeffrey T; Murphy, Debra A; Chen, Xinguang; Harris, D Robert; Belzer, Marvin E

2009-12-01

To determine if Healthy Choices, a motivational interviewing intervention targeting multiple risk behaviors, improved human immunodeficiency virus (HIV) viral load. A randomized, 2-group repeated measures design with analysis of data from baseline and 6- and 9-month follow-up collected from 2005 to 2007. Five US adolescent medicine HIV clinics. A convenience sample with at least 1 of 3 risk behaviors (nonadherence to HIV medications, substance abuse, and unprotected sex) was enrolled. The sample was aged 16 to 24 years and primarily African American. Of the 205 enrolled, 19 did not complete baseline data collections, for a final sample size of 186. Young people living with HIV were randomized to the intervention plus specialty care (n = 94) or specialty care alone (n = 92). The 3- and 6-month follow-up rates, respectively, were 86% and 82% for the intervention group and 81% and 73% for controls. Intervention Healthy Choices was a 4-session individual clinic-based motivational interviewing intervention delivered during a 10-week period. Motivational interviewing is a method of communication designed to elicit and reinforce intrinsic motivation for change. Outcome Measure Plasma viral load. Youth randomized to Healthy Choices showed a significant decline in viral load at 6 months postintervention compared with youth in the control condition (beta = -0.36, t = -2.15, P = .03), with those prescribed antiretroviral medications showing the lowest viral loads. Differences were no longer significant at 9 months. A motivational interviewing intervention targeting multiple risk behaviors resulted in short-term improvements in viral load for youth living with HIV. Trial Registration clinicaltrials.gov Identifier: NCT00103532.

Project Eban: An HIV/STD Intervention for African American Couples

PubMed Central

2010-01-01

Objective To describe the Eban HIV/STD Risk Reduction Intervention being evaluated in the NIMH Multisite HIV/STD Prevention trial for heterosexual African American couples, including the integrated theoretical framework, the structure, core elements and procedures of the intervention and how the content was shaped by culturally congruent concepts to address the needs of the study target population. Design The Eban HIV/STD Risk Reduction Intervention is designed to address multilevel individual, interpersonal and community level factors that contribute to HIV/STD transmission risk behaviors among heterosexual African American couples who are HIV serodiscordant. Methods The Eban HIV/STD Risk Reduction Intervention employs a mixed modality, couples-based approach that is based on an integrated ecological framework incorporating social cognitive theory and uses an Afro-centric paradigm that is informed by previous evidence-based couples HIV prevention interventions. For this randomized controlled trial, African American serodiscordant couples were recruited from four urban sites (Atlanta, Los Angeles, New York and Philadelphia) and were randomized to either the Eban HIV/STD Risk Reduction Intervention (treatment condition) or a Health Promotion Intervention that served as an attentional control condition. Both interventions had 4 individual couple sessions and 4 group sessions, but only the treatment condition was focused on reducing HIV/STD risk behaviors. Behavioral and biological data were collected at baseline, immediately after the intervention, and at 6 and 12 months. The theoretical framework, core elements and content of each session are described and lessons learned from this intervention trial are discussed. Results An HIV prevention intervention combining couple and group sessions can be feasibly implemented with African American HIV serodiscordant couples who remain at high risk of HIV/STD transmission. The lessons learned from the trial suggest that the participants responded very well to both the couple and group sessions. Participant feedback suggests that the cultural congruence of the intervention and use of African American co-facilitators made them feel comfortable disclosing risky behaviors. Participant feedback also suggests that the intervention’s couples-based focus on enhancing dyadic communication and decision-making skills were key to helping the couples work together to overcome barriers to using condoms. Conclusion Participant and facilitator evaluations of the Eban Risk Reduction Intervention suggest that couples responded well to the Afro-centric content and mixed modalities of the intervention sessions. Couple sessions were optimal for enhancing interpersonal and microlevel factors, including communication, problem solving, and decision making. PMID:18724186

Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

PubMed Central

Law, Mary; Darrah, Johanna; Pollock, Nancy; Rosenbaum, Peter; Russell, Dianne; Walter, Stephen D; Petrenchik, Theresa; Wilson, Brenda; Wright, Virginia

2007-01-01

Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment). Discussion This paper presents the background information, design and protocol for a randomized controlled trial comparing a task/context-focused approach to a child-focused remediation approach in improving functional outcomes for young children with cerebral palsy. Trial registration [clinical trial registration #: NCT00469872] PMID:17900362

A Framework for Designing Cluster Randomized Trials with Binary Outcomes

ERIC Educational Resources Information Center

Spybrook, Jessaca; Martinez, Andres

2011-01-01

The purpose of this paper is to provide a frame work for approaching a power analysis for a CRT (cluster randomized trial) with a binary outcome. The authors suggest a framework in the context of a simple CRT and then extend it to a blocked design, or a multi-site cluster randomized trial (MSCRT). The framework is based on proportions, an…

Brief Report: Social Disability in Autism Spectrum Disorder--Results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Trials

ERIC Educational Resources Information Center

Scahill, Lawrence; Hallett, Victoria; Aman, Michael G.; McDougle, Christopher J.; Arnold, L. Eugene; McCracken, James T.; Tierney, Elaine; Deng, Yanhong; Dziura, James; Vitiello, Benedetto

2013-01-01

There is growing interest in measuring social disability as a core element of autism spectrum disorders in medication trials. We conducted a secondary analysis on the Aberrant Behavior Checklist Social Withdrawal subscale using data from two federally-funded, multi-site, randomized trials with risperidone. Study 1 included 52 subjects assigned to…

Cost of Behavioral Interventions Utilizing Electronic Drug Monitoring for Antiretroviral Therapy Adherence

PubMed Central

Rasu, Rafia S.; Malewski, David F.; Banderas, Julie W.; Thomson, Domonique Malomo; Goggin, Kathy

2013-01-01

Objective To provide data on the actual costs associated with behavioral ART adherence interventions and electronic drug monitoring used in a clinical trial to inform their implementation in future studies and real-world practice. Methods Direct and time costs were calculated from a multi-site three-arm randomized controlled ART adherence trial. HIV positive participants (n = 204) were randomized to standard care (SC), enhanced counseling (EC), or EC and modified directly observed therapy (mDOT) interventions. Electronic drug monitoring (EDM) was used. Costs were calculated for various components of the 24-week adherence intervention. This economic evaluation was conducted from the perspective of an agency that may wish to implement these strategies. Sensitivity analyses were conducted to examine costs and savings associated with different scenarios. Results Total direct costs were $126,068 ($618/patient). Initial time costs were $53,590 ($262/patient). Base cost of labor was $0.36/minute. EC costs for 134 patients were $18,427 ($137/patient) and mDOT for 64 patients cost $18,638 ($291/patient). Total per patient costs were: SC=$880, EC=$1,018, EC/mDOT=$1,309. Removing driving costs evidenced the most variable impact on savings between the three study arms. The tornado diagram (sensitivity analysis) showed a graphical representation of how each sensitivity assumption reduced costs compared to each other and the resulting comparative costs for each group. Conclusion This novel economic analysis provides valuable cost information to guide treatment implementation and research design decisions. PMID:23337364

Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

ERIC Educational Resources Information Center

Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

2009-01-01

A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

A multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission.

PubMed

Shepperd, Sasha; Cradduck-Bamford, Andrea; Butler, Chris; Ellis, Graham; Godfrey, Mary; Gray, Alastair; Hemsley, Anthony; Khanna, Pradeep; Langhorne, Peter; McCaffrey, Patricia; Mirza, Lubena; Pushpangadan, Maj; Ramsay, Scott; Schiff, Rebekah; Stott, David; Young, John; Yu, Ly-Mee

2017-10-23

There is concern that existing models of acute hospital care will become unworkable as the health service admits an increasing number of frail older people with complex health needs, and that there is inadequate evidence to guide the planning of acute hospital level services. We aim to evaluate whether geriatrician-led admission avoidance to hospital at home is an effective alternative to hospital admission. We are conducting a multi-site randomised open trial of geriatrician-led admission avoidance hospital at home, compared with admission to hospital. We are recruiting older people with markers of frailty or prior dependence who have been referred to admission avoidance hospital at home for an acute medical event. This includes patients presenting with delirium, functional decline, dependence, falls, immobility or a background of dementia presenting with physical disease. Participants are randomised using a computerised random number generator to geriatrician-led admission avoidance hospital at home or a control group of inpatient admission in a 2:1 ratio in favour of the intervention. The primary endpoint 'living at home' (the inverse of death or living in a residential care setting) is measured at 6 months follow-up, and we also collect data on this outcome at 12 months. Secondary outcomes include the incidence of delirium, mortality, new long-term residential care, cognitive impairment, activities of daily living, quality of life and quality-adjusted survival, length of stay, readmission or transfer to hospital. We will conduct a parallel economic evaluation, and a process evaluation that includes an interview study to explore the experiences of patients and carers. Health systems around the world are examining how to provide acute hospital-level care to older adults in greater numbers with a fixed or shrinking hospital resource. This trial is the first large multi-site randomised trial of geriatrician-led admission avoidance hospital at home, and will provide evidence on alternative models of healthcare for older people who require hospital admission. ISRCTN60477865 : Registered on 10 March 2014. Trial Sponsor: University of Oxford. Version 3.1, 14/06/2016.

Project STYLE: a multisite RCT for HIV prevention among youths in mental health treatment.

PubMed

Brown, Larry K; Hadley, Wendy; Donenberg, Geri R; DiClemente, Ralph J; Lescano, Celia; Lang, Delia M; Crosby, Richard; Barker, David; Oster, Danielle

2014-03-01

The study examined the efficacy of family-based and adolescent-only HIV prevention programs in decreasing HIV risk and improving parental monitoring and sexual communication among youths in mental health treatment. A randomized controlled trial (RCT) with 721 adolescents (ages 13-18 years) and their caregivers from mental health settings in three U.S. cities were randomly assigned to one of three theory-based, structured group interventions: family-based HIV prevention, adolescent-only HIV prevention, and adolescent-only health promotion. Interventions were delivered during an all-day workshop. Assessments were completed at baseline and three months postintervention. Compared with those in the health intervention, adolescents in the HIV prevention interventions reported fewer unsafe sex acts (adjusted rate ratio=.49, p=.01), greater condom use (adjusted relative change=59%, p=.01), and greater likelihood of avoiding sex (adjusted odds ratio=1.44, p=.05). They also showed improved HIV knowledge (p<.01) and self-efficacy (p<.05). The family-based intervention, compared with the other interventions, produced significant improvements in parent-teen sexual communication (p<.01), parental monitoring (p<.01), and parental permissiveness (p=.05). This RCT found that the HIV prevention interventions reduced sexual risk behavior over three months in a large, diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex. These interventions show promise.

Gender-transformative Bandebereho couples' intervention to promote male engagement in reproductive and maternal health and violence prevention in Rwanda: Findings from a randomized controlled trial.

PubMed

Doyle, Kate; Levtov, Ruti G; Barker, Gary; Bastian, Gautam G; Bingenheimer, Jeffrey B; Kazimbaya, Shamsi; Nzabonimpa, Anicet; Pulerwitz, Julie; Sayinzoga, Felix; Sharma, Vandana; Shattuck, Dominick

2018-01-01

Rigorous evidence of the effectiveness of male engagement interventions, particularly on how these interventions impact relationship power dynamics and women's decision-making, remains limited. This study assessed the impact of the Bandebereho gender-transformative couples' intervention on impact on multiple behavioral and health-related outcomes influenced by gender norms and power relations. We conducted a multi-site randomised controlled trial in four Rwandan districts with expectant/current fathers and their partners, who were randomised to the intervention (n = 575 couples) or control group (n = 624 couples). Primary outcomes include women's experience of physical and sexual IPV, women's attendance and men's accompaniment at ANC, modern contraceptive use, and partner support during pregnancy. At 21-months post-baseline, 1123 men and 1162 partners were included in intention to treat analysis. Generalized estimating equations with robust standard errors were used to fit the models. The Bandebereho intervention led to substantial improvements in multiple reported outcomes. Compared to the control group, women in the intervention group reported: less past-year physical (OR 0.37, p<0.001) and sexual IPV (OR 0.34, p<0.001); and greater attendance (IRR 1.09, p<0.001) and male accompaniment at antenatal care (IRR 1.50, p<0.001); and women and men in the intervention group reported: less child physical punishment (women: OR 0.56, p = 0.001; men: OR 0.66, p = 0.005); greater modern contraceptive use (women: OR 1.53, p = 0.004; men: OR 1.65, p = 0.001); higher levels of men's participation in childcare and household tasks (women: beta 0.39, p<0.001; men: beta 0.33, p<0.001); and less dominance of men in decision-making. Our study strengthens the existing evidence on male engagement approaches; together with earlier studies our findings suggest that culturally adapted gender-transformative interventions with men and couples can be effective at changing deeply entrenched gender inequalities and a range of health-related behavioral outcomes. ClinicalTrials.gov NCT02694627.

Pathways curriculum and family interventions to promote healthful eating and physical activity in American Indian schoolchildren

PubMed Central

Davis, Sally M.; Clay, Theresa; Smyth, Mary; Gittelsohn, Joel; Arviso, Vivian; Flint-Wagner, Hilary; Rock, Bonnie Holy; Brice, Richard A.; Metcalfe, Lauve; Stewart, Dawn; Vu, Maihan; Stone, Elaine J.

2016-01-01

Background Pathways, a multisite school-based study aimed at promoting healthful eating and increasing physical activity, was a randomized field trial including 1704 American Indian third to fifth grade students from 41 schools (21 intervention, 20 controls) in seven American Indian communities. Methods The intervention schools received four integrated components: a classroom curriculum, food service, physical activity, and family modules. The curriculum and family components were based on Social Learning Theory, American Indian concepts, and results from formative research. Process evaluation data were collected from teachers (n = 235), students (n = 585), and families. Knowledge, Attitudes, and Behavior Questionnaire data were collected from 1150 students including both intervention and controls. Results There were significant increases in knowledge and cultural identity in children in intervention compared to control schools with a significant retention of knowledge over the 3 years, based on the results of repeating the third and fourth grade test items in the fifth grade. Family members participated in Family Events and take-home activities, with fewer participating each year. Conclusion A culturally appropriate school intervention can promote positive changes in knowledge, cultural identity, and self-reported healthful eating and physical activity in American Indian children and environmental change in school food service. PMID:14636806

Designing an audio computer-assisted self-interview (ACASI) system in a multisite trial: a brief report.

PubMed

2008-09-01

To describe the advantages and limitations of an audio computer-assisted self-interview (ACASI) system in a multisite trial with African American couples and to present the steps in designing, testing, and implementing a system. The ACASI system evolved from a paper and pencil interview that was pilot tested. Based on this initial work, the paper and pencil interview was translated into storyboards that were the basis of the development of ACASI system. Storyboards consisted of 1 page per question and provided the programmers with the test of the question, valid responses, and any instructions that were to be read to the participants. Storyboards were further translated into flow diagrams representing each module of the survey and illustrating the skip patterns used to navigate a participant through the survey. Provisions were also made to insert a face-to-face interview, into the ACASI assessment process, to elicit sexual abuse history data, which typically requires specially trained data collectors with active listening skills to help participants reframe and coordinate times, places and, emotionally difficult memories. The ACASI was successfully developed and implemented in the main trial. During an exit interview, respondents indicated that they liked using the ACASI and indicating that they favored it as the method to answer questions. It is feasible to implement an ACASI system in a multisite study in a timely and efficient way.

Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01] - study protocol and baseline practice and provider characteristics

PubMed Central

2013-01-01

Background Inappropriate antibiotic prescribing for nonbacterial infections leads to increases in the costs of care, antibiotic resistance among bacteria, and adverse drug events. Acute respiratory infections (ARIs) are the most common reason for inappropriate antibiotic use. Most prior efforts to decrease inappropriate antibiotic prescribing for ARIs (e.g., educational or informational interventions) have relied on the implicit assumption that clinicians inappropriately prescribe antibiotics because they are unaware of guideline recommendations for ARIs. If lack of guideline awareness is not the reason for inappropriate prescribing, educational interventions may have limited impact on prescribing rates. Instead, interventions that apply social psychological and behavioral economic principles may be more effective in deterring inappropriate antibiotic prescribing for ARIs by well-informed clinicians. Methods/design The Application of Behavioral Economics to Improve the Treatment of Acute Respiratory Infections (BEARI) Trial is a multisite, cluster-randomized controlled trial with practice as the unit of randomization. The primary aim is to test the ability of three interventions based on behavioral economic principles to reduce the rate of inappropriate antibiotic prescribing for ARIs. We randomized practices in a 2 × 2 × 2 factorial design to receive up to three interventions for non-antibiotic-appropriate diagnoses: 1) Accountable Justifications: When prescribing an antibiotic for an ARI, clinicians are prompted to record an explicit justification that appears in the patient electronic health record; 2) Suggested Alternatives: Through computerized clinical decision support, clinicians prescribing an antibiotic for an ARI receive a list of non-antibiotic treatment choices (including prescription options) prior to completing the antibiotic prescription; and 3) Peer Comparison: Each provider’s rate of inappropriate antibiotic prescribing relative to top-performing peers is reported back to the provider periodically by email. We enrolled 269 clinicians (practicing attending physicians or advanced practice nurses) in 49 participating clinic sites and collected baseline data. The primary outcome is the antibiotic prescribing rate for office visits with non-antibiotic-appropriate ARI diagnoses. Secondary outcomes will examine antibiotic prescribing more broadly. The 18-month intervention period will be followed by a one year follow-up period to measure persistence of effects after interventions cease. Discussion The ongoing BEARI Trial will evaluate the effectiveness of behavioral economic strategies in reducing inappropriate prescribing of antibiotics. Trials registration ClinicalTrials.gov: NCT01454947 PMID:23806017

Safer Sex Media Messages and Adolescent Sexual Behavior: 3-Year Follow-Up Results From Project iMPPACS

PubMed Central

Romer, Daniel; Valois, Robert F.; Vanable, Peter; Carey, Michael P.; Stanton, Bonita; Brown, Larry; DiClemente, Ralph; Salazar, Laura F.

2013-01-01

Objectives. We estimated the long-term (36-month) effects of Project iMPPACS, a multisite randomized controlled trial of mass media and small-group intervention for African American adolescents. Methods. We collected 6 waves of longitudinal data on program participants aged 14 to 17 years (n = 1139) in Providence, Rhode Island; Syracuse, New York; Columbia, South Carolina; and Macon, Georgia, 36 months (December 2009–December 2010) after the intervention began (August 2006–January 2008). Seemingly unrelated regressions at each wave estimated the effects of 3 types of mass media messages (the thematic mediators: selection, pleasure, and negotiation) on condom use intention and self-reported unprotected vaginal sex events. Results. All 3 mediators of behavior change that were introduced during the media intervention were sustained at the follow-up assessments at least 18 months after the intervention ended, with intention having the largest correlation. Unprotected vaginal sex increased with each wave of the study, although cities receiving media exposure had smaller increases. Conclusions. Project iMPPACS demonstrates that mass media influence delivered over an extended period, when adolescents were beginning to learn patterns of behavior associated with sex, persisted after the media program ended. PMID:23153149

Safer sex media messages and adolescent sexual behavior: 3-year follow-up results from project iMPPACS.

PubMed

Hennessy, Michael; Romer, Daniel; Valois, Robert F; Vanable, Peter; Carey, Michael P; Stanton, Bonita; Brown, Larry; DiClemente, Ralph; Salazar, Laura F

2013-01-01

We estimated the long-term (36-month) effects of Project iMPPACS, a multisite randomized controlled trial of mass media and small-group intervention for African American adolescents. We collected 6 waves of longitudinal data on program participants aged 14 to 17 years (n = 1139) in Providence, Rhode Island; Syracuse, New York; Columbia, South Carolina; and Macon, Georgia, 36 months (December 2009-December 2010) after the intervention began (August 2006-January 2008). Seemingly unrelated regressions at each wave estimated the effects of 3 types of mass media messages (the thematic mediators: selection, pleasure, and negotiation) on condom use intention and self-reported unprotected vaginal sex events. All 3 mediators of behavior change that were introduced during the media intervention were sustained at the follow-up assessments at least 18 months after the intervention ended, with intention having the largest correlation. Unprotected vaginal sex increased with each wave of the study, although cities receiving media exposure had smaller increases. Project iMPPACS demonstrates that mass media influence delivered over an extended period, when adolescents were beginning to learn patterns of behavior associated with sex, persisted after the media program ended.

A Randomized Controlled Trial to Compare Computer-assisted Motivational Intervention with Didactic Educational Counseling to Reduce Unprotected Sex in Female Adolescents.

PubMed

Gold, Melanie A; Tzilos, Golfo K; Stein, L A R; Anderson, Bradley J; Stein, Michael D; Ryan, Christopher M; Zuckoff, Allan; DiClemente, Carlo

2016-02-01

To examine a computer-assisted, counselor-guided motivational intervention (CAMI) aimed at reducing the risk of unprotected sexual intercourse. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: We conducted a 9-month, longitudinal randomized controlled trial with a multisite recruitment strategy including clinic, university, and social referrals, and compared the CAMI with didactic educational counseling in 572 female adolescents with a mean age of 17 years (SD = 2.2 years; range = 13-21 years; 59% African American) who were at risk for pregnancy and sexually transmitted diseases. The primary outcome was the acceptability of the CAMI according to self-reported rating scales. The secondary outcome was the reduction of pregnancy and sexually transmitted disease risk using a 9-month, self-report timeline follow-back calendar of unprotected sex. The CAMI was rated easy to use. Compared with the didactic educational counseling, there was a significant effect of the intervention which suggested that the CAMI helped reduce unprotected sex among participants who completed the study. However, because of the high attrition rate, the intent to treat analysis did not demonstrate a significant effect of the CAMI on reducing the rate of unprotected sex. Among those who completed the intervention, the CAMI reduced unprotected sex among an at-risk, predominantly minority sample of female adolescents. Modification of the CAMI to address methodological issues that contributed to a high drop-out rate are needed to make the intervention more acceptable and feasible for use among sexually active predominantly minority, at-risk, female adolescents. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Increasing the response rate of text messaging data collection: a delayed randomized controlled trial

PubMed Central

Li, Ye; Wang, Wei; Wu, Qiong; van Velthoven, Michelle Helena; Chen, Li; Du, Xiaozhen; Zhang, Yanfeng; Rudan, Igor; Car, Josip

2015-01-01

Objective To test the effectiveness of multiple interventions on increasing the response rate of text messaging for longitudinal data collection. Methods Our cohort included 283 caregivers of children aged 6–12 months who were participating in an anemia program in rural China. Using text messages to collect data on anemia medication adherence, we conducted a delayed randomized controlled trial to test multiple interventions (an additional four reminders; a ¥5.0 (US$0.79) credit reward for replying; and a feedback text message). After a 6-week pilot study with week 7 as the baseline measurement, we randomly allocated all participants into two groups: group 1 (n = 142) and group 2 (n = 141). During weeks 8–11, we introduced the interventions to group 1, and in weeks 12–15 the intervention was introduced to both groups. We compared the response rates between groups and explored factors affecting the response rate. Results During weeks 8–11, the response rates in group 1 increased and were significantly higher than in group 2 (p<0.05). During weeks 12–15, the response rate increased significantly in group 2 (p>0.05) and slightly decreased in group 1. Younger participants or participants who had children with lower hemoglobin concentration were more likely to reply (p = 0.02). Sending four reminders on the second day contributed to only 286 (11.7%) extra text messages. Discussion Our study showed that multiple interventions were effective in increasing response rate of text messaging data collection in rural China. Conclusions Larger multi-site studies are needed to find the most effective way of using these interventions to allow usage of text messaging data collection for health research. PMID:25332355

Improving sexual health in men with prostate cancer: randomised controlled trial of exercise and psychosexual therapies

PubMed Central

2014-01-01

Background Despite being a critical survivorship care issue, there is a clear gap in current knowledge of the optimal treatment of sexual dysfunction in men with prostate cancer. There is sound theoretical rationale and emerging evidence that exercise may be an innovative therapy to counteract sexual dysfunction in men with prostate cancer. Furthermore, despite the multidimensional aetiology of sexual dysfunction, there is a paucity of research investigating the efficacy of integrated treatment models. Therefore, the purpose of this study is to: 1) examine the efficacy of exercise as a therapy to aid in the management of sexual dysfunction in men with prostate cancer; 2) determine if combining exercise and brief psychosexual intervention results in more pronounced improvements in sexual health; and 3) assess if any benefit of exercise and psychosexual intervention on sexual dysfunction is sustained long term. Methods/Design A three-arm, multi-site randomised controlled trial involving 240 prostate cancer survivors will be implemented. Participants will be randomised to: 1) ‘Exercise’ intervention; 2) ‘Exercise + Psychosexual’ intervention; or 3) ‘Usual Care’. The Exercise group will receive a 6-month, group based, supervised resistance and aerobic exercise intervention. The Exercise + Psychosexual group will receive the same exercise intervention plus a brief psychosexual self-management intervention that addresses psychological and sexual well-being. The Usual Care group will maintain standard care for 6 months. Measurements for primary and secondary endpoints will take place at baseline, 6 months (post-intervention) and 1 year follow-up. The primary endpoint is sexual health and secondary endpoints include key factors associated with sexual health in men with prostate cancer. Discussion Sexual dysfunction is one of the most prevalent and distressing consequences of prostate cancer. Despite this, very little is known about the management of sexual dysfunction and current health care services do not adequately meet sexual health needs of survivors. This project will examine the potential role of exercise in the management of sexual dysfunction and evaluate a potential best-practice management approach by integrating pharmacological, physiological and psychological treatment modalities to address the complex and multifaceted aetiology of sexual dysfunction following cancer. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613001179729. PMID:24641777

Avoiding Boundary Estimates in Hierarchical Linear Models through Weakly Informative Priors

ERIC Educational Resources Information Center

Chung, Yeojin; Rabe-Hesketh, Sophia; Gelman, Andrew; Dorie, Vincent; Liu, Jinchen

2012-01-01

Hierarchical or multilevel linear models are widely used for longitudinal or cross-sectional data on students nested in classes and schools, and are particularly important for estimating treatment effects in cluster-randomized trials, multi-site trials, and meta-analyses. The models can allow for variation in treatment effects, as well as…

The Relations among Measurements of Informant Discrepancies within a Multisite Trial of Treatments for Childhood Social Phobia

ERIC Educational Resources Information Center

De Los Reyes, Andres; Alfano, Candice A.; Beidel, Deborah C.

2010-01-01

Discrepancies between informants' reports of children's behavior are robustly observed in clinical child research and have important implications for interpreting the outcomes of controlled treatment trials. However, little is known about the basic psychometric properties of these discrepancies. This study examined the relation between…

A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

ERIC Educational Resources Information Center

Kerson, Cynthia

2013-01-01

Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

Using weighted trait indices to select the best performing broccoli hybrids in multi-site and multi-year trials

USDA-ARS?s Scientific Manuscript database

Understanding and implementing evaluation data from vegetable trials conducted across multiple years and environments by multiple raters presents numerous challenges. In order to select new broccoli hybrids suitable for eastern production, the SCRI East Coast Broccoli Project has conducted over 32 p...

Improving Quality of Life and Depression After Stroke Through Telerehabilitation

PubMed Central

Linder, Susan M.; Rosenfeldt, Anson B.; Bay, R. Curtis; Sahu, Komal; Wolf, Steven L.

2015-01-01

OBJECTIVE. The aim of this study was to determine the effects of home-based robot-assisted rehabilitation coupled with a home exercise program compared with a home exercise program alone on depression and quality of life in people after stroke. METHOD. A multisite randomized controlled clinical trial was completed with 99 people <6 mo after stroke who had limited access to formal therapy. Participants were randomized into one of two groups, (1) a home exercise program or (2) a robot-assisted therapy + home exercise program, and participated in an 8-wk home intervention. RESULTS. We observed statistically significant changes in all but one domain on the Stroke Impact Scale and the Center for Epidemiologic Studies Depression Scale for both groups. CONCLUSION. A robot-assisted intervention coupled with a home exercise program and a home exercise program alone administered using a telerehabilitation model may be valuable approaches to improving quality of life and depression in people after stroke. PMID:26122686

Virtual reality and robotics for stroke rehabilitation: where do we go from here?

PubMed

Wade, Eric; Winstein, Carolee J

2011-01-01

Promoting functional recovery after stroke requires collaborative and innovative approaches to neurorehabilitation research. Task-oriented training (TOT) approaches that include challenging, adaptable, and meaningful activities have led to successful outcomes in several large-scale multisite definitive trials. This, along with recent technological advances of virtual reality and robotics, provides a fertile environment for furthering clinical research in neurorehabilitation. Both virtual reality and robotics make use of multimodal sensory interfaces to affect human behavior. In the therapeutic setting, these systems can be used to quantitatively monitor, manipulate, and augment the users' interaction with their environment, with the goal of promoting functional recovery. This article describes recent advances in virtual reality and robotics and the synergy with best clinical practice. Additionally, we describe the promise shown for automated assessments and in-home activity-based interventions. Finally, we propose a broader approach to ensuring that technology-based assessment and intervention complement evidence-based practice and maintain a patient-centered perspective.

Improving Quality of Life and Depression After Stroke Through Telerehabilitation.

PubMed

Linder, Susan M; Rosenfeldt, Anson B; Bay, R Curtis; Sahu, Komal; Wolf, Steven L; Alberts, Jay L

2015-01-01

The aim of this study was to determine the effects of home-based robot-assisted rehabilitation coupled with a home exercise program compared with a home exercise program alone on depression and quality of life in people after stroke. A multisite randomized controlled clinical trial was completed with 99 people<6 mo after stroke who had limited access to formal therapy. Participants were randomized into one of two groups, (1) a home exercise program or (2) a robot-assisted therapy+home exercise program, and participated in an 8-wk home intervention. We observed statistically significant changes in all but one domain on the Stroke Impact Scale and the Center for Epidemiologic Studies Depression Scale for both groups. A robot-assisted intervention coupled with a home exercise program and a home exercise program alone administered using a telerehabilitation model may be valuable approaches to improving quality of life and depression in people after stroke. Copyright © 2015 by the American Occupational Therapy Association, Inc.

Smoking, drinking, and depression: comorbidity in head and neck cancer patients undergoing radiotherapy.

PubMed

McCarter, Kristen; Baker, Amanda L; Britton, Benjamin; Wolfenden, Luke; Wratten, Chris; Bauer, Judith; Halpin, Sean A; Carter, Gregory; Beck, Alison K; Leigh, Lucy; Oldmeadow, Christopher

2018-04-19

We aimed to determine the prevalence and co-occurrence of tobacco smoking, alcohol consumption, and depressive symptoms among a sample of head and neck cancer (HNC) patients undergoing radiotherapy. A total of 307 HNC patients participated in a multi-site stepped-wedge randomized controlled trial (RCT) evaluating the effectiveness of a dietitian-delivered health behavior intervention in patients with HNC undergoing radiotherapy. During week one of radiotherapy patients completed measures of smoking, alcohol consumption, and level of depression. Approximately one-fifth (21%) of patients had two or more co-occurring problems: current smoking, hazardous alcohol use, and/or likely presence of a major depressive episode (MDE). Approximately one-third (34%) of the sample were current smokers, one-third (31%) were drinking hazardously and almost one-fifth (19%) had likely cases of depression. Comorbidity of smoking, hazardous alcohol use, and MDE is high in HNC patients, and interventions need to address this cluster of cancer risk factors. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Reliability of instruments in a cooperative, multisite study: employment intervention demonstration program.

PubMed

Salyers, M P; McHugo, G J; Cook, J A; Razzano, L A; Drake, R E; Mueser, K T

2001-09-01

Reliability of well-known instruments was examined in 202 people with severe mental illness participating in a multisite vocational study. We examined interrater reliability of the Positive and Negative Syndrome Scale (PANSS) and the internal consistency and test-retest reliability of the PANSS, the Rosenberg Self-Esteem Scale, the Medical Outcomes Study Short Form-36 (SF-36), and the Quality of Life Interview. Most scales had good levels of reliability, with intraclass correlation coefficients (ICCs) and coefficient alphas above .70. However, the SF-36 scales were generally less stable over time, particularly Social Functioning (ICC = .55). Test-retest reliability was lower among less educated respondents and among ethnic minorities. We recommend close monitoring of psychometric issues in future multisite studies.

Protocol for a randomised trial of higher versus lower intensity patient–provider communication interventions to reduce antibiotic misuse in two paediatric ambulatory clinics in the USA

PubMed Central

Goggin, Kathy; Bradley-Ewing, Andrea; Myers, Angela L; Lee, Brian R; Delay, Kirsten B; Schlachter, Sarah; Ramphal, Areli; Pina, Kimberly; Yu, David; Weltmer, Kirsten; Linnemayr, Sebastian; Butler, Christopher C; Newland, Jason G

2018-01-01

Introduction Children with acute respiratory tract infections (ARTIs) are prescribed up to 11.4 million unnecessary antibiotic prescriptions annually. Inadequate parent–provider communication is a chief contributor, yet efforts to reduce overprescribing have only indirectly targeted communication or been impractical. This paper describes our multisite, parallel group, cluster randomised trial comparing two feasible interventions for enhancing parent–provider communication on the rate of inappropriate antibiotic prescribing (primary outcome) and revisits, adverse drug reactions and parent-rated quality of shared decision-making, parent–provider communication and visit satisfaction (secondary outcomes). Methods/analysis We will attempt to recruit all eligible paediatricians and nurse practitioners (currently 47) at an academic children’s hospital and a private practice. Using a 1:1 randomisation, providers will be assigned to a higher intensity education and communication skills or lower intensity education-only intervention and trained accordingly. We will recruit 1600 eligible parent–child dyads. Parents of children ages 1–5 years who present with ARTI symptoms will be managed by providers trained in either the higher or lower intensity intervention. Before their consultation, all parents will complete a baseline survey and view a 90 s gain-framed antibiotic educational video. Parent–child dyads consulting with providers trained in the higher intensity intervention will, in addition, receive a gain-framed antibiotic educational brochure promoting cautious use of antibiotics and rate their interest in receiving an antibiotic which will be shared with their provider before the visit. All parents will complete a postconsultation survey and a 2-week follow-up phone survey. Due to the two-stage nested design (parents nested within providers and clinics), we will employ generalised linear mixed-effect regression models. Ethics/dissemination Ethical approval was obtained from the Children’s Mercy Hospital Pediatric Institutional Review Board (#16060466). Results will be submitted for publication in peer-reviewed journals. Trial registration number NCT03037112; Pre-results. PMID:29743330

Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial.

PubMed

Davis, Lori L; Kyriakides, Tassos C; Suris, Alina M; Ottomanelli, Lisa A; Mueller, Lisa; Parker, Pamela E; Resnick, Sandra G; Toscano, Richard; Scrymgeour, Alexandra A; Drake, Robert E

2018-04-01

Posttraumatic stress disorder (PTSD) often interferes with a person's ability to obtain or sustain employment, which leads to premature exit from the labor force and reduced income. To determine whether individual placement and support (IPS)-supported employment is more effective than stepwise vocational rehabilitation involving transitional work assignments at helping veterans with PTSD attain steady, competitive employment. The Veterans Individual Placement and Support Toward Advancing Recovery (VIP-STAR) study was a prospective, multisite, randomized clinical trial that included 541 unemployed veterans with PTSD at 12 Veterans Affairs medical centers. Data were collected from December 23, 2013, to May 3, 2017. Intent-to-treat analysis was performed. Individual placement and support is a supported employment intervention that rapidly engages people with disabilities in community job development to obtain work based on their individual job preferences. Transitional work is a stepwise vocational rehabilitation intervention that assigns people temporarily to noncompetitive jobs as preparation for competitive employment in the community. A priori hypotheses were that, compared with those in transitional work, more participants in the IPS group would become steady workers (primary) and earn more income from competitive jobs (secondary) over 18 months. Steady worker was defined as holding a competitive job for at least 50% of the 18-month follow-up period. A total of 541 participants (n = 271 IPS; n = 270 transitional work) were randomized. Mean (SD) age was 42.2 (11) years; 99 (18.3%) were women, 274 (50.6%) were white, 225 (41.6%) were African American, and 90 (16.6%) were of Hispanic, Spanish, or Latino ethnicity. More participants in the IPS group achieved steady employment than in the transitional work group (105 [38.7%] vs 63 [23.3%]; odds ratio, 2.14; 95% CI, 1.46-3.14). A higher proportion of IPS participants attained any competitive job (186 [68.6%] vs 154 [57.0%]; P = .005) and had higher cumulative earnings from competitive jobs (median [interquartile range] $7290 [$23 174] in IPS vs $1886 [$17 167] in transitional work; P = .004). This multisite trial demonstrated significantly greater effectiveness of IPS-supported employment over stepwise transitional work vocational rehabilitation for veterans living with chronic PTSD. The results provide supporting evidence for increasing access to IPS for veterans living with PTSD. clinicaltrials.gov Identifier: NCT01817712.

Evaluating Area-Based Interventions: The Case of "Communities for Children"

ERIC Educational Resources Information Center

Cortis, Natasha

2008-01-01

Increasingly, governments in wealthy countries are designing early intervention initiatives around principles of "community regeneration" or "place management". Because these initiatives are multi-site, aimed at long-term systemic change, and implemented amidst a range of other initiatives, assessing their quality and outcomes…

Developing Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT): protocol for a pilot randomized controlled trial.

PubMed

Watson, Dennis P; Ray, Bradley; Robison, Lisa; Xu, Huiping; Edwards, Rhiannon; Salyers, Michelle P; Hill, James; Shue, Sarah

2017-01-01

There is a lack of evidence-based substance use disorder treatment and services targeting returning inmates. Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT) is a community-driven, recovery-oriented approach to substance abuse care which has the potential to address this service gap. SUPPORT is modeled after Indiana's Access to Recovery program, which was closed due to lack of federal support despite positive improvements in clients' recovery outcomes. SUPPORT builds on noted limitations of Indiana's Access to Recovery program. The ultimate goal of this project is to establish SUPPORT as an effective and scalable recovery-oriented system of care. A necessary step we must take before launching a large clinical trial is pilot testing the SUPPORT intervention. The pilot will take place at Public Advocates in Community Re-Entry (PACE), nonprofit serving individuals with felony convictions who are located in Marion County, Indiana (Indianapolis). The pilot will follow a basic parallel randomized design to compare clients receiving SUPPORT with clients receiving standard services. A total of 80 clients within 3 months of prison release will be recruited to participate and randomly assigned to one of the two intervention arms. Quantitative measures will be collected at multiple time points to understand SUPPORT's impact on recovery capital and outcomes. We will also collect qualitative data from SUPPORT clients to better understand their program and post-discharge experiences. Successful completion of this pilot will prepare us to conduct a multi-site clinical trial. The ultimate goal of this future work is to develop an evidence-based and scalable approach to treating substance use disorder among persons returning to society after incarceration. ClinicalTrials.gov (Clinical Trials ID: NCT03132753 and Protocol Number: 1511731907). Registered 28 April 2017.

The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.

PubMed

Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M

2016-03-09

Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way mHealth programs have yet to be tested for HIV prevention in a community-based setting with this population. ClinicalTrials.gov NCT02437123 https://clinicaltrials.gov/show/NCT02437123 (registered 4 May 2015). Protocol version: 24 July 2015.

Mediators of effects of a selective family-focused violence prevention approach for middle school students.

PubMed

2012-02-01

This study examined how parenting and family characteristics targeted in a selective prevention program mediated effects on key youth proximal outcomes related to violence perpetration. The selective intervention was evaluated within the context of a multi-site trial involving random assignment of 37 schools to four conditions: a universal intervention composed of a student social-cognitive curriculum and teacher training, a selective family-focused intervention with a subset of high-risk students, a condition combining these two interventions, and a no-intervention control condition. Two cohorts of sixth-grade students (total N = 1,062) exhibiting high levels of aggression and social influence were the sample for this study. Analyses of pre-post change compared to controls using intent-to-treat analyses found no significant effects. However, estimates incorporating participation of those assigned to the intervention and predicted participation among those not assigned revealed significant positive effects on student aggression, use of aggressive strategies for conflict management, and parental estimation of student's valuing of achievement. Findings also indicated intervention effects on two targeted family processes: discipline practices and family cohesion. Mediation analyses found evidence that change in these processes mediated effects on some outcomes, notably aggressive behavior and valuing of school achievement. Results support the notion that changing parenting practices and the quality of family relationships can prevent the escalation in aggression and maintain positive school engagement for high-risk youth.

Feasibility of a Centralized Clinical Trials Coverage Analysis: A Joint Initiative of the American Society of Clinical Oncology and the National Cancer Institute.

PubMed

Szczepanek, Connie M; Hurley, Patricia; Good, Marjorie J; Denicoff, Andrea; Willenberg, Kelly; Dawson, Casey; Kurbegov, Dax

2017-06-01

Clinical trial billing compliance is a challenge that is faced by overburdened clinical trials sites. The requirements place institutions and research sites at increased potential for financial risk. To reduce their risk, sites develop a coverage analysis (CA) before opening each trial. For multisite trials, this translates into system-wide redundancies, inconsistencies, trial delays, and potential costs to sites and patients. These factors exacerbate low accrual rates to cancer clinical trials. ASCO and the National Cancer Institute (NCI) collaborated to address this problem. An ASCO Research Community Forum working group proposed the concept of providing centrally developed CAs to research sites at protocol startup. The group collaborated with NCI and billing compliance experts to hold a symposium for key stakeholders to share knowledge, build skills, provide tools to conduct centralized CAs, and strategize about the next steps. Forty-eight attendees, who represented a range of stakeholders, participated in the symposium. As a result of this initiative, NCI directed the Cancer Trials Support Unit to convene a working group with NCI's National Clinical Trials Network (NCTN) and Community Oncology Research Program (NCORP) to develop tools and processes for generating CAs for their trials. A CA template with core elements was developed and is being adapted in a pilot project across NCTN Group and NCORP Research Bases. Centralized CAs for multisite trials-using standardized tools and templates-are feasible. They have the potential to reduce risk for patients and sites, forecast budget needs, and help decrease trial startup times that impede patient access and accrual to clinical trials.

Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a multidimensional web tool intervention to improve cardiometabolic health in patients with severe mental illness.

PubMed

Looijmans, Anne; Jörg, Frederike; Bruggeman, Richard; Schoevers, Robert; Corpeleijn, Eva

2017-03-21

The cardiometabolic health of persons with a severe mental illness (SMI) is alarming with obesity rates of 45-55% and diabetes type 2 rates of 10-15%. Unhealthy lifestyle behaviours play a large role in this. Despite the multidisciplinary guideline for SMI patients recommending to monitor and address patients' lifestyle, most mental health care professionals have limited lifestyle-related knowledge and skills, and (lifestyle) treatment protocols are lacking. Evidence-based practical lifestyle tools may support both patients and staff in improving patients' lifestyle. This paper describes the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial, to investigate whether a multidimensional lifestyle intervention using a web tool can be effective in improving cardiometabolic health in SMI patients. The LION study is a 12-month pragmatic single-blind multi-site cluster randomised controlled trial. 21 Flexible Assertive Community Treatment (ACT) teams and eight sheltered living teams of five mental health organizations in the Netherlands are invited to participate. Per team, nurses are trained in motivational interviewing and use of the multidimensional web tool, covering lifestyle behaviour awareness, lifestyle knowledge, motivation and goal setting. Nurses coach patients to change their lifestyle using the web tool, motivational interviewing and stages-of-change techniques during biweekly sessions in a) assessing current lifestyle behaviour using the traffic light method (healthy behaviours colour green, unhealthy behaviours colour red), b) creating a lifestyle plan with maximum three attainable lifestyle goals and c) discussing the lifestyle plan regularly. The study population is SMI patients and statistical inference is on patient level using multilevel analyses. Primary outcome is waist circumference and other cardiometabolic risk factors after six and twelve months intervention, which are measured as part of routine outcome monitoring using standard protocols. Secondary outcomes include depressive and negative symptoms, cost-effectiveness, and barriers and facilitators in intervention implementation. Adequate health care should target both mental health and lifestyle behaviours in SMI patients. This trial contributes by studying a 12-month multidimensional lifestyle intervention as a potential evidence based (nursing) tool for targeting multiple lifestyle behaviours in SMI patients. Nederlands Trialregister NTR3765 (trialregister.nl; registered 21 December 2012).

Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

ERIC Educational Resources Information Center

Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

2014-01-01

This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

Effects of Check and Connect on Attendance, Behavior, and Academics: A Randomized Effectiveness Trial

ERIC Educational Resources Information Center

Maynard, Brandy R.; Kjellstrand, Elizabeth K.; Thompson, Aaron M.

2014-01-01

Objectives: This study examined the effects of Check & Connect (C&C) on the attendance, behavior, and academic outcomes of at-risk youth in a field-based effectiveness trial. Method: A multisite randomized block design was used, wherein 260 primarily Hispanic (89%) and economically disadvantaged (74%) students were randomized to treatment…

Fidelity Failures in Brief Strategic Family Therapy for Adolescent Drug Abuse: A Clinical Analysis.

PubMed

Lebensohn-Chialvo, Florencia; Rohrbaugh, Michael J; Hasler, Brant P

2018-04-30

As evidence-based family treatments for adolescent substance use and conduct problems gain traction, cutting edge research moves beyond randomized efficacy trials to address questions such as how these treatments work and how best to disseminate them to community settings. A key factor in effective dissemination is treatment fidelity, which refers to implementing an intervention in a manner consistent with an established manual. While most fidelity research is quantitative, this study offers a qualitative clinical analysis of fidelity failures in a large, multisite effectiveness trial of Brief Strategic Family Therapy (BSFT) for adolescent drug abuse, where BSFT developers trained community therapists to administer this intervention in their own agencies. Using case notes and video recordings of therapy sessions, an independent expert panel first rated 103 cases on quantitative fidelity scales grounded in the BSFT manual and the broader structural-strategic framework that informs BSFT intervention. Because fidelity was generally low, the panel reviewed all cases qualitatively to identify emergent types or categories of fidelity failure. Ten categories of failures emerged, characterized by therapist omissions (e.g., failure to engage key family members, failure to think in threes) and commissions (e.g., off-model, nonsystemic formulations/interventions). Of these, "failure to think in threes" appeared basic and particularly problematic, reflecting the central place of this idea in structural theory and therapy. Although subject to possible bias, our observations highlight likely stumbling blocks in exporting a complex family treatment like BSFT to community settings. These findings also underscore the importance of treatment fidelity in family therapy research. © 2018 Family Process Institute.

A Randomized Trial Comparing Live and Telemedicine Delivery of an Imagery-based Behavioral Intervention for Breast Cancer Survivors: Reducing Symptoms and Barriers to Care

PubMed Central

Freeman, Lyn W.; White, Rebecca; Ratcliff, Chelsea G.; Sutton, Sue; Stewart, Mary; Palmer, J. Lynn; Link, Judith; Cohen, Lorenzo

2015-01-01

Objective This multi-site randomized trial evaluates the quality of life (QOL) benefits of an imagery-based group intervention titled “Envision the Rhythms of Life” (ERL). Methods Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-hour group sessions at a community center with therapist present (live-delivery; LD, n=48); therapist streamed via telemedicine (telemedicine-delivery; TD, n=23); or to a waitlist control group (WL, n=47). Weekly individual phone calls to encourage at-home practice began at session one and continued until the 3-month follow-up. Seven self-report measures of QOL were examined at baseline, 1 and 3 months post-treatment including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. Results The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. LMM analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared to WL across the follow-up (p’s <0.01). Changes in fatigue, cognitive dysfunction, sleep disturbance, and health-related and breast cancer-related QOL were clinically significant. There were no differences between LD and TD. Conclusions Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared to a waitlist control. Further, there were no significant differences between live- and telemedicine-delivery, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas. PMID:25146413

Specificity of Problem-Solving Skills Training in Mothers of Children Newly Diagnosed With Cancer: Results of a Multisite Randomized Clinical Trial

PubMed Central

Sahler, Olle Jane Z.; Dolgin, Michael J.; Phipps, Sean; Fairclough, Diane L.; Askins, Martha A.; Katz, Ernest R.; Noll, Robert B.; Butler, Robert W.

2013-01-01

Purpose Diagnosis of cancer in a child can be extremely stressful for parents. Bright IDEAS, a problem-solving skills training (PSST) intervention, has been shown to decrease negative affectivity (anxiety, depression, post-traumatic stress symptoms) in mothers of newly diagnosed patients. This study was designed to determine the specificity of PSST by examining its direct and indirect (eg, social support) effects compared with a nondirective support (NDS) intervention. Patients and Methods This randomized clinical trial included 309 English- or Spanish-speaking mothers of children diagnosed 2 to 16 weeks before recruitment. Participants completed assessments prerandomization (T1), immediately postintervention (T2), and at 3-month follow-up (T3). Both PSST and NDS consisted of eight weekly 1-hour individual sessions. Outcomes included measures of problem-solving skill and negative affectivity. Results There were no significant between-group differences at baseline (T1). Except for level of problem-solving skill, which was directly taught in the PSST arm, outcome measures improved equally in both groups immediately postintervention (T2). However, at the 3-month follow-up (T3), mothers in the PSST group continued to show significant improvements in mood, anxiety, and post-traumatic stress; mothers in the NDS group showed no further significant gains. Conclusion PSST is an effective and specific intervention whose beneficial effects continue to grow after the intervention ends. In contrast, NDS is an effective intervention while it is being administered, but its benefits plateau when active support is removed. Therefore, teaching coping skills at diagnosis has the potential to facilitate family resilience over the entire course of treatment. PMID:23358975

Life review therapy for older adults with moderate depressive symptomatology: a pragmatic randomized controlled trial.

PubMed

Korte, J; Bohlmeijer, E T; Cappeliez, P; Smit, F; Westerhof, G J

2012-06-01

BACKGROUND. Although there is substantial evidence for the efficacy of life review therapy as an early treatment of depression in later life, its effectiveness in natural settings has not been studied. The present study evaluates an intervention based on life review and narrative therapy in a large multi-site, pragmatic randomized controlled trial(RCT). METHOD. Life review therapy was compared with care as usual. The primary outcome was depressive symptoms;secondary outcomes were anxiety symptoms, positive mental health, quality of life, and current major depressive episode (MDE). To identify groups for whom the intervention was particularly effective, moderator analyses were carried out (on sociodemographic variables, personality traits, reminiscence functions, clinically relevant depressive and anxiety symptoms, and past MDEs). RESULTS. Compared with care as usual (n=102), life review therapy (n=100) was effective in reducing depressive symptoms, at post-treatment (d=0.60, B= -5.3, p<0.001), at 3-month follow-up (d=0.50, B= -5.0, p<0.001) and for the intervention also at 9-month follow-up (t=5.7, p<0.001). The likelihood of a clinically significant change in depressive symptoms was significantly higher [odds ratio (OR) 3.77, p<0.001 at post-treatment ; OR 3.76, p<0.001 at the 3-month follow-up]. Small significant effects were found for symptoms of anxiety and positive mental health.Moderator analyses showed only two significant moderators, the personality trait of extraversion and the reminiscence function of boredom reduction. CONCLUSIONS. This study shows the effectiveness of life review therapy as an early intervention for depression in an ecologically valid context, supporting its applicability to a broad target group. The intervention is also effective in reducing anxiety symptoms and strengthening positive mental health.

A randomized trial using telehealth technology to link caregivers with dementia care experts for in-home caregiving support: FamTechCare protocol.

PubMed

Williams, Kristine; Blyler, Diane; Vidoni, Eric D; Shaw, Clarissa; Wurth, JoEllen; Seabold, Denise; Perkhounkova, Yelena; Van Sciver, Angela

2018-06-01

The number of persons with dementia (PWD) in the United States is expected to reach 16 million by 2050. Due to the behavioral and psychological symptoms of dementia, caregivers face challenging in-home care situations that lead to a range of negative health outcomes such as anxiety and depression for the caregivers and nursing home placement for PWD. Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) is a multisite randomized controlled trial evaluating the effects of a telehealth intervention on caregiver well-being and PWD behavioral symptoms. The FamTechCare intervention provides individualized dementia-care strategies to in-home caregivers based on video recordings that the caregiver creates of challenging care situations. A team of dementia care experts review videos submitted by caregivers and provide interventions to improve care weekly for the experimental group. Caregivers in the control group receive feedback for improving care based on a weekly phone call with the interventionist and receive feedback on their videos at the end of the 3-month study. Using linear mixed modeling, we will compare experimental and control group outcomes (PWD behavioral symptoms and caregiver burden) after 1 and 3 months. An exploratory descriptive design will identify a typology of interventions for telehealth support for in-home dementia caregivers. Finally, the cost for FamTechCare will be determined and examined in relation to hypothesized effects on PWD behavioral symptoms, placement rates, and caregiver burden. This research will provide the foundation for future research for telehealth interventions with this population, especially for families in rural or remote locations. © 2018 Wiley Periodicals, Inc.

An ounce of prevention: A pre-randomization protocol to improve retention in substance use disorder clinical trials.

PubMed

Northrup, Thomas F; Greer, Tracy L; Walker, Robrina; Rethorst, Chad D; Warden, Diane; Stotts, Angela L; Trivedi, Madhukar H

2017-01-01

Missing data in substance use disorder (SUD) research pose a significant threat to internal validity. Participants terminate involvement or become less likely to attend intervention and research visits for many reasons, which should be addressed prior to becoming problematic. During a 9-month study targeting stimulant abuse, early dropouts and participant reported attendance barriers led to implementing a structured, pre-randomization protocol with participants about retention and solution-focused strategies (the "Fireside Chat"). Our aim is to outline this approach and present data on intervention participation and research visit attendance after implementation. STimulant Reduction using Dosed Exercise (STRIDE) was a two-arm, multisite randomized clinical trial testing treatment-as-usual for stimulant abuse/dependence augmented by Exercise or Health Education. For both groups, study intervention visits at the site were scheduled 3/week for 12weeks followed by 1/week for 24weeks. During The Chat, research staff thoroughly reviewed participants' expectations, and barriers and solutions to retention. Fifteen participants were randomized (to Exercise or Health Education) prior to and fourteen were randomized after Chat implementation. Intervention and monthly follow-up attendance (before and after implementation) were compared at the site (N=29) that developed and rigorously implemented The Chat. Individuals who participated in The Chat (n=14) attended significantly more intervention visits during weeks 1-12 (p<0.001) and weeks 13-36 (p<0.05) and attended more research visits (p<0.001). Proactive discussion of expectations and barriers prior to randomization was associated with greater study attendance. SUD researchers should consider tailoring this approach to suit their needs. Further investigation is warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

Low-intensity case management increases contact with primary care in recently released prisoners: a single-blinded, multisite, randomised controlled trial

PubMed Central

Alati, Rosa; Longo, Marie; Spittal, Matthew J; Boyle, Frances M; Williams, Gail M; Lennox, Nicholas G

2016-01-01

Background The world prison population is large and growing. Poor health outcomes after release from prison are common, but few programmes to improve health outcomes for ex-prisoners have been rigorously evaluated. The aim of this study was to evaluate the impact of individualised case management on contact with health services during the first 6 months post-release. Methods Single-blinded, randomised, controlled trial. Baseline assessment with N=1325 adult prisoners in Queensland, Australia, within 6 weeks of expected release; follow-up interviews 1, 3 and 6 months post-release. The intervention consisted of provision of a personalised booklet (‘Passport’) at the time of release, plus up to four brief telephone contacts in the first 4 weeks post-release. Results Of 1179 eligible participants, 1003 (85%) completed ≥1 follow-up interview. In intention-to-treat analyses, 53% of the intervention group and 41% of the control group reported contacting a general practitioner (GP) at 1 month post-release (difference=12%, 95% CI 5% to 19%). Similar effects were observed for GP contact at 3 months (difference=9%, 95% CI 2% to 16%) and 6 months (difference=8%, 95% CI 1% to 15%), and for mental health (MH) service contact at 6 months post release (difference=8%, 95% CI 3% to 14%). Conclusions Individualised case management in the month after release from prison increases usage of primary care and MH services in adult ex-prisoners for at least 6 months post-release. Given the poor health profile of ex-prisoners, there remains an urgent need to develop and rigorously evaluate interventions to increase health service contact in this profoundly marginalised population. Trial registration number ACTRN12608000232336. PMID:26787201

Effect of Patient Navigation on Breast Cancer Screening Among African American Medicare Beneficiaries: A Randomized Controlled Trial.

PubMed

Marshall, Jessie Kimbrough; Mbah, Olive M; Ford, Jean G; Phelan-Emrick, Darcy; Ahmed, Saifuddin; Bone, Lee; Wenzel, Jennifer; Shapiro, Gary R; Howerton, Mollie; Johnson, Lawrence; Brown, Qiana; Ewing, Altovise; Pollack, Craig Evan

2016-01-01

There is growing evidence that patient navigation improves breast cancer screening rates; however, there are limited efficacy studies of its effect among African American older adult women. To evaluate the effect of patient navigation on screening mammography among African American female Medicare beneficiaries in Baltimore, MD. The Cancer Prevention and Treatment Demonstration (CPTD), a multi-site study, was a randomized controlled trial conducted from April 2006 through December 2010. Community-based and clinical setting. The CPTD Screening Trial enrolled 1905 community-dwelling African American female Medicare beneficiaries who were ≥65 years of age and resided in Baltimore, MD. Participants were recruited from health clinics, community centers, health fairs, mailings using Medicare rosters, and phone calls. Participants were randomized to either: printed educational materials on cancer screening (control group) or printed educational materials + patient navigation services designed to help participants overcome barriers to cancer screening (intervention group). Self-reported receipt of mammography screening within 2 years of the end of the study. The median follow-up period for participants in this analysis was 17.8 months. In weighted multivariable logistic regression analyses, women in the intervention group had significantly higher odds of being up to date on mammography screening at the end of the follow-up period compared to women in the control group (odds ratio [OR] 2.26, 95 % confidence interval [CI]1.59-3.22). The effect of the intervention was stronger among women who were not up to date with mammography screening at enrollment (OR 3.63, 95 % CI 2.09-6.38). Patient navigation among urban African American Medicare beneficiaries increased self-reported mammography utilization. The results suggest that patient navigation for mammography screening should focus on women who are not up to date on their screening.

A Randomized Controlled Trial of a Long-Term Professional Mentoring Program for Children at Risk: Outcomes Across the First 5 Years.

PubMed

Eddy, J Mark; Martinez, Charles R; Grossman, Jean Baldwin; Cearley, Jennifer J; Herrera, Danita; Wheeler, Alice C; Rempel, Jeff S; Foney, Dana; Gau, Jeff M; Burraston, Bert O; Harachi, Tracy W; Haggerty, Kevin P; Seeley, John R

2017-11-01

Child outcomes due to a paid professional mentoring program, Friends of the Children (FOTC), were investigated across the first 5 years of an ongoing multi-site randomized controlled trial. Participants were 278 children attending kindergarten or first grade who were identified as "at risk" for adjustment problems during adolescence. The program was delivered through established nonprofit community-based organizations. Mentors were hired to work full time and were provided training, supervision, and support to work individually with small numbers of children. Recruitment took place across a 3-year period. Random assignment to the intervention condition or a services as usual control condition was conducted at the level of the individual, blocking on school and child sex. After the initial assessment, follow-up assessments were conducted every 6 months. Differences in growth curves across the elementary school years were examined in intent-to-treat analyses. Significant effects favoring FOTC were found in terms of caregiver ratings of positive school behavior and less trouble in school, with a trend for higher child behavioral and emotional strengths. Effect sizes were in the range typical in recent trials of youth mentoring.

Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial.

PubMed

Reiss, Kate; Andersen, Kathryn; Barnard, Sharmani; Ngo, Thoai D; Biswas, Kamal; Smith, Christopher; Carpenter, James; Church, Kathryn; Nuremowla, Sadid; Pearson, Erin

2017-10-03

Adoption of modern contraceptive methods after menstrual regulation (MR) is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs) are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh. This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and experience of violence during the 12 month study period. Mobile phones offer a low-cost mechanism for providing individualised support to women with contraception outside of the clinic setting. This study will provide information on the effects of such an intervention among MR clients in Bangladesh. Trial registered with clinicaltrials.gov Registration number: NCT02579785 Date of registration: 16th October 2015.

Community-Based Early Intervention for Children with Behavioural, Emotional and Social Problems: Evaluation of the Scallywags Scheme

ERIC Educational Resources Information Center

Lovering, Kathryn; Frampton, Ian; Crowe, Ben; Moseley, Alice; Broadhead, Moira

2006-01-01

Scallywags is a community-based, early intervention programme for young children (aged 3-7) with behavioural, emotional and social problems, which integrates work in the home and school with a parenting curriculum and direct work with children. A pre-post intervention study across multi-sites of 340 participants is reported. Using standardised…

Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer

PubMed Central

Emery, Jon; Doorey, Juanita; Jefford, Michael; King, Madeleine; Pirotta, Marie; Hayne, Dickon; Martin, Andrew; Trevena, Lyndal; Lim, Tee; Constable, Roger; Hawks, Cynthia; Hyatt, Amelia; Hamid, Akhlil; Violet, John; Gill, Suki; Frydenberg, Mark; Schofield, Penelope

2014-01-01

Introduction Men with prostate cancer require long-term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. There is growing recognition of the potential role of primary care in cancer follow-up. This paper describes the protocol for a phase II multisite randomised controlled trial of a novel model of shared care for the follow-up of men after completing treatment for low-moderate risk prostate cancer. Methods and analysis The intervention is a shared care model of follow-up visits in the first 12 months after completing treatment for prostate cancer with the following specific components: a survivorship care plan, general practitioner (GP) management guidelines, register and recall systems, screening for distress and unmet needs and patient information resources. Eligible men will have completed surgery and/or radiotherapy for low-moderate risk prostate cancer within the previous 8 weeks and have a GP who consents to participate. Ninety men will be randomised to the intervention or current hospital follow-up care. Study outcome measures will be collected at baseline, 3, 6 and 12 months and include anxiety, depression, unmet needs, prostate cancer-specific quality of life and satisfaction with care. Clinical processes and healthcare resource usage will also be measured. The principal emphasis of the analysis will be on obtaining estimates of the treatment effect size and assessing feasibility in order to inform the design of a subsequent phase III trial. Ethics and dissemination Ethics approval has been granted by the University of Western Australia and from all hospital recruitment sites in Western Australia and Victoria. Results of this phase II trial will be reported in peer-reviewed publications and in conference presentations. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12610000938000 PMID:24604487

The Study Designed by a Committee

PubMed Central

Henry, David B.; Farrell, Albert D.

2009-01-01

This article describes the research design of the Multisite Violence Prevention Project (MVPP), organized and funded by the National Center for Injury Prevention and Control (NCIPC) at the Centers for Disease Control and Prevention (CDC). CDC's objectives, refined in the course of collaboration among investigators, were to evaluate the efficacy of universal and targeted interventions designed to produce change at the school level. The project's design was developed collaboratively, and is a 2 × 2 cluster-randomized true experimental design in which schools within four separate sites were assigned randomly to four conditions: (1) no-intervention control group, (2) universal intervention, (3) targeted intervention, and (4) combined universal and targeted interventions. A total of 37 schools are participating in this study with 8–12 schools per site. The impact of the interventions on two successive cohorts of sixth-grade students will be assessed based on multiple waves of data from multiple sources of information, including teachers, students, parents, and archival data. The nesting of students within teachers, families, schools and sites created a number of challenges for designing and implementing the study. The final design represents both resolution and compromise on a number of creative tensions existing in large-scale prevention trials, including tensions between cost and statistical power, and between internal and external validity. Strengths and limitations of the final design are discussed. PMID:14732183

A Multisite Randomized Trial of a Cognitive Skills Program for Male Mentally Disordered Offenders: Violence and Antisocial Behavior Outcomes

ERIC Educational Resources Information Center

Cullen, Alexis E.; Clarke, Amory Y.; Kuipers, Elizabeth; Hodgins, Sheilagh; Dean, Kimberlie; Fahy, Tom

2012-01-01

Objective: Despite a large evidence base indicating that cognitive skills programs can reduce reoffending in individuals without mental illness, there have been no randomized controlled trials (RCTs) to determine their effectiveness in mentally disordered offenders (MDOs). In the first RCT of a cognitive skills program for MDOs, we aimed to…

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

ERIC Educational Resources Information Center

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Does Maintenance CBT Contribute to Long-Term Treatment Response of Panic Disorder with or without Agoraphobia? A Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

White, Kamila S.; Payne, Laura A.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.; Saksa, John R.; Barlow, David H.

2013-01-01

Objective: We examined the possibility that maintenance cognitive behavior therapy (M-CBT) may improve the likelihood of sustained improvement and reduced relapse in a multi-site randomized controlled clinical trial of patients who met criteria for panic disorder with or without agoraphobia. Method: Participants were all patients (N = 379) who…

A Multisite Randomized Trial of Social Norms Marketing Campaigns to Reduce College Student Drinking: A Replication Failure

ERIC Educational Resources Information Center

DeJong, William; Schneider, Shari Kessel; Towvim, Laura Gomberg; Murphy, Melissa J.; Doerr, Emily E.; Simonsen, Neal R.; Mason, Karen E.; Scribner, Richard A.

2009-01-01

A 14-site randomized trial tested the effectiveness of social norms marketing (SNM) campaigns, which present accurate student survey data in order to correct misperceptions of subjective drinking norms and thereby drive down alcohol use. Cross-sectional student surveys were conducted by mail at baseline and at posttest 3 years later. Hierarchical…

Multi-site Study of Diffusion Metric Variability: Characterizing the Effects of Site, Vendor, Field Strength, and Echo Time using the Histogram Distance.

PubMed

Helmer, K G; Chou, M-C; Preciado, R I; Gimi, B; Rollins, N K; Song, A; Turner, J; Mori, S

2016-02-27

MRI-based multi-site trials now routinely include some form of diffusion-weighted imaging (DWI) in their protocol. These studies can include data originating from scanners built by different vendors, each with their own set of unique protocol restrictions, including restrictions on the number of available gradient directions, whether an externally-generated list of gradient directions can be used, and restrictions on the echo time (TE). One challenge of multi-site studies is to create a common imaging protocol that will result in a reliable and accurate set of diffusion metrics. The present study describes the effect of site, scanner vendor, field strength, and TE on two common metrics: the first moment of the diffusion tensor field (mean diffusivity, MD), and the fractional anisotropy (FA). We have shown in earlier work that ROI metrics and the mean of MD and FA histograms are not sufficiently sensitive for use in site characterization. Here we use the distance between whole brain histograms of FA and MD to investigate within- and between-site effects. We concluded that the variability of DTI metrics due to site, vendor, field strength, and echo time could influence the results in multi-center trials and that histogram distance is sensitive metrics for each of these variables.

Healthy Children, Strong Families 2: A randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches.

PubMed

Tomayko, Emily J; Prince, Ronald J; Cronin, Kate A; Parker, Tassy; Kim, Kyungmann; Grant, Vernon M; Sheche, Judith N; Adams, Alexandra K

2017-04-01

Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of a randomized clinical trial have been described. Methods Healthy Children, Strong Families 2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two less-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyle intervention ( Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group ( Safety Journey) for 1 year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities' request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities' request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active control group and a design allowing all families to receive the intervention. This collective effort took additional time but was critical to secure community engagement. Hiring and retaining qualified local site coordinators was a challenge but was strongly related to successful recruitment and retention of study families. Local infrastructure has also been critical to project success. Other challenges included geographic dispersion of study communities and providing appropriate incentives to retain families in a 2-year study. Conclusion This multisite intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. Healthy Children, Strong Families 2's innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and less-studied obesity risk factors (stress/sleep), measurement of both adult and child outcomes, social networking support for geographically dispersed households, and a community selected active control group. Our data will address a literature gap regarding multiple risk factors and their relationship to health outcomes in American Indian families.

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

PubMed Central

DeWalt, Darren A; Broucksou, Kimberly A; Hawk, Victoria; Baker, David W; Schillinger, Dean; Ruo, Bernice; Bibbins-Domingo, Kirsten; Holmes, Mark; Weinberger, Morris; Macabasco-O'Connell, Aurelia; Pignone, Michael

2009-01-01

Background Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. Discussion Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. Trial Registration ClinicalTrials.gov NCT00378950 PMID:19519904

NCORP Gets Underway

Cancer.gov

NCI has awarded 53 new 5-year grants to researchers across the country to conduct multi-site cancer clinical trials and cancer care delivery research studies in their communities. The grants are being awarded under the NCI Community Oncology Research Prog

A Randomized Control Trial: Supplementing Hearing Aid Use with Listening and Communication Enhancement (LACE) Auditory Training.

PubMed

Saunders, Gabrielle H; Smith, Sherri L; Chisolm, Theresa H; Frederick, Melissa T; McArdle, Rachel A; Wilson, Richard H

2016-01-01

To examine the effectiveness of the Listening and Communication Enhancement (LACE) program as a supplement to standard-of-care hearing aid intervention in a Veteran population. A multisite randomized controlled trial was conducted to compare outcomes following standard-of-care hearing aid intervention supplemented with (1) LACE training using the 10-session DVD format, (2) LACE training using the 20-session computer-based format, (3) placebo auditory training (AT) consisting of actively listening to 10 hr of digitized books on a computer, and (4) educational counseling-the control group. The study involved 3 VA sites and enrolled 279 veterans. Both new and experienced hearing aid users participated to determine if outcomes differed as a function of hearing aid user status. Data for five behavioral and two self-report measures were collected during three research visits: baseline, immediately following the intervention period, and at 6 months postintervention. The five behavioral measures were selected to determine whether the perceptual and cognitive skills targeted in LACE training generalized to untrained tasks that required similar underlying skills. The two self-report measures were completed to determine whether the training resulted in a lessening of activity limitations and participation restrictions. Outcomes were obtained from 263 participants immediately following the intervention period and from 243 participants 6 months postintervention. Analyses of covariance comparing performance on each outcome measure separately were conducted using intervention and hearing aid user status as between-subject factors, visit as a within-subject factor, and baseline performance as a covariate. No statistically significant main effects or interactions were found for the use of LACE on any outcome measure. Findings from this randomized controlled trial show that LACE training does not result in improved outcomes over standard-of-care hearing aid intervention alone. Potential benefits of AT may be different than those assessed by the performance and self-report measures utilized here. Individual differences not assessed in this study should be examined to evaluate whether AT with LACE has any benefits for particular individuals. Clinically, these findings suggest that audiologists may want to temper the expectations of their patients who embark on LACE training.

Motivational Interviewing or Reminders for Glaucoma Medication Adherence? Results of a Multi-Site Randomized Controlled Trial

PubMed Central

Schmiege, Sarah J.; Mansberger, Steven L.; Sheppler, Christina; Kammer, Jeffrey; Fitzgerald, Timothy; Kahook, Malik Y.

2017-01-01

Objective Nonadherence reduces glaucoma treatment efficacy. Motivational interviewing (MI) is a well-studied adherence intervention, but has not been tested in glaucoma. Reminder interventions also may improve adherence. Design 201 patients with glaucoma or ocular hypertension were urn-randomized to receive MI delivered by an ophthalmic technician (OT), usual care, or a minimal behavioral intervention (reminder calls). Main Outcome Measures Outcomes included electronic monitoring with Medication Event Monitoring System (MEMS) bottles, two self-report adherence measures, patient satisfaction, and clinical outcomes. Multilevel modeling was used to test differences in MEMS results by group over time; ANCOVA was used to compare groups on other measures. Results Reminder calls increased adherence compared to usual care based on MEMS, p = .005, and self-report, p = .04. MI had a nonsignificant effect but produced higher satisfaction than reminder calls, p = .007. Treatment fidelity was high on most measures, with observable differences in behavior between groups. All groups had high baseline adherence that limited opportunities for change. Conclusion Reminder calls, but not MI, led to better adherence than usual care. Although a large literature supports MI, reminder calls might be a cost-effective intervention for patients with high baseline adherence. Replication is needed with less adherent participants. PMID:27701902

The Comparative Efficacy of Lifestyle Intervention and Metformin by Educational Attainment in the Diabetes Prevention Program

PubMed Central

O’Brien, Matthew J.; Whitaker, Robert C.; Yu, Daohai; Ackermann, Ronald T.

2015-01-01

Objective Educational attainment is inversely associated with type 2 diabetes risk, but it is unknown whether education impacts individuals’ diabetes prevention efforts. We examined the comparative efficacy of intensive lifestyle intervention and metformin by educational attainment among participants in the Diabetes Prevention Program (DPP), an ongoing U.S. multi-site trial beginning in 1996. Methods We studied 2,910 DPP participants randomized to receive lifestyle intervention, metformin, or placebo. Stratifying by educational attainment, diabetes incidence and relative risk reductions by treatment assignment were estimated using Cox proportional hazards regression. Results 47% of participants had completed college and 53% had not. Compared to placebo, lifestyle participants who had completed college demonstrated a 68% reduction in diabetes incidence (95% CI=56, 77), whereas those with less education experienced a 47% risk reduction (95% CI=29, 61). For metformin participants, college graduates experienced a 49% relative risk reduction (95% CI=33, 62), compared to 23% (95% CI=1, 41) among those with lower educational attainment. There was a statistically significant education-by-treatment interaction with incident diabetes (p=0.03). Conclusions Intensive lifestyle intervention and metformin have greater efficacy among highly educated individuals. Future efforts to deliver these treatments and study their dissemination may be more effective if tailored to individuals’ educational background. PMID:26024851

The comparative efficacy of lifestyle intervention and metformin by educational attainment in the Diabetes Prevention Program.

PubMed

O'Brien, Matthew J; Whitaker, Robert C; Yu, Daohai; Ackermann, Ronald T

2015-08-01

Educational attainment is inversely associated with type 2 diabetes risk, but it is unknown whether education impacts individuals' diabetes prevention efforts. We examined the comparative efficacy of intensive lifestyle intervention and metformin by educational attainment among participants in the Diabetes Prevention Program (DPP), an ongoing U.S. multi-site trial beginning in 1996. We studied 2,910 DPP participants randomized to receive lifestyle intervention, metformin, or placebo. Stratifying by educational attainment, diabetes incidence and relative risk reductions by treatment assignment were estimated using Cox proportional hazards regression. 47% of participants had completed college and 53% had not. Compared to placebo, lifestyle participants who had completed college demonstrated a 68% reduction in diabetes incidence (95% CI=56, 77), whereas those with less education experienced a 47% risk reduction (95% CI=29, 61). For metformin participants, college graduates experienced a 49% relative risk reduction (95% CI=33, 62), compared to 23% (95% CI=1, 41) among those with lower educational attainment. There was a statistically significant education-by-treatment interaction with incident diabetes (p=0.03). Intensive lifestyle intervention and metformin have greater efficacy among highly educated individuals. Future efforts to deliver these treatments and study their dissemination may be more effective if tailored to individuals' educational background. Copyright © 2015 Elsevier Inc. All rights reserved.

A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity.

PubMed

Erickson, Zachary D; Kwan, Crystal L; Gelberg, Hollie A; Arnold, Irina Y; Chamberlin, Valery; Rosen, Jennifer A; Shah, Chandresh; Nguyen, Charles T; Hellemann, Gerhard; Aragaki, Dixie R; Kunkel, Charles F; Lewis, Melissa M; Sachinvala, Neena; Sonza, Patrick A; Pierre, Joseph M; Ames, Donna

2017-04-01

Weight gain and other metabolic sequelae of antipsychotic medications can lead to medication non-adherence, reduced quality of life, increased costs, and premature mortality. Of the approaches to address this, behavioral interventions are less invasive, cost less, and can result in sustained long-term benefits. We investigated behavioral weight management interventions for veterans with mental illness across four medical centers within the Veterans Affairs (VA) Healthcare System. We conducted a 12-month, multi-site extension of our previous randomized, controlled study, comparing treatment and control groups. Veterans (and some non-veteran women) diagnosed with mental illness, overweight (defined as having a BMI over 25), and required ongoing antipsychotic therapy. One group received "Lifestyle Balance" (LB; modified from the Diabetes Prevention Program) consisting of classes and individual nutritional counseling with a dietitian. A second group received less intensive "Usual Care" (UC) consisting of weight monitoring and provision of self-help. Participants completed anthropometric and nutrition assessments weekly for 8 weeks, then monthly. Psychiatric, behavioral, and physical assessments were conducted at baseline and months 2, 6, and 12. Metabolic and lipid laboratory tests were performed quarterly. Participants in both groups lost weight. LB participants had a greater decrease in average waist circumference [F(1,1244) = 11.9, p < 0.001] and percent body fat [F(1,1121) = 4.3, p = 0.038]. Controlling for gender yielded statistically significant changes between groups in BMI [F(1,1246) = 13.9, p < 0.001]. Waist circumference and percent body fat decreased for LB women [F(1,1243) = 22.5, p < 0.001 and F(1,1221) = 4.8, p = 0.029, respectively]. The majority of LB participants kept food and activity journals (92%), and average daily calorie intake decreased from 2055 to 1650 during the study (p < 0.001). Behavioral interventions specifically designed for individuals with mental illness can be effective for weight loss and improve dietary behaviors. "Lifestyle Balance" integrates well with VA healthcare's patient-centered "Whole Health" approach. ClinicalTrials.gov identifier NCT01052714.

Improved Prevention Counseling by HIV Care Providers in a Multisite, Clinic-Based Intervention: Positive STEPs

ERIC Educational Resources Information Center

Thrun, Mark; Cook, Paul F.; Bradley-Springer, Lucy A.; Gardner, Lytt; Marks, Gary; Wright, Julie; Wilson, Tracey E.; Quinlivan, E. Byrd; O'Daniels, Christine; Raffanti, Stephen; Thompson, Melanie; Golin, Carol

2009-01-01

The Centers for Disease Control and Prevention have recommended that HIV care clinics incorporate prevention into clinical practice. This report summarizes HIV care providers' attitudes and counseling practices before and after they received training to deliver a counseling intervention to patients. Providers at seven HIV clinics received training…

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

PubMed Central

2016-01-01

Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Conclusions Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV). PMID:26883052

WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

PubMed Central

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Schornstein, Katrin; Vernooij-Dassen, Myrra; Olde-Rikkert, Marcel; Huell, Michael

2009-01-01

Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion. Discussion The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment. The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform. PMID:19799779

Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

PubMed

Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

2015-07-10

Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

Gender differences among treatment-seeking adults with cannabis use disorder: Clinical profiles of women and men enrolled in the achieving cannabis cessation-evaluating N-acetylcysteine treatment (ACCENT) study.

PubMed

Sherman, Brian J; McRae-Clark, Aimee L; Baker, Nathaniel L; Sonne, Susan C; Killeen, Therese K; Cloud, Kasie; Gray, Kevin M

2017-03-01

Recent evidence suggests that women may fare worse than men in cannabis trials with pharmacologic interventions. Identifying baseline clinical profiles of treatment-seeking cannabis-dependent adults could inform gender-specific treatment planning and development. The current study compared baseline demographic, cannabis use, and psychiatric factors between women (n = 86) and men (n = 216) entering the Achieving Cannabis Cessation-Evaluating N-acetylcysteine Treatment (ACCENT) study, a multi-site, randomized controlled trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Women reported greater withdrawal intensity (p = .001) and negative impact of withdrawal (p = .001), predominantly due to physiological and mood symptoms. Women were more likely to have lifetime panic disorder (p = .038) and current agoraphobia (p = .022), and reported more days of poor physical health (p = .006) and cannabis-related medical problems (p = .023). Women reporting chronic pain had greater mean pain scores than men with chronic pain (p = .006). Men and women did not differ on any measures of baseline cannabis use. Cannabis-dependent women may present for treatment with more severe and impairing withdrawal symptoms and psychiatric conditions compared to cannabis-dependent men. This might help explain recent evidence suggesting that women fare worse than men in cannabis treatment trials of pharmacologic interventions. Baseline clinical profiles of treatment-seeking adults can inform gender-specific treatment planning and development. Cannabis-dependent women may benefit from integrated treatment focusing on co-occurring psychiatric disorders and targeted treatment of cannabis withdrawal syndrome.(Am J Addict 2017;26:136-144). © 2017 American Academy of Addiction Psychiatry.

Gender differences among treatment-seeking adults with cannabis use disorder: Clinical profiles of women and men enrolled in the Achieving Cannabis Cessation – Evaluating N-acetylcysteine Treatment (ACCENT) study

PubMed Central

Sherman, Brian J.; McRae-Clark, Aimee L.; Baker, Nathaniel L.; Sonne, Susan C.; Killeen, Therese K.; Cloud, Kasie; Gray, Kevin M.

2017-01-01

Background and Objectives Recent evidence suggests that women may fare worse than men in cannabis trials with pharmacologic interventions. Identifying baseline clinical profiles of treatment-seeking cannabis-dependent adults could inform gender-specific treatment planning and development. Methods The current study compared baseline demographic, cannabis use, and psychiatric factors between women (n = 86) and men (n = 216) entering the Achieving Cannabis Cessation – Evaluating N-acetylcysteine Treatment (ACCENT) study, a multi-site, randomized controlled trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Results Women reported greater withdrawal intensity (p = 0.001) and negative impact of withdrawal (p = 0.001), predominantly due to physiological and mood symptoms. Women were more likely to have lifetime panic disorder (p = 0.038) and current agoraphobia (p = 0.022), and reported more days of poor physical health (p = 0.006) and cannabis-related medical problems (p = 0.023). Women reporting chronic pain had greater mean pain scores than men with chronic pain (p = 0.006). Men and women did not differ on any measures of baseline cannabis use. Discussion and Conclusion Cannabis-dependent women may present for treatment with more severe and impairing withdrawal symptoms and psychiatric conditions compared to cannabis-dependent men. This might help explain recent evidence suggesting that women fare worse than men in cannabis treatment trials of pharmacologic interventions. Baseline clinical profiles of treatment-seeking adults can inform gender-specific treatment planning and development. Scientific Significance Cannabis-dependent women may benefit from integrated treatment focusing on co-occurring psychiatric disorders and targeted treatment of cannabis withdrawal syndrome. PMID:28152236

The Patient Remote Intervention and Symptom Management System (PRISMS) - a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial.

PubMed

Breen, Sibilah; Ritchie, David; Schofield, Penelope; Hsueh, Ya-Seng; Gough, Karla; Santamaria, Nick; Kamateros, Rose; Maguire, Roma; Kearney, Nora; Aranda, Sanchia

2015-10-19

Outpatient chemotherapy is a core treatment for haematological malignancies; however, its toxicities frequently lead to distressing/potentially life-threatening side-effects (neutropenia/infection, nausea/vomiting, mucositis, constipation/diarrhoea, fatigue). Early detection/management of side-effects is vital to improve patient outcomes, decrease morbidity and limit lengthy/costly hospital admissions. The ability to capture patient-reported health data in real-time, is regarded as the 'gold-standard' to allow rapid clinical decision-making/intervention. This paper presents the protocol for a Phase 3 multi-site randomised controlled trial evaluating a novel nurse-led Telehealth intervention for remote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients. Two hundred and twenty-two patients will be recruited from two hospitals. Eligibility criteria include: diagnosis of chronic lymphocytic leukaemia/Hodgkin's/non-Hodgkin's lymphoma; aged ≥ 18 years; receiving ≥ 2 cycles chemotherapy. Patients will be randomised 1:1 to either the control or intervention arm with stratification by diagnosis, chemotherapy toxicity (high versus low), receipt of previous chemotherapy and hospital. Patients allocated to the control arm will receive 'Usual Care' whilst those allocated to the intervention will receive the intervention in addition to 'Usual Care'. Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional scales for up to four chemotherapy cycles. Should patient data exceed pre-determined limits an Email alert is delivered to the treatment team, prompting nurses to view patient data, and contact the patient to provide clinical intervention. In addition, six scheduled nursing interventions will be completed to educate/support patients in use of the software. Patient outcomes will be measured cyclically (midpoint and end of cycles) via pen-and-paper self-report alongside review of the patient medical record. The primary outcome is burden due to nausea, mucositis, constipation and fatigue. Secondary outcomes include: burden due to vomiting and diarrhoea; psychological distress; ability to self-manage health; level of cancer information/support needs and; utilisation of health services. Analyses will be intention-to-treat. A cost-effectiveness analysis is planned. This trial is the first in the world to test a remote monitoring/management intervention for adult haematological cancer patients receiving chemotherapy. Future use of such interventions have the potential to improve patient outcomes/safety and decrease health care costs by enabling early detection/clinical intervention. ACTRN12614000516684 . Date registered: 12 March 2014 (registered retrospectively).

National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: a cluster randomized trial.

PubMed

El-Bassel, Nabila; Jemmott, John B; Landis, J Richard; Pequegnat, Willo; Wingood, Gina M; Wyatt, Gail E; Bellamy, Scarlett L

2010-09-27

Human immunodeficiency virus (HIV) has disproportionately affected African Americans. Couple-level interventions may be a promising intervention strategy. To determine if a behavioral intervention can reduce HIV/sexually transmitted disease (STD) risk behaviors among African American HIV serodiscordant couples, a cluster randomized controlled trial (Eban) was conducted in Atlanta, Georgia; Los Angeles, California; New York, New York; and Philadelphia, Pennsylvania; with African American HIV serodiscordant heterosexual couples who were eligible if both partners were at least 18 years old and reported unprotected intercourse in the previous 90 days and awareness of each other's serostatus. One thousand seventy participants were enrolled (mean age, 43 years; 40% of male participants were HIV positive). Couples were randomized to 1 of 2 interventions: couple-focused Eban HIV/STD risk-reduction intervention or attention-matched individual-focused health promotion comparison. The primary outcomes were the proportion of condom-protected intercourse acts and cumulative incidence of STDs (chlamydia, gonorrhea, or trichomonas). Data were collected preintervention and postintervention, and at 6- and 12-month follow-ups. Data were analyzed for 535 randomized couples: 260 in the intervention group and 275 in the comparison group; 81.9% were retained at the 12-month follow-up. Generalized estimating equation analyses revealed that the proportion of condom-protected intercourse acts was larger among couples in the intervention group (0.77) than in the comparison group (0.47; risk ratio, 1.24; 95% confidence interval [CI], 1.09 to 1.41; P = .006) when adjusted for the baseline criterion measure. The adjusted percentage of couples using condoms consistently was higher in the intervention group (63%) than in the comparison group (48%; risk ratio, 1.45; 95% CI, 1.24 to 1.70; P < .001). The adjusted mean number of (log)unprotected intercourse acts was lower in the intervention group than in the comparison group (mean difference, -1.52; 95% CI, -2.07 to -0.98; P < .001). The cumulative STD incidence over the 12-month follow-up did not differ between couples in the intervention and comparison groups. The overall HIV seroconversion at the 12-month follow-up was 5 (2 in the intervention group, 3 in the comparison group) of 535 individuals, which translates to 935 per 100,000 population. To our knowledge, this is the first randomized controlled intervention trial to report significant reductions in HIV/STD risk behaviors among African American HIV serodiscordant couples. clinicaltrials.gov Identifier: NCT00644163.

Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study.

PubMed

Tierney, Elaine; Aman, Michael; Stout, David; Pappas, Krista; Arnold, L Eugene; Vitiello, Benedetto; Scahill, Lawrence; McDougle, Christopher; McCracken, James; Wheeler, Courtney; Martin, Andres; Posey, David; Shah, Bhavik

2007-03-01

Subjects who view experimental procedures as worthwhile are more likely to participate in clinical trials and comply with study procedures. Designing studies that consider the consumer's perspective will help to forge a better alliance between participants and researchers. Participant satisfaction is seldom assessed in pharmacological research. In this paper, we report on parent satisfaction in a randomized clinical trial in children with autistic disorder and severely disruptive behavior. Parents of 101 children with autism who had participated in a multi-site 8-week double-blind clinical trial of risperidone were given a questionnaire at the end to elicit their perceptions of the appropriateness and acceptability of clinical trial procedures. Ninety-six (95.0%) parents returned the questionnaire. Of these, 80.0 to 96.8%, depending on the question, expressed satisfaction with their child's research participation regardless of treatment outcome or assignment to active drug or placebo. In all, 90.5% of parents indicated that they would "definitely" recommend the clinical trial to other families with similar children. A total of 92.7% indicated that they would rejoin the clinical trial if they had to do it all over again. Ethnic minority subjects were more satisfied than white participants with the use of "learning tests". Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.

Mediators of Effects of a Selective Family-Focused Violence Prevention Approach for Middle School Students

PubMed Central

2013-01-01

This study examined how parenting and family characteristics targeted in a selective prevention program mediated effects on key youth proximal outcomes related to violence perpetration. The selective intervention was evaluated within the context of a multi-site trial involving random assignment of 37 schools to four conditions: a universal intervention composed of a student social-cognitive curriculum and teacher training, a selective family-focused intervention with a subset of high-risk students, a condition combining these two interventions, and a no-intervention control condition. Two cohorts of sixth-grade students (total N=1,062) exhibiting high levels of aggression and social influence were the sample for this study. Analyses of pre-post change compared to controls using intent-to-treat analyses found no significant effects. However, estimates incorporating participation of those assigned to the intervention and predicted participation among those not assigned revealed significant positive effects on student aggression, use of aggressive strategies for conflict management, and parental estimation of student’s valuing of achievement. Findings also indicated intervention effects on two targeted family processes: discipline practices and family cohesion. Mediation analyses found evidence that change in these processes mediated effects on some outcomes, notably aggressive behavior and valuing of school achievement. Results support the notion that changing parenting practices and the quality of family relationships can prevent the escalation in aggression and maintain positive school engagement for high-risk youth. PMID:21932067

TelePain: Primary Care Chronic Pain Management through Weekly Didactic and Case-based Telementoring.

PubMed

Flynn, Diane M; Eaton, Linda H; McQuinn, Honor; Alden, Ashley; Meins, Alexa R; Rue, Tessa; Tauben, David J; Doorenbos, Ardith Z

2017-12-01

Chronic pain is a significant problem among military personnel and a priority of the military health system. The U.S. Army Surgeon General's Pain Management Task Force recommends using telehealth capabilities to enhance pain management. This article describes the development and evaluation of a telehealth intervention (TelePain) designed to improve access to pain specialist consultation in the military health system. The study uses a wait-list controlled clinical trial to test: 1) effectiveness of the intervention, and 2) interviews to assess barriers and facilitators of the intervention implementation. The intervention involves a didactic presentation based on the Joint Pain Education Curriculum followed by patient case presentations and multi-disciplinary discussion via videoconference by clinicians working in the military health system. A panel of pain specialists representing pain medicine, internal medicine, anesthesiology, rehabilitation medicine, psychiatry, addiction medicine, health psychology, pharmacology, nursing, and complementary and integrative pain management provide pain management recommendations for each patient case. We use the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) to measure patient outcomes, including pain, sleep, fatigue, anxiety, and depression. This article reports some of the challenges and lessons learned during early implementation of the TelePain intervention. Weekly telephone meetings among the multisite research team were instrumental in problem solving, identifying problem areas, and developing solutions. Solutions for recruitment challenges included additional outreach and networking to military health providers, both building on.

Gender-based Outcomes and Acceptability of a Computer-assisted Psychosocial Intervention for Substance Use Disorders.

PubMed

Campbell, Aimee N C; Nunes, Edward V; Pavlicova, Martina; Hatch-Maillette, Mary; Hu, Mei-Chen; Bailey, Genie L; Sugarman, Dawn E; Miele, Gloria M; Rieckmann, Traci; Shores-Wilson, Kathy; Turrigiano, Eva; Greenfield, Shelly F

2015-06-01

Digital technologies show promise for increasing treatment accessibility and improving quality of care, but little is known about gender differences. This secondary analysis uses data from a multi-site effectiveness trial of a computer-assisted behavioral intervention, conducted within NIDA's National Drug Abuse Clinical Trials Network, to explore gender differences in intervention acceptability and treatment outcomes. Men (n=314) and women (n=192) were randomly assigned to 12-weeks of treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week. TES is composed of 62 Web-delivered, multimedia modules, covering skills for achieving and maintaining abstinence plus prize-based incentives contingent on abstinence and treatment adherence. Outcomes were: (1) abstinence from drugs and heavy drinking in the last 4weeks of treatment, (2) retention, (3) social functioning, and (4) drug and alcohol craving. Acceptability was the mean score across five indicators (i.e., interesting, useful, novel, easy to understand, and satisfaction). Gender did not moderate the effect of treatment on any outcome. Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12. Acceptability was positively associated with abstinence, but only among women (p=.01). Findings suggest that men and women derive similar benefits from participating in a computer-assisted intervention, a promising outcome as technology-based treatments expand. Acceptability was associated with abstinence outcomes among women. Future research should explore characteristics of women who report less satisfaction with this modality of treatment and ways to improve overall acceptability. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of a Mobile Web App on Kidney Transplant Candidates' Knowledge About Increased Risk Donor Kidneys: A Randomized Controlled Trial.

PubMed

Gordon, Elisa J; Sohn, Min-Woong; Chang, Chih-Hung; McNatt, Gwen; Vera, Karina; Beauvais, Nicole; Warren, Emily; Mannon, Roslyn B; Ison, Michael G

2017-06-01

Kidney transplant candidates (KTCs) must provide informed consent to accept kidneys from increased risk donors (IRD), but poorly understand them. We conducted a multisite, randomized controlled trial to evaluate the efficacy of a mobile Web application, Inform Me, for increasing knowledge about IRDs. Kidney transplant candidates undergoing transplant evaluation at 2 transplant centers were randomized to use Inform Me after routine transplant education (intervention) or routine transplant education alone (control). Computer adaptive learning method reinforced learning by embedding educational material, and initial (test 1) and additional test questions (test 2) into each chapter. Knowledge (primary outcome) was assessed in person after education (tests 1 and 2), and 1 week later by telephone (test 3). Controls did not receive test 2. Willingness to accept an IRD kidney (secondary outcome) was assessed after tests 1 and 3. Linear regression test 1 knowledge scores were used to test the significance of Inform Me exposure after controlling for covariates. Multiple imputation was used for intention-to-treat analysis. Two hundred eighty-eight KTCs participated. Intervention participants had higher test 1 knowledge scores (mean difference, 6.61; 95% confidence interval [95% CI], 5.37-7.86) than control participants, representing a 44% higher score than control participants' scores. Intervention participants' knowledge scores increased with educational reinforcement (test 2) compared with control arm test 1 scores (mean difference, 9.50; 95% CI, 8.27-10.73). After 1 week, intervention participants' knowledge remained greater than controls' knowledge (mean difference, 3.63; 95% CI, 2.49-4.78) (test 3). Willingness to accept an IRD kidney did not differ between study arms at tests 1 and 3. Inform Me use was associated with greater KTC knowledge about IRD kidneys above routine transplant education alone.

A randomized trial comparing live and telemedicine deliveries of an imagery-based behavioral intervention for breast cancer survivors: reducing symptoms and barriers to care.

PubMed

Freeman, Lyn W; White, Rebecca; Ratcliff, Chelsea G; Sutton, Sue; Stewart, Mary; Palmer, J Lynn; Link, Judith; Cohen, Lorenzo

2015-08-01

This multi-site randomized trial evaluates the quality of life (QOL) benefits of an imagery-based group intervention titled 'Envision the Rhythms of Life'(ERL). Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-h group sessions at a community center with therapist present (live delivery (LD), n = 48), therapist streamed via telemedicine (telemedicine delivery (TD), n = 23), or to a waitlist control (WL) group (n = 47). Weekly individual phone calls to encourage at-home practice began at session one and continued until the 3-month follow-up. Seven self-report measures of QOL were examined at baseline, 1-month and 3-month post-treatments including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. Linear multilevel modeling analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared with WL across the follow-up (p's < 0.01). Changes in fatigue, cognitive dysfunction, sleep disturbance, and health-related and breast cancer-related QOL were clinically significant. There were no differences between LD and TD. Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared with WL. Further, there were no significant differences between LD and TD, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas. Copyright © 2014 John Wiley & Sons, Ltd.

Recruiting a Diverse Group of Middle School Girls Into the Trial of Activity for Adolescent Girls

PubMed Central

Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

2009-01-01

BACKGROUND School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among middle school—aged girls. TAAG provided a unique opportunity to recruit large cohorts of randomly sampled girls within 36 diverse middle schools across the United States. METHODS Key elements of the formative planning, coordination, and design of TAAG’s recruitment efforts included flexibility, tailoring, and the use of incentives. Various barriers, including a natural disaster, political tension, and district regulations, were encountered throughout the recruitment process, but coordinated strategies and frequent communication between the 6 TAAG sites were helpful in tailoring the recruitment process at the 36 intervention and control schools. RESULTS Progressively refined recruitment strategies and specific attention to the target audience of middle school girls resulted in overall study recruitment rates of 80%, 85%, and 89%, for the baseline, posttest, and follow-up period, respectively. DISCUSSION The steady increase in recruitment rates over time is attributed to an emphasis on successful strategies and a willingness to modify less successful methods. Open and consistent communication, an increasingly coordinated recruitment strategy, interactive recruitment presentations, and participant incentives resulted in an effective recruitment campaign. PMID:18808471

Helping Seniors Plan for Posthospital Discharge Needs Before a Hospitalization Occurs: Results from the Randomized Control Trial of PlanYourLifespan.org.

PubMed

Lindquist, Lee A; Ramirez-Zohfeld, Vanessa; Sunkara, Priya D; Forcucci, Chris; Campbell, Dianne S; Mitzen, Phyllis; Ciolino, Jody D; Kricke, Gayle; Seltzer, Anne; Ramirez, Ana V; Cameron, Kenzie A

2017-11-01

Investigate the effect of PlanYourLifespan.org (PYL) on knowledge of posthospital discharge options. Multisite randomized controlled trial. Nonhospitalized adults, aged =65 years, living in urban, suburban, and rural areas of Texas, Illinois, and Indiana. PYL is a national, publicly available tool that provides education on posthospital therapy choices and local home-based resources. Participants completed an in-person baseline survey, followed by exposure to intervention or attention control (AC) websites, then 1-month and 3-month telephone surveys. The primary knowledge outcome was measured with 6 items (possible 0-6 points) pertaining to hospital discharge needs. Among 385 participants randomized, mean age was 71.9 years (standard deviation 5.6) and 79.5% of participants were female. At 1 month, the intervention group had a 0.6 point change (standard deviation = 1.6) versus the AC group who had a -0.1 point change in knowledge score. Linear mixed modeling results suggest sex, health literacy level, level of education, income, and history of high blood pressure/kidney disease were significant predictors of knowledge over time. Controlling for these variables, treatment effect remained significant (P < 0.0001). Seniors who used PYL demonstrated an increased understanding of posthospitalization and home services compared to the control group. © 2017 Society of Hospital Medicine

Young Adults in the Workplace: A Multisite Initiative of Substance Use Prevention Programs. RTI Press Book

ERIC Educational Resources Information Center

Bray, Jeremy W., Ed.; Galvin, Deborah M., Ed.; Cluff, Laurie A., Ed.

2011-01-01

Although higher rates of substance use among young adults aged 16 to 24 are well-established (OAS, 2010), existing workplace substance use prevention and early intervention programs primarily target older workers. These data suggest that workplaces need substance abuse prevention and early intervention programs that are proven to be efficacious…

Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure.

PubMed

El-Jawahri, Areej; Paasche-Orlow, Michael K; Matlock, Dan; Stevenson, Lynne Warner; Lewis, Eldrin F; Stewart, Garrick; Semigran, Marc; Chang, Yuchiao; Parks, Kimberly; Walker-Corkery, Elizabeth S; Temel, Jennifer S; Bohossian, Hacho; Ooi, Henry; Mann, Eileen; Volandes, Angelo E

2016-07-05

Conversations about goals of care and cardiopulmonary resuscitation (CPR)/intubation for patients with advanced heart failure can be difficult. This study examined the impact of a video decision support tool and patient checklist on advance care planning for patients with heart failure. This was a multisite, randomized, controlled trial of a video-assisted intervention and advance care planning checklist versus a verbal description in 246 patients ≥64 years of age with heart failure and an estimated likelihood of death of >50% within 2 years. Intervention participants received a verbal description for goals of care (life-prolonging care, limited care, and comfort care) and CPR/intubation plus a 6-minute video depicting the 3 levels of care, CPR/intubation, and an advance care planning checklist. Control subjects received only the verbal description. The primary analysis compared the proportion of patients preferring comfort care between study arms immediately after the intervention. Secondary outcomes were CPR/intubation preferences and knowledge (6-item test; range, 0-6) after intervention. In the intervention group, 27 (22%) chose life-prolonging care, 31 (25%) chose limited care, 63 (51%) selected comfort care, and 2 (2%) were uncertain. In the control group, 50 (41%) chose life-prolonging care, 27 (22%) selected limited care, 37 (30%) chose comfort care, and 8 (7%) were uncertain (P<0.001). Intervention participants (compared with control subjects) were more likely to forgo CPR (68% versus 35%; P<0.001) and intubation (77% versus 48%; P<0.001) and had higher mean knowledge scores (4.1 versus 3.0; P<0.001). Patients with heart failure who viewed a video were more informed, more likely to select a focus on comfort, and less likely to desire CPR/intubation compared with patients receiving verbal information only. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01589120. © 2016 American Heart Association, Inc.

Generating evidence to narrow the treatment gap for mental disorders in sub-Saharan Africa: rationale, overview and methods of AFFIRM.

PubMed

Lund, C; Alem, A; Schneider, M; Hanlon, C; Ahrens, J; Bandawe, C; Bass, J; Bhana, A; Burns, J; Chibanda, D; Cowan, F; Davies, T; Dewey, M; Fekadu, A; Freeman, M; Honikman, S; Joska, J; Kagee, A; Mayston, R; Medhin, G; Musisi, S; Myer, L; Ntulo, T; Nyatsanza, M; Ofori-Atta, A; Petersen, I; Phakathi, S; Prince, M; Shibre, T; Stein, D J; Swartz, L; Thornicroft, G; Tomlinson, M; Wissow, L; Susser, E

2015-06-01

There is limited evidence on the acceptability, feasibility and cost-effectiveness of task-sharing interventions to narrow the treatment gap for mental disorders in sub-Saharan Africa. The purpose of this article is to describe the rationale, aims and methods of the Africa Focus on Intervention Research for Mental health (AFFIRM) collaborative research hub. AFFIRM is investigating strategies for narrowing the treatment gap for mental disorders in sub-Saharan Africa in four areas. First, it is assessing the feasibility, acceptability and cost-effectiveness of task-sharing interventions by conducting randomised controlled trials in Ethiopia and South Africa. The AFFIRM Task-sharing for the Care of Severe mental disorders (TaSCS) trial in Ethiopia aims to determine the acceptability, affordability, effectiveness and sustainability of mental health care for people with severe mental disorder delivered by trained and supervised non-specialist, primary health care workers compared with an existing psychiatric nurse-led service. The AFFIRM trial in South Africa aims to determine the cost-effectiveness of a task-sharing counselling intervention for maternal depression, delivered by non-specialist community health workers, and to examine factors influencing the implementation of the intervention and future scale up. Second, AFFIRM is building individual and institutional capacity for intervention research in sub-Saharan Africa by providing fellowship and mentorship programmes for candidates in Ethiopia, Ghana, Malawi, Uganda and Zimbabwe. Each year five Fellowships are awarded (one to each country) to attend the MPhil in Public Mental Health, a joint postgraduate programme at the University of Cape Town and Stellenbosch University. AFFIRM also offers short courses in intervention research, and supports PhD students attached to the trials in Ethiopia and South Africa. Third, AFFIRM is collaborating with other regional National Institute of Mental Health funded hubs in Latin America, sub-Saharan Africa and south Asia, by designing and executing shared research projects related to task-sharing and narrowing the treatment gap. Finally, it is establishing a network of collaboration between researchers, non-governmental organisations and government agencies that facilitates the translation of research knowledge into policy and practice. This article describes the developmental process of this multi-site approach, and provides a narrative of challenges and opportunities that have arisen during the early phases. Crucial to the long-term sustainability of this work is the nurturing and sustaining of partnerships between African mental health researchers, policy makers, practitioners and international collaborators.

Methods to Limit Attrition in Longitudinal Comparative Effectiveness Trials: Lessons from the Lithium Use for Bipolar Disorder (LiTMUS) Study

PubMed Central

Sylvia, Louisa G.; Reilly-Harrington, Noreen A.; Leon, Andrew C.; Kansky, Christine I.; Ketter, Terence A.; Calabrese, Joseph R.; Thase, Michael E.; Bowden, Charles L.; Friedman, Edward S.; Ostacher, Michael J.; Iosifescu, Dan V.; Severe, Joanne; Nierenberg, Andrew A.

2013-01-01

Background High attrition rates which occur frequently in longitudinal clinical trials of interventions for bipolar disorder limit the interpretation of results. Purpose The aim of this article is to present design approaches that limited attrition in the Lithium Use for Bipolar Disorder (LiTMUS) Study. Methods LiTMUS was a 6-month randomized, longitudinal multi-site comparative effectiveness trial that examined bipolar participants who were at least mildly ill. Participants were randomized to either low to moderate doses of lithium or no lithium, in addition to other treatments needed for mood stabilization administered in a guideline-informed, empirically supported, and personalized fashion (N=283). Results Components of the study design that may have contributed to the low attrition rate of the study included use of: (1) an intent-to-treat design; (2) a randomized adjunctive single-blind design; (3) participant reimbursement; (4) intent-to-attend the next study visit (includes a discussion of attendance obstacles when intention is low); (5) quality care with limited participant burden; and (6) target windows for study visits. Limitations Site differences and the effectiveness and tolerability data have not been analyzed yet. Conclusions These components of the LiTMUS study design may have reduced the probability of attrition which would inform the design of future randomized clinical effectiveness trials. PMID:22076437

Maternal Opioid Treatment: Human Experimental Research (MOTHER) – Approach, Issues, and Lessons Learned

PubMed Central

Jones, Hendrée E.; Fischer, Gabriele; Heil, Sarah H.; Kaltenbach, Karol; Martin, Peter R.; Coyle, Mara G.; Selby, Peter; Stine, Susan M.; O’Grady, Kevin E.; Arria, Amelia M.

2015-01-01

Aims The Maternal Opioid Treatment: Human Experimental Research (MOTHER) project, an eight-site randomized, double-blind, double-dummy, flexible-dosing, parallel-group clinical trial is described. This study is the most current – and single most comprehensive – research effort to investigate the safety and efficacy of maternal and prenatal exposure to methadone and buprenorphine. Methods The MOTHER study design is outlined, and its basic features are presented. Conclusions At least seven important lessons have been learned from the MOTHER study: (1) an interdisciplinary focus improves the design and methods of a randomized clinical trial; (2) multiple sites in a clinical trial present continuing challenges to the investigative team due to variations in recruitment goals, patient populations, and hospital practices that in turn differentially impact recruitment rates, treatment compliance, and attrition; (3) study design and protocols must be flexible in order to meet the unforeseen demands of both research and clinical management; (4) staff turnover needs to be addressed with a proactive focus on both hiring and training; (5) the implementation of a protocol for the treatment of a particular disorder may identify important ancillary clinical issues worthy of investigation; (6) timely tracking of data in a multi-site trial is both demanding and unforgiving; and, (7) complex multi-site trials pose unanticipated challenges that complicate the choice of statistical methods, thereby placing added demands on investigators to effectively communicate their results. PMID:23106924

Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial.

PubMed

Simon, Gregory E; Beck, Arne; Rossom, Rebecca; Richards, Julie; Kirlin, Beth; King, Deborah; Shulman, Lisa; Ludman, Evette J; Penfold, Robert; Shortreed, Susan M; Whiteside, Ursula

2016-09-15

Suicide remains the 10th-ranked most frequent cause of death in the United States, accounting for over 40,000 deaths per year. Nonfatal suicide attempts lead to over 200,000 hospitalizations and 600,000 emergency department visits annually. Recent evidence indicates that responses to the commonly used Patient Health Questionnaire (PHQ9) can identify outpatients who are at risk of suicide attempt and suicide death and that specific psychotherapy or Care Management programs can prevent suicide attempts in high-risk patients. Motivated by these developments, the NIMH-funded Mental Health Research Network has undertaken a multisite trial of two outreach programs to prevent suicide attempts among outpatients identified by routinely administered PHQ9 questionnaires. Outpatients who are at risk of suicide attempt are automatically identified using data from electronic health records (EHRs). Following a modified Zelen design, all those identified are assigned to continued usual care (i.e., no contact) or to be offered one of two population-based outreach programs. A Care Management intervention includes systematic outreach to assess suicide risk, EHR-based tools to implement risk-based care pathways, and care management to facilitate recommended follow-up. A Skills Training intervention includes interactive online training in Dialectical Behavior Therapy skills, supported by reminder and reinforcement messages from a skills coach. Each intervention supplements, rather than replaces, usual care; participants may receive any other services normally available. Interventions are delivered primarily by secure messaging through EHR patient portals. Suicide attempts and deaths following randomization are identified using state vital statistics data and health system EHR and insurance claim data. Primary evaluation will compare risk of suicide attempt or death over 18 months according to the initial assignment, regardless of intervention participation. Recruitment is underway in three health systems (Group Health Cooperative, HealthPartners, and Kaiser Permanente Colorado). Over 2500 participants have been randomized as of 1 March 2016, with enrollment averaging approximately 100 per week. Assessing the effectiveness of population-based suicide prevention requires adherence to the principles of pragmatic trials: population-based enrollment, accepting variable treatment participation, assessing outcomes using health record data, and analyses based on intent-to-treat. ClinicalTrials.gov registration # NCT02326883 , registered on 23 December 2014.

Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial.

PubMed

Sharps, Phyllis W; Bullock, Linda F; Campbell, Jacquelyn C; Alhusen, Jeanne L; Ghazarian, Sharon R; Bhandari, Shreya S; Schminkey, Donna L

2016-11-01

Perinatal intimate partner violence (IPV) is common and has significant negative health outcomes for mothers and infants. This study evaluated the effectiveness of an IPV intervention in reducing violence among abused women in perinatal home visiting programs. This assessor-blinded multisite randomized control trial of 239 women experiencing perinatal IPV was conducted from 2006 to 2012 in U.S. urban and rural settings. The Domestic Violence Enhanced Home Visitation Program (DOVE) intervention group (n = 124) received a structured abuse assessment and six home visitor-delivered empowerment sessions integrated into home visits. All participants were screened for IPV and referred appropriately. IPV was measured by the Conflicts Tactics Scale2 at baseline through 24 months postpartum. There was a significant decrease in IPV over time (F = 114.23; p < 0.001) from baseline to 1, 3, 6, 12, 18, and 24 months postpartum (all p < 0.001). Additional models examining change in IPV from baseline indicated a significant treatment effect (F = 6.45; p < 0.01). Women in the DOVE treatment group reported a larger mean decrease in IPV scores from baseline compared to women in the usual care group (mean decline 40.82 vs. 35.87). All models accounted for age and maternal depression as covariates. The DOVE intervention was effective in decreasing IPV and is brief, thereby facilitating its incorporation within well-woman and well-child care visits, as well as home visiting programs, while satisfying recommendations set forth in the Affordable Care Act for IPV screening and brief counseling.

Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

PubMed Central

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-01-01

Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. PMID:26500170

Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial

PubMed Central

Bullock, Linda F.; Campbell, Jacquelyn C.; Alhusen, Jeanne L.; Ghazarian, Sharon R.; Bhandari, Shreya S.; Schminkey, Donna L.

2016-01-01

Abstract Background: Perinatal intimate partner violence (IPV) is common and has significant negative health outcomes for mothers and infants. This study evaluated the effectiveness of an IPV intervention in reducing violence among abused women in perinatal home visiting programs. Materials and Methods: This assessor-blinded multisite randomized control trial of 239 women experiencing perinatal IPV was conducted from 2006 to 2012 in U.S. urban and rural settings. The Domestic Violence Enhanced Home Visitation Program (DOVE) intervention group (n = 124) received a structured abuse assessment and six home visitor-delivered empowerment sessions integrated into home visits. All participants were screened for IPV and referred appropriately. IPV was measured by the Conflicts Tactics Scale2 at baseline through 24 months postpartum. Results: There was a significant decrease in IPV over time (F = 114.23; p < 0.001) from baseline to 1, 3, 6, 12, 18, and 24 months postpartum (all p < 0.001). Additional models examining change in IPV from baseline indicated a significant treatment effect (F = 6.45; p < 0.01). Women in the DOVE treatment group reported a larger mean decrease in IPV scores from baseline compared to women in the usual care group (mean decline 40.82 vs. 35.87). All models accounted for age and maternal depression as covariates. Conclusions: The DOVE intervention was effective in decreasing IPV and is brief, thereby facilitating its incorporation within well-woman and well-child care visits, as well as home visiting programs, while satisfying recommendations set forth in the Affordable Care Act for IPV screening and brief counseling. PMID:27206047

Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.

PubMed

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-11-01

Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers' illness perception of dental caries and increase utilization of care by children with restorative dental needs. A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter+DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter+DIG; and (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3-8; extraction). Enrollment commenced summer 2015 with results in summer 2016. This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. Copyright © 2015 Elsevier Inc. All rights reserved.

The efficacy of an opportunistic cognitive behavioral intervention package (OCB) on substance use and comorbid suicide risk: a multisite randomized controlled trial.

PubMed

Morley, Kirsten C; Sitharthan, Gomathi; Haber, Paul S; Tucker, Peter; Sitharthan, Thiagarajan

2014-02-01

People with substance use disorders who present with suicidal behavior are at high risk of subsequent suicide. There are few effective treatments specifically tailored for this population that diminish this risk. We aimed to assess the impact of an opportunistic cognitive behavioral intervention package (OCB) among adult outpatients with a substance use and comorbid suicide risk. A randomized controlled trial was conducted across 2 sites in which 185 patients presenting with suicide risk and concurrent substance use received either OCB (8 sessions plus group therapy) or treatment as usual (TAU) over a 6-month period. Primary outcomes were suicidal behavior (suicide attempts, suicidal intent and presence of suicide ideation) and level of drug and alcohol consumption. Secondary outcomes were changes in psychological measures of suicide ideation, depression, anxiety, and self-efficacy. There were no completed suicides, and only 2 participants reported suicide attempts at follow-up. Suicide ideation, alcohol consumption, and cannabis use fell over time but no significant Treatment × Time differences were found. There were also no differences between OCB and TAU over time on psychological measures of depression, anxiety, or self-efficacy. Suicide ideation at 6-month follow-up was predicted by cannabis use and higher scores on the Brief Psychiatric Rating Scale at baseline. The opportunistic cognitive behavioral intervention package did not appear to be beneficial in reducing suicide ideation, drug and alcohol consumption, or depression relative to treatment as usual. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Mobile phone messages to provide support to women during the home phase of medical abortion in South Africa: a randomised controlled trial.

PubMed

Constant, Deborah; de Tolly, Katherine; Harries, Jane; Myer, Landon

2014-09-01

Home use of misoprostol for medical abortion is more convenient for many women than in-clinic use but requires management of abortion symptoms at home without provider backup. This study evaluated whether automated text messages to women undergoing medical abortion can reduce anxiety and emotional discomfort, and whether the messages can better prepare women for symptoms they experience. A multisite randomized controlled trial was conducted in which women undergoing early medical abortion were allocated to receive standard of care (SOC) only (n=235) or SOC+a messaging intervention (n=234). Consenting women were interviewed at the clinic after taking mifepristone and again at their follow-up clinic visit 2-3 weeks later; the intervention group received text messages over the duration of this period. Emotional outcomes were evaluated using the Hospital Anxiety and Depression Scale, Adler's 12-item emotional scale and the Impact of Event Scale-Revised. Preparedness for the abortion symptoms and overall satisfaction with the procedure were assessed using 4-point Likert-type scales. Between baseline and follow-up, anxiety decreased more (p=0.013), and less emotional stress was experienced (adjusted for baseline anxiety, p=0.015), in the intervention compared to the SOC group. Participants in the intervention group were also more likely to report that they felt very well prepared for the bleeding (p<0.001), pain (p=0.042) and side effects (p=0.027) they experienced. Acceptability and other negative emotions relating to the abortion did not differ between study groups. Ninety-nine percent of the intervention group stated that they would recommend the messages to a friend having the same procedure. Text messages to women following mifepristone administration for early medical abortion may assist them in managing symptoms and appear highly acceptable to recipients. This randomized controlled trial provides evidence for the effectiveness of text messages following mifepristone administration in strengthening medical abortion care. The messages were associated with significant reductions in women's anxiety and stress during the abortion process; they improved preparedness for the abortion symptoms experienced and appeared highly acceptable. Copyright © 2014 Elsevier Inc. All rights reserved.

Multi-site Study of Diffusion Metric Variability: Characterizing the Effects of Site, Vendor, Field Strength, and Echo Time using the Histogram Distance

PubMed Central

Helmer, K. G.; Chou, M-C.; Preciado, R. I.; Gimi, B.; Rollins, N. K.; Song, A.; Turner, J.; Mori, S.

2016-01-01

MRI-based multi-site trials now routinely include some form of diffusion-weighted imaging (DWI) in their protocol. These studies can include data originating from scanners built by different vendors, each with their own set of unique protocol restrictions, including restrictions on the number of available gradient directions, whether an externally-generated list of gradient directions can be used, and restrictions on the echo time (TE). One challenge of multi-site studies is to create a common imaging protocol that will result in a reliable and accurate set of diffusion metrics. The present study describes the effect of site, scanner vendor, field strength, and TE on two common metrics: the first moment of the diffusion tensor field (mean diffusivity, MD), and the fractional anisotropy (FA). We have shown in earlier work that ROI metrics and the mean of MD and FA histograms are not sufficiently sensitive for use in site characterization. Here we use the distance between whole brain histograms of FA and MD to investigate within- and between-site effects. We concluded that the variability of DTI metrics due to site, vendor, field strength, and echo time could influence the results in multi-center trials and that histogram distance is sensitive metrics for each of these variables. PMID:27350723

Implementing a low-cost web-based clinical trial management system for community studies: a case study.

PubMed

Geyer, John; Myers, Kathleen; Vander Stoep, Ann; McCarty, Carolyn; Palmer, Nancy; DeSalvo, Amy

2011-10-01

Clinical trials with multiple intervention locations and a single research coordinating center can be logistically difficult to implement. Increasingly, web-based systems are used to provide clinical trial support with many commercial, open source, and proprietary systems in use. New web-based tools are available which can be customized without programming expertise to deliver web-based clinical trial management and data collection functions. To demonstrate the feasibility of utilizing low-cost configurable applications to create a customized web-based data collection and study management system for a five intervention site randomized clinical trial establishing the efficacy of providing evidence-based treatment via teleconferencing to children with attention-deficit hyperactivity disorder. The sites are small communities that would not usually be included in traditional randomized trials. A major goal was to develop database that participants could access from computers in their home communities for direct data entry. Discussed is the selection process leading to the identification and utilization of a cost-effective and user-friendly set of tools capable of customization for data collection and study management tasks. An online assessment collection application, template-based web portal creation application, and web-accessible Access 2007 database were selected and customized to provide the following features: schedule appointments, administer and monitor online secure assessments, issue subject incentives, and securely transmit electronic documents between sites. Each tool was configured by users with limited programming expertise. As of June 2011, the system has successfully been used with 125 participants in 5 communities, who have completed 536 sets of assessment questionnaires, 8 community therapists, and 11 research staff at the research coordinating center. Total automation of processes is not possible with the current set of tools as each is loosely affiliated, creating some inefficiency. This system is best suited to investigations with a single data source e.g., psychosocial questionnaires. New web-based applications can be used by investigators with limited programming experience to implement user-friendly, efficient, and cost-effective tools for multi-site clinical trials with small distant communities. Such systems allow the inclusion in research of populations that are not usually involved in clinical trials.

Feasibility of a Web-Based Self-Management Intervention for Intermittent Urinary Catheter Users with Spinal Cord Injury

PubMed Central

Wilde, Mary H.; McMahon, James M.; Fairbanks, Eileen; Brasch, Judith; Parshall, Robert; Zhang, Feng; Miner, Sarah; Thayer, Deborah; Schneiderman, Dan; Harrington, Brian

2016-01-01

Purpose The purpose of this study was to evaluate the feasibility of a new web-based intermittent catheter self-management intervention. Design We tested the acceptability and usability of intervention components, which included multiple web-based materials (an online urinary diary adapted for mobile phone use and an educational booklet), three phone calls with a nurse, and a peer led discussion forum. Subjects and setting Thirty adults with spinal cord injury using an intermittent catheter for bladder drainage were enrolled; 26 participants received the nurses’ phone based consultations. Methods Preliminary effectiveness of new self-efficacy and self-management scales were evaluated using baseline and three month online surveys. Participants’ perceived value of the intervention components, self-management changes, and suggestions were assessed with data from the three month surveys followed by brief tape-recorded interviews. Results Several catheter practices improved somewhat over three months including. The frequency of catheterizations every 4–6 hours increased from 71% to 77%. Self-management of neurogenic bladder dysfunction increased significantly (P= .032); participant comments indicated that fluid intake was the biggest change. Catheter related self-efficacy and quality of life scores increased. The frequency of urinary tract infection and pain did not change significantly. For feasibility, intervention components, with the exception of the forum, were rated highly by the majority of participants for usefulness, satisfaction (desired information), and web-based usability. Conclusion Further testing of this intervention is recommended in a multi-site randomized clinical trial. PMID:27488740

Healthy Children, Strong Families 2: a randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches

PubMed Central

Tomayko, Emily J; Prince, Ronald J; Cronin, Kate A; Parker, Tassy; Kim, KyungMann; Grant, Vernon M; Sheche, Judith N; Adams, Alexandra K

2017-01-01

Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 (HCSF2) is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of an RCT have been described. Methods HCSF2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two lesser-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyles intervention (Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group (Safety Journey) for one year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities’ request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons Learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities’ request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active control group and a design allowing all families to receive the intervention. This collective effort took additional time but was critical to secure community engagement. Hiring and retaining qualified local site coordinators was a challenge but was strongly related to successful recruitment and retention of study families. Local infrastructure has also been critical to project success. Other challenges included geographic dispersion of study communities and providing appropriate incentives to retain families in a two-year study. Conclusions This multi-site intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. HCSF2’s innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and lesser-studied obesity risk factors (stress/sleep), measurement of both adult and child outcomes, social networking support for geographically dispersed households, and a community selected active control group. Our data will address a literature gap regarding multiple risk factors and their relationship to health outcomes in American Indian families. PMID:28064525

Motivational tools to improve probationer treatment outcomes.

PubMed

Taxman, Faye S; Walters, Scott T; Sloas, Lincoln B; Lerch, Jennifer; Rodriguez, Mayra

2015-07-01

Motivational interviewing (MI) is a promising practice to increase motivation, treatment retention, and reducing recidivism among offender populations. Computer-delivered interventions have grown in popularity as a way to change behaviors associated with drug and alcohol use. Motivational Assistance Program to Initiate Treatment (MAPIT) is a three arm, multisite, randomized controlled trial, which examines the impact of Motivational interviewing (MI), a motivational computer program (MC), and supervision as usual (SAU) on addiction treatment initiation, engagement, and retention. Secondary outcomes include drug/alcohol use, probation progress, recidivism (i.e., criminal behavior) and HIV/AIDS testing and treatment among probationers. Participant characteristics are measured at baseline, 2, and 6 months after assignment. The entire study will include 600 offenders, with each site recruiting 300 offenders (Baltimore City, Maryland and Dallas, Texas). All participants will go through standard intake procedures for probation and participate in probation requirements as usual. After standard intake, participants will be recruited and screened for eligibility. The results of this clinical trial will fill a gap in knowledge about ways to motivate probationers to participate in addiction treatment and HIV care. This randomized clinical trial is innovative in the way it examines the use of in-person vs. technological approaches to improve probationer success. NCT01891656. Copyright © 2015. Published by Elsevier Inc.

Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors

PubMed Central

2012-01-01

Background Studies of implementation of efficacious human immunodeficiency virus (HIV) prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs) among female sex workers (FSWs) in 12 cities across Mexico. Our protocol will test a ‘train-the-trainer’ implementation model for transporting the Mujer Segura (Healthy Woman) intervention into community-based organizations (CBOs). Methods We have partnered with Mexican Foundation for Family Planning (Mexfam), a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs). Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia); they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors’ fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura intervention will be analyzed, and across CBOs, correlations will be examined between individual and organizational provider characteristics and intervention efficacy. Discussion This cooperative, bi-national research study will provide critical insights into barriers and facilitating factors associated with implementing interventions in CBOs using the ‘train the trainer’ model. Our work builds on similar scale-up strategies that have been effective in the United States. This study has the potential to increase our knowledge of the generalizability of such strategies across health issues, national contexts, and organizational contexts. Trial registration NCT01465607 PMID:23107285

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

PubMed

Bul, Kim C M; Kato, Pamela M; Van der Oord, Saskia; Danckaerts, Marina; Vreeke, Leonie J; Willems, Annik; van Oers, Helga J J; Van Den Heuvel, Ria; Birnie, Derk; Van Amelsvoort, Thérèse A M J; Franken, Ingmar H A; Maras, Athanasios

2016-02-16

The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called "Plan-It Commander") as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV).

A comparison of African American and Caucasian stimulant users in 12-step facilitation treatment

PubMed Central

Peavy, K. Michelle; Garrett, Sharon; Doyle, Suzanne; Donovan, Dennis

2017-01-01

Engagement in 12-step meetings and activities has been shown to be a powerful aid to recovery from substance use disorders. However, only limited attention has been given to ethnic and racial differences in attitudes toward 12-step and involvement. This study utilized data from a large multisite trial testing the effectiveness of a 12-step facilitation therapy with stimulant-dependent treatment seekers. We compared baseline differences and treatment outcomes between African American and Caucasian participants. A select few baseline differences were found (i.e., African Americans reported higher levels of spirituality than Caucasians; African American participants indicated more perceived benefits of 12-step involvement; Caucasians were more likely to endorse future involvement in 12-step). There were no outcome differences (e.g., substance use outcomes, 12-step meeting attendance). The tested intervention produced similar outcomes for both groups, indicating that it may be useful across racial categories. PMID:27294812

A comparison of African American and Caucasian stimulant users in 12-step facilitation treatment.

PubMed

Peavy, K Michelle; Garrett, Sharon; Doyle, Suzanne; Donovan, Dennis

2017-01-01

Engagement in 12-step meetings and activities has been shown to be a powerful aid to recovery from substance use disorders. However, only limited attention has been given to ethnic and racial differences in attitudes toward 12-step and involvement. This study utilized data from a large multisite trial testing the effectiveness of a 12-step facilitation therapy with stimulant-dependent treatment seekers. We compared baseline differences and treatment outcomes between African American and Caucasian participants. A select few baseline differences were found (i.e., African Americans reported higher levels of spirituality than Caucasians; African American participants indicated more perceived benefits of 12-step involvement; Caucasians were more likely to endorse future involvement in 12-step). There were no outcome differences (e.g., substance use outcomes, 12-step meeting attendance). The tested intervention produced similar outcomes for both groups, indicating that it may be useful across racial categories.

Accuracy of self-reported smoking abstinence in clinical trials of hospital-initiated smoking interventions.

PubMed

Scheuermann, Taneisha S; Richter, Kimber P; Rigotti, Nancy A; Cummins, Sharon E; Harrington, Kathleen F; Sherman, Scott E; Zhu, Shu-Hong; Tindle, Hilary A; Preacher, Kristopher J

2017-12-01

To estimate the prevalence and predictors of failed biochemical verification of self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions. Comparison of characteristics between participants who verified and those who failed to verify self-reported abstinence. Multi-site randomized clinical trials conducted between 2010 and 2014 in hospitals throughout the United States. Recently hospitalized smokers who reported tobacco abstinence 6 months post-randomization and provided a saliva sample for verification purposes (n = 822). Outcomes were salivary cotinine-verified smoking abstinence at 10 and 15 ng/ml cut-points. Predictors and correlates included participant demographics and tobacco use; hospital diagnoses and treatment; and study characteristics collected via surveys and electronic medical records. Usable samples were returned by 69.8% of the 1178 eligible trial participants who reported 7-day point prevalence abstinence. The proportion of participants verified as quit was 57.8% [95% confidence interval (CI) = 54.4, 61.2; 10 ng/ml cut-off] or 60.6% (95% CI = 57.2, 63.9; 15 ng/ml). Factors associated independently with verification at 10 ng/ml were education beyond high school education [odds ratio (OR) = 1.51; 95% CI = 1.07, 2.11], continuous abstinence since hospitalization (OR = 2.82; 95% CI = 2.02, 3.94), mailed versus in-person sample (OR = 3.20; 95% CI = 1.96, 5.21) and race. African American participants were less likely to verify abstinence than white participants (OR = 0.64; 95% CI = 0.44, 0.93). Findings were similar for verification at 15 ng/ml. Verification rates did not differ by treatment group. In the United States, high rates (40%) of recently hospitalized smokers enrolled in smoking cessation trials fail biochemical verification of their self-reported abstinence. © 2017 Society for the Study of Addiction.

Conceptualizing the multidimensional nature of self-efficacy: assessment of situational context and level of behavioral challenge to maintain safer sex. National Institute of Mental Health Multisite HIV Prevention Trial Group.

PubMed

Murphy, D A; Stein, J A; Schlenger, W; Maibach, E

2001-07-01

A. Bandura (1991) argued that self-efficacy measurement should be specific both to the situation in which the behavior occurs and level of challenge in that situation. Measures consistent with the 2 dimensions were developed with graded challenge levels and differing gender-appropriate situations. Participants were 1,496 controls in the National Institute of Mental Health Multisite HIV Prevention Trial recruited from STD clinics and health service centers (925 women and 571 men). The authors tested 4 separate-sex confirmatory factor analysis models as follows: (a) Condom negotiation efficacy as a unitary construct across situations and gradation of difficulty; (b) situation as preeminent, which transfers across skills whatever the gradation of difficulty; (c) skill as predominant, irrespective of situation; and (d) a multidimensional design that simultaneously accounts for both situation and graded difficulty. Consistent with Bandura's theory, the multidimensional model provided the best fit for both samples.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.

PubMed

Sung, Vivian W; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S; Moalli, Pamela; Newman, Diane K; Richter, Holly E; Ridgeway, Beri; Smith, Ariana L; Weidner, Alison C; Meikle, Susan

2016-10-01

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

Cumulative proportion of responders analysis (CPRA) as a tool to assess treatment outcome in alcohol clinical trials.

PubMed

Falk, Daniel E; Litten, Raye Z; Anton, Raymond F; Kranzler, Henry R; Johnson, Bankole A

2014-03-01

Several definitions of treatment response have been proposed for alcohol clinical trials (e.g., abstinence and no heavy drinking). However, each of these outcomes allows only one definition of successful response. In contrast, the cumulative proportion of responders analysis (CPRA) includes all of the possible drinking response cutoff points, providing a more complete picture of the therapeutic effects of a treatment. CPRA has been used to examine the efficacy of analgesics but not alcohol pharmacotherapy. To demonstrate its potential utility, we conducted CPRA in two large alcohol treatment trials: the COMBINE (Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence) trial (naltrexone) and a multisite topiramate trial. CPRA was used to demonstrate the efficacy of naltrexone and topiramate on continuous measures of in-treatment drinking-heavy drinking days and drinks per day-and their reductions from pretreatment. All possible cutoff points were portrayed for each measure. We provide graphs to illustrate the effects of the active medications compared with placebo and examined them statistically over a number of salient drinking outcomes to evaluate their efficacy. Treatment group responder curves were not parallel across the entire range of cutoff points; rather, they separated only at lower levels of drinking. In general, effect sizes increased by 0.10-0.15 when going from the lowest drinking level cutoff (i.e., abstinence and no heavy drinking) to the cutoff associated with the maximal treatment effect. CPRA may be useful in designing subsequent trials and helping to illustrate for treatment providers the likelihood of treatment success given various definitions of a positive response.

Physicians' satisfaction with a collaborative disease management program for late-life depression in primary care.

PubMed

Levine, Stuart; Unützer, Jürgen; Yip, Judy Y; Hoffing, Marc; Leung, Moon; Fan, Ming-Yu; Lin, Elizabeth H B; Grypma, Lydia; Katon, Wayne; Harpole, Linda H; Langston, Christopher A

2005-01-01

This study describes physicians' satisfaction with care for patients with depression before and after the implementation of a primary care-based collaborative care program. Project Improving Mood, Promoting Access to Collaborative Treatment for late-life depression (IMPACT) is a multisite, randomized controlled trial comparing a primary care-based collaborative disease management program for late-life depression with care as usual. A total of 450 primary care physicians at 18 participating clinics participated in a satisfaction survey before and 12 months after IMPACT initiation. The preintervention survey focused on physicians' satisfaction with current mental health resources and ability to provide depression care. The postintervention survey repeated these and added questions about physician's experience with the IMPACT collaborative care model. Before intervention, about half (54%) of the participating physicians were satisfied with resources to treat patients with depression. After intervention, more than 90% reported the intervention as helpful in treating patients with depression and 82% felt that the intervention improved patients' clinical outcomes. Participating physicians identified proactive patient follow-up and patient education as the most helpful components of the IMPACT model. Physicians perceived a substantial need for improving depression treatment in primary care. They were very satisfied with the IMPACT collaborative care model for treating depressed older adults and felt that similar care management models would also be helpful for treating other chronic medical illnesses.

A Virtual Reality Curriculum for Pediatric Residents Decreases Rates of Influenza Vaccine Refusal.

PubMed

Real, Francis J; DeBlasio, Dominick; Beck, Andrew F; Ollberding, Nicholas J; Davis, David; Cruse, Bradley; Samaan, Zeina; McLinden, Daniel; Klein, Melissa D

Influenza vaccine hesitancy is common in the primary care setting. Though physicians can affect caregivers' attitudes toward vaccination, physicians report uneasiness discussing vaccine hesitancy. Few studies have targeted physician-patient communication training as a means to decrease vaccination refusal. An immersive virtual reality (VR) curriculum was created to teach pediatric residents communication skills when discussing influenza vaccine hesitancy. This pilot curriculum consisted of 3 VR simulations during which residents counseled graphical character representatives (avatars) who expressed vaccine hesitancy. Participants were randomized to the intervention (n = 24) or control (n = 21) group. Only residents in the intervention group underwent the VR curriculum. Impact of the curriculum was assessed through difference in influenza vaccine refusal rates between the intervention and control groups in the 3 months after the VR curriculum. Participants included postgraduate level (PL) 2 and PL3 pediatric residents. All eligible residents (n = 45) participated; the survey response rate was 100%. In patients aged 6 to 59 months, residents in the intervention group had a decreased rate of influenza vaccination refusal in the postcurriculum period compared to the control group (27.8% vs 37.1%; P = .03). Immersive VR may be an effective modality to teach communication skills to medical trainees. Next steps include evaluation of the curriculum in a larger, multisite trial. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

School gardens and physical activity: a randomized controlled trial of low-income elementary schools.

PubMed

Wells, Nancy M; Myers, Beth M; Henderson, Charles R

2014-12-01

This study examines effects of a school garden intervention on elementary school children's physical activity (PA). Twelve schools in New York were randomly assigned to receive the school garden intervention (n=6) or to the waitlist control group that later received gardens (n=6). PA was measured by self-report survey (Girls Health Enrichment Multi-site Study Activity Questionnaire) (N=227) and accelerometry (N=124, 8 schools) at baseline (Fall 2011) and follow-up (Spring 2012, Fall 2012, Spring 2013). Direct observation (N=117, 4 schools) was employed to compare indoor (classroom) and outdoor (garden) PA. Analysis was by general linear mixed models. Survey data indicate garden intervention children's reports of usual sedentary activity decreased from pre-garden baseline to post-garden more than the control group children's (Δ=-.19, p=.001). Accelerometry data reveal that during the school day, children in the garden intervention showed a greater increase in percent of time spent in moderate and moderate-to-vigorous PA from baseline to follow-up than the control group children (Δ=+.58, p=.010; Δ=+1.0, p=.044). Direct observation within-group comparison of children at schools with gardens revealed that children move more and sit less during an outdoor garden-based lesson than during an indoor, classroom-based lesson. School gardens show some promise to promote children's PA. clinicaltrials.gov # NCT02148315. Copyright © 2014 Elsevier Inc. All rights reserved.

Feasibility and Acceptability of Internet-delivered Cognitive Behavioral Therapy for Chronic Pain in Adolescents With Sickle Cell Disease and Their Parents.

PubMed

Palermo, Tonya M; Dudeney, Joanne; Santanelli, James P; Carletti, Alexie; Zempsky, William T

2018-03-01

Pain is a clinical hallmark of sickle cell disease (SCD), and is rarely optimally managed. Cognitive-behavioral therapy (CBT) for pain has been effectively delivered through the Internet in other pediatric populations. We tested feasibility and acceptability of an Internet-delivered CBT intervention in 25 adolescents with SCD (64% female, mean age=14.8 y) and their parents randomized to Internet CBT (n=15) or Internet Pain Education (n=10). Participants completed pretreatment/posttreatment measures. Eight dyads completed semistructured interviews to evaluate treatment acceptability. Feasibility indicators included recruitment and participation rates, engagement and adherence to intervention, and completion of outcome measures. In total, 87 referrals were received from 9 study sites; our recruitment rate was 60% from those families approached for screening. Among participants, high levels of initial intervention engagement (>90%), and adherence (>70%) were demonstrated. Most participants completed posttreatment outcome and diary measures (>75%). Retention at posttreatment was 80%. High treatment acceptability was reported in interviews. Our findings suggest that Internet-delivered CBT for SCD pain is feasible and acceptable to adolescents with SCD and their parents. Engagement and adherence were good. Next steps are to modify recruitment plans to enhance enrollment and determine efficacy of Internet CBT for SCD pain in a large multisite randomized controlled trial.

Conducting Rapid, Relevant Research

PubMed Central

Glasgow, Russell E.; Kessler, Rodger S.; Ory, Marcia G.; Roby, Dylan; Gorin, Sherri Sheinfeld; Krist, Alex

2015-01-01

The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current “gold standard” clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation–focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include: use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions. PMID:24953520

Conducting rapid, relevant research: lessons learned from the My Own Health Report project.

PubMed

Glasgow, Russell E; Kessler, Rodger S; Ory, Marcia G; Roby, Dylan; Gorin, Sherri Sheinfeld; Krist, Alex

2014-08-01

The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current "gold standard" clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation-focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions. Published by Elsevier Inc.

Tailoring mind-body therapies to individual needs: patients' program preference and psychological traits as moderators of the effects of mindfulness-based cancer recovery and supportive-expressive therapy in distressed breast cancer survivors.

PubMed

Carlson, Linda E; Tamagawa, Rie; Stephen, Joanne; Doll, Richard; Faris, Peter; Dirkse, Dale; Speca, Michael

2014-11-01

Mindfulness-based cancer recovery (MBCR) and supportive-expressive therapy (SET) are well-validated psycho-oncological interventions, and we have previously reported health benefits of both programs. However, little is known about patients' characteristics or program preferences that may influence outcomes. Therefore, this study examined moderators of the effects of MBCR and SET on psychological well-being among breast cancer survivors. A multi-site randomized controlled trial was conducted between 2007 and 2012 in two Canadian cities (Calgary and Vancouver). A total of 271 distressed stage I-III breast cancer survivors were randomized into MBCR, SET or a 1-day stress management seminar (SMS). Baseline measures of moderator variables included program preference, personality traits, emotional suppression, and repressive coping. Outcome measures of mood, stress symptoms, quality of life, spiritual well-being, post-traumatic growth, social support, and salivary cortisol were measured pre- and post intervention. Hierarchical regression analyses were used to assess moderator effects on outcomes. The most preferred program was MBCR (55%). Those who were randomized to their preference improved more over time on quality of life and spiritual well-being post-intervention regardless of the actual intervention type received. Women with greater psychological morbidity at baseline showed greater improvement in stress symptoms and quality of life if they received their preferred versus nonpreferred program. Patients' program preference and baseline psychological functioning, rather than personality, were predictive of program benefits. These results suggest incorporating program preference can maximize the efficacy of integrative oncology interventions, and emphasize the methodological importance of assessing and accommodating for preferences when conducting mind-body clinical trials. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A randomized controlled trial of culturally tailored dance and reducing screen time to prevent weight gain in low-income African American girls: Stanford GEMS.

PubMed

Robinson, Thomas N; Matheson, Donna M; Kraemer, Helena C; Wilson, Darrell M; Obarzanek, Eva; Thompson, Nikko S; Alhassan, Sofiya; Spencer, Tirzah R; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; Killen, Joel D

2010-11-01

To test a 2-year community- and family-based obesity prevention program for low-income African American girls: Stanford GEMS (Girls' health Enrichment Multi-site Studies). Randomized controlled trial with follow-up measures scheduled at 6, 12, 18, and 24 months. Low-income areas of Oakland, California. African American girls aged 8 to 10 years (N=261) and their parents or guardians. Families were randomized to one of two 2-year, culturally tailored interventions: (1) after-school hip-hop, African, and step dance classes and a home/family-based intervention to reduce screen media use or (2) information-based health education. Changes in body mass index (BMI). Changes in BMI did not differ between groups (adjusted mean difference [95% confidence interval] = 0.04 [-0.18 to 0.27] per year). Among secondary outcomes, fasting total cholesterol level (adjusted mean difference, -3.49 [95% confidence interval, -5.28 to -1.70] mg/dL per year), low-density lipoprotein cholesterol level (-3.02 [-4.74 to -1.31] mg/dL per year), incidence of hyperinsulinemia (relative risk, 0.35 [0.13 to 0.93]), and depressive symptoms (-0.21 [-0.42 to -0.001] per year) decreased more among girls in the dance and screen time reduction intervention. In exploratory moderator analysis, the dance and screen time reduction intervention slowed BMI gain more than health education among girls who watched more television at baseline (P = .02) and/or those whose parents or guardians were unmarried (P = .01). A culturally tailored after-school dance and screen time reduction intervention for low-income, preadolescent African American girls did not significantly reduce BMI gain compared with health education but did produce potentially clinically important reductions in lipid levels, hyperinsulinemia, and depressive symptoms. There was also evidence for greater effectiveness in high-risk subgroups of girls.

76 FR 44512 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

... research enterprise, the proliferation of multi-site clinical trials and observational studies, the... and Drug Administration 21 CFR Parts 50 and 56 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators AGENCIES: The...

Managing personal health information in distributed research network environments.

PubMed

Bredfeldt, Christine E; Butani, Amy L; Pardee, Roy; Hitz, Paul; Padmanabhan, Sandy; Saylor, Gwyn

2013-10-08

Studying rare outcomes, new interventions and diverse populations often requires collaborations across multiple health research partners. However, transferring healthcare research data from one institution to another can increase the risk of data privacy and security breaches. A working group of multi-site research programmers evaluated the need for tools to support data security and data privacy. The group determined that data privacy support tools should: 1) allow for a range of allowable Protected Health Information (PHI); 2) clearly identify what type of data should be protected under the Health Insurance Portability and Accountability Act (HIPAA); and 3) help analysts identify which protected health information data elements are allowable in a given project and how they should be protected during data transfer. Based on these requirements we developed two performance support tools to support data programmers and site analysts in exchanging research data. The first tool, a workplan template, guides the lead programmer through effectively communicating the details of multi-site programming, including how to run the program, what output the program will create, and whether the output is expected to contain protected health information. The second performance support tool is a checklist that site analysts can use to ensure that multi-site program output conforms to expectations and does not contain protected health information beyond what is allowed under the multi-site research agreements. Together the two tools create a formal multi-site programming workflow designed to reduce the chance of accidental PHI disclosure.

Multidimensional family therapy HIV/STD risk-reduction intervention: an integrative family-based model for drug-involved juvenile offenders.

PubMed

Marvel, Francoise; Rowe, Cynthia L; Colon-Perez, Lissette; DiClemente, Ralph J; Liddle, Howard A

2009-03-01

Drug and juvenile justice involved youths show remarkably high rates of human immunodeficiency virus (HIV)/sexually transmitted disease (STD) risk behaviors. However, existing interventions aimed at reducing adolescent HIV risk behavior have rarely targeted these vulnerable young adolescents, and many approaches focus on individual-level change without attention to family or contextual influences. We describe a new, family-based HIV/ STD prevention model that embeds HIV/STD focused multifamily groups within an adolescent drug abuse and delinquency evidence-based treatment, Multidimensional Family Therapy (MDFT). The approach has been evaluated in a multisite randomized clinical trial with juvenile justice involved youths in the National Institute on Drug Abuse Criminal Justice Drug Abuse Treatment Studies (www.cjdats.org). Preliminary baseline to 6-month outcomes are promising. We describe research on family risk and protective factors for adolescent problem behaviors, and offer a rationale for family-based approaches to reduce HIV/STD risk in this population. We describe the development and implementation of the Multidimensional Family Therapy HIV/STD risk-reduction intervention (MDFT-HIV/ STD) in terms of using multifamily groups and their integration in standard MDFT and also offers a clinical vignette. The potential significance of this empirically based intervention development work is high; MDFT-HIV/STD is the first model to address largely unmet HIV/STD prevention and sexual health needs of substance abusing juvenile offenders within the context of a family-oriented evidence-based intervention.

Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase

PubMed Central

Tan, Gabriel; Rintala, Diana H.; Jensen, Mark P.; Richards, J. Scott; Holmes, Sally Ann; Parachuri, Rama; Lashgari-Saegh, Shamsi; Price, Larry R.

2011-01-01

Background Chronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes. Objective Explore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain. Study design Multi-site, double-blind, sham-controlled study. Participants Adults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES. Intervention Application of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess ‘as-needed’ CES use. Outcome measures Change in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment. Results The active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal–Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group × time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59). Conclusions On average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief. PMID:21756567

Evaluation of Child Care Subsidy Strategies: Implementation of Three Language and Literacy Interventions in Project Upgrade. OPRE 2011-4

ERIC Educational Resources Information Center

Layzer, Carolyn J.; Layzer, Jean I.; Wolf, Anne

2010-01-01

This report describes the design and implementation of the three interventions tested in Project Upgrade, one of four experiments conducted as part of the Evaluation of Child Care Subsidy Strategies. The evaluation was a multi-site, multi-year effort to determine whether and how different child care subsidy policies and procedures and quality…

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial.

PubMed

DeWalt, Darren A; Broucksou, Kimberly A; Hawk, Victoria; Baker, David W; Schillinger, Dean; Ruo, Bernice; Bibbins-Domingo, Kirsten; Holmes, Mark; Weinberger, Morris; Macabasco-O'Connell, Aurelia; Pignone, Michael

2009-06-11

Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months. Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success.The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. ClinicalTrials.gov (http://www.clinicaltrials.gov/) NCT00378950.

Unexpected individual clinical site variation in eradication rates of group a streptococci by penicillin in multisite clinical trials.

PubMed

Kaplan, Edward L; Oakes, J Michael; Johnson, Dwight R

2007-12-01

Previously, we reported an unexpectedly large percentage of failures by penicillin to eradicate group A streptococci (GAS) from the upper respiratory tract. Because penicillin has been the recommended therapy for the treatment of GAS pharyngitis, our report prompted controversy. Data from clinical trials in which our laboratory has participated demonstrated marked variation in GAS eradication rates among clinical sites. The reasons for such variation have never been adequately examined. We performed statistical analyses of site variation in eradication rates to assess the potential effect on reported reduced penicillin efficacy. Penicillin GAS eradication rates were compared using data from 4 large multisite pharyngitis treatment trials (75 clinical sites; 1158 subjects). Variation in eradication rates among clinical sites was statistically evaluated [chi(2) tests and generalized estimating equation (GEE) regression models]. There was significant site-to-site variation in GAS eradication rates in each of the trials (range, 17-100%; P < 0.005) as well as between separate trials (mean range, 58-69%; P < 0.033). GEE modeling indicated that GAS eradication rates were significantly higher for clinical sites participating in more than one clinical trial. The statistically significant site-to-site variation in penicillin eradication rates was related to factors (dependencies) at individual sites. Such factors may affect assessment of therapeutic efficacy and indicate a necessity for considering clinical site variation before reporting pooled efficacy data from multiple sites; combined data may result in misleading clinical implications. This is the first report documenting significant variation resulting from individual clinical site-related factors and offers a possible explanation for reduced penicillin eradication.

Multi-site study of diffusion metric variability: effects of site, vendor, field strength, and echo time on regions-of-interest and histogram-bin analyses.

PubMed

Helmer, K G; Chou, M-C; Preciado, R I; Gimi, B; Rollins, N K; Song, A; Turner, J; Mori, S

2016-02-27

It is now common for magnetic-resonance-imaging (MRI) based multi-site trials to include diffusion-weighted imaging (DWI) as part of the protocol. It is also common for these sites to possess MR scanners of different manufacturers, different software and hardware, and different software licenses. These differences mean that scanners may not be able to acquire data with the same number of gradient amplitude values and number of available gradient directions. Variability can also occur in achievable b-values and minimum echo times. The challenge of a multi-site study then, is to create a common protocol by understanding and then minimizing the effects of scanner variability and identifying reliable and accurate diffusion metrics. This study describes the effect of site, scanner vendor, field strength, and TE on two diffusion metrics: the first moment of the diffusion tensor field (mean diffusivity, MD), and the fractional anisotropy (FA) using two common analyses (region-of-interest and mean-bin value of whole brain histograms). The goal of the study was to identify sources of variability in diffusion-sensitized imaging and their influence on commonly reported metrics. The results demonstrate that the site, vendor, field strength, and echo time all contribute to variability in FA and MD, though to different extent. We conclude that characterization of the variability of DTI metrics due to site, vendor, field strength, and echo time is a worthwhile step in the construction of multi-center trials.

Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

PubMed

McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

2014-11-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

PubMed Central

McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

2014-01-01

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

The home stroke rehabilitation and monitoring system trial: a randomized controlled trial.

PubMed

Linder, Susan M; Rosenfeldt, Anson B; Reiss, Aimee; Buchanan, Sharon; Sahu, Komal; Bay, Curtis R; Wolf, Steven L; Alberts, Jay L

2013-01-01

Because many individuals poststroke lack access to the quality and intensity of rehabilitation to improve upper extremity motor function, a home-based robotic-assisted upper extremity rehabilitation device is being paired with an individualized home exercise program. The primary aim of this project is to determine the effectiveness of robotic-assisted home therapy compared with a home exercise program on upper extremity motor recovery and health-related quality of life for stroke survivors in rural and underserved locations. The secondary aim is to explore whether initial degree of motor function of the upper limb may be a factor in predicting the extent to which patients with stroke may be responsive to a home therapy approach. We hypothesize that the home exercise program intervention, when enhanced with robotic-assisted therapy, will result in significantly better outcomes in motor function and quality of life. A total of 96 participants within six-months of a single, unilateral ischemic, or hemorrhagic stroke will be recruited in this prospective, single-blind, multisite randomized clinical trial. The primary outcome is the change in upper extremity function using the Action Research Arm Test. Secondary outcomes include changes in: upper extremity function (Wolf Motor Function Test), upper extremity impairment (upper extremity portion of the Fugl-Meyer Test), self-reported quality of life (Stroke Impact Scale), and affect (Centers for Epidemiologic Studies Depression Scale). Similar or greater improvements in upper extremity function using the combined robotic home exercise program intervention compared with home exercise program alone will be interpreted as evidence that supports the introduction of in-home technology to augment the recovery of function poststroke. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia.

PubMed

Gomar, Jesús J; Valls, Elia; Radua, Joaquim; Mareca, Celia; Tristany, Josep; del Olmo, Francisco; Rebolleda-Gil, Carlos; Jañez-Álvarez, María; de Álvaro, Francisco J; Ovejero, María R; Llorente, Ana; Teixidó, Cristina; Donaire, Ana M; García-Laredo, Eduardo; Lazcanoiturburu, Andrea; Granell, Luis; Mozo, Cristina de Pablo; Pérez-Hernández, Mónica; Moreno-Alcázar, Ana; Pomarol-Clotet, Edith; McKenna, Peter J

2015-11-01

The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Assessment in Multisite Randomized Clinical Trials of Patients with Autistic Disorder: The Autism RUPP Network.

ERIC Educational Resources Information Center

Arnold, L. Eugene; Aman, Michael G.; Martin, Andres; Collier-Crespin, Angie; Vitiello, Benedetto; Tierney, Elaine; Asarnow, Robert; Bell-Bradshaw, Felicia; Freeman, Betty Jo; Gates-Ulanet, Patricia; Klin, Ami; McCracken, James T.; McDougle, Christopher J.; McGough, James J.; Posey, David J.; Scahill, Lawrence; Swiezy, Naomi B.; Ritz, Louise; Volkmar, Fred

2000-01-01

This paper explains how the Autism Research Units on Pediatric Psychopharmacology (RUPP Autism Network) resolved common assessment problems including communication problems compromising use of the patient as informant, broad subject heterogeneity, difficulties in assessing low-end IQs, scarcity of autism-adapted cognitive and neuropsychological…

Estimating Cross-Site Impact Variation in the Presence of Heteroscedasticity

ERIC Educational Resources Information Center

Bloom, Howard S.; Porter, Kristin E.; Weiss, Michael J.; Raudenbush, Stephen

2013-01-01

To date, evaluation research and policy analysis have focused mainly on average program impacts and paid little systematic attention to their variation. Recently, the growing number of multi-site randomized trials that are being planned and conducted make it increasingly feasible to study "cross-site" variation in impacts. Important…

A Self-Management Programme of Activity Coping and Education - SPACE for COPD(C) - in primary care: The protocol for a pragmatic trial.

PubMed

Bourne, Claire LA; Kanabar, Pratiksha; Mitchell, Katy; Schreder, Sally; Houchen-Wolloff, Linzy; Bankart, M John G; Apps, Lindsay; Hewitt, Stacey; Harvey-Dunstan, Theresa; Singh, Sally J

2017-07-10

National guidance for chronic obstructive pulmonary disease (COPD) suggests that self-management support be provided for patients. Our institution has developed a standardised, manual-based, supported self-management programme: Self-Management Programme of Activity Coping and Education (SPACE for COPD(C)). SPACE was previously piloted on a 1-2-1 basis, delivered by researchers, to individuals with COPD. Discussions with stakeholders highlighted considerable interest in delivering the SPACE for COPD(C) intervention as a group-based self-management programme facilitated by healthcare professionals (HCPs) in primary care settings. The study aims are to explore the feasibility, acceptability and efficacy for the intervention to be delivered and supported by HCPs and to examine whether group-based delivery of SPACE for COPD(C), with sustained support, improves patient outcomes following the SPACE for COPD(C) intervention. A prospective, multi-site, single-blinded randomised controlled trial (RCT) will be conducted, with follow-up at 6 and 9 months. Participants will be randomly assigned to either the control group (usual care) or intervention group (a six-session, group-based SPACE for COPD(C)self-management programme delivered over 5 months). The primary outcome is change in COPD assessment test at 6 months.A discussion session will be conducted with HCPs who deliver the intervention to discuss and gain insight into any potential facilitators/barriers to implementing the intervention in practice. Furthermore, we will conduct semi-structured focus groups with intervention participants to understand feasibility and acceptability. All qualitative data will be analysed thematically. The project has received a favourable opinion from South Hampshire B Research Ethics Committee, REC reference: 14/SC/1169 and full R&D approval from the University Hospitals of Leicester NHS Trust: 152408.Study results will be disseminated through appropriate peer-reviewed journals, national and international respiratory/physiotherapy conferences, via the Collaboration and Leadership in Applied Health Research and Care and through social media. ISRCTN17942821; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Group antenatal intervention to reduce perinatal stress and depressive symptoms related to intergenerational conflicts: a randomized controlled trial.

PubMed

Leung, Sharron S K; Lam, T H

2012-11-01

Intergenerational conflicts are a major source of stress, which might lead to depression in new mothers. The conflict is heightened when grandparents are involved in childcare. To examine the effectiveness of an interpersonal psychotherapy oriented group intervention to reduce stress and depressive symptoms in new mothers and enhance happiness and self-efficacy in managing intergenerational conflict in childcare. This study is one of the intervention projects of FAMILY: A Jockey Club Initiative for a Harmonious Society, funded by The Hong Kong Jockey Club Charities Trust. Multisite randomized controlled trial with two arms: an intervention group attended an additional 4-week program and a control group who received usual care only. Six Maternal and Child Health Centres in Hong Kong From September 2009 to January 2010, 156 pregnant women who would have grandparents involved in childcare were recruited at their 14-32 weeks' gestation. Participants were randomized to groups using computer generated random sequences by blinded recruitment staff. Primary outcomes were stress and depressive symptoms immediately after the intervention and 6-8 weeks after delivery. Secondary outcomes were happiness and self-efficacy in managing conflict. After screening 2870 pregnant women, 156 eligible participants were randomized. Intention-to-treat analysis showed that the intervention group (n=78) had significantly lower perceived stress (p=0.017; Cohen d=0.38) and greater happiness (p=0.004; Cohen d=0.41) than the control group (n=78) immediately after the intervention. However, the effects were not sustained at postnatal follow-up. Subgroup analysis showed that participants with depressive symptoms (EPDS>12) at baseline reported significantly lower stress, greater happiness (p=0.035 and 0.037, respectively; both Cohen d=0.61), greater self-efficacy in managing conflict (p=0.012; Cohen d=0.76) than the control group after the intervention. Also, after delivery, they had significantly greater self-efficacy in managing conflict (p=0.025; Cohen d=0.61) and more able to cooperate with grandparents in childcare (p=0.046; Cohen d=0.59) than the control group. The intervention was effective in reducing stress and enhancing happiness among new mothers, particularly those with higher EPDS scores. Postnatal follow-up contacts as booster interventions may be needed to achieve lasting effects of the intervention. Copyright © 2012 Elsevier Ltd. All rights reserved.

Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children's Oncology Group.

PubMed

Robb, Sheri L; Burns, Debra S; Stegenga, Kristin A; Haut, Paul R; Monahan, Patrick O; Meza, Jane; Stump, Timothy E; Cherven, Brooke O; Docherty, Sharron L; Hendricks-Ferguson, Verna L; Kintner, Eileen K; Haight, Ann E; Wall, Donna A; Haase, Joan E

2014-03-15

To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant (HSCT) for adolescents/young adults (AYAs), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: 1) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; 2) decrease risk factors of illness-related distress and defensive coping; and 3) increase outcomes of self-transcendence and resilience. This was a multisite randomized, controlled trial (COG-ANUR0631) conducted at 8 Children's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase's Resilience in Illness Model (RIM). Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning, and resilience at baseline (T1), postintervention (T2), and 100 days posttransplant (T3). At T2, the TMV group reported significantly better courageous coping (Effect Size [ES], 0.505; P = .030). At T3, the TMV group reported significantly better social integration (ES, 0.543; P = .028) and family environment (ES, 0.663; P = .008), as well as moderate nonsignificant effect sizes for spiritual perspective (ES, 0.450; P = .071) and self-transcendence (ES, 0.424; P = .088). The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high-risk cancer treatment. We recommend the TMV be examined in a broader population of AYAs with high-risk cancers. © 2013 American Cancer Society.

Impact of Intensive Lifestyle Intervention on Depression and Health-Related Quality of Life in Type 2 Diabetes: The Look AHEAD Trial

PubMed Central

2014-01-01

OBJECTIVE We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1–4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores. RESULTS ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75–0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores. CONCLUSIONS ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs. PMID:24855155

The Juvenile Justice Behavioral Health Services Cascade: A new framework for measuring unmet substance use treatment services needs among adolescent offenders.

PubMed

Belenko, Steven; Knight, Danica; Wasserman, Gail A; Dennis, Michael L; Wiley, Tisha; Taxman, Faye S; Oser, Carrie; Dembo, Richard; Robertson, Angela A; Sales, Jessica

2017-03-01

Substance use and substance use disorders are highly prevalent among youth under juvenile justice (JJ) supervision, and related to delinquency, psychopathology, social problems, risky sex and sexually transmitted infections, and health problems. However, numerous gaps exist in the identification of behavioral health (BH) problems and in the subsequent referral, initiation and retention in treatment for youth in community justice settings. This reflects both organizational and systems factors, including coordination between justice and BH agencies. This paper presents a new framework, the Juvenile Justice Behavioral Health Services Cascade ("Cascade"), for measuring unmet substance use treatment needs to illustrate how the cascade approach can be useful in understanding service delivery issues and identifying strategies to improve treatment engagement and outcomes for youth under community JJ supervision. We discuss the organizational and systems barriers for linking delinquent youth to BH services, and explain how the Cascade can help understand and address these barriers. We provide a detailed description of the sequential steps and measures of the Cascade, and then offer an example of its application from the Juvenile Justice - Translational Research on Interventions for Adolescents in the Legal System project (JJ-TRIALS), a multi-site research cooperative funded by the National Institute on Drug Abuse. As illustrated with substance abuse treatment, the Cascade has potential for informing and guiding efforts to improve behavioral health service linkages for adolescent offenders, developing and testing interventions and policies to improve interagency and cross-systems coordination, and informing the development of measures and interventions for improving the implementation of treatment in complex multisystem service settings. Clinical Trials Registration number - NCT02672150. Copyright © 2017 Elsevier Inc. All rights reserved.

The personalized reminder information and social management system (PRISM) trial: rationale, methods and baseline characteristics.

PubMed

Czaja, Sara J; Boot, Walter R; Charness, Neil; A Rogers, Wendy; Sharit, Joseph; Fisk, Arthur D; Lee, Chin Chin; Nair, Sankaran N

2015-01-01

Technology holds promise in terms of providing support to older adults. To date, there have been limited robust systematic efforts to evaluate the psychosocial benefits of technology for older people and identify factors that influence both the usability and uptake of technology systems. In response to these issues, we developed the Personal Reminder Information and Social Management System (PRISM), a software application designed for older adults to support social connectivity, memory, knowledge about topics, leisure activities and access to resources. This trail is evaluating the impact of access to the PRISM system on outcomes such as social isolation, social support and connectivity. This paper reports on the approach used to design the PRISM system, study design, methodology and baseline data for the trial. The trial is multi-site randomized field trial. PRISM is being compared to a Binder condition where participants received a binder that contained content similar to that found on PRISM. The sample includes 300 older adults, aged 65-98 years, who lived alone and at risk for being isolated. The primary outcome measures for the trial include indices of social isolation and support and well-being. Secondary outcomes measures include indices of computer proficiency, technology uptake and attitudes towards technology. Follow-up assessments occurred at 6 and 12 months post-randomization. The results of this study will yield important information about the potential value of technology for older adults. The study also demonstrates how a user-centered iterative design approach can be incorporated into the design and evaluation of an intervention protocol. Copyright © 2014 Elsevier Inc. All rights reserved.

The Personalized Reminder Information and Social Management System (PRISM) Trial: Rationale, Methods and Baseline Characteristics

PubMed Central

Czaja, Sara J.; Boot, Walter R.; Charness, Neil; Rogers, Wendy; Sharit, Joseph; Fisk, Arthur D.; Lee, Chin Chin; Nair, Sankaran N.

2014-01-01

Technology holds promise in terms of providing support to older adults. To date there have been limited robust systematic efforts to evaluate the psychosocial benefits of technology for older people and identify factors that influence both the usability and uptake of technology systems. In response to these issues we developed the Personal Reminder Information and Social Management System (PRISM), a software application designed for older adults to support social connectivity, memory, knowledge about topics, leisure activities and access to resources. This trail is evaluating the impact of access to the PRISM system on outcomes such as social isolation, social support and connectivity. This paper reports on the approach used to design the PRISM system, study design, methodology and baseline data for the trial. The trial is multi-site randomized field trial. PRISM is being compared to a Binder condition where participants received a binder that contained content similar to that found on PRISM. The sample includes 300 older adults, aged 65 – 98 years, who lived alone and at risk for being isolated. The primary outcome measures for the trial include indices of social isolation and support and well-being. Secondary outcomes measures include indices of computer proficiency, technology uptake and attitudes towards technology. Follow-up assessments occurred at 6 and 12 months post-randomization. The results of this study will yield important information about the potential value of technology for older adults. The study also demonstrates how a user-centered iterative design approach can be incorporated into the design and evaluation of an intervention protocol. PMID:25460342

ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol.

PubMed

Allary, C; Bourmaud, A; Tinquaut, F; Oriol, M; Kalecinski, J; Dutertre, V; Lechopier, N; Pommier, M; Benoist, Y; Rousseau, S; Regnier, V; Buthion, V; Chauvin, F

2016-07-07

The mass colorectal cancer screening program was implemented in 2008 in France, targeting 16 million French people aged between 50 and 74. The current adhesion is insufficient and the participation rate is even lower among the underserved population, increasing health inequalities within our health care system. Patient Navigation programs have proved their efficiency to promote the access to cancer screening and diagnosis. The purpose of the study is to assess the implementation of a patient navigation intervention that has been described in another cultural environment and another health care system. The main objective of the program is to increase the colorectal cancer screening participation rate among the deprived population through the intervention of a navigator to promote the Fecal Occult Blood Test (FOBT) and complementary exams. We performed a multisite cluster randomized controlled trial, with three groups (one experimental group and two control groups) for 18 months. The study attempts to give a better understanding of the adhesion barriers to colorectal cancer screening among underserved populations. If this project is cost-effective, it could create a dynamic based on peer approaches that could be developed for other cancer screening programs and other chronic diseases. NCT02369757.

Provision of bednets and water filters to delay HIV-1 progression: cost-effectiveness analysis of a Kenyan multisite study.

PubMed

Kern, Eli; Verguet, Stéphane; Yuhas, Krista; Odhiambo, Frederick H; Kahn, James G; Walson, Judd

2013-08-01

To estimate the effectiveness, costs and cost-effectiveness of providing long-lasting insecticide-treated nets (LLINs) and point-of-use water filters to antiretroviral therapy (ART)-naïve HIV-infected adults and their family members, in the context of a multisite study in Kenya of 589 HIV-positive adults followed on average for 1.7 years. The effectiveness, costs and cost-effectiveness of the intervention were estimated using an epidemiologic-cost model. Model epidemiologic inputs were derived from the Kenya multisite study data, local epidemiological data and from the published literature. Model cost inputs were derived from published literature specific to Kenya. Uncertainty in the model estimates was assessed through univariate and multivariate sensitivity analyses. We estimated net cost savings of about US$ 26 000 for the intervention, over 1.7 years. Even when ignoring net cost savings, the intervention was found to be very cost-effective at a cost of US$ 3100 per death averted or US$ 99 per disability-adjusted life year (DALY) averted. The findings were robust to the sensitivity analysis and remained most sensitive to both the duration of ART use and the cost of ART per person-year. The provision of LLINs and water filters to ART-naïve HIV-infected adults in the Kenyan study resulted in substantial net cost savings, due to the delay in the initiation of ART. The addition of an LLIN and a point-of-use water filter to the existing package of care provided to ART-naïve HIV-infected adults could bring substantial cost savings to resource-constrained health systems in low- and middle-income countries. © 2013 Blackwell Publishing Ltd.

A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial

PubMed Central

Imam, Bita; Finlayson, Heather C; Eng, Janice J; Payne, Michael WC; Jarus, Tal; Goldsmith, Charles H; Mitchell, Ian M

2014-01-01

Background The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed “Wii.n.Walk”, an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. Objective The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. Methods This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants’ homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks’ duration. The primary outcome measure will be the “Two-Minute Walk Test” to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Results Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Conclusions Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Trial Registration Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP). PMID:25533902

A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments.

PubMed

Newton, Amanda S; Dow, Nadia; Dong, Kathryn; Fitzpatrick, Eleanor; Cameron Wild, T; Johnson, David W; Ali, Samina; Colman, Ian; Rosychuk, Rhonda J

2017-08-11

This study piloted procedures and obtained data on intervention acceptability to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a computer-based brief intervention in the emergency department (ED). Two-arm, multi-site, pilot RCT. Adolescents aged 12-17 years presenting to three Canadian pediatric EDs from July 2010 to January 2013 for an alcohol-related complaint. Standard medical care plus computer-based screening and personalised assessment feedback (experimental group) or standard care plus computer-based sham (control group). ED and research staff, and adolescents were blinded to allocation. Main: change in alcohol consumption from baseline to 1- and 3 months post-intervention. Secondary: recruitment and retention rates, intervention acceptability and feasibility, perception of group allocation among ED and research staff, and change in health and social services utilisation. Of the 340 adolescents screened, 117 adolescents were eligible and 44 participated in the study (37.6% recruitment rate). Adolescents allocated to the intervention found it easy, quick and informative, but were divided on the credibility of the feedback provided (agreed it was credible: 44.4%, disagreed: 16.7%, unsure: 16.7%, no response: 22.2%). We found no evidence of a statistically significant relationship between which interventions adolescents were allocated to and which interventions staff thought they received. Alcohol consumption, and health and social services data were largely incomplete due to modest study retention rates of 47.7% and 40.9% at 1- and 3 months post-intervention, respectively. A computer-based intervention was acceptable to adolescents and delivery was feasible in the ED in terms of time to use and ease of use. However, adjustments are needed to the intervention to improve its credibility. A definitive RCT will be feasible if protocol adjustments are made to improve recruitment and retention rates; and increase the number of study sites and research staff. clinicaltrials.gov NCT01146665. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Efficacy and safety of the Shexiang Baoxin Pill for the treatment of coronary artery disease not amenable to revascularisation: study protocol for a randomised, placebo-controlled, double-blinded trial

PubMed Central

Tian, Pan-pan; Li, Jun; Gao, Jian; Li, Ying

2018-01-01

Introduction Coronary artery disease (CAD) not amenable to revascularisation indicates that the coronary arteries have severe diffuse lesions or calcifications, or that CAD is complicated with severe multiple-organ disease. Currently, Western medicines available for the treatment of CAD not amenable to revascularisation are limited. Shexiang Baoxin Pill (SBP), a type of Chinese patent medicine, has been widely used to treat CAD in China for many years. Previous studies have shown that long-term administration of SBP (1–2 pills three times daily, for at least 6 months) for treatment of CAD is effective and safe, with a significant, long-term effect. This study aims to evaluate the efficacy and safety of SBP in patients with CAD not amenable to revascularisation. Methods and analysis This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 440 participants will be randomly allocated to two groups: the intervention group and the placebo group. Based on conventional treatment with Western medicine, the intervention group will be treated with SBP and the placebo group will be treated with SBP placebo. The primary outcomes include major adverse cardiovascular events (including angina, acute myocardial infarction, pulmonary embolism and aortic dissection). The secondary outcomes include C reactive protein, B-type natriuretic peptide, ECG, echocardiographic parameters (ejection fraction percentage and the E/A ratio) and hospital readmission rates due to CAD. Assessments will be performed at baseline (before randomisation) and at 24 weeks after randomisation. Ethics and dissemination The protocol has been approved by the Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (reference: 2016-129-KY-01). The results of this study will be published in a peer-reviewed journal and will be used as a basis for a multisite trial. Trial registration number NCT03072121; Pre-results. PMID:29444778

REACH: study protocol of a randomised trial of rehabilitation very early in congenital hemiplegia

PubMed Central

Boyd, Roslyn N; Ziviani, Jenny; Sakzewski, Leanne; Novak, Iona; Badawi, Nadia; Pannek, Kerstin; Elliott, Catherine; Greaves, Susan; Guzzetta, Andrea; Whittingham, Koa; Valentine, Jane; Morgan, Cathy; Wallen, Margaret; Eliasson, Ann-Christin; Findlay, Lisa; Ware, Robert; Fiori, Simona; Rose, Stephen

2017-01-01

Objectives Congenital hemiplegia is the most common form of cerebral palsy (CP). Children with unilateral CP show signs of upper limb asymmetry by 8 months corrected age (ca) but are frequently not referred to therapy until after 12 months ca. This study compares the efficacy of infant-friendly modified constraint-induced movement therapy (Baby mCIMT) to infant friendly bimanual therapy (Baby BIM) on upper limb, cognitive and neuroplasticity outcomes in a multisite randomised comparison trial. Methods and analysis 150 infants (75 in each group), aged between 3 and 6 months ca, with asymmetric brain injury and clinical signs of upper extremity asymmetry will be recruited. Children will be randomised centrally to receive equal doses of either Baby mCIMT or Baby BIM. Baby mCIMT comprises restraint of the unimpaired hand using a simple restraint (eg, glove, sock), combined with intensive parent implemented practice focusing on active use of the impaired hand in a play-based context. In contrast, Baby BIM promotes active play requiring both hands in a play-based context. Both interventions will be delivered by parents at home with monthly home visits and interim telecommunication support by study therapists. Assessments will be conducted at study entry; at 6, 12 months ca immediately postintervention (primary outcome) and 24 months ca (retention). The primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes include the Bayley Scale for Infant and Toddler Development (cognitive and motor domains) and the Hand Assessment of Infants. A subset of children will undertake MRI scans at 24 months ca to evaluate brain lesion severity and brain (re)organisation after intervention. Ethics and dissemination Full ethical approvals for this study have been obtained from the relevant sites. The findings will be disseminated in peer-reviewed publications. Trial registration number Australian and New Zealand Clinical Trials Registry: ACTRN12615000180516, Pre results. PMID:28928195

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol

PubMed Central

Bird, Marie-Louise; Muthalib, Makii

2018-01-01

Introduction The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors. Methods and analysis In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3–5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention. Ethics and dissemination The study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017–087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings. Trial registration number ACTRN12617000745347; Pre-results. PMID:29317414

Examining longitudinal stimulant use and treatment attendance as parallel outcomes in two contingency management randomized clinical trials

PubMed Central

McPherson, Sterling; Brooks, Olivia; Barbosa-Leiker, Celestina; Lederhos, Crystal; Lamp, Amanda; Murphy, Sean; Layton, Matthew; Roll, John

2015-01-01

The primary aim of this study was to examine stimulant use and longitudinal treatment attendance in one ‘parallel outcomes’ model in order to determine how these two outcomes are related to one another during treatment, and to quantify how the intervention impacts these two on- and off-target outcomes differently. Data came from two multi-site randomized clinical trials (RCTs) of contingency management (CM) that targeted stimulant use. We used parallel multilevel modeling to examine the impact of multiple pre-specified covariates, including selected Addiction Severity Index (ASI) scores, age and sex, in addition to CM on concurrent attendance and stimulant use in two separate analyses, i.e., one per trial. In one trial, CM was positively associated with attending treatment throughout the trial (β = 0.060, p < 0.05). In the second trial, CM predicted negative urinalysis (−UA) over the 12-week treatment period (β = 0.069, p < 0.05). In both trials, there was a significant, positive relationship between attendance and −UA submission, but in the first trial a −UA at both baseline and over time was related to attendance over time (r = 0.117; r = 0.013, respectively) and in the second trial, a −UA submission at baseline was associated with increased attendance over time (r = 0.055). These findings indicate that stimulant use and treatment attendance over time are related but distinct outcomes that, when analyzed simultaneously, portray a more informative picture of their predictors and the separate trajectories of each. This ‘indirect reinforcement’ between two clinically meaningful on-target (directly reinforced behavior) and off-target (indirectly reinforced behavior) outcomes is in need of further examination in order to fully exploit the potential clinical benefits that could be realized in substance use disorder treatment trials. PMID:26456717

Examining Longitudinal Stimulant Use and Treatment Attendance as Parallel Outcomes in Two Contingency Management Randomized Clinical Trials.

PubMed

McPherson, Sterling; Brooks, Olivia; Barbosa-Leiker, Celestina; Lederhos, Crystal; Lamp, Amanda; Murphy, Sean; Layton, Matthew; Roll, John

2016-02-01

The primary aim of this study was to examine stimulant use and longitudinal treatment attendance in one 'parallel outcomes' model in order to determine how these two outcomes are related to one another during treatment, and to quantify how the intervention impacts these two on- and off-target outcomes differently. Data came from two multi-site randomized clinical trials (RCTs) of contingency management (CM) that targeted stimulant use. We used parallel multilevel modeling to examine the impact of multiple pre-specified covariates, including selected Addiction Severity Index (ASI) scores, age and sex, in addition to CM on concurrent attendance and stimulant use in two separate analyses, i.e., one per trial. In one trial, CM was positively associated with attending treatment throughout the trial (β=0.060, p<0.05). In the second trial, CM predicted negative urinalysis ((-)UA) over the 12-week treatment period (β=0.069, p<0.05). In both trials, there was a significant, positive relationship between attendance and (-)UA submission, but in the first trial a (-)UA at both baseline and over time was related to attendance over time (r=0.117; r=0.013, respectively) and in the second trial, a (-)UA submission at baseline was associated with increased attendance over time (r=0.055). These findings indicate that stimulant use and treatment attendance over time are related but distinct outcomes that, when analyzed simultaneously, portray a more informative picture of their predictors and the separate trajectories of each. This 'indirect reinforcement' between two clinically meaningful on-target (directly reinforced behavior) and off-target (indirectly reinforced behavior) outcomes is in need of further examination in order to fully exploit the potential clinical benefits that could be realized in substance use disorder treatment trials. Copyright © 2015 Elsevier Inc. All rights reserved.

Psychiatric Syndromes in Adolescents with Marijuana Abuse and Dependency in Outpatient Treatment

ERIC Educational Resources Information Center

Diamond, Guy; Panichelli-Mindel, Susan M.; Shera, David; Dennis, Mike; Tims, Frank; Ungemack, Jane

2006-01-01

Objective: The purpose of the current study to assist in understanding the prevalence and clinical correlates of psychiatric distress in adolescents seeking outpatient services for marijuana abuse or dependency. Methods: In a multi-site randomized clinical trial, 600 adolescents and their parents were assessed at intake using the Global Appraisals…

Under What Assumptions Do Site-by-Treatment Instruments Identify Average Causal Effects?

ERIC Educational Resources Information Center

Reardon, Sean F.; Raudenbush, Stephen W.

2013-01-01

The increasing availability of data from multi-site randomized trials provides a potential opportunity to use instrumental variables methods to study the effects of multiple hypothesized mediators of the effect of a treatment. We derive nine assumptions needed to identify the effects of multiple mediators when using site-by-treatment interactions…

A Weighting Method for Assessing Between-Site Heterogeneity in Causal Mediation Mechanism

ERIC Educational Resources Information Center

Qin, Xu; Hong, Guanglei

2017-01-01

When a multisite randomized trial reveals between-site variation in program impact, methods are needed for further investigating heterogeneous mediation mechanisms across the sites. We conceptualize and identify a joint distribution of site-specific direct and indirect effects under the potential outcomes framework. A method-of-moments procedure…

Functioning and Quality of Life in the Treatment for Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Vitiello, Benedetto; Rohde, Paul; Silva, Susan; Wells, Karen; Casat, Charles; Waslick, Bruce; Simons, Anne; Reinecke, Mark; Weller, Elizabeth; Kratochvil, Christopher; Walkup, John; Pathak, Sanjeev; Robins, Michele; March, John

2006-01-01

Obective: To test whether 12-week treatment of major depression improved the level of functioning, global health, and quality of life of adolescents. Method: The Treatment for Adolescents With Depression Study was a multisite, randomized clinical trial of fluoxetine, cognitive-behavioral therapy (CBT), their combination (COMB), or clinical…

Tool for evaluating research implementation challenges: A sense-making protocol for addressing implementation challenges in complex research settings

PubMed Central

2013-01-01

Background Many challenges arise in complex organizational interventions that threaten research integrity. This article describes a Tool for Evaluating Research Implementation Challenges (TECH), developed using a complexity science framework to assist research teams in assessing and managing these challenges. Methods During the implementation of a multi-site, randomized controlled trial (RCT) of organizational interventions to reduce resident falls in eight nursing homes, we inductively developed, and later codified the TECH. The TECH was developed through processes that emerged from interactions among research team members and nursing home staff participants, including a purposive use of complexity science principles. Results The TECH provided a structure to assess challenges systematically, consider their potential impact on intervention feasibility and fidelity, and determine actions to take. We codified the process into an algorithm that can be adopted or adapted for other research projects. We present selected examples of the use of the TECH that are relevant to many complex interventions. Conclusions Complexity theory provides a useful lens through which research procedures can be developed to address implementation challenges that emerge from complex organizations and research designs. Sense-making is a group process in which diverse members interpret challenges when available information is ambiguous; the groups’ interpretations provide cues for taking action. Sense-making facilitates the creation of safe environments for generating innovative solutions that balance research integrity and practical issues. The challenges encountered during implementation of complex interventions are often unpredictable; however, adoption of a systematic process will allow investigators to address them in a consistent yet flexible manner, protecting fidelity. Research integrity is also protected by allowing for appropriate adaptations to intervention protocols that preserve the feasibility of ‘real world’ interventions. PMID:23281623

Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing.

PubMed

Fenwick, Jennifer; Toohill, Jocelyn; Gamble, Jenny; Creedy, Debra K; Buist, Anne; Turkstra, Erika; Sneddon, Anne; Scuffham, Paul A; Ryding, Elsa L

2015-10-30

High levels of childbirth fear impact birth preparation, obstetric outcomes and emotional wellbeing for around one in five women living in developed countries. Higher rates of obstetric intervention and caesarean section (CS) are experienced in fearful women. The efficacy of interventions to reduce childbirth fear is unclear, with no previous randomised controlled trials reporting birth outcomes or postnatal psychological wellbeing following a midwife led intervention. Between May 2012 and June 2013 women in their second trimester of pregnancy were recruited. Women with a fear score ≥ 66 on the Wijma Delivery Expectancy / Experience Questionnaire (W-DEQ) were randomised to receive telephone psycho-education by a midwife, or usual maternity care. A two armed non-blinded parallel (1:1) multi-site randomised controlled trial with participants allocated in blocks of ten and stratified by hospital site and parity using an electronic centralised computer service. The outcomes of the RCT on obstetric outcomes, maternal psychological well-being, parenting confidence, birth satisfaction, and future birth preference were analysed by intention to treat and reported here. 1410 women were screened for high childbirth fear (W-DEQ ≥66). Three hundred and thirty-nine (n = 339) women were randomised (intervention n = 170; controls n = 169). One hundred and eighty-four women (54 %) returned data for final analysis at 6 weeks postpartum (intervention n = 91; controls n = 93). Compared to controls the intervention group had a clinically meaningful but not statistically significant reduction in overall caesarean section (34 % vs 42 %, p = 0.27) and emergency CS rates (18 % vs 25 %, p = 0.23). Fewer women in the intervention group preferred caesarean section for a future pregnancy (18 % vs 30 %, p = 0.04). All other obstetric variables remained similar. There were no differences in postnatal depression symptoms scores, parenting confidence, or satisfaction with maternity care between groups, but a lower incidence of flashbacks about their birth in the intervention group compared to controls (14 % vs 26 %, p = 0.05). Postnatally women who received psycho-education reported that the 'decision aid' helped reduce their fear (53 % vs 37 %, p = 0.02). Following a brief antenatal midwife-led psycho-education intervention for childbirth fear women were less likely to experience distressing flashbacks of birth and preferred a normal birth in a future pregnancy. A reduction in overall CS rates was also found. Psycho-education for fearful women has clinical benefits for the current birth and expectations of future pregnancies. Australian New Zealand Controlled Trials Registry ACTRN12612000526875 , 17th May 2012.

A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial.

PubMed

Imam, Bita; Miller, William C; Finlayson, Heather C; Eng, Janice J; Payne, Michael Wc; Jarus, Tal; Goldsmith, Charles H; Mitchell, Ian M

2014-12-22

The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed "Wii.n.Walk", an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants' homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks' duration. The primary outcome measure will be the "Two-Minute Walk Test" to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP).

Does 'Time Together' increase quality of interaction and decrease stress? A study protocol of a multisite nursing intervention in psychiatric inpatient care, using a mixed method approach.

PubMed

Molin, Jenny; Lindgren, Britt-Marie; Graneheim, Ulla Hällgren; Ringnér, Anders

2017-08-28

Despite the long-known significance of the nurse-patient relationship, research in psychiatric inpatient care still reports unfulfilled expectations of, and difficulties in, interactions and relationships between patients and staff. Interventions that create structures to allow quality interactions between patients and staff are needed to solve these problems. The aim of this project is to test effects of the nursing intervention Time Together and to evaluate the intervention process. This is a multisite study with a single-system experimental design using frequent measures. The primary outcomes are quality interactions for patients and perceived stress for staff. Secondary outcomes are levels of symptoms of anxiety and depression for patients and stress of conscience for staff. A process evaluation is performed to describe contextual factors and experiences. Data are collected using questionnaires, participant observations and semistructured interviews. For analysis of quantitative data, both visual and statistical methods will be used. Qualitative data will be analysed using qualitative content analysis. Ethical approval was granted by the Ethical Review Board in the region (Dnr 2016/339-31). The findings will contribute to the development of nursing interventions in general, but more specifically to the development of the intervention. This is relevant both nationally and internationally as similar interventions are needed but sparse. The findings will be disseminated through conference presentations and peer-reviewed publications. NCT02981563. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Randomized Clinical Trial of Therapeutic Music Video Intervention for Resilience Outcomes in Adolescents/Young Adults Undergoing Hematopoietic Stem Cell Transplant: A Report from the Children’s Oncology Group

PubMed Central

Robb, Sheri L.; Burns, Debra S.; Stegenga, Kristin A.; Haut, Paul R.; Monahan, Patrick O.; Meza, Jane; Stump, Timothy E.; Cherven, Brooke O.; Docherty, Sharron L.; Hendricks-Ferguson, Verna L.; Kintner, Eileen K.; Haight, Ann E.; Wall, Donna A.; Haase, Joan E.

2013-01-01

Background To reduce the risk of adjustment problems associated with Hematopoietic Stem Cell Transplant (HSCT) for adolescents/young adults (AYA), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: (a) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; (b) decrease risk factors of illness-related distress and defensive coping; and (c) increase outcomes of self-transcendence and resilience. Methods A multi-site, randomized controlled trial (COG-ANUR0631) conducted at 8 Children’s Oncology Group sites involving 113 AYA aged 11–24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase’s Resilience in Illness Model. Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning and resilience at baseline (T1), post-intervention (T2), and 100-days post-transplant (T3). Results At T2, the TMV group reported significantly better courageous coping (ES=0.505; P=0.030). At T3, the TMV group reported significantly better social integration (ES=0.543; P=.028) and family environment (ES=0.663; P=0.008), as well as moderate non-significant effect sizes for spiritual perspective (E=0.450; P=0.071) and self-transcendence (ES=0.424; P=0.088). Conclusion The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high risk cancer treatment. We recommend the TMV be examined in a broader population of AYA with high risk cancers. PMID:24469862

Cognitive and Behavioral Resilience Among Young Gay and Bisexual Men Living with HIV.

PubMed

Hussen, Sophia A; Harper, Gary W; Rodgers, Caryn R R; van den Berg, Jacob J; Dowshen, Nadia; Hightow-Weidman, Lisa B

2017-08-01

HIV/AIDS disproportionately affects young gay, bisexual, and other men who have sex with men (Y-GBMSM). Resilience remains understudied among Y-GBMSM living with HIV, but represents a potentially important framework for improving HIV-related outcomes in this population. We sought to explore cognitive and behavioral dimensions of resilience and their correlates among Y-GBMSM to gain insights to inform future interventions. Our study sample consisted of 200 Y-GBMSM living with HIV enrolled in a multisite study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants completed a one-time, self-administered structured questionnaire, including validated scales capturing a range of cognitive, behavioral, demographic, and psychosocial data. Utilizing these data, we examined cognitive and behavioral dimensions of resilience and their potential psychosocial correlates using linear regression modeling. Multiple regression analyses demonstrated that education, stigma, social support, ethnic identity, internalized homonegativity, and behavioral resilience were statistically significant predictors of cognitive resilience (P < 0.001, R 2  = 0.678). Social support satisfaction and cognitive resilience were significant predictors of behavioral resilience (P < 0.001, R 2  = 0.141). Our findings point to potential strategies for incorporating resilience-promoting features into future interventions to support Y-GBMSM living with HIV. Specifically, strengths-based interventions in this population should seek to enhance social support, promote positive identity development, and encourage education. Future research can also seek to utilize and refine our measures of resilience among youth.

Development of a Multi-Target Contingency Management Intervention for HIV Positive Substance Users.

PubMed

Stitzer, Maxine; Calsyn, Donald; Matheson, Timothy; Sorensen, James; Gooden, Lauren; Metsch, Lisa

2017-01-01

Contingency management (CM) interventions generally target a single behavior such as attendance or drug use. However, disease outcomes are mediated by complex chains of both healthy and interfering behaviors enacted over extended periods of time. This paper describes a novel multi-target contingency management (CM) program developed for use with HIV positive substance users enrolled in a CTN multi-site study (0049 Project HOPE). Participants were randomly assigned to usual care (referral to health care and SUD treatment) or 6-months strength-based patient navigation interventions with (PN+CM) or without (PN only) the CM program. Primary outcome of the trial was viral load suppression at 12-months post-randomization. Up to $1160 could be earned over 6 months under escalating schedules of reinforcement. Earnings were divided among eight CM targets; two PN-related (PN visits; paperwork completion; 26% of possible earnings), four health-related (HIV care visits, lab blood draw visits, medication check, viral load suppression; 47% of possible earnings) and two drug-use abatement (treatment entry; submission of drug negative UAs; 27% of earnings). The paper describes rationale for selection of targets, pay amounts and pay schedules. The CM program was compatible with and fully integrated into the PN intervention. The study design will allow comparison of behavioral and health outcomes for participants receiving PN with and without CM; results will inform future multi-target CM development. Copyright © 2016 Elsevier Inc. All rights reserved.

The Effectiveness of a Psychoeducation Intervention delivered via WhatsApp for mothers of children with Autism Spectrum Disorder (ASD) in the Kingdom of Saudi Arabia: A randomized controlled trial.

PubMed

Hemdi, A; Daley, D

2017-11-01

Mothers of children with autism spectrum disorder (ASD) report high levels of stress and lower levels of well-being than parents of typically developing children. Current interventions for ASD typically focus on working with the child rather than delivering strategies to help support parents. To evaluate the effectiveness of a psychoeducation intervention developed to support mothers of children with ASD in Saudi Arabia. Sixty-two mothers (23-52 years) of children (26-78 months) were recruited to a multisite randomized controlled trials of the intervention. The intervention consisted of one face-to-face session (60 min) and four virtual sessions (30 min each) delivered using WhatsApp. Parenting stress was the primary outcome, with secondary outcomes focusing on maternal depression, anxiety, and happiness, and child behaviour problems and ASD symptoms. Data were collected at baseline T1, immediately postintervention T2 and 8-week follow-up T3. One-way analysis of covariance was used at T2 and T3 with T1 scores entered as a covariate. Improvements were found at T2 for stress (F = 234.34, p = .00, and d = -1.52) and depression (F = 195.70, p = .00, and d = -2.14) but not anxiety, and these results were maintained at T3. Changes in child behaviour problems were limited to improvements in hyperactivity at T2 (F = 133.66, p = .00, and d = -1.54). Although changes in stress and depression were statistically significant, change to clinically normal levels was limited to depression. None of the participants had recovered after the intervention (Parent Stress Index Short Form stress scores), whereas 23 mothers (71.87%) in the intervention group had recovered at T2 and 22 (68.75%) at T3 (Hospital Anxiety and Depression Scale depression scores). This intervention with WhatsApp support is beneficial but may need to be augmented with other forms of support for mothers of children with ASD including more condensed sessions on stress and interventions targeting anxiety. © 2017 John Wiley & Sons Ltd.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

Behavior management for children and adolescents with acquired brain injury.

PubMed

Slifer, Keith J; Amari, Adrianna

2009-01-01

Behavioral problems such as disinhibition, irritability, restlessness, distractibility, and aggression are common after acquired brain injury (ABI). The persistence and severity of these problems impair the brain-injured individual's reintegration into family, school, and community life. Since the early 1980s, behavior analysis and therapy have been used to address the behavioral sequelae of ABI. These interventions are based on principles of learning and behavior that have been robustly successful when applied across a broad range of other clinical populations. Most of the research on behavioral treatment after ABI has involved clinical case studies or studies employing single-subject experimental designs across a series of cases. The literature supports the effectiveness of these interventions across ages, injury severities, and stages of recovery after ABI. Recommended guidelines for behavior management include: direct behavioral observations, systematic assessment of environmental and within-patient variables associated with aberrant behavior, antecedent management to minimize the probability of aberrant behavior, provision of functionally equivalent alternative means of controlling the environment, and differential reinforcement to shape positive behavior and coping strategies while not inadvertently shaping emergent, disruptive sequelae. This package of interventions requires direction by a highly skilled behavioral psychologist or therapist who systematically monitors target behavior to evaluate progress and guide treatment decisions. A coordinated multisite effort is needed to design intervention protocols that can be studied prospectively in randomized controlled trials. However, there will continue to be an important role for single subject experimental design for studying the results of individualized interventions and obtaining pilot data to guide subsequent randomized controlled trails. (c) 2009 Wiley-Liss, Inc.

National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples

PubMed Central

El-Bassel, Nabila; Jemmott, John B.; Landis, J. Richard; Pequegnat, Willo; Wingood, Gina M.; Wyatt, Gail E.; Bellamy, Scarlett L.

2014-01-01

Background Human immunodeficiency virus (HIV) has disproportionately affected African Americans. Couple-level interventions may be a promising intervention strategy. Methods To determine if a behavioral intervention can reduce HIV/sexually transmitted disease (STD) risk behaviors among African American HIV serodiscordant couples, a cluster randomized controlled trial (Eban) was conducted in Atlanta, Georgia; Los Angeles, California; New York, New York; and Philadelphia, Pennsylvania; with African American HIV serodiscordant heterosexual couples who were eligible if both partners were at least 18 years old and reported unprotected intercourse in the previous 90 days and awareness of each other's serostatus. One thousand seventy participants were enrolled (mean age, 43 years; 40% of male participants were HIV positive). Couples were randomized to 1 of 2 interventions: couple-focused Eban HIV/STD risk-reduction intervention or attention-matched individual-focused health promotion comparison. The primary outcomes were the proportion of condom-protected intercourse acts and cumulative incidence of STDs (chlamydia, gonorrhea, or trichomonas). Data were collected preintervention and postintervention, and at 6- and 12-month follow-ups. Results Data were analyzed for 535 randomized couples: 260 in the intervention group and 275 in the comparison group; 81.9% were retained at the 12-month follow-up. Generalized estimating equation analyses revealed that the proportion of condom-protected intercourse acts was larger among couples in the intervention group (0.77) than in the comparison group (0.47; risk ratio, 1.24; 95% confidence interval [CI], 1.09 to 1.41; P=.006) when adjusted for the baseline criterion measure. The adjusted percentage of couples using condoms consistently was higher in the intervention group (63%) than in the comparison group (48%; risk ratio, 1.45; 95% CI, 1.24 to 1.70; P<.001). The adjusted mean number of (log)unprotected intercourse acts was lower in the intervention group than in the comparison group (mean difference, –1.52; 95% CI, –2.07 to –0.98; P<.001). The cumulative STD incidence over the 12-month follow-up did not differ between couples in the intervention and comparison groups. The overall HIV sero-conversion at the 12-month follow-up was 5 (2 in the intervention group, 3 in the comparison group) of 535 individuals, which translates to 935 per 100 000 population. Conclusion To our knowledge, this is the first randomized controlled intervention trial to report significant reductions in HIV/STD risk behaviors among African American HIV serodiscordant couples. PMID:20625011

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

PubMed

Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

2000-08-01

Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

Further Validation of the Pathways Housing First Fidelity Scale.

PubMed

Goering, Paula; Veldhuizen, Scott; Nelson, Geoffrey B; Stefancic, Ana; Tsemberis, Sam; Adair, Carol E; Distasio, Jino; Aubry, Tim; Stergiopoulos, Vicky; Streiner, David L

2016-01-01

This study examined whether Housing First fidelity ratings correspond to program operation descriptions from administrative data and predict client outcomes. A multisite, randomized controlled trial (At Home/Chez Soi) in five Canadian cities included two assessments of 12 programs over two years. Outcomes for 1,158 clients were measured every six months. Associations between fidelity ratings and administrative data (Spearman correlations) and participant outcomes (mixed-effects modeling) were examined. Fidelity ratings were generally good (mean ± SD=136.6 ± 10.3 out of a possible range of 38-152; 87% of maximum value). Fidelity was significantly associated with three of four measures of program operation, with correlations between .55 and .60. Greater program fidelity was associated with improvement in housing stability, community functioning, and quality of life. Variation in program fidelity was associated with operations and outcomes, supporting scale validity and intervention effectiveness. These findings reinforced the value of using fidelity monitoring to conduct quality assurance and technical assistance activities.

Using Growth Curves To Determine the Timing of the Booster Sessions.

ERIC Educational Resources Information Center

Hennessy, Michael; Bolan, Gail A.; Hoxworth, Tamara; Iatesta, Michael; Rhodes, Fen; Zenilman, Jonathan M.

1999-01-01

Demonstrates an application of a method for using growth curves to determine the timing of booster sessions to reinforce the cognitive messages or behavior changes of interventions. Uses data from a multisite randomized experiment that compared three counseling and testing methods for preventing sexual disease transmission. Presents…

Special Diabetes Program for Indians: Retention in Cardiovascular Risk Reduction

ERIC Educational Resources Information Center

Manson, Spero M.; Jiang, Luohua; Zhang, Lijing; Beals, Janette; Acton, Kelly J.; Roubideaux, Yvette

2011-01-01

Purpose: This study examined the associations between participant and site characteristics and retention in a multisite cardiovascular disease risk reduction project. Design and Methods: Data were derived from the Special Diabetes Program for Indians Healthy Heart Demonstration Project, an intervention to reduce cardiovascular risk among American…

INTroducing A Care bundle To prevent pressure injury (INTACT) in at-risk patients: A protocol for a cluster randomised trial.

PubMed

Chaboyer, Wendy; Bucknall, Tracey; Webster, Joan; McInnes, Elizabeth; Banks, Merrilyn; Wallis, Marianne; Gillespie, Brigid M; Whitty, Jennifer A; Thalib, Lukman; Roberts, Shelley; Cullum, Nicky

2015-11-01

Pressure injuries are a significant clinical and economic issue, affecting both patients and the health care system. Many pressure injuries in hospitals are facility acquired, and are largely preventable. Despite growing evidence and directives for pressure injury prevention, implementation of preventative strategies is suboptimal, and pressure injuries remain a serious problem in hospitals. This study will test the effectiveness and cost-effectiveness of a patient-centred pressure injury prevention care bundle on the development of hospital acquired pressure injury in at-risk patients. This is a multi-site, parallel group cluster randomised trial. The hospital is the unit of randomisation. Adult medical and surgical patients admitted to the study wards of eight hospitals who are (a) deemed to be at risk of pressure injury (i.e. have reduced mobility), (b) expected to stay in hospital for ≥48h, (c) admitted to hospital in the past 36h; and (d) able to provide informed consent will be eligible to participate. Consenting patients will receive either the pressure injury prevention care bundle or standard care. The care bundle contains three main messages: (1) keep moving; (2) look after your skin; and (3) eat a healthy diet. Nurses will receive education about the intervention. Patients will exit the study upon development of a pressure injury, hospital discharge or 28 days, whichever comes first; transfer to another hospital or transfer to critical care and mechanically ventilated. The primary outcome is incidence of hospital acquired pressure injury. Secondary outcomes are pressure injury stage, patient participation in care and health care costs. A health economic sub-study and a process evaluation will be undertaken alongside the trial. Data will be analysed at the cluster (hospital) and patient level. Estimates of hospital acquired pressure injury incidence in each group, group differences and 95% confidence interval and p values will be reported. To our knowledge, this is the first trial of an intervention to incorporate a number of pressure injury prevention strategies into a care bundle focusing on patient participation and nurse-patient partnership. The results of this study will provide important information on the effectiveness and cost-effectiveness of this intervention in preventing pressure injuries in at-risk patients. If the results confirm the utility of the developed care bundle, it could have a significant impact on clinical practice worldwide. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613001343796. Copyright © 2015 Elsevier Ltd. All rights reserved.

Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis.

PubMed

Gauthier, Lynne V; Kane, Chelsea; Borstad, Alexandra; Strahl, Nancy; Uswatte, Gitendra; Taub, Edward; Morris, David; Hall, Alli; Arakelian, Melissa; Mark, Victor

2017-06-08

Constraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined. This protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in Neurological Disorders (NeuroQOL). This multi-site RCT is designed to determine comparative effectiveness of in-home technology-based delivery of CI therapy versus standard upper extremity rehabilitation and in-clinic CI therapy. The study design also enables evaluation of the effect of therapist contact time on treatment outcomes within a therapist-as-consultant model of gaming and technology-based rehabilitation. Clinicaltrials.gov, NCT02631850 .

Design of a multi-site multi-state clinical trial of home monitoring of chronic disease in the community in Australia.

PubMed

Celler, Branko G; Sparks, Ross; Nepal, Surya; Alem, Leila; Varnfield, Marlien; Li, Jane; Jang-Jaccard, Julian; McBride, Simon J; Jayasena, Rajiv

2014-12-15

Telehealth services based on at-home monitoring of vital signs and the administration of clinical questionnaires are being increasingly used to manage chronic disease in the community, but few statistically robust studies are available in Australia to evaluate a wide range of health and socio-economic outcomes. The objectives of this study are to use robust statistical methods to research the impact of at home telemonitoring on health care outcomes, acceptability of telemonitoring to patients, carers and clinicians and to identify workplace cultural factors and capacity for organisational change management that will impact on large scale national deployment of telehealth services. Additionally, to develop advanced modelling and data analytics tools to risk stratify patients on a daily basis to automatically identify exacerbations of their chronic conditions. A clinical trial is proposed at five locations in five states and territories along the Eastern Seaboard of Australia. Each site will have 25 Test patients and 50 case matched control patients. All participants will be selected based on clinical criteria of at least two hospitalisations in the previous year or four or more admissions over the last five years for a range of one or more chronic conditions. Control patients are matched according to age, sex, major diagnosis and their Socio-Economic Indexes for Areas (SEIFA). The Trial Design is an Intervention control study based on the Before-After-Control-Impact (BACI) design. Our preliminary data indicates that most outcome variables before and after the intervention are not stationary, and accordingly we model this behaviour using linear mixed-effects (lme) models which can flexibly model within-group correlation often present in longitudinal data with repeated measures. We expect reduced incidence of unscheduled hospitalisation as well as improvement in the management of chronically ill patients, leading to better and more cost effective care. Advanced data analytics together with clinical decision support will allow telehealth to be deployed in very large numbers nationally without placing an excessive workload on the monitoring facility or the patient's own clinicians. Registered with Australian New Zealand Clinical Trial Registry on 1st April 2013. Trial ID: ACTRN12613000635763.

Protocol for the melatools skin self-monitoring trial: a phase II randomised controlled trial of an intervention for primary care patients at higher risk of melanoma.

PubMed

Mills, Katie; Emery, Jon; Lantaff, Rebecca; Radford, Michael; Pannebakker, Merel; Hall, Per; Burrows, Nigel; Williams, Kate; Saunders, Catherine L; Murchie, Peter; Walter, Fiona M

2017-11-28

Melanoma is the fifth most common cancer in the UK. Incidence rates have quadrupled over the last 30 years and continue to rise, especially among younger people. As routine screening of the general population is not currently recommended in the UK, a focus on secondary prevention through early detection and prompt treatment in individuals at increased risk of melanoma could make an important contribution to improve melanoma outcomes. This paper describes the protocol for a phase II, multisite, randomised controlled trial, in the primary care setting, for patients at increased risk of melanoma. A skin self-monitoring (SSM) smartphone 'App' was used to improve symptom appraisal and encourage help seeking in primary care, thereby promoting early presentation with skin changes suspicious of melanoma. We aim to recruit 200 participants from general practice waiting rooms in the East of England. Eligible patients are those identified at higher melanoma risk (using a real-time risk assessment tool), without a personal history of melanoma, aged 18 to 75 years. Participants will be invited to a primary care nurse consultation, and randomised to the intervention group (standard written advice on skin cancer detection and sun protection, loading of an SSM 'App' onto the participant's smartphone and instructions on use including self-monitoring reminders) or control group (standard written advice alone). The primary outcomes are consultation rates for changes to a pigmented skin lesion, and the patient interval (time from first noticing a skin change to consultation). Secondary outcomes include patient sun protection behaviours, psychosocial outcomes, and measures of trial feasibility and acceptability. NHS ethical approval has been obtained from Cambridgeshire and Hertfordshire research ethics committee (REC reference 16/EE/0248). The findings from the MelaTools SSM Trial will be disseminated widely through peer-reviewed publications and scientific conferences. ISCTRN16061621. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Efficacy of a single late-dormant application of mineral oil plus chlorothalonil for control of peach scab, caused by Venturia carpophila

USDA-ARS?s Scientific Manuscript database

Peach scab, caused by Venturia carpophila, is a major disease of peach across the southeastern United States. In multi-year, multi-site field trials, mineral oil plus chlorothalonil late-dormant treatments suppressed both scab incidence and severity, as previously reported for almond scab in Califor...

Bridging the Gap between Science and Practice: The Effective Nationwide Transport of MST Programs in Norway

ERIC Educational Resources Information Center

Ogden, Terje; Christensen, Bernadette; Sheidow, Ashli J.; Holth, Per

2008-01-01

The successful nationwide transport and evaluation of Multisystemic Therapy (MST) programs in Norway is described. This description is provided within the context of the nation's movement towards the adoption of evidence-based practices (EBPs) during the past decade, the conduct of a multisite randomized clinical trial to examine the effectiveness…

Remission and Residual Symptoms after Short-Term Treatment in the Treatment of Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Kennard, Betsy; Silva, Susan; Vitiello, Benedetto; Curry, John; Kratochvil, Christopher; Simons, Anne; Hughes, Jennifer; Feeny, Norah; Weller, Elizabeth; Sweeney, Michael; Reinecke, Mark; Pathak, Sanjeev; Ginsburg, Golda; Emslie, Graham; March, John

2006-01-01

Objective: To ascertain remission rates in depressed youth participating in the Treatment for Adolescents With Depression Study (TADS), a multisite clinical trial that randomized 439 adolescents with major depressive disorder (MDD) to a 12-week treatment of fluoxetine (FLX), cognitive-behavioral therapy (CBT), their combination (COMB), or clinical…

Remission and Recovery in the Treatment for Adolescents with Depression Study (TADS): Acute and Long-Term Outcomes

ERIC Educational Resources Information Center

Kennard, Betsy D.; Silva, Susan G.; Tonev, Simon; Rohde, Paul; Hughes, Jennifer L.; Vitiello, Benedetto; Kratochvil, Christopher J.; Curry, John F.; Emslie, Graham J.; Reinecke, Mark; March, John

2009-01-01

The remission and recovery rates of adolescent patients with depression who were treated with fluoxetine, cognitive-behavioral therapy, their combination, and placebos were examined through a multisite clinical trial. It is concluded that most depressed adolescents who received such therapies achieved remission at the end of nine months.

Remission after Acute Treatment in Children and Adolescents with Anxiety Disorders: Findings from the CAMS

ERIC Educational Resources Information Center

Ginsburg, Golda S.; Kendall, Philip C.; Sakolsky, Dara; Compton, Scott N.; Piacentini, John; Albano, Anne Marie; Walkup, John T.; Sherrill, Joel; Coffey, Kimberly A.; Rynn, Moira A.; Keeton, Courtney P.; McCracken, James T.; Bergman, Lindsey; Iyengar, Satish; Birmaher, Boris; March, John

2011-01-01

Objective: To report on remission rates in anxious youth who participated in the Child/Adolescent Anxiety Multimodal Study (CAMS). The CAMS, a multisite clinical trial, randomized 488 children and adolescents (ages 7-17 years; 79% Caucasian; 50% female) with separation, social, and/or generalized anxiety disorder to a 12-week treatment of…

Planning and conducting a multi-institutional project on fatigue.

PubMed

Nail, L M; Barsevick, A M; Meek, P M; Beck, S L; Jones, L S; Walker, B L; Whitmer, K R; Schwartz, A L; Stephen, S; King, M E

1998-09-01

To describe the process used in proposal development and study implementation for a complex multisite project on cancer treatment-related fatigue (CRF), identify strategies used to manage the project, and provide recommendations for teams planning multisite research. Information derived from project team meeting records, correspondence, proposals, and personal recollection. The project was built on preexisting relationships among the three site investigators who then built a team including faculty, research coordinators, staff nurses, and students. Study sites had a range of organizational models, and the proposal was designed to capitalize on the organizational and resource strengths of each setting. Three team members drawn from outside oncology nursing provided expertise in measurement and experience with fatigue in other populations. Planning meetings were critical to the success of the project. Conference calls, fax technology, and electronic mail were used for communication. Flexibility was important in managing crises and shifting responsibility for specific components of the work. The team documented and evaluated the process used for multisite research, completed a major instrumentation study, and developed a cognitive-behavioral intervention for CRF. Accomplishments during the one-year planning grant exceeded initial expectations. The process of conducting multisite research is complex, especially when the starting point is a planning grant with specific research protocols to be developed and implemented over one year. Explicit planning for decision-making processes to be used throughout the project, acknowledging the differences among the study settings and planning the protocols to capitalize upon those differences, and recruiting a strong research team that included a member with planning grant and team-building expertise were essential elements for success. Specific recommendations for others planning multisite research are related to team-building, team membership, communication, behavioral norms, role flexibility, resources, feedback, problem management, and shared recognition.

Influence of homogeneity of student characteristics in a group-based social competence intervention.

PubMed

Stichter, Janine P; Herzog, Melissa J; Malugen, Emily; Schoemann, Alexander M

2018-06-18

Although some literature reviews cited mixed results for group-based social competence interventions in schools, existing descriptions of intervention efficacy often lack attention on important factors that may moderate differential response. Some studies suggest that individual characteristics such as diagnosis (i.e., specific deficit clusters) or behavioral profiles may be important social outcome moderators. Given the interactive nature of group-based interventions, understanding how individual characteristics combine to influence outcomes for the group as a whole is an important next step. By using a multisite cluster randomized control trial (n = 274), the current study explores the impact that varying student characteristics have on outcomes of the Social Competence Intervention for Adolescents (SCI-A; Stichter, Herzog, Owens, & Malugen, 2016; Stichter et al., 2010) compared to outcomes of business-as-usual (BAU) practices. Researchers hypothesized that (a) SCI-A would be more effective than BAU in improving ratings of students' social functioning when students within groups were more similar to each other on relevant diagnostic and behavioral indicators, and (b) that within SCI-A only, more versus less homogenous groups would demonstrate greater social outcome gains. Results offer some support for these hypotheses: SCI-A was more effective in improving social communication and motivation when groups were diagnostically similar (ds > 0.55). Considering changes in social awareness and communication, SCI-A was more effective when groups were heterogeneous on socially competent behavior (ds > 1.32) and less effective when groups were heterogeneous on antisocial behavior (ds > 1.00). The authors discuss the implications and importance of research exploring factors such as group composition that may moderate intervention response in applied settings. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial.

PubMed

Edbrooke, Lara; Aranda, Sanchia; Granger, Catherine L; McDonald, Christine F; Krishnasamy, Mei; Mileshkin, Linda; Irving, Louis; Braat, Sabine; Clark, Ross A; Gordon, Ian; Denehy, Linda

2017-09-29

Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting. This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12614001268639 : (4/12/14).

The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation.

PubMed

Wolf, Steven L; Sahu, Komal; Bay, R Curtis; Buchanan, Sharon; Reiss, Aimee; Linder, Susan; Rosenfeldt, Anson; Alberts, Jay

2015-01-01

Geographical location, socioeconomic status, and logistics surrounding transportation impede access of poststroke individuals to comprehensive rehabilitative services. Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing remote monitoring and adjusting therapy for underserved populations. The Hand Mentor Pro (HMP) was incorporated within a home exercise program (HEP) to improve upper-extremity (UE) functional capabilities poststroke. To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months poststroke and characterized as underserved. In this prospective, single-blinded, multisite, randomized controlled trial, 99 hemiparetic participants with limited access to UE rehabilitation were randomized to either (1) the experimental group, which received combined HEP and HMP for 3 h/d ×5 days ×8 weeks, or (2) the control group, which received HEP only at an identical dosage. Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription. The Action Research Arm Test and Wolf Motor Function Test along with the Fugl-Meyer Assessment (UE) were primary and secondary outcome measures, respectively, undertaken before and after the interventions. Both groups demonstrated improvement across all UE outcomes. Robotic + HEP and HEP only were both effectively delivered remotely. There was no difference between groups in change in motor function over time. Additional research is necessary to determine the appropriate dosage of HMP and HEP. © The Author(s) 2015.

The HAAPI (Home Arm Assistance Progression Initiative) Trial: - A Novel Robotics Delivery Approach in Stroke Rehabilitation

PubMed Central

Wolf, Steven L.; Sahu, Komal; Bay, R. Curtis; Buchanan, Sharon; Reiss, Aimee; Linder, Susan; Rosenfeldt, Anson; Alberts, Jay

2015-01-01

Background Geographical location, socioeconomic status and logistics surrounding transportation impede access of post-stroke individuals to comprehensive rehabilitative services. Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing for the remote monitoring and adjusting therapy for underserved populations. The Hand Mentor Pro (HMP), was incorporated within a home exercise program (HEP) to improve upper extremity functional capabilities post-stroke. Objective To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months post-stroke and characterized as underserved. Methods In this prospective, single-blinded, multisite, randomized controlled trial, 99 hemiparetic participants with limited access to upper extremity rehabilitation were randomized to the: 1) experimental group which received combined HEP and HMP for 3 hrs/day x 5 days x 8 weeks; or 2) control group which received HEP only at an identical dosage. Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription. The Action Research Arm Test and Wolf Motor Function Test along with the Fugl Meyer Assessment (upper extremity) were primary and secondary outcome measures respectively, undertaken before and after the interventions. Results Both groups demonstrated improvement across all upper extremity outcomes. Conclusions Robotic+HEP and HEP only were both effectively delivered remotely. There was no difference between groups in change in motor function over time, additional research is necessary to determine appropriate dosage of HMP and HEP. PMID:25782693

Food security among individuals experiencing homelessness and mental illness in the At Home/Chez Soi Trial.

PubMed

O'Campo, Patricia; Hwang, Stephen W; Gozdzik, Agnes; Schuler, Andrée; Kaufman-Shriqui, Vered; Poremski, Daniel; Lazgare, Luis Ivan Palma; Distasio, Jino; Belbraouet, Slimane; Addorisio, Sindi

2017-08-01

Individuals experiencing homelessness are particularly vulnerable to food insecurity. The At Home/Chez Soi study provides a unique opportunity to first examine baseline levels of food security among homeless individuals with mental illness and second to evaluate the effect of a Housing First (HF) intervention on food security in this population. At Home/Chez Soi was a 2-year randomized controlled trial comparing the effectiveness of HF compared with usual care among homeless adults with mental illness, stratified by level of need for mental health services (high or moderate). Logistic regressions tested baseline associations between food security (US Food Security Survey Module), study site, sociodemographic variables, duration of homelessness, alcohol/substance use, physical health and service utilization. Negative binomial regression determined the impact of the HF intervention on achieving levels of high or marginal food security over an 18-month follow-up period (6 to 24 months). Community settings at five Canadian sites (Moncton, Montreal, Toronto, Winnipeg and Vancouver). Homeless adults with mental illness (n 2148). Approximately 41 % of our sample reported high or marginal food security at baseline, but this figure varied with gender, age, mental health issues and substance use problems. High need participants who received HF were more likely to achieve marginal or high food security than those receiving usual care, but only at the Toronto and Moncton sites. Our large multi-site study demonstrated low levels of food security among homeless experiencing mental illness. HF showed promise for improving food security among participants with high levels of need for mental health services, with notable site differences.

Run-Reversal Equilibrium for Clinical Trial Randomization

PubMed Central

Grant, William C.

2015-01-01

In this paper, we describe a new restricted randomization method called run-reversal equilibrium (RRE), which is a Nash equilibrium of a game where (1) the clinical trial statistician chooses a sequence of medical treatments, and (2) clinical investigators make treatment predictions. RRE randomization counteracts how each investigator could observe treatment histories in order to forecast upcoming treatments. Computation of a run-reversal equilibrium reflects how the treatment history at a particular site is imperfectly correlated with the treatment imbalance for the overall trial. An attractive feature of RRE randomization is that treatment imbalance follows a random walk at each site, while treatment balance is tightly constrained and regularly restored for the overall trial. Less predictable and therefore more scientifically valid experiments can be facilitated by run-reversal equilibrium for multi-site clinical trials. PMID:26079608

Psychometric performance and responsiveness of the functional outcomes of sleep questionnaire and sleep apnea quality of life instrument in a randomized trial: the HomePAP study.

PubMed

Billings, Martha E; Rosen, Carol L; Auckley, Dennis; Benca, Ruth; Foldvary-Schaefer, Nancy; Iber, Conrad; Zee, Phyllis C; Redline, Susan; Kapur, Vishesh K

2014-12-01

Measures of health-related quality of life (HRQL) specific for sleep disorders have had limited psychometric evaluation in the context of randomized controlled trials (RCTs). We investigated the psychometric properties of the Functional Outcomes of Sleep Questionnaire (FOSQ) and Sleep Apnea Quality of Life Instrument (SAQLI). We evaluated the FOSQ and SAQLI construct and criterion validity, determined a minimally important difference, and assessed for associations of responsiveness to baseline subject characteristics and continuous positive airway pressure (CPAP) adherence in a RCT population. Secondary analysis of data collected in a multisite RCT of home versus laboratory-based diagnosis and treatment of obstructive sleep apnea (HomePAP trial). Individuals enrolled in the HomePAP trial (n = 335). N/A. The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity, correlating with Medical Outcomes Study 36-Item Short Form Survey domains. Correlations were weaker with the Epworth Sleepiness Scale (ESS). Both the FOSQ and SAQLI scores improved after 3 mo with CPAP therapy. Averaging 4 h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference. Baseline depressive symptoms and sleepiness predicted FOSQ and SAQLI responsiveness; demographic, objective obstructive sleep apnea (OSA) severity and sleep habits were not predictive in linear regression. The FOSQ and SAQLI are responsive to CPAP intervention, with the FOSQ being more sensitive to differences in CPAP adherence than the SAQLI. These instruments provide unique information about health outcomes beyond that provided by changes in physiological measures of OSA severity (apnea-hypopnea index). Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP) URL: http://clinicaltrials.gov/show/NCT00642486. NIH clinical trials registry number: NCT00642486. © 2014 Associated Professional Sleep Societies, LLC.

Oral paracetamol versus oral ibuprofen for closure of haemodynamically significant patent ductus arteriosus in preterm neonates (<32 weeks): a blinded, randomised, active-controlled, non-inferiority trial

PubMed Central

Kumar, Ashutosh; Sundaram, Venkataseshan; Yadav, Rahul; Oleti, Tejo Pratap; Murki, Srinivas; Krishna, Arun; Sundaram, Mangalabharathi; Saini, Shiv Sajan; Dutta, Sourabh

2017-01-01

Introduction Haemodynamically significant patent ductus arteriosus (hsPDA) is a common cause of mortality and morbidity in preterm infants. Existing medical therapies with ibuprofen or indomethacin have multiple adverse effects. Hence, an alternative drug like paracetamol given through oral route with less side effects need to be tested in an appropriate study design with least risk of bias to arrive at a conclusion. Methods and analysis Multisite, randomised, active-controlled, non-inferiority design. The primary objective is to study the efficacy of oral paracetamol for closure of hsPDA in comparison to oral ibuprofen in preterm neonates of <32 weeks’ gestation. Randomisation web-based and allocation concealment would be done; the treating team, investigators, outcome assessors and laboratory personnel would be blinded from the intervention. Echocardiography images would be coded for independent review. Closure of PDA by the end of last dose of study drug or earlier would be the study endpoint. A sample size of 196 neonates would be enrolled with a non-inferiority margin of 15%. Both intention-to-treat and per-protocol analysis will be done to assess the effect of contamination and protocol violations in the primary outcome. Ethics and dissemination The trial would follow international code of ethics for clinical trial. The trial protocol was approved by the Institute Ethics Committee of all three centres. All serious adverse events would be reported in detail to the Institute Ethics Committee. A written informed consent would be obtained from one of the parents. No plan has been made for dissemination. Trial registration number CTRI/2014/08/004805. PMID:29637155

The promise of recovery: narratives of hope among homeless individuals with mental illness participating in a Housing First randomised controlled trial in Toronto, Canada

PubMed Central

Kirst, Maritt; Zerger, Suzanne; Wise Harris, Deborah; Plenert, Erin; Stergiopoulos, Vicky

2014-01-01

Objectives Hope is widely embraced as an important factor in the recovery process. The role of housing in inspiring hope and facilitating recovery has been explored with homeless populations but is not well understood. This study explores perspectives on hopes for recovery and the role of housing on these hopes from the perspective of homeless adults experiencing mental illness participating in a multisite Housing First randomised controlled trial in Canada. The study draws on data from in-depth qualitative interviews with participants from the Toronto, Ontario site of the ‘At Home/Chez Soi’ Project. Design In-depth interviews were conducted with a subsample of participants from a larger Housing First randomised controlled trial. Setting The research took place in Toronto, Canada. Participants 60 participants in the larger trial (36 from the Housing First group and 24 from the Treatment as Usual group) took part in in-depth interviews. Method Participants for the in-depth interviews were purposively selected from the larger trial sample in Toronto and participated in an interview at the beginning of the study (baseline). Data from the baseline interviews were analysed using the constant comparative method derived from grounded theory methods. Results Participants’ narratives show clear visualisation of goals for recovery, and emphasise that housing is an integral factor that can facilitate hope and support dimensions of recovery. However, some participants had difficulty adjusting to housing, and were concerned about feeling socially isolated, which could have negative implications for hopefulness and recovery. Conclusions Housing First interventions should explicitly incorporate hope-inspiring, recovery-oriented approaches and support participants while adjusting to housing in order to sustain hopefulness. PMID:24589826

A multi-site randomised controlled trial of evidence-based supported employment for adults with severe and persistent mental illness.

PubMed

Waghorn, Geoffrey; Dias, Shannon; Gladman, Beverley; Harris, Meredith; Saha, Sukanta

2014-12-01

The Individual Placement and Support (IPS) approach is an evidence-based form of supported employment for people with severe and persistent mental illness. This approach is not yet widely available in Australia even though there is mounting evidence of its generalisability outside the USA. One previous Australian randomised controlled trial found that IPS is effective for young people with first episode psychosis. The aim of the current trial was to assess the effectiveness of evidence-based supported employment when implemented for Australian adult consumers of public mental health services by utilising existing service systems. A four-site randomised control trial design (n = 208) was conducted in Brisbane (two sites), Townsville and Cairns. The intervention consisted of an IPS supported employment service hosted by a community mental health team. The control condition was delivered at each site by mental health teams referring consumers to other disability employment services in the local area. At 12 months, those in the IPS condition had 2.4 times greater odds of commencing employment than those in the control condition (42.5% vs. 23.5%). The conditions did not differ on secondary employment outcomes including job duration, hours worked, or job diversity. Attrition was higher than expected in both conditions with 28.4% completing the baseline interview but taking no further part in the study. The results support previous international findings that IPS-supported employment is more effective than non-integrated supported employment. IPS can be successfully implemented this way in Australia, but with a loss of effect strength compared to previous USA trials. © 2014 Occupational Therapy Australia.

Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection

PubMed Central

Kreimer, Aimée R.; Schiffman, Mark; Herrero, Rolando; Wacholder, Sholom; Rodriguez, Ana Cecilia; Lowy, Douglas R.; Porras, Carolina; Schiller, John T.; Quint, Wim; Jimenez, Silvia; Safaeian, Mahboobeh; Struijk, Linda; Schussler, John; Hildesheim, Allan; Gonzalez, Paula

2016-01-01

Background: Previous Costa Rica Vaccine Trial (CVT) reports separately demonstrated vaccine efficacy against HPV16 and HPV18 (HPV16/18) infections at the cervical, anal, and oral regions; however, the combined overall multisite efficacy (protection at all three sites) and vaccine efficacy among women infected with HPV16 or HPV18 prior to vaccination are less known. Methods: Women age 18 to 25 years from the CVT were randomly assigned to the HPV16/18 vaccine (Cervarix) or a hepatitis A vaccine. Cervical, oral, and anal specimens were collected at the four-year follow-up visit from 4186 women. Multisite and single-site vaccine efficacies (VEs) and 95% confidence intervals (CIs) were computed for one-time detection of point prevalent HPV16/18 in the cervical, anal, and oral regions four years after vaccination. All statistical tests were two-sided. Results: The multisite woman-level vaccine efficacy was highest among “naïve” women (HPV16/18 seronegative and cervical HPV high-risk DNA negative at vaccination) (vaccine efficacy = 83.5%, 95% CI = 72.1% to 90.8%). Multisite woman-level vaccine efficacy was also demonstrated among women with evidence of a pre-enrollment HPV16 or HPV18 infection (seropositive for HPV16 and/or HPV18 but cervical HPV16/18 DNA negative at vaccination) (vaccine efficacy = 57.8%, 95% CI = 34.4% to 73.4%), but not in those with cervical HPV16 and/or HPV18 DNA at vaccination (anal/oral HPV16/18 VE = 25.3%, 95% CI = -40.4% to 61.1%). Concordant HPV16/18 infections at two or three sites were also less common in HPV16/18-infected women in the HPV vaccine vs control arm (7.4% vs 30.4%, P < .001). Conclusions: This study found high multisite vaccine efficacy among “naïve” women and also suggests the vaccine may provide protection against HPV16/18 infections at one or more anatomic sites among some women infected with these types prior to HPV16/18 vaccination. PMID:26467666

Multi-site randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders

PubMed Central

Hien, Denise A.; Wells, Elizabeth A.; Jiang, Huiping; Suarez-Morales, Lourdes; Campbell, Aimee N. C.; Cohen, Lisa R.; Miele, Gloria M.; Killeen, Therese; Brigham, Gregory S.; Zhang, Yulei; Hansen, Cheri; Hodgkins, Candace; Hatch-Maillette, Mary; Brown, Chanda; Kulaga, Agatha; Kristman-Valente, Allison; Chu, Melissa; Sage, Robert; Robinson, James A.; Liu, David; Nunes, Edward V.

2009-01-01

We compared the effectiveness of Seeking Safety (SS), an integrated cognitive behavioral treatment for substance use disorder (SUD) and post-traumatic stress disorder (PTSD), to an active comparison health education group (Women’s Health Education [WHE]) within NIDA’s Clinical Trials Network. We randomized 353 women to receive 12 sessions of SS (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment at post-treatment and 3-, 6-, and 12-months post-treatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS) and PTSD Symptom Scale-Self Report (PSS-SR), and substance use (self-reported abstinence in the prior 7 days and days per week of any substance use). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively), but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline, when 46% of participants were abstinent. Study results do not favor SS over WHE as an adjunct to SUD treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions. PMID:19634955

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.

PubMed

Cambron, Jerrilyn A; Hawk, Cheryl; Evans, Roni; Long, Cynthia R

2004-06-01

To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain. Multisite pilot study for a randomized, placebo-controlled clinical trial. Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States. Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist. The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts. In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site. Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.

Reducing catheter-associated urinary tract infections in hospitals: study protocol for a multi-site randomised controlled study.

PubMed

Mitchell, Brett G; Fasugba, Oyebola; Gardner, Anne; Koerner, Jane; Collignon, Peter; Cheng, Allen C; Graves, Nicholas; Morey, Peter; Gregory, Victoria

2017-11-28

Despite advances in infection prevention and control, catheter-associated urinary tract infections (CAUTIs) are common and remain problematic. A number of measures can be taken to reduce the risk of CAUTI in hospitals. Appropriate urinary catheter insertion procedures are one such method. Reducing bacterial colonisation around the meatal or urethral area has the potential to reduce CAUTI risk. However, evidence about the best antiseptic solutions for meatal cleaning is mixed, resulting in conflicting recommendations in guidelines internationally. This paper presents the protocol for a study to evaluate the effectiveness (objective 1) and cost-effectiveness (objective 2) of using chlorhexidine in meatal cleaning prior to catheter insertion, in reducing catheter-associated asymptomatic bacteriuria and CAUTI. A stepped wedge randomised controlled trial will be undertaken in three large Australian hospitals over a 32-week period. The intervention in this study is the use of chlorhexidine (0.1%) solution for meatal cleaning prior to catheter insertion. During the first 8 weeks of the study, no hospital will receive the intervention. After 8 weeks, one hospital will cross over to the intervention with the other two participating hospitals crossing over to the intervention at 8-week intervals respectively based on randomisation. All sites complete the trial at the same time in 2018. The primary outcomes for objective 1 (effectiveness) are the number of cases of CAUTI and catheter-associated asymptomatic bacteriuria per 100 catheter days will be analysed separately using Poisson regression. The primary outcome for objective 2 (cost-effectiveness) is the changes in costs relative to health benefits (incremental cost-effectiveness ratio) from adoption of the intervention. Results will be disseminated via peer-reviewed journals and presentations at relevant conferences.A dissemination plan it being developed. Results will be published in the peer review literature, presented at relevant conferences and communicated via professional networks. Ethics approval has been obtained. 12617000373370, approved 13/03/2017. Protocol version 1.1. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Training on the DSM-5 Cultural Formulation Interview Improves Cultural Competence in General Psychiatry Residents: A Multi-site Study.

PubMed

Mills, Stacia; Wolitzky-Taylor, Kate; Xiao, Anna Q; Bourque, Marie Claire; Rojas, Sandra M Peynado; Bhattacharya, Debanjana; Simpson, Annabelle K; Maye, Aleea; Lo, Pachida; Clark, Aaron; Lim, Russell; Lu, Francis G

2016-10-01

The authors assessed whether a 1-h didactic session on the DSM-5 Cultural Formulation Interview (CFI) improves cultural competence of general psychiatry residents. Psychiatry residents at six residency programs completed demographics and pre-intervention questionnaires, were exposed to a 1-h session on the CFI, and completed a post-intervention questionnaire. Repeated measures ANCOVA compared pre- to post-intervention change. Linear regression assessed whether previous cultural experience predicted post-intervention scores. Mean scores on the questionnaire significantly changed from pre- to post-intervention (p < 0.001). Previous cultural experience did not predict post-intervention scores. Psychiatry residents' cultural competence scores improved with a 1-h session on the CFI but with notable limitations.

A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness.

PubMed

Johnson, Miriam J; Booth, Sara; Currow, David C; Lam, Lawrence T; Phillips, Jane L

2016-05-01

The handheld fan is an inexpensive and safe way to provide facial airflow, which may reduce the sensation of chronic refractory breathlessness, a frequently encountered symptom. To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial comparing the efficacy of a handheld fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions, measuring recruitment rates; data quality; and potential primary outcome measures. This was a Phase II, multisite, international, parallel, nonblinded, mixed-methods randomized controlled trial. Participants were centrally randomized to fan or control. All received breathlessness self-management/exercise advice and were followed up weekly for four weeks. Participants/carers were invited to participate in a semistructured interview at the study's conclusion. Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 completed the study. Site recruitment varied from 0.25 to 3.3/month and screening:randomization from 1.1:1 to 8.5:1. There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (two-thirds of data missing). No harms were observed. Three interview themes included 1) a fan is a helpful self-management strategy, 2) a fan aids recovery, and 3) a symptom control trial was welcome. A definitive, multisite trial to study the use of the handheld fan as part of self-management of chronic refractory breathlessness is feasible. Participants found the fan useful. However, the value of information for changing practice or policy is unlikely to justify the expense of such a trial, given perceived benefits, the minimal costs, and an absence of harms demonstrated in this study. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Quality assurance of research protocols conducted in the community: the National Institute on Drug Abuse Clinical Trials Network experience.

PubMed

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-04-01

Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. : QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed.

Quality assurance of research protocols conducted in the community: The National Institute on Drug Abuse Clinical Trials Network Experience

PubMed Central

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-01-01

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. Purpose: This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Methods: The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Results: Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. Limitations: QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. Conclusions: The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed. PMID:19342468

Cardiovascular disease medication health literacy among Indigenous peoples: design and protocol of an intervention trial in Indigenous primary care services.

PubMed

Crengle, Sue; Smylie, Janet; Kelaher, Margaret; Lambert, Michelle; Reid, Susan; Luke, Joanne; Anderson, Ian; Harré Hindmarsh, Jennie; Harwood, Matire

2014-07-12

Cardiovascular diseases (CVD) are leading causes of mortality and morbidity among Indigenous people in New Zealand, Australia and Canada and are a major driver of the inequities in life expectancy between Indigenous and non-Indigenous people in these countries. Evidence-based pharmaceutical management of CVD can significantly reduce mortality and morbidity for persons diagnosed with CVD or for those at intermediate or high risk of CVD. Health literacy has been identified as a major barrier in the communication and implementation of appropriate pharmaceutical management plans for CVD. Addressing health literacy is particularly relevant in Indigenous populations where there are unique health and adult literacy challenges. This study will examine the effect of a customized, structured CVD medication programme, delivered by health professionals, on the health literacy of Indigenous people with, or at risk, of CVD. Primary outcomes are patient's knowledge about CVD medications; secondary outcomes examine changes in health literacy skills and practices. The study will employ a multi-site pre-post design with multiple measurement points to assess intervention efficacy. Participants will be recruited from four Indigenous primary care services in Australia, Canada and New Zealand. Three educational sessions will be delivered over four weeks. A tablet application will support the education sessions and produce a customized pill card for each participant. Participants will be provided with written information about CVD medications. Medication knowledge scores, and specific health literacy skills and practices will be assessed before and after the three sessions. Statistical analyses will identify significant changes in outcomes over each session, and from the pre-session one to post-session three time points. This study will make an important contribution to understanding the effect of a structured primary care-based intervention on CVD health literacy in Indigenous populations. The study also illustrates the incorporation of Indigenous health research principles and processes in clinical trials and provides insights that may be useful in other contexts. Australian and New Zealand Clinical Trials Register (ACTRN12612001309875; date of registration 18/12/2012).

Genetic Parameters and the Impact of Off-Types for Theobroma cacao L. in a Breeding Program in Brazil

PubMed Central

DuVal, Ashley; Gezan, Salvador A.; Mustiga, Guiliana; Stack, Conrad; Marelli, Jean-Philippe; Chaparro, José; Livingstone, Donald; Royaert, Stefan; Motamayor, Juan C.

2017-01-01

Breeding programs of cacao (Theobroma cacao L.) trees share the many challenges of breeding long-living perennial crops, and genetic progress is further constrained by both the limited understanding of the inheritance of complex traits and the prevalence of technical issues, such as mislabeled individuals (off-types). To better understand the genetic architecture of cacao, in this study, 13 years of phenotypic data collected from four progeny trials in Bahia, Brazil were analyzed jointly in a multisite analysis. Three separate analyses (multisite, single site with and without off-types) were performed to estimate genetic parameters from statistical models fitted on nine important agronomic traits (yield, seed index, pod index, % healthy pods, % pods infected with witches broom, % of pods other loss, vegetative brooms, diameter, and tree height). Genetic parameters were estimated along with variance components and heritabilities from the multisite analysis, and a trial was fingerprinted with low-density SNP markers to determine the impact of off-types on estimations. Heritabilities ranged from 0.37 to 0.64 for yield and its components and from 0.03 to 0.16 for disease resistance traits. A weighted index was used to make selections for clonal evaluation, and breeding values estimated for the parental selection and estimation of genetic gain. The impact of off-types to breeding progress in cacao was assessed for the first time. Even when present at <5% of the total population, off-types altered selections by 48%, and impacted heritability estimations for all nine of the traits analyzed, including a 41% difference in estimated heritability for yield. These results show that in a mixed model analysis, even a low level of pedigree error can significantly alter estimations of genetic parameters and selections in a breeding program. PMID:29250097

Building Evaluation Capacity in Local Programs for Multisite Nutrition Education Interventions

ERIC Educational Resources Information Center

Fourney, Andrew; Gregson, Jennifer; Sugerman, Sharon; Bellow, Andrew

2011-01-01

From 2004-2008, capacity to conduct program evaluation was built among the "Network for a Healthy California's" 48 largest local partners. Capacity building was done within a framework of Empowerment Evaluation and Utility-Focused evaluation. Tools included: a Scope of Work template, a handbook, a compendium of surveys, an evaluation…

Preventing Serious Conduct Problems in School-Age Youth: The Fast Track Program

ERIC Educational Resources Information Center

Slough, Nancy M.; McMahon, Robert J.; Bierman, Karen L.; Coie, John D.; Dodge, Kenneth A.; Foster, E. Michael; Greenberg, Mark T.; Lochman, John E.; McMahon, Robert J.; Pinderhughes, Ellen E.

2008-01-01

Children with early-starting conduct problems have a very poor prognosis and exact a high cost to society. The Fast Track project is a multisite, collaborative research project investigating the efficacy of a comprehensive, long-term, multicomponent intervention designed to "prevent" the development of serious conduct problems in high-risk…

Is a Response to Intervention (RTI) Approach to Preschool Language and Early Literacy Instruction Needed?

ERIC Educational Resources Information Center

Greenwood, Charles R.; Carta, Judith J.; Atwater, Jane; Goldstein, Howard; Kaminski, Ruth; McConnell, Scott

2013-01-01

Preschool experience plays a role in children's development. However, for programs with language and early literacy goals, the question remains whether preschool instructional experiences are sufficiently effective to achieve these goals for all children. In a multisite study, the authors conducted a process-product description of preschool…

The Impact of Tutoring on Early Reading Achievement for Children with and without Attention Problems

ERIC Educational Resources Information Center

Rabiner, David L.; Malone, Patrick S.

2004-01-01

This study examined whether the benefits of reading tutoring in first grade were moderated by children's level of attention problems. Participants were 581 children from the intervention and control samples of Fast Track, a longitudinal multisite investigation of the development and prevention of conduct problems. Standardized reading achievement…

Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial.

PubMed

Lester, Richard T; Ritvo, Paul; Mills, Edward J; Kariri, Antony; Karanja, Sarah; Chung, Michael H; Jack, William; Habyarimana, James; Sadatsafavi, Mohsen; Najafzadeh, Mehdi; Marra, Carlo A; Estambale, Benson; Ngugi, Elizabeth; Ball, T Blake; Thabane, Lehana; Gelmon, Lawrence J; Kimani, Joshua; Ackers, Marta; Plummer, Francis A

2010-11-27

Mobile (cell) phone communication has been suggested as a method to improve delivery of health services. However, data on the effects of mobile health technology on patient outcomes in resource-limited settings are limited. We aimed to assess whether mobile phone communication between health-care workers and patients starting antiretroviral therapy in Kenya improved drug adherence and suppression of plasma HIV-1 RNA load. WelTel Kenya1 was a multisite randomised clinical trial of HIV-infected adults initiating antiretroviral therapy (ART) in three clinics in Kenya. Patients were randomised (1:1) by simple randomisation with a random number generating program to a mobile phone short message service (SMS) intervention or standard care. Patients in the intervention group received weekly SMS messages from a clinic nurse and were required to respond within 48 h. Randomisation, laboratory assays, and analyses were done by investigators masked to treatment allocation; however, study participants and clinic staff were not masked to treatment. Primary outcomes were self-reported ART adherence (>95% of prescribed doses in the past 30 days at both 6 and 12 month follow-up visits) and plasma HIV-1 viral RNA load suppression (<400 copies per mL) at 12 months. The primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00830622. Between May, 2007, and October, 2008, we randomly assigned 538 participants to the SMS intervention (n=273) or to standard care (n=265). Adherence to ART was reported in 168 of 273 patients receiving the SMS intervention compared with 132 of 265 in the control group (relative risk [RR] for non-adherence 0·81, 95% CI 0·69-0·94; p=0·006). Suppressed viral loads were reported in 156 of 273 patients in the SMS group and 128 of 265 in the control group, (RR for virologic failure 0·84, 95% CI 0·71-0·99; p=0·04). The number needed to treat (NNT) to achieve greater than 95% adherence was nine (95% CI 5·0-29·5) and the NNT to achieve viral load suppression was 11 (5·8-227·3). Patients who received SMS support had significantly improved ART adherence and rates of viral suppression compared with the control individuals. Mobile phones might be effective tools to improve patient outcome in resource-limited settings. US President's Emergency Plan for AIDS Relief. Copyright © 2010 Elsevier Ltd. All rights reserved.

Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial.

PubMed

Huang, Beatrice; Willard-Grace, Rachel; De Vore, Denise; Wolf, Jessica; Chirinos, Chris; Tsao, Stephanie; Hessler, Danielle; Su, George; Thom, David H

2017-06-09

Chronic obstructive pulmonary disease (COPD) severely hinders quality of life for those affected and is costly to the health care system. Care gaps in areas such as pharmacotherapy, inhaler technique, and knowledge of disease are prevalent, particularly for vulnerable populations served by community clinics. Non-professionally licensed health coaches have been shown to be an effective and cost-efficient solution in bridging care gaps and facilitating self-management for patients with other chronic diseases, but no research to date has explored their efficacy in improving care for people living with COPD. This is multi-site, single blinded, randomized controlled trial evaluates the efficacy of health coaches to facilitate patient self-management of disease and improve quality of life for patients with moderate to severe COPD. Spirometry, survey, and an exercise capacity test are conducted at baseline and at 9 months. A short survey is administered by phone at 3 and 6 months post-enrollment. The nine month health coaching intervention focuses on enhancing disease understanding and symptom awareness, improving use of inhalers; making personalized plans to increase physical activity, smoking cessation, or otherwise improve disease management; and facilitating care coordination. The results of this study will provide evidence regarding the efficacy and feasibility of health coaching to improve self-management and quality of life for urban underserved patients with moderate to severe COPD. ClinicalTrials.gov identifier NCT02234284 . Registered 12 August 2014.

Evaluating the impact of patients' online access to doctors' visit notes: designing and executing the OpenNotes project

PubMed Central

2012-01-01

Background Providers and policymakers are pursuing strategies to increase patient engagement in health care. Increasingly, online sections of medical records are viewable by patients though seldom are clinicians' visit notes included. We designed a one-year multi-site trial of online patient accessible office visit notes, OpenNotes. We hypothesized that patients and primary care physicians (PCPs) would want it to continue and that OpenNotes would not lead to significant disruptions to doctors' practices. Methods/Design Using a mixed methods approach, we designed a quasi-experimental study in 3 diverse healthcare systems in Boston, Pennsylvania, and Seattle. Two sites had existing patient internet portals; the third used an experimental portal. We targeted 3 key areas where we hypothesized the greatest impacts: beliefs and attitudes about OpenNotes, use of the patient internet portals, and patient-doctor communication. PCPs in the 3 sites were invited to participate in the intervention. Patients who were registered portal users of participating PCPs were given access to their PCPs' visit notes for one year. PCPs who declined participation in the intervention and their patients served as the comparison groups for the study. We applied the RE-AIM framework to our design in order to capture as comprehensive a picture as possible of the impact of OpenNotes. We developed pre- and post-intervention surveys for online administration addressing attitudes and experiences based on interviews and focus groups with patients and doctors. In addition, we tracked use of the internet portals before and during the intervention. Results PCP participation varied from 19% to 87% across the 3 sites; a total of 114 PCPs enrolled in the intervention with their 22,000 patients who were registered portal users. Approximately 40% of intervention and non-intervention patients at the 3 sites responded to the online survey, yielding a total of approximately 38,000 patient surveys. Discussion Many primary care physicians were willing to participate in this "real world" experiment testing the impact of OpenNotes on their patients and their practices. Results from this trial will inform providers, policy makers, and patients who contemplate such changes at a time of exploding interest in transparency, patient safety, and improving the quality of care. PMID:22500560

Predictors of Abstinence: National Institute of Drug Abuse Multisite Buprenorphine/Naloxone Treatment Trial in Opioid-Dependent Youth

ERIC Educational Resources Information Center

Subramaniam, Geetha A.; Warden, Diane; Minhajuddin, Abu; Fishman, Marc J.; Stitzer, Maxine L.; Adinoff, Bryon; Trivedi, Madhukar; Weiss, Roger; Potter, Jennifer; Poole, Sabrina A.; Woody, George E.

2011-01-01

Objective: To examine predictors of opioid abstinence in buprenorphine/naloxone (Bup/Nal)-assisted psychosocial treatment for opioid-dependent youth. Method: Secondary analyses were performed of data from 152 youth (15-21 years old) randomly assigned to 12 weeks of extended Bup/Nal therapy or up to 2 weeks of Bup/Nal detoxification with weekly…

Psychometric Study of the Aberrant Behavior Checklist in Fragile X Syndrome and Implications for Targeted Treatment

ERIC Educational Resources Information Center

Sansone, Stephanie M.; Widaman, Keith F.; Hall, Scott S.; Reiss, Allan L.; Lightbody, Amy; Kaufmann, Walter E.; Berry-Kravis, Elizabeth; Lachiewicz, Ave; Brown, Elaine C.; Hessl, David

2012-01-01

Animal studies elucidating the neurobiology of fragile X syndrome (FXS) have led to multiple controlled trials in humans, with the Aberrant Behavior Checklist-Community (ABC-C) commonly adopted as a primary outcome measure. A multi-site collaboration examined the psychometric properties of the ABC-C in 630 individuals (ages 3-25) with FXS using…

Impact of Supplemental Site Grants to Increase African-American Accrual for SELECT

PubMed Central

Cook, Elise D.; Arnold, Kathryn B.; Hermos, John A.; McCaskill-Stevens, Worta; Moody-Thomas, Sarah; Probstfield, Jeffrey L.; Hamilton, Sandra J.; Campbell, Russell D.; Anderson, Karen B.; Minasian, Lori M.

2014-01-01

Background Low rates of minority recruitment in prevention studies may reduce the generalizability of study results to minority populations, including African Americans. High African American accrual to prevention studies requires additional resources and focused efforts. Objective To analyze the impact of Minority Recruitment Enhancement Grants (MREGs) on African American recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Results Fifteen of 427 SELECT sites received MREGs after they demonstrated early success in minority recruitment. After receiving the grants, the average monthly rate of African American recruitment at these sites increased from 27.2% to 31.5%, and total average monthly recruitment also increased. Sites that did not receive grants, including sites that did not apply, increased average monthly African American recruitment from 11.0% to 14.6% but declined in total average monthly recruitment. Conclusions and Implications Sites who received MREGs modestly increased both the proportion of African American recruits and total recruits. These results are tempered by the high cost of the intervention, the relatively low number of SELECT sites that applied for the grants and the administrative delays in implementation. Nevertheless, targeted grants may be a useful multi-site intervention to increase African American accrual for a prevention study where adequate African American recruitment is essential. PMID:20156960

Preventing Weight Gain and Obesity: Indirect Effects of the Family Check-Up in Early Childhood

PubMed Central

Smith, Justin D.; Montaño, Zorash; Dishion, Thomas J.; Shaw, Daniel S.; Wilson, Melvin N.

2014-01-01

The early signs of obesity are observable in early childhood. Although the most promising prevention approaches are family centered, few relevant early prevention programs exist. This study evaluated the effects of an evidence-based, home-visiting intervention, the Family Check-Up (FCU), on the trajectory of children’s weight gain. The FCU was designed to prevent the development of behavior problems by improving family management practices; children’s weight has not been an explicit target. On the basis of previous research and conceptual models, we hypothesized that intervention effects on parenting practices, specifically caregivers’ use of positive behavior support (PBS) strategies in toddlerhood, would mediate improvements in children’s weight trajectories. A total of 731 indigent caregiver–child dyads from a multisite randomized intervention trial were examined. Observational assessment of parenting and mealtime behaviors occurred from age 2 to 5. The child’s body mass index (BMI) was assessed yearly from age 5 to 9.5. Path analysis with a latent growth model revealed a significant indirect effect of the FCU on the trajectory of BMI in later childhood. Improvements in caregivers’ PBS in toddlerhood, which was related to the nutritional quality of the meals caregivers served to the child during the mealtime task, served as the intervening process. Further, findings indicate that the FCU prevents progression to overweight and obese status amongst at-risk children. These study results add to existing evidence that has demonstrated that family-based interventions aimed at improving general family management skills are effective at preventing weight gain. Future directions are discussed. PMID:25263212

Women, Co-occurring Disorders, and Violence Study: evaluation design and study population.

PubMed

McHugo, G J; Kammerer, N; Jackson, E W; Markoff, L S; Gatz, M; Larson, M J; Mazelis, R; Hennigan, K

2005-03-01

The Women, Co-occurring Disorders, and Violence Study (WCDVS) was a multi-site cooperative study to evaluate new service models for women with co-occurring mental health and substance use disorders and a history of physical and/or sexual abuse. Despite common features in the service interventions and evaluation procedures, diversity across the nine sites plus differences introduced by non-random assignment led to numerous methodological challenges. This article describes the design, measurement, and analysis decisions behind the WCDVS and lays the foundation for understanding participant-level outcomes and service costs. This article also describes the study population, as recruited and following attrition at the 6-month follow-up, in order to address the threat of selection bias to inferences drawn from this multi-site study.

Effectiveness of the Engagement and Counseling for Latinos (ECLA) Intervention in Low-Income Latinos

PubMed Central

Ludman, Evette; Kafali, Nilay; Lapatin, Sheri; Vila, Doriliz; Shrout, Patrick E.; Keefe, Kristen; Cook, Benjamin; Ault, Andrea; Li, Xinliang; Bauer, Amy; Epelbaum, Claudia; Alcantara, Carmela; Pineda, Tulia Inés Guerra; Tejera, Gloria Gonzalez; Suarez, Gloria; Leon, Karla; Lessios, Anna S.; Ramirez, Rafael R; Canino, Glorisa

2014-01-01

Background Persistent disparities in access and quality of mental health care for Latinos indicate a need for evidence-based, culturally adapted and outside-the-clinic-walls treatments. Objective Evaluate treatment effectiveness of telephone (ECLA –T) or face-to-face (ECLA-F) delivery of a 6–8 session cognitive behavioral therapy and care-management intervention for low-income Latinos, as compared to usual care for depression. Design Multi-site randomized controlled trial. Setting Eight community health clinics in Boston, Massachusetts and San Juan, Puerto Rico. Participants 257 Latino patients recruited from primary care between May 2011 and September 2012. Main Outcome Measures The primary outcome was severity of depression, assessed with the Patient Health Questionnaire-9 (PHQ-9) and the Hopkins Symptom Checklist-20 (HSCL-20). The secondary outcome was functioning over the previous 30 days, measured using the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). Results Both telephone and face-to-face versions of the ECLA were more effective than usual care. The effect sizes of both intervention conditions on PHQ-9 were moderate when combined data from both sites are analyzed (.56 and .64 for face-to-face and telephone, respectively). Similarly, effect sizes of ECLA-F and ECLA-T on the HSCL were quite large in the Boston site (.64 and .73. respectively) but not in Puerto Rico (.10 and .03). Conclusions and Relevance The intervention appears to help Latino patients reduce depressive symptoms and improve functioning. Of particular importance is the higher treatment initiation for the telephone vs. face-to-face intervention (89.7% vs. 78.8%), which suggests that telephone-based care may improve access and quality of care. PMID:25310525

Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence

PubMed Central

Hill, Jonathan C.; Foster, Nadine E.; Protheroe, Joanne

2017-01-01

Background & aims Musculoskeletal pain, the most common cause of disability globally, is most frequently managed in primary care. People with musculoskeletal pain in different body regions share similar characteristics, prognosis, and may respond to similar treatments. This overview aims to summarise current best evidence on currently available treatment options for the five most common musculoskeletal pain presentations (back, neck, shoulder, knee and multi-site pain) in primary care. Methods A systematic search was conducted. Initial searches identified clinical guidelines, clinical pathways and systematic reviews. Additional searches found recently published trials and those addressing gaps in the evidence base. Data on study populations, interventions, and outcomes of intervention on pain and function were extracted. Quality of systematic reviews was assessed using AMSTAR, and strength of evidence rated using a modified GRADE approach. Results Moderate to strong evidence suggests that exercise therapy and psychosocial interventions are effective for relieving pain and improving function for musculoskeletal pain. NSAIDs and opioids reduce pain in the short-term, but the effect size is modest and the potential for adverse effects need careful consideration. Corticosteroid injections were found to be beneficial for short-term pain relief among patients with knee and shoulder pain. However, current evidence remains equivocal on optimal dose, intensity and frequency, or mode of application for most treatment options. Conclusion This review presents a comprehensive summary and critical assessment of current evidence for the treatment of pain presentations in primary care. The evidence synthesis of interventions for common musculoskeletal pain presentations shows moderate-strong evidence for exercise therapy and psychosocial interventions, with short-term benefits only from pharmacological treatments. Future research into optimal dose and application of the most promising treatments is needed. PMID:28640822

Laying the foundation for Connect to Protect: a multi-site community mobilization intervention to reduce HIV/AIDS incidence and prevalence among urban youth.

PubMed

Ziff, Mauri A; Harper, Gary W; Chutuape, Kate S; Deeds, Bethany Griffin; Futterman, Donna; Francisco, Vincent T; Muenz, Larry R; Ellen, Jonathan M

2006-05-01

Despite the considerable resources that have been dedicated to HIV prevention interventions and services over the past decade, HIV incidence among young people in the United States remains alarmingly high. One reason is that the majority of prevention efforts continue to focus solely on modifying individual behavior, even though public health research strongly suggests that changes to a community's structural elements, such as their programs, practices, and laws or policies, may result in more effective and sustainable outcomes. Connect to Protect is a multi-city community mobilization intervention that focuses on altering or creating community structural elements in ways that will ultimately reduce youth HIV incidence and prevalence. The project, which spans 6 years, is sponsored by the Adolescent Medicine Trials Network for HIV/AIDS Interventions at multiple urban clinical research sites. This paper provides an overview of the study's three phases and describes key factors in setting a firm foundation for the initiation and execution of this type of undertaking. Connect to Protect's community mobilization approach to achieving structural change represents a relatively new and broad direction in HIV prevention research. To optimize opportunities for its success, time and resources must be initially placed into laying the groundwork. This includes activities such as building a strong overarching study infrastructure to ensure protocol tasks can be met across sites; tapping into local site and community expertise and knowledge; forming collaborative relationships between sites and community organizations and members; and fostering community input on and support for changes at a structural level. Failing to take steps such as these may lead to insurmountable implementation problems for an intervention of this kind.

Recent Internet Use and Associations with Clinical Outcomes among Patients Entering Addiction Treatment Involved in a Web-Delivered Psychosocial Intervention Study.

PubMed

Tofighi, B; Campbell, A N C; Pavlicova, M; Hu, M C; Lee, J D; Nunes, E V

2016-10-01

The acceptability and clinical impact of a web-based intervention among patients entering addiction treatment who lack recent internet access are unclear. This secondary analysis of a national multisite treatment study (NIDA Clinical Trials Network-0044) assessed for acceptability and clinical impact of a web-based psychosocial intervention among participants enrolling in community-based, outpatient addiction treatment programs. Participants were randomly assigned to 12 weeks of a web-based therapeutic education system (TES) based on the community reinforcement approach plus contingency management versus treatment as usual (TAU). Demographic and clinical characteristics, and treatment outcomes were compared among participants with recent internet access in the 90 days preceding enrollment (N = 374) and without internet access (N = 133). Primary outcome variables included (1) acceptability of TES (i.e., module completion; acceptability of web-based intervention) and (2) clinical impact (i.e., self-reported abstinence confirmed by urine drug/breath alcohol tests; retention measured as time to dropout). Internet use was common (74 %) and was more likely among younger (18-49 years old) participants and those who completed high school (p < .001). Participants randomized to TES (n = 255) without baseline internet access rated the acceptability of TES modules significantly higher than those with internet access (t = 2.49, df = 218, p = .01). There was a near significant interaction between treatment, baseline abstinence, and internet access on time to dropout (χ 2 (1) = 3.8089, p = .051). TES was associated with better retention among participants not abstinent at baseline who had internet access (X 2 (1) = 6.69, p = .01). These findings demonstrate high acceptability of this web-based intervention among participants that lacked recent internet access.

The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From Three Multisite Studies With Adolescents and Adults

PubMed Central

Posner, Kelly; Brown, Gregory K.; Stanley, Barbara; Brent, David A.; Yershova, Kseniya V.; Oquendo, Maria A.; Currier, Glenn W.; Melvin, Glenn A.; Greenhill, Laurence; Shen, Sa; Mann, J. John

2013-01-01

Objective Research on suicide prevention and interventions requires a standard method for assessing both suicidal ideation and behavior to identify those at risk and to track treatment response. The Columbia–Suicide Severity Rating Scale (C-SSRS) was designed to quantify the severity of suicidal ideation and behavior. The authors examined the psychometric properties of the scale. Method The C-SSRS’s validity relative to other measures of suicidal ideation and behavior and the internal consistency of its intensity of ideation subscale were analyzed in three multisite studies: a treatment study of adolescent suicide attempters (N=124); a medication efficacy trial with depressed adolescents (N=312); and a study of adults presenting to an emergency department for psychiatric reasons (N=237). Results The C-SSRS demonstrated good convergent and divergent validity with other multi-informant suicidal ideation and behavior scales and had high sensitivity and specificity for suicidal behavior classifications compared with another behavior scale and an independent suicide evaluation board. Both the ideation and behavior subscales were sensitive to change over time. The intensity of ideation subscale demonstrated moderate to strong internal consistency. In the adolescent suicide attempters study, worst-point lifetime suicidal ideation on the C-SSRS predicted suicide attempts during the study, whereas the Scale for Suicide Ideation did not. Participants with the two highest levels of ideation severity (intent or intent with plan) at baseline had higher odds for attempting suicide during the study. Conclusions These findings suggest that the C-SSRS is suitable for assessment of suicidal ideation and behavior in clinical and research settings. PMID:22193671

Bottom-up implementation of disease-management programmes: results of a multisite comparison.

PubMed

Lemmens, K M M; Nieboer, A P; Rutten-Van Mölken, M P M H; van Schayck, C P; Spreeuwenberg, C; Asin, J D; Huijsman, R

2011-01-01

To evaluate the implementation of three regional disease-management programmes on chronic obstructive pulmonary disease (COPD) based on bottlenecks experienced in professional practice. The authors performed a multisite comparison of three Dutch regional disease-management programmes combining patient-related, professional-directed and organisational interventions. Process (Assessing Chronic Illness Care survey) and outcome (disease specific quality of life (clinical COPD questionnaire (CCQ); chronic respiratory questionnaire (CRQ)), Medical Research Council dyspnoea and patients' experiences) data were collected for 370 COPD patients and their care providers. Bottlenecks in region A were mostly related to patient involvement, in region B to organisational issues and in region C to both. Selected interventions related to identified bottlenecks were implemented in all programmes, except for patient-related interventions in programme A. Within programmes, significant improvements were found on dyspnoea and patients' experiences with practice nurses. Outcomes on quality of life differed between programmes: programme A did not show any significant improvements; programme B did show any significant improvements on CCQ total (p<0.001), functional (p=0.011) and symptom (p<0.001), CRQ fatigue (p<0.001) and emotional scales (p<0.001); in programme C, CCQ symptom (p<0.001) improved significantly, whereas CCQ mental score (p<0.001) deteriorated significantly. Regression analyses showed that programmes with better implementation of selected interventions resulted in relatively larger improvements in quality of life (CCQ). Bottom-up implementation of COPD disease-management programmes is a feasible approach, which in multiple settings leads to significant improvements in outcomes of care. Programmes with a better fit between implemented interventions and bottlenecks showed more positive changes in outcomes.

Planning a multi-site, complex intervention for homeless people with mental illness: the relationships between the national team and local sites in Canada's At Home/Chez Soi project.

PubMed

Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula; Dudley, Michael; O'Campo, Patricia; Patterson, Michelle; Piat, Myra; Prévost, Natasha; Strehlau, Verena; Vallée, Catherine

2013-06-01

This research focused on the relationships between a national team and five project sites across Canada in planning a complex, community intervention for homeless people with mental illness called At Home/Chez Soi, which is based on the Housing First model. The research addressed two questions: (a) what are the challenges in planning? and (b) what factors that helped or hindered moving project planning forward? Using qualitative methods, 149 national, provincial, and local stakeholders participated in key informant or focus group interviews. We found that planning entails not only intervention and research tasks, but also relational processes that occur within an ecology of time, local context, and values. More specifically, the relationships between the national team and the project sites can be conceptualized as a collaborative process in which national and local partners bring different agendas to the planning process and must therefore listen to, negotiate, discuss, and compromise with one another. A collaborative process that involves power-sharing and having project coordinators at each site helped to bridge the differences between these two stakeholder groups, to find common ground, and to accomplish planning tasks within a compressed time frame. While local context and culture pushed towards unique adaptations of Housing First, the principles of the Housing First model provided a foundation for a common approach across sites and interventions. The implications of the findings for future planning and research of multi-site, complex, community interventions are noted.

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.

PubMed

Johnson, Liam; Bird, Marie-Louise; Muthalib, Makii; Teo, Wei-Peng

2018-01-09

The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors. In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention. The study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings. ACTRN12617000745347; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Effects of Collaborative Strategic Reading Instruction on the Reading Comprehension of Middle School Students: Year 1

ERIC Educational Resources Information Center

Mohammed, Sarojani S.; Swanson, Elizabeth; Roberts, Greg; Vaughn, Sharon; Klingner, Janette K.; Boardman, Alison Gould

2010-01-01

This project is a multi-site, multi-year study designed to test the efficacy of a fully developed intervention, Collaborative Strategic Reading (CSR), with adolescent readers. In year 1, the research questions were: (1) "Does CSR improve reading comprehension for adolescent readers attending relatively low SES schools?"; and (2)…

Striving for Effectiveness in the Treatment of Adolescent Depression: Cognitive Behavior Therapy for Multisite Community Intervention

ERIC Educational Resources Information Center

Curry, John F.; Wells, Karen C.

2005-01-01

The Treatment for Adolescents With Depression Study (TADS) was designed to compare the relative and combined effectiveness of cognitive behavior therapy (CBT) and fluoxetine, each of which had demonstrated efficacy in carefully controlled single-site studies. Models of CBT from these efficacy studies served as the foundation for the TADS…

Model Programs to Address Obesity and Cardiometabolic Disease: Interventions for Suboptimal Nutrition and Sedentary Lifestyles.

PubMed

Nash, Mark S; Kressler, Jochen

2016-09-01

Problems posed by obesity-related endocrine diseases embody a national health crisis. Caloric excess and sedentary lifestyle from which they develop also pose significant challenges for rehabilitation providers. Almost two thirds of the U.S. population are currently overweight or obese, a number that has increased by >10% within the last decade and is expected to grow. An overweight body habitus is strongly associated with clinical hazards, including cardiometabolic syndrome, diabetes hypertension, and coronary artery disease. The component health risks of the cardiometabolic syndrome include coalescing of risk factors that predict a health calamity unless effective interventions can be developed and widely adopted. Obesity by itself is now considered an American Diabetes Association-qualified disability, but it is also disturbingly prevalent in other physical disability groupings of adults and children. This monograph describes successes of the Diabetes Prevention Program (DPP), a National Institutes of Health multisite randomized controlled trial that reported significant weight reduction and a 58% decreased incidence of type-2 diabetes accompanying 1 year of structured lifestyle intervention. This treatment benefit (1) exceeded that of metformin pharmacotherapy, (2) was so powerful that the trial was closed before reaching endpoints, and (3) was judged cost-effective for the patient and society. The DPP roadmap incorporating physical activity, diet, and behavioral approaches has been widely adapted to specific community, faith, racial, ethnic, school, and national populations with excellent outcomes success. The lockstep physical activity approach, activity prescription, and long-term success of the program are described and compared with other programs to illustrate effective countermeasures for the pandemics of obesity and obesity-related cardioendocrine disease. We will illustrate adaptation of the DPP for a cohort of persons with disability from spinal cord injury and the benefits observed. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The effects of housing stability on service use among homeless adults with mental illness in a randomized controlled trial of housing first.

PubMed

Kerman, Nick; Sylvestre, John; Aubry, Tim; Distasio, Jino

2018-03-20

Housing First is an effective intervention to stably house and alter service use patterns in a large proportion of homeless people with mental illness. However, it is unknown whether there are differences in the patterns of service use over time among those who do or do not become stably housed and what effect, if any, Housing First has on these differing service use patterns. This study explored changes in the service use of people with mental illness who received Housing First compared to standard care, and how patterns of use differed among people who did and did not become stably housed. The study design was a multi-site randomized controlled trial of Housing First, a supported housing intervention. 2039 participants (Housing First: n = 1131; standard care: n = 908) were included in this study. Outcome variables include nine types of self-reported service use over 24 months. Linear mixed models examined what effects the intervention and housing stability had on service use. Participants who achieved housing stability, across the two groups, had decreased use of inpatient psychiatric hospitals and increased use of food banks. Within the Housing First group, unstably housed participants spent more time in prison over the study period. The Housing First and standard care groups both had decreased use of emergency departments and homeless shelters. The temporal service use changes that occurred as homeless people with mental illness became stably housed are similar for those receiving Housing First or standard care, with the exception of time in prison. Service use patterns, particularly with regard to psychiatric hospitalizations and time in prison, may signify persons who are at-risk of recurrent homelessness. Housing support teams should be alert to the impacts of stay-based services, such as hospitalizations and incarcerations, on housing stability and offer an increased level of support to tenants during critical periods, such as discharges. ISRCTN. ISRCTN42520374 . Registered 18 August 2009.

Variability of acute extracellular action potential measurements with multisite silicon probes

PubMed Central

Scott, Kimberly M.; Du, Jiangang; Lester, Henry A.; Masmanidis, Sotiris C.

2012-01-01

Device miniaturization technologies have led to significant advances in sensors for extracellular measurements of electrical activity in the brain. Multisite, silicon-based probes containing implantable electrode arrays afford greater coverage of neuronal activity than single electrodes and therefore potentially offer a more complete view of how neuronal ensembles encode information. However, scaling up the number of sites is not sufficient to ensure capture of multiple neurons, as action potential signals from extracellular electrodes may vary due to numerous factors. In order to understand the large-scale recording capabilities and potential limitations of multisite probes, it is important to quantify this variability, and to determine whether certain key device parameters influence the recordings. Here we investigate the effect of four parameters, namely, electrode surface, width of the structural support shafts, shaft number, and position of the recording site relative to the shaft tip. This study employs acutely implanted silicon probes containing up to 64 recording sites, whose performance is evaluated by the metrics of noise, spike amplitude, and spike detection probability. On average, we find no significant effect of device geometry on spike amplitude and detection probability but we find significant differences among individual experiments, with the likelihood of detecting spikes varying by a factor of approximately three across trials. PMID:22971352

Pre-Visit Prioritization for Complex Patients with Diabetes: Randomized Trial Design and Implementation within an Integrated Health Care System

PubMed Central

Grant, Richard W; Uratsu, Connie S; Hansen, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-01-01

Background/Aims Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. Methods We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. Results This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015 – 6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) Navigating research vs. quality improvement requirements; (2) Addressing informed consent considerations; and (3) Introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for “self-learning health system” research. Conclusions By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. PMID:26820612

Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system.

PubMed

Grant, Richard W; Uratsu, Connie S; Estacio, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-03-01

Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015-6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) navigating research vs. quality improvement requirements; (2) addressing informed consent considerations; and (3) introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for "self-learning health system" research. By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. Copyright © 2016 Elsevier Inc. All rights reserved.

Augmenting cognitive training in older adults (The ACT Study): Design and Methods of a Phase III tDCS and cognitive training trial.

PubMed

Woods, Adam J; Cohen, Ronald; Marsiske, Michael; Alexander, Gene E; Czaja, Sara J; Wu, Samuel

2018-02-01

Adults over age 65 represent the fastest growing population in the US. Decline in cognitive abilities is a hallmark of advanced age and is associated with loss of independence and dementia risk. There is a pressing need to develop effective interventions for slowing or reversing the cognitive aging process. While certain forms of cognitive training have shown promise in this area, effects only sometimes transfer to neuropsychological tests within or outside the trained domain. This paper describes a NIA-funded Phase III adaptive multisite randomized clinical trial, examining whether transcranial direct current stimulation (tDCS) of frontal cortices enhances neurocognitive outcomes achieved from cognitive training in older adults experiencing age-related cognitive decline: the Augmenting Cognitive Training in Older Adults study (ACT). ACT will enroll 360 participants aged 65 to 89 with age-related cognitive decline, but not dementia. Participants will undergo cognitive training intervention or education training-control combined with tDCS or sham tDCS control. Cognitive training employs a suite of eight adaptive training tasks focused on attention/speed of processing and working memory from Posit Science BrainHQ. Training control involves exposure to educational nature/history videos and related content questions of the same interval/duration as the cognitive training. Participants are assessed at baseline, after training (12weeks), and 12-month follow-up on our primary outcome measure, NIH Toolbox Fluid Cognition Composite Score, as well as a comprehensive neurocognitive, functional, clinical and multimodal neuroimaging battery. The findings from this study have the potential to significantly enhance efforts to ameliorate cognitive aging and slow dementia. Copyright © 2017 Elsevier Inc. All rights reserved.

Coping strategies as a mediator of internet-delivered psychosocial treatment: Secondary analysis from a NIDA CTN multisite effectiveness trial.

PubMed

Lévesque, Annie; Campbell, Aimee N C; Pavlicova, Martina; Hu, Mei-Chen; Walker, Robrina; McClure, Erin A; Ghitza, Udi E; Bailey, Genie; Stitzer, Maxine; Nunes, Edward V

2017-02-01

Coping strategies are a predictor of abstinence among patients with substance use disorders. However, little is known regarding the role of coping strategies in the effectiveness of the Community Reinforcement Approach (CRA). Using data from a 12week randomized control trial assessing the effectiveness of the Therapeutic Education System (TES), an internet-delivered version of the CRA combined with contingency management, we tested the role of coping strategies as a mediator of treatment effectiveness. 507 participants entering 10 outpatient addiction treatment programs received either treatment-as-usual (TAU), a counselor-delivered treatment (Arm 1), or reduced TAU plus TES wherein 2h of TAU per week were replaced by TES (Arm 2). Abstinence from drugs and alcohol was evaluated using urine toxicology and self-report. Coping strategies were measured using the Coping Strategies Scale-Brief Version. Mediation analyses were done following Baron and Kenny's and path analysis approaches. The average baseline coping strategies scores were not significantly different between the two treatment arms. Overall, TES intervention was significantly associated with higher coping strategies scores when accounting for baseline scores (F 1,1342 =8.3, p=0.004). Additionally, higher coping strategies scores at week 12 were associated with an increased likelihood of abstinence during the last 4weeks of the treatment, while accounting for treatment assignment and baseline abstinence. The effect of TES intervention on abstinence was no longer significant after controlling for coping strategies scores at week 12. Our results support the importance of coping skills as a partial mediator of the effectiveness of an internet-version of the CRA combined with contingency management. Copyright © 2016. Published by Elsevier Ltd.

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

PubMed

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

Telemedicine with clinical decision support for critical care: a systematic review.

PubMed

Mackintosh, Nicola; Terblanche, Marius; Maharaj, Ritesh; Xyrichis, Andreas; Franklin, Karen; Keddie, Jamie; Larkins, Emily; Maslen, Anna; Skinner, James; Newman, Samuel; De Sousa Magalhaes, Joana Hiew; Sandall, Jane

2016-10-18

Telemedicine applications aim to address variance in clinical outcomes and increase access to specialist expertise. Despite widespread implementation, there is little robust evidence about cost-effectiveness, clinical benefits, and impact on quality and safety of critical care telemedicine. The primary objective was to determine the impact of critical care telemedicine (with clinical decision support available 24/7) on intensive care unit (ICU) and hospital mortality and length of stay in adults and children. The secondary objectives included staff and patient experience, costs, protocol adherence, and adverse events. Data sources included MEDLINE, EMBASE, CINAHL, Cochrane Library databases, Health Technology Assessment Database, Web of Science, OpenGrey, OpenDOAR, and the HMIC through to December 2015. Randomised controlled trials and quasi-experimental studies were eligible for inclusion. Eligible studies reported on differences between groups using the telemedicine intervention and standard care. Two review authors screened abstracts and assessed potentially eligible studies using Cochrane guidance. Two controlled before-after studies met the inclusion criteria. Both were assessed as high risk of bias. Meta-analysis was not possible as we were unable to disaggregate data between the two studies. One study used a non-randomised stepped-wedge design in seven ICUs. Hospital mortality was the primary outcome which showed a reduction from 13.6 % (CI, 11.9-15.4 %) to 11.8 % (CI, 10.9-12.8 %) during the intervention period with an adjusted odds ratio (OR) of 0.40 (95 % CI, 0.31-0.52; p = .005). The second study used a non-randomised, unblinded, pre-/post-assessment of telemedicine interventions in 56 adult ICUs. Hospital mortality (primary outcome) reduced from 11 to 10 % (adjusted hazard ratio (HR) = 0.84; CI, 0.78-0.89; p = <.001). This review highlights the poor methodological quality of most studies investigating critical care telemedicine. The results of the two included studies showed a reduction in hospital mortality in patients receiving the intervention. Further multi-site randomised controlled trials or quasi-experimental studies with accompanying process evaluations are urgently needed to determine effectiveness, implementation, and associated costs. PROSPERO CRD42014007406.

Treatment of chronically depressed patients: A multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) for chronic depressions versus usual secondary care

PubMed Central

Wiersma, Jenneke E; van Schaik, Digna JF; van Oppen, Patricia; McCullough, James P; Schoevers, Robert A; Dekker, Jack J; Blom, Marc BJ; Maas, Kristel; Smit, Johannes H; Penninx, Brenda WJH; Beekman, Aartjan TF

2008-01-01

Background 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) is a form of psychotherapy specifically developed for patients with chronic depression. In a study in the U.S., remarkable favorable effects of CBASP have been demonstrated. However, no other studies have as yet replicated these findings and CBASP has not been tested outside the United States. This protocol describes a randomized controlled trial on the effectiveness of CBASP in the Netherlands. Methods/Design The purpose of the present paper is to report the study protocol of a multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) for chronic depression in the Netherlands. In this study, CBASP in combination with medication, will be tested versus usual secondary care in combination with medication. The aim is to recruit 160 patients from three mental health care organizations. Depressive symptoms will be assessed at baseline, after 8 weeks, 16 weeks, 32 weeks and 52 weeks, using the 28-item Inventory for Depressive Symptomatology (IDS). Effect modification by co morbid anxiety, alcohol consumption, general and social functioning and working alliance will be tested. GEE analyses of covariance, controlling for baseline value and center will be used to estimate the overall treatment effectiveness (difference in IDS score) at post-treatment and follow up. The primary analysis will be by 'intention to treat' using double sided tests. An economic analysis will compare the two groups in terms of mean costs and cost-effectiveness from a societal perspective. Discussion The study will provide an answer to the question whether the favorable effects of CBASP can be replicated outside the US. Trial Registration The Dutch Cochrane Center, NTR1090. PMID:18366729

Global Health Diplomacy, Monitoring & Evaluation, and the Importance of Quality Assurance & Control: Findings from NIMH Project Accept (HPTN 043): A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand.

PubMed

Kevany, Sebastian; Khumalo-Sakutukwa, Gertrude; Singh, Basant; Chingono, Alfred; Morin, Stephen

2016-01-01

Provision and scale-up of high quality, evidence-based services is essential for successful international HIV prevention interventions in order to generate and maintain intervention uptake, study integrity and participant trust, from both health service delivery and diplomatic perspectives. We developed quality assurance (QAC) procedures to evaluate staff fidelity to a cluster-randomized trial of the NIMH Project Accept (HPTN 043) assessing the effectiveness of a community-based voluntary counseling and testing strategy. The intervention was comprised of three components-Mobile Voluntary Counseling and Testing (MVCT), Community Mobilization (CM) and Post-Test Support Services (PTSS). QAC procedures were based on standardized criteria, and were designed to assess both provider skills and adherence to the intervention protocol. Supervisors observed a random sample of 5% to 10% of sessions each month and evaluated staff against multiple criteria on scales of 1-5. A score of 5 indicated 100% adherence, 4 indicated 95% adherence, and 3 indicated 90% adherence. Scores below 3 were considered unsatisfactory, and protocol deviations were discussed with the respective staff. During the first year of the intervention, the mean scores of MVCT and CM staff across the 5 study sites were 4 (95% adherence) or greater and continued to improve over time. Mean QAC scores for the PTSS component were lower and displayed greater fluctuations. Challenges to PTSS staff were identified as coping with the wide range of activities in the PTSS component and the novelty of the PTSS process. QAC fluctuations for PTSS were also associated with new staff hires or changes in staff responsibilities. Through constant staff monitoring and support, by Year 2, QAC scores for PTSS activities had reached those of MVCT and CM. The implementation of a large-sale, evidence based HIV intervention requires extensive QAC to ensure implementation effectiveness. Ongoing appraisal of study staff across sites ensures consistent and high quality delivery of all intervention components, in keeping with the goals of the study protocol, while also providing a forum for corrective feedback, additional supervision and retraining of staff. QAC ensures staff fidelity to study procedures and is critical to the successful delivery of multi-site HIV prevention interventions, as well as the delivery of services scaled up in programmatic situations.

Measuring economic outcomes of alcohol treatment using the Economic Form 90.

PubMed

Bray, Jeremy W; Zarkin, Gary A; Miller, William R; Mitra, Debanjali; Kivlahan, Daniel R; Martin, Daniel J; Couper, David J; Cisler, Ron A

2007-03-01

This article assesses the ability of the economic outcome measures in the Economic Form 90 to detect differences across levels of alcohol dependence as measured by the Alcohol Dependence Scale. We used baseline data from the Combining Medications and Behavioral Interventions (COMBINE) Study, a large, multisite clinical trial, to assess the extent to which the economic items on the Economic Form 90 instrument can detect differences across levels of alcohol dependence. After adjusting for differences in demographic characteristics, the Economic Form 90 can detect significant differences across a range of dependence severity levels for the economic outcomes of inpatient medical care, emergency-department medical care, behavioral health care, being on parole or probation, and missed workdays, conditional on being employed. We did not detect significant differences across dependence severity for employment status, outpatient medical care, other criminal justice involvement, or motor vehicle accidents. The Economic Form 90 can identify differences in many economic outcomes associated with differing levels of alcohol dependence. This suggests that the Economic Form 90 may be useful in assessing changes in economic outcomes that result from changes in alcohol dependence.

A Comparison of Two Internet Programs for Adolescents with Type 1 Diabetes: Design and Methods

PubMed Central

Grey, Margaret; Whittemore, Robin; Liberti, Lauren; Delamater, Alan; Murphy, Kathryn; Faulkner, Melissa S.

2012-01-01

Implementing psycho-educational programs for youth with type 1 diabetes in clinical care and reaching diverse youth with type 1 diabetes is challenging due to youth, provider, and organizational barriers. This study was designed to compare the effectiveness of an internet coping skills training program with a control condition of internet diabetes education. Each program consists of 5 weekly interactive lessons; the coping skills training program also provides the ability for youth to interact with each other as well as a health coach. Approximately 300 youth with type 1 diabetes will be recruited to participate in this multi-site clinical trial. The primary outcomes are metabolic control, quality of life, and family conflict. Secondary outcomes include stress, coping, self-efficacy, and social competence. Usage, satisfaction, and cost will also be evaluated. In addition, mediators and moderators to intervention effects will be explored. An internet based psycho-educational program for youth with type 1 diabetes may be a promising approach that can be easily be integrated into clinical care. PMID:22484337

Sexual Health Transformation among College Student Educators in an Arts-Based HIV Prevention Intervention: A Qualitative Cross-Site Analysis

ERIC Educational Resources Information Center

Dunlap, Shannon L.; Taboada, Arianna; Merino, Yesenia; Heitfeld, Suzanne; Gordon, Robert J.; Gere, David; Lightfoot, Alexandra F.

2017-01-01

We examined the sexual health change process experienced by 26 college student sexual health educators from three geographic regions of the United States who participated in a multisite arts-based sexual health prevention program. We conducted eight focus groups and used a phenomenological approach to analyze data. We drew from social cognitive…

Key Principles in Providing Integrated Behavioral Health Services for Young Children and Their Families: The "Starting Early Starting Smart" Experience.

ERIC Educational Resources Information Center

Hanson, Lori, Comp.; Deere, David, Comp.; Lee, Carol Amundson, Comp.; Lewin, Amy, Comp.; Seval, Carolyn, Comp.

This paper describes the Starting Early Starting Smart (SESS) project, an early intervention program that has been developed in the context of the national, multi-site program and evaluation. The emphasis in SESS is on the integration of behavioral health services into easily accessible, non-threatening settings where caregivers naturally and…

Quantifying Variation in Head Start Effects on Young Children's Cognitive and Socio-Emotional Skills Using Data from the National Head Start Impact Study

ERIC Educational Resources Information Center

Bloom, Howard S.; Weiland, Christina

2015-01-01

This paper uses data from the Head Start Impact Study (HSIS), a nationally representative multisite randomized trial, to quantify variation in effects of Head Start during 2002-2003 on children's cognitive and socio-emotional outcomes relative to the effects of other local alternatives, including parent care. We find that (1) treatment and control…

Preventing Serious Conduct Problems in School-Age Youths: The Fast Track Program

PubMed Central

Slough, Nancy M.; McMahon, Robert J.; Bierman, Karen L.; Coie, John D.; Dodge, Kenneth A.; Foster, E. Michael; Greenberg, Mark T.; Lochman, John E.; McMahon, Robert J.; Pinderhughes, Ellen E.

2009-01-01

Children with early-starting conduct Problems have a very poor prognosis and exact a high cost to society. The Fast Track project is a multisite, collaborative research project investigating the efficacy of a comprehensive, long-term, multicomponent intervention designed to prevent the development of serious conduct problems in high-risk children. In this article, we (a) provide an overview of the development model that serves as the conceptual foundation for the Fast Track intervention and describe its integration into the intervention model; (b) outline the research design and intervention model, with an emphasis on the elementary school phase of the intervention; and (c) summarize findings to dale concerning intervention outcomes. We then provide a case illustration, and conclude with a discussion of guidelines for practitioners who work with children with conduct problems. PMID:19890487

The burden of healthcare-associated Clostridium difficile infection in a non-metropolitan setting.

PubMed

Bond, S E; Boutlis, C S; Yeo, W W; Pratt, W A B; Orr, M E; Miyakis, S

2017-04-01

Healthcare-associated Clostridium difficile infection (HCA-CDI) remains a major cause of morbidity and mortality in industrialized countries. However, few data exist on the burden of HCA-CDI in multi-site non-metropolitan settings. This study examined the introduction of an antimicrobial stewardship programme (ASP) in relation to HCA-CDI rates, and the effect of HCA-CDI on length of stay (LOS) and hospital costs. A comparative before-and-after intervention study of patients aged ≥16 years with HCA-CDI from December 2010 to April 2016 across the nine hospitals of a non-metropolitan health district in New South Wales, Australia was undertaken. The intervention comprised a multi-site ASP supported by a clinical decision support system, with subsequent introduction of email feedback of HCA-CDI cases to admitting medical officers. HCA-CDI rates, comparative LOS and hospital costs, prior use of antimicrobials and proton pump inhibitors, and appropriateness of CDI treatment. HCA-CDI rates rose from 3.07 to 4.60 cases per 10,000 occupied bed-days pre-intervention, and remained stable at 4 cases per 10,000 occupied bed-days post-intervention (P=0.24). Median LOS (17 vs six days; P<0.01) and hospital costs (AU$19,222 vs $7861; P<0.01) were significantly greater for HCA-CDI cases (N=91) than for matched controls (N=172). Half of the patients with severe HCA-CDI (4/8) did not receive initial appropriate treatment (oral vancomycin). HCA-CDI placed a significant burden on the regional and rural health service through increased LOS and hospital costs. Interventions targeting HCA-CDI could be employed to consolidate the effects of ASPs. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Assessing change in perceived community leadership readiness in the Obesity Prevention and Lifestyle program.

PubMed

Kostadinov, Iordan; Daniel, Mark; Jones, Michelle; Cargo, Margaret

2016-02-01

Issue addressed The context of community-based childhood obesity prevention programs can influence the effects of these intervention programs. Leadership readiness for community mobilisation for childhood obesity prevention is one such contextual factor. This study assessed perceived community leadership readiness (PCLR) at two time points in a state-wide, multisite community-based childhood obesity prevention program. Methods PCLR was assessed across 168 suburbs of 20 intervention communities participating in South Australia's Obesity Prevention and Lifestyle (OPAL) program. Using a validated online PCLR tool, four key respondents from each community rated each suburb within their respective community on a nine-point scale for baseline and 2015. Average PCLR and change scores were calculated using the general linear model with suburbs nested in communities. Relationships between demographic variables and change in PCLR were evaluated using multiple regression. Ease of survey use was also assessed. Results Average PCLR increased between baseline (3.51, s.d.=0.82) and 2015 (5.23, s.d.=0.89). PCLR rose in 18 of 20 intervention communities. PCLR was inversely associated with suburb population size (r 2 =0.03, P=0.03, β=-0.25) and positively associated with intervention duration (r 2 change=0.08, P=0.00, β=0.29). Only 8% of survey respondents considered the online assessment tool difficult to use. Conclusions PCLR increased over the course of the OPAL intervention. PCLR varied between and within communities. Online assessment of PCLR has utility for multisite program evaluations. So what? Use of a novel, resource-efficient online tool to measure the key contextual factors of PCLR has enabled a better understanding of the success and generalisability of the OPAL program.

Successful ingredients in the SMILE study: resident, staff, and management factors influence the effects of humor therapy in residential aged care.

PubMed

Brodaty, Henry; Low, Lee-Fay; Liu, Zhixin; Fletcher, Jennifer; Roast, Joel; Goodenough, Belinda; Chenoweth, Lynn

2014-12-01

To test the hypothesis that individual and institutional-level factors influence the effects of a humor therapy intervention on aged care residents. Data were from the humor therapy group of the Sydney Multisite Intervention of LaughterBosses and ElderClowns, or SMILE, study, a single-blind cluster randomized controlled trial of humor therapy conducted over 12 weeks; assessments were performed at baseline, week 13, and week 26. One hundred eighty-nine individuals from 17 Sydney residential aged care facilities were randomly allocated to the humor therapy intervention. Professional performers called "ElderClowns" provided 9-12 weekly humor therapy 2-hour sessions, augmented by trained staff, called "LaughterBosses." Outcome measures were as follows: Cornell Scale for Depression in Dementia, Cohen-Mansfield Agitation Inventory, Neuropsychiatric Inventory, the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and proxy-rated quality of life in dementia population scale. Facility-level measures were as follows: support of the management for the intervention, commitment levels of LaughterBosses, Environmental Audit Tool scores, and facility level of care provided (high/low). Resident-level measures were engagement, functional ability, disease severity, and time-in-care. Multilevel path analyses simultaneously modeled resident engagement at the individual level (repeated measures) and the effects of management support and staff commitment to humor therapy at the cluster level. Models indicated flow-on effects, whereby management support had positive effects on LaughterBoss commitment, and LaughterBoss commitment increased resident engagement. Higher resident engagement was associated with reduced depression, agitation, and neuropsychiatric scores. Effectiveness of psychosocial programs in residential aged care can be enhanced by management support, staff commitment, and active resident engagement. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Pre-Implementation Strategies to Adapt and Implement a Veteran Peer Coaching Intervention to Improve Mental Health Treatment Engagement Among Rural Veterans.

PubMed

Koenig, Christopher J; Abraham, Traci; Zamora, Kara A; Hill, Coleen; Kelly, P Adam; Uddo, Madeline; Hamilton, Michelle; Pyne, Jeffrey M; Seal, Karen H

2016-09-01

Telephone motivational coaching has been shown to increase urban veteran mental health treatment initiation. However, no studies have tested telephone motivational coaching delivered by veteran peers to facilitate mental health treatment initiation and engagement. This study describes pre-implementation strategies with 8 Veterans Affairs (VA) community-based outpatient clinics in the West and Mid-South United States to adapt and implement a multisite pragmatic randomized controlled trial of telephone peer motivational coaching for rural veterans. We used 2 pre-implementation strategies, Formative Evaluation (FE) research and Evidence-Based Quality Improvement (EBQI) meetings to adapt the intervention to stakeholders' needs and cultural contexts. FE data were qualitative, semi-structured interviews with rural veterans and VA clinic staff. Results were rapidly analyzed and presented to stakeholders during EBQI meetings to optimize the intervention implementation. FE research results showed that VA clinic providers felt overwhelmed by veterans' mental health needs and acknowledged limited mental health services at VA clinics. Rural veteran interviews indicated geographical, logistical, and cultural barriers to VA mental health treatment initiation and a preference for self-care to cope with mental health symptoms. EBQI meetings resulted in several intervention adaptations, including veteran study recruitment, peer veteran coach training, and an expanded definition of mental health care outcomes. As the VA moves to cultivate community partnerships in order to personalize and expand access to care for rural veterans, pre-implementation processes with engaged stakeholders, such as those described here, can help guide other researchers and clinicians to achieve proactive and veteran-centered health care services. © 2016 National Rural Health Association.

Internet-delivered Treatment for Substance Abuse: A Multi-site Randomized Controlled Clinical Trial

PubMed Central

Campbell, Aimee N. C.; Nunes, Edward V.; Matthews, Abigail G.; Stitzer, Maxine; Miele, Gloria M.; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A.; Kyle, Tiffany L.; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E.

2014-01-01

Objective Drug and alcohol abuse constitutes a major public health problem. Computer-delivered interventions have potential to improve access to quality care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System, an internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Method Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to 12-weeks of treatment-as-usual (n=252) or treatment-as-usual + Therapeutic Education System, whereby the intervention substituted for 2 hours of standard care per week (n=255). Therapeutic Education System consists of 62 computer-interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment-as-usual consisted of individual and group counseling at the participating programs. Primary outcomes were (1) abstinence from drugs and heavy drinking measured by twice weekly urine drug screens and self-report, and (2) time to drop-out from treatment. Results Compared to treatment-as-usual, those receiving Therapeutic Education System reduced dropout from treatment (Hazard Ratio=0.72 [95% CI, 0.57-0.92], P=.010), and increased abstinence (Odds Ratio=1.62 [95% CI: 1.12-2.35], P=.010), an effect that was more pronounced among patients with a positive urine drug and/or breath alcohol screen at the point of study entry (n=228) (Odds Ratio=2.18 [95% CI: 1.30-3.68], P=.003). Conclusion Internet-delivered interventions, such as Therapeutic Education System, have the potential to expand access and improve addiction treatment outcomes; additional research is needed to assess effectiveness in non-specialty clinical systems and to differentiate the effect of Community Reinforcement Approach and Contingency Management. PMID:24700332

Cost-effectiveness of on-site versus off-site collaborative care for depression in rural FQHCs.

PubMed

Pyne, Jeffrey M; Fortney, John C; Mouden, Sip; Lu, Liya; Hudson, Teresa J; Mittal, Dinesh

2015-05-01

Collaborative care for depression in primary care settings is effective and cost-effective. However, there is minimal evidence to support the choice of on-site versus off-site models. This study examined the cost-effectiveness of on-site practice-based collaborative care (PBCC) versus off-site telemedicine-based collaborative care (TBCC) for depression in federally qualified health centers (FQHCs). In a multisite, randomized, pragmatic comparative cost-effectiveness trial, 19,285 patients were screened for depression, 2,863 (14.8%) screened positive, and 364 were enrolled. Telephone interview data were collected at baseline and at six, 12, and 18 months. Base case analysis used Arkansas FQHC health care costs, and secondary analysis used national cost estimates. Effectiveness measures were depression-free days and quality-adjusted life years (QALYs) derived from depression-free days, the 12-Item Short-Form Survey, and the Quality of Well-Being (QWB) Scale. Nonparametric bootstrap with replacement methods were used to generate an empirical joint distribution of incremental costs and QALYs and acceptability curves. The TBCC intervention resulted in more depression-free days and QALYs but at a greater cost than the PBCC intervention. The disease-specific (depression-free day) and generic (QALY) incremental cost-effectiveness ratios (ICERs) were below their respective ICER thresholds for implementation, suggesting that the TBCC intervention was more cost effective than the PBCC intervention. These results support the cost-effectiveness of TBCC in medically underserved primary care settings. Information about whether to insource (make) or outsource (buy) depression care management is important, given the current interest in patient-centered medical homes, value-based purchasing, and bundled payments for depression care.

Internet-delivered treatment for substance abuse: a multisite randomized controlled trial.

PubMed

Campbell, Aimee N C; Nunes, Edward V; Matthews, Abigail G; Stitzer, Maxine; Miele, Gloria M; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A; Kyle, Tiffany L; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E

2014-06-01

Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255). TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment as usual consisted of individual and group counseling at the participating programs. The primary outcome measures were abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment. Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35). This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry (N=228) (odds ratio=2.18, 95% CI=1.30, 3.68). Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes. Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES.

Psychopharmacological strategies in the management of posttraumatic stress disorder (PTSD): what have we learned?

PubMed

Bernardy, Nancy C; Friedman, Matthew J

2015-04-01

There have been significant advancements in the pharmacologic management of posttraumatic stress disorder (PTSD) in the past two decades. Multisite randomized clinical trials (RCTs) have noted the efficacy of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNR Is) for PTSD treatment. Unfortunately, there have been no new medications approved to treat PTSD in the past 10 years. Although there have been exciting new findings in our knowledge of the neurobiology of PTSD, clinical trials testing new medications have lagged. This review summarizes recent research that builds on the unique pathophysiology of PTSD and suggests ways to move the field forward.

Computerised CBT for depressed adolescents: Randomised controlled trial.

PubMed

Smith, Patrick; Scott, Rebecca; Eshkevari, Ertimiss; Jatta, Fatoumata; Leigh, Eleanor; Harris, Victoria; Robinson, Alex; Abeles, Paul; Proudfoot, Judy; Verduyn, Chrissie; Yule, William

2015-10-01

Depression in adolescents is a common and impairing problem. Effective psychological therapies for depression are not accessed by most adolescents. Computerised therapy offers huge potential for improving access to treatment. To test the efficacy of Stressbusters, a Computerised-CBT (C-CBT) programme for depression in young people. Multi-site, schools-based, RCT of C-CBT compared to Waiting List, for young people (N = 112; aged 12-16) with significant symptoms of depression, using multiple-informants (adolescents, parents, teachers), with follow-up at 3 and 6 months. Relative to being on a Waiting List, C-CBT was associated with statistically significant and clinically meaningful improvements in symptoms of depression and anxiety according to adolescent self-report; and with a trend towards improvements in depression and anxiety according to parent-report. Improvements were maintained at follow-up. Treatment gains were similar for boys and girls across the participating age range. Treatment effect was partially mediated by changes in ruminative thinking. Teachers rated adolescents as having few emotional or behavioural problems, both before and after intervention. C-CBT had no detectable effect on academic attainment. In the month after intervention, young people who received C-CBT had significantly fewer absences from school than those on the Waiting List. C-CBT shows considerable promise for the treatment of mild-moderate depression in adolescents. Copyright © 2015 Elsevier Ltd. All rights reserved.

Role of Social Support in Predicting Caregiver Burden

PubMed Central

Rodakowski, Juleen; Skidmore, Elizabeth R.; Rogers, Joan C.; Schulz, Richard

2012-01-01

Objective To examine the unique contribution of social support to burden in caregivers of adults aging with spinal cord injuries (SCI). Design Secondary analyses of cross-sectional data from a large cohort of adults aging with SCI and their primary caregivers. Setting Multiple community locations in Pittsburgh, PA, and Miami, FL. Participants Caregivers of community-dwelling adults aging with SCI (n=173) were interviewed as part of a multisite randomized clinical trial. The mean age of caregivers was 53 years (SD=15) and of care-recipients 55 years (SD=13). Interventions Not applicable. Main Outcome Measures The primary outcome was caregiver burden measured with the Abridged Version of the Zarit Burden Interview. A hierarchical multiple regression analysis examined social supports (social integration, received social support, and negative social interactions) effect on burden in caregivers of adults aging while controlling for demographic characteristics and caregiving characteristics. Results After controlling for demographic characteristics and caregiving characteristics, social integration (β̂ =−.16, P<.05), received social support (β̂ =−.15, P<.05), and negative social interactions (β̂ =.21, P<.01) were significant independent predictors of caregiver burden. Conclusions Findings demonstrate that social support is an important factor associated with burden in caregivers of adults aging with SCI. Social support should be considered for assessments and interventions designed to identify and reduce caregiver burden. PMID:22824248

Strategies for communicating contraceptive effectiveness.

PubMed

Lopez, Laureen M; Steiner, Markus; Grimes, David A; Hilgenberg, Deborah; Schulz, Kenneth F

2013-04-30

Knowledge of contraceptive effectiveness is crucial to making an informed choice. The consumer has to comprehend the pros and cons of the contraceptive methods being considered. Choice may be influenced by understanding the likelihood of pregnancy with each method and factors that influence effectiveness. To review all randomized controlled trials comparing strategies for communicating to consumers the effectiveness of contraceptives in preventing pregnancy. Through February 2013, we searched the computerized databases of MEDLINE, POPLINE, CENTRAL, PsycINFO and CINAHL, ClinicalTrials.gov, and ICTRP. Previous searches also included EMBASE. We also examined references lists of relevant articles. For the initial review, we wrote to known investigators for information about other published or unpublished trials. We included randomized controlled trials that compared methods for communicating contraceptive effectiveness to consumers. The comparison could be usual practice or an alternative to the experimental intervention.Outcome measures were knowledge of contraceptive effectiveness, attitude about contraception or toward any particular contraceptive, and choice or use of contraceptive method. For the initial review, two authors independently extracted the data. One author entered the data into RevMan, and a second author verified accuracy. For the update, an author and a research associate extracted, entered, and checked the data.For dichotomous variables, we calculated the Mantel-Haenszel odds ratio with 95% confidence intervals (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. Seven trials met the inclusion criteria and had a total of 4526 women. Five were multi-site studies. Four trials were conducted in the USA, while Nigeria and Zambia were represented by one study each, and one trial was done in both Jamaica and India.Two trials provided multiple sessions for participants. In one study that examined contraceptive choice, women in the expanded program were more likely to choose sterilization (OR 4.26; 95% CI 2.46 to 7.37) or use a modern contraceptive method (OR 2.35; 95% CI 1.82 to 3.03), i.e., sterilization, pills, injectable, intrauterine device or barrier method. For the other study, the groups received educational interventions with differing format and intensity. Both groups reportedly had increases in contraceptive use, but they did not differ significantly by six months in consistent use of an effective contraceptive, i.e., sterilization, IUD, injectable, implant, and consistent use of oral contraceptives, diaphragm, or male condoms.Five trials provided one session and focused on testing educational material or media. In one study, knowledge gain favored a slide-and-sound presentation versus a physician's oral presentation (MD -19.00; 95% CI -27.52 to -10.48). In another trial, a table with contraceptive effectiveness categories led to more correct answers than a table based on pregnancy numbers [ORs were 2.42 (95% CI 1.43 to 4.12) and 2.19 (95% CI 1.21 to 3.97)] or a table with effectiveness categories and pregnancy numbers [ORs were 2.58 (95% CI 1.5 to 4.42) and 2.03 (95% CI 1.13 to 3.64)]. Still another trial provided structured counseling with a flipchart on contraceptive methods. The intervention and usual-care groups did not differ significantly in choice of contraceptive method (by effectiveness category) or in continuation of the chosen method at three months. Lastly, a study with couples used videos to communicate contraceptive information (control, motivational, contraceptive methods, and both motivational and methods videos). The analyses showed no significant difference between the groups in the types of contraceptives chosen. These trials varied greatly in the types of participants and interventions to communicate contraceptive effectiveness. Therefore, we cannot say overall what would help consumers choose an appropriate contraceptive method. For presenting pregnancy risk data, one trial showed that effectiveness categories were better than pregnancy numbers. In another trial, audiovisual aids worked better than the usual oral presentation. Strategies should be tested in clinical settings and measured for their effect on contraceptive choice. More detailed reporting of intervention content would help in interpreting results. Reports could also include whether the instruments used to assess knowledge or attitudes were tested for validity or reliability. Follow-up should be incorporated to assess retention of knowledge over time. The overall quality of evidence was considered to be low for this review, given that five of the seven studies provided low or very low quality evidence.

Merging universal and indicated prevention programs: the Fast Track model. Conduct Problems Prevention Research Group.

PubMed

2000-01-01

Fast Track is a multisite, multicomponent preventive intervention for young children at high risk for long-term antisocial behavior. Based on a comprehensive developmental model, this intervention includes a universal-level classroom program plus social-skill training, academic tutoring, parent training, and home visiting to improve competencies and reduce problems in a high-risk group of children selected in kindergarten. The theoretical principles and clinical strategies utilized in the Fast Track Project are described to illustrate the interplay between basic developmental research, the understanding of risk and protective factors, and a research-based model of preventive intervention that integrates universal and indicated models of prevention.

Discussing prognosis and end-of-life care in the final year of life: a randomised controlled trial of a nurse-led communication support programme for patients and caregivers

PubMed Central

Walczak, Adam; Butow, Phyllis N; Clayton, Josephine M; Tattersall, Martin H N; Davidson, Patricia M; Young, Jane; Epstein, Ronald M

2014-01-01

Introduction Timely communication about life expectancy and end-of-life care is crucial for ensuring good patient quality-of-life at the end of life and a good quality of death. This article describes the protocol for a multisite randomised controlled trial of a nurse-led communication support programme to facilitate patients’ and caregivers’ efforts to communicate about these issues with their healthcare team. Methods and analysis This NHMRC-sponsored trial is being conducted at medical oncology clinics located at/affiliated with major teaching hospitals in Sydney, Australia. Patients with advanced, incurable cancer and life expectancy of less than 12 months will participate together with their primary informal caregiver where possible. Guided by the self-determination theory of health-behaviour change, the communication support programme pairs a purpose-designed Question Prompt List (QPL—an evidence-based list of questions patients/caregivers can ask clinicians) with nurse-led exploration of QPL content, communication challenges, patient values and concerns and the value of early discussion of end-of-life issues. Oncologists are also cued to endorse patient and caregiver question asking and use of the QPL. Behavioural and self-report data will be collected from patients/caregivers approximately quarterly for up to 2.5 years or until patient death, after which patient medical records will be examined. Analyses will examine the impact of the intervention on patients’ and caregivers’ participation in medical consultations, their self-efficacy in medical encounters, quality-of-life, end-of-life care receipt and quality-of-death indicators. Ethics and dissemination Approvals have been granted by the human ethics review committee of Royal Prince Alfred Hospital and governance officers at each participating site. Results will be reported in peer-reviewed publications and conference presentations. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12610000724077. PMID:24969786

Putting brain training to the test in the workplace: a randomized, blinded, multisite, active-controlled trial.

PubMed

Borness, Catherine; Proudfoot, Judith; Crawford, John; Valenzuela, Michael

2013-01-01

Cognitive training (CT) is effective at improving cognitive outcomes in children with and without clinical impairment as well as older individuals. Yet whether CT is of any preventative health benefit to working age adults is controversial. Our objective was therefore to investigate the real-world efficacy of CT in the workplace, involving employees from across the working-age spectrum and addressing many of the design issues that have limited trials to date. 135 white collar employees of a large Australian public sector organization were randomised to either 16 weeks (20 minutes three times per week) of online CT or an active control (AC) program of equal length and structure. Cognitive, wellbeing and productivity outcome measures were analysed across three timepoints: baseline, immediately after training and 6 months post-training. CT effects on cognitive outcomes were limited, even after planned subgroup analyses of cognitive capacity and age. Unexpectedly, we found that our AC condition, which comprised viewing short documentaries about the natural world, had more impact. Compared to the CT group, 6 months after the end of training, those in the AC group experienced a significant increase in their self-reported Quality of Life (Effect Size g = .34 vs -.15; TIME×GROUP p = .003), decrease in stress levels (g = .22 vs -.19; TIME x GROUP p = .03), and overall improvement in Psychological Wellbeing (g = .32 vs -.06; TIME×GROUP p = .02). CT does not appear to positively impact cognition or wellbeing amongst white collar office workers; however, short time-out respite activities may have value in the promotion of psychological wellbeing. Given looming challenges to workplace productivity, further work-based interventional research targeting employee mental health is recommended. THIS TRIAL WAS REGISTERED WITH THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12610000604000 (http://www.anzctr.org.au/TrialSearch.aspx).

Young People's Participation in the Development of a Self-Care Intervention--A Multi-Site Formative Research Study

ERIC Educational Resources Information Center

Kime, Nicola; McKenna, Jim; Webster, Liz

2013-01-01

The poor outcomes of young people with chronic health conditions indicate that current services and self-care programmes are not meeting the needs of young people. How young people self-manage their condition impacts on long-term health outcomes, but there is little published evidence that details the development of self-care programmes and their…

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2015-02-01

25.0) 9 (47.4) Marital Status Single 12 (30.8) 6 (30.0) 6 (31.6) Married 20 (51.3) 11 (55.0) 9 (47.4) Cohabitating/ Unmarried Partner 1 (2.6) 0 1...inpatient stay, we have not met our recruitment goal. Please see Figure 1 below, which displays the rate of recruitment, projected vs . actual. Page

A Multisite, Randomized Clinical Trial of Virtual Reality and Prolonged Exposure Therapy for Active Duty Soldiers with PTSD

DTIC Science & Technology

2015-02-01

Department of Defense, Washington Headquarters Services , Directorate for Information Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite...1204, Arlington, VA 22202- 4302. Respondents should be aware that notwithstanding any other provision of law , no person shall be subject to any...conducted for both treatments. Service members were assessed before randomization, after 5 sessions, at posttreatment, and 3- and 6-months posttreatment

Empirically Derived Subtypes of Adolescent Depression: Latent Profile Analysis of Co-Occurring Symptoms in the Treatment for Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Herman, Keith C.; Ostrander, Rick; Walkup, John T.; Silva, Susan G.; March, John S.

2007-01-01

A latent profile analysis was conducted on the co-occurring symptoms of 423 adolescents diagnosed with major depressive disorder as part of the Treatment for Adolescents with Depression Study (TADS), a multisite, randomized treatment trial. The participants had a mean (SD) age of 14.6 (1.5) years; of the sample, 45.6% was male and 73.8% was white.…

Economic Analysis of a Multi-Site Prevention Program: Assessment of Program Costs and Characterizing Site-level Variability

PubMed Central

Corso, Phaedra S.; Ingels, Justin B.; Kogan, Steven M.; Foster, E. Michael; Chen, Yi-Fu; Brody, Gene H.

2013-01-01

Programmatic cost analyses of preventive interventions commonly have a number of methodological difficulties. To determine the mean total costs and properly characterize variability, one often has to deal with small sample sizes, skewed distributions, and especially missing data. Standard approaches for dealing with missing data such as multiple imputation may suffer from a small sample size, a lack of appropriate covariates, or too few details around the method used to handle the missing data. In this study, we estimate total programmatic costs for a prevention trial evaluating the Strong African American Families-Teen program. This intervention focuses on the prevention of substance abuse and risky sexual behavior. To account for missing data in the assessment of programmatic costs we compare multiple imputation to probabilistic sensitivity analysis. The latter approach uses collected cost data to create a distribution around each input parameter. We found that with the multiple imputation approach, the mean (95% confidence interval) incremental difference was $2149 ($397, $3901). With the probabilistic sensitivity analysis approach, the incremental difference was $2583 ($778, $4346). Although the true cost of the program is unknown, probabilistic sensitivity analysis may be a more viable alternative for capturing variability in estimates of programmatic costs when dealing with missing data, particularly with small sample sizes and the lack of strong predictor variables. Further, the larger standard errors produced by the probabilistic sensitivity analysis method may signal its ability to capture more of the variability in the data, thus better informing policymakers on the potentially true cost of the intervention. PMID:23299559

Economic analysis of a multi-site prevention program: assessment of program costs and characterizing site-level variability.

PubMed

Corso, Phaedra S; Ingels, Justin B; Kogan, Steven M; Foster, E Michael; Chen, Yi-Fu; Brody, Gene H

2013-10-01

Programmatic cost analyses of preventive interventions commonly have a number of methodological difficulties. To determine the mean total costs and properly characterize variability, one often has to deal with small sample sizes, skewed distributions, and especially missing data. Standard approaches for dealing with missing data such as multiple imputation may suffer from a small sample size, a lack of appropriate covariates, or too few details around the method used to handle the missing data. In this study, we estimate total programmatic costs for a prevention trial evaluating the Strong African American Families-Teen program. This intervention focuses on the prevention of substance abuse and risky sexual behavior. To account for missing data in the assessment of programmatic costs we compare multiple imputation to probabilistic sensitivity analysis. The latter approach uses collected cost data to create a distribution around each input parameter. We found that with the multiple imputation approach, the mean (95 % confidence interval) incremental difference was $2,149 ($397, $3,901). With the probabilistic sensitivity analysis approach, the incremental difference was $2,583 ($778, $4,346). Although the true cost of the program is unknown, probabilistic sensitivity analysis may be a more viable alternative for capturing variability in estimates of programmatic costs when dealing with missing data, particularly with small sample sizes and the lack of strong predictor variables. Further, the larger standard errors produced by the probabilistic sensitivity analysis method may signal its ability to capture more of the variability in the data, thus better informing policymakers on the potentially true cost of the intervention.

Mindfulness-Based Cancer Recovery (MBCR) versus Supportive Expressive Group Therapy (SET) for distressed breast cancer survivors: evaluating mindfulness and social support as mediators.

PubMed

Schellekens, Melanie P J; Tamagawa, Rie; Labelle, Laura E; Speca, Michael; Stephen, Joanne; Drysdale, Elaine; Sample, Sarah; Pickering, Barbara; Dirkse, Dale; Savage, Linette Lawlor; Carlson, Linda E

2017-06-01

Despite growing evidence in support of mindfulness as an underlying mechanism of mindfulness-based interventions (MBIs), it has been suggested that nonspecific therapeutic factors, such as the experience of social support, may contribute to the positive effects of MBIs. In the present study, we examined whether change in mindfulness and/or social support mediated the effect of Mindfulness-Based Cancer Recovery (MBCR) compared to another active intervention (i.e. Supportive Expressive Group Therapy (SET)), on change in mood disturbance, stress symptoms and quality of life. A secondary analysis was conducted of a multi-site randomized clinical trial investigating the impacts of MBCR and SET on distressed breast cancer survivors (MINDSET). We applied the causal steps approach with bootstrapping to test mediation, using pre- and post-intervention questionnaire data of the participants who were randomised to MBCR (n = 69) or SET (n = 70). MBCR participants improved significantly more on mood disturbance, stress symptoms and social support, but not on quality of life or mindfulness, compared to SET participants. Increased social support partially mediated the impact of MBCR versus SET on mood disturbance and stress symptoms. Because no group differences on mindfulness and quality of life were observed, no mediation analyses were performed on these variables. Findings showed that increased social support was related to more improvement in mood and stress after MBCR compared to support groups, whereas changes in mindfulness were not. This suggests a more important role for social support in enhancing outcomes in MBCR than previously thought.

Angiotensin-Converting Enzyme Inhibitor Use by Older Adults Is Associated with Greater Functional Responses to Exercise

PubMed Central

Buford, Thomas W.; Manini, Todd M.; Hsu, Fang-Chi; Cesari, Matteo; Anton, Stephen D.; Nayfield, Susan; Stafford, Randall S.; Church, Timothy S.; Pahor, Marco; Carter, Christy S.

2013-01-01

OBJECTIVES To assess the association between angiotensin converting enzyme inhibitors (ACEis) and improvements in the physical function of older adults in response to chronic exercise training. DESIGN Secondary analysis of the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) study, a multisite randomized clinical trial to evaluate the effects of chronic exercise on the physical function of older adults at risk for mobility disability. SETTING Four academic research centers within the United States. PARTICIPANTS Four hundred twenty-four individuals aged 70 to 89 with mild to moderate functional impairments categorized for this analysis as ACEi users, users of other antihypertensive drugs, or antihypertensive nonusers. INTERVENTION A 12-month intervention of structured physical activity (PA) or health education promoting successful aging (SA). MEASUREMENTS Change in walking speed during a 400-m test and performance on a battery of short-duration mobility tasks (Short Physical Performance Battery (SPPB)). RESULTS Physical activity significantly improved the adjusted walking speed of ACEi users (P < .001) but did not of nonusers. PA improved the adjusted SPPB score of ACEi users (P < .001) and of persons who used other antihypertensive drugs (P = .005) but not of antihypertensive nonusers (P = .91). The percentage of ACEi users deriving clinically significant benefit from exercise training for walking speed (30%) and SPPB score (48%) was dramatically higher than for nonusers (14% and 12%, respectively). CONCLUSION For older adults at risk for disability, exercise-derived improvements in physical function were greater for ACEi users than users of other antihypertensive drugs and antihypertensive nonusers. PMID:22726232

Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors.

PubMed

Patterson, Thomas L; Semple, Shirley J; Chavarin, Claudia V; Mendoza, Doroteo V; Santos, Lorena E; Chaffin, Mark; Palinkas, Lawrence A; Strathdee, Steffanie A; Aarons, Gregory A

2012-10-29

Studies of implementation of efficacious human immunodeficiency virus (HIV) prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs) among female sex workers (FSWs) in 12 cities across Mexico. Our protocol will test a 'train-the-trainer' implementation model for transporting the Mujer Segura (Healthy Woman) intervention into community-based organizations (CBOs). We have partnered with Mexican Foundation for Family Planning (Mexfam), a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs). Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia); they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors' fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura intervention will be analyzed, and across CBOs, correlations will be examined between individual and organizational provider characteristics and intervention efficacy. This cooperative, bi-national research study will provide critical insights into barriers and facilitating factors associated with implementing interventions in CBOs using the 'train the trainer' model. Our work builds on similar scale-up strategies that have been effective in the United States. This study has the potential to increase our knowledge of the generalizability of such strategies across health issues, national contexts, and organizational contexts. NCT01465607.

Using focus groups to develop a culturally sensitive videotape intervention for HIV-positive women.

PubMed

Murdaugh, C; Russell, R B; Sowell, R

2000-12-01

Research-based interventions for women with the human immunodeficiency virus (HIV) are usually developed without input from the women who receive the intervention. An exploratory study was performed using focus group methodology to develop a culturally sensitive videotape intervention for educating HIV-positive women about pregnancy and antiretroviral use. Women who met the study criteria were HIV-positive and of childbearing age. These women volunteered to participate in the focus groups to provide information on decisions concerning pregnancy and antiretroviral use during pregnancy to decrease perinatal transmission. A total of five focus groups were conducted in 1998. Responses to three questions that were relevant to the video are presented in this article. Information gained from the focus groups was used successfully to develop a videotape currently being used in a multisite intervention study. Focus group methodology is a useful strategy to develop culturally and content relevant educational interventions for research and practice.

Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV) results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community), participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their best possible outcome and may contribute to a functional decline following discharge from formal rehabilitation. Best practice guidelines recommend a prolonged period of rehabilitation, however this is expensive and therefore not undertaken in most publicly funded centres. An effective, cost-effective, and preference-sensitive therapy using basic technology to assist programme delivery may improve patient autonomy as they leave formal rehabilitation and return home. Trial registration ACTRN12612000464864 PMID:23216861

Multisite musculoskeletal pain in adolescence and later mental health disorders: a population-based registry study of Norwegian youth: the NAAHS cohort study

PubMed Central

Eckhoff, Christian; Straume, Bjørn; Kvernmo, Siv

2017-01-01

Objectives To examine the association between multisite musculoskeletal pain in adolescence and mental health disorders in young adulthood. Design and setting Data were obtained from a linkage between the Norwegian Patient Registry (2008–2012) and the Norwegian Arctic Adolescent Health Study, a school-based survey conducted among 10th grade students in North Norway (2003–2005). Participants In total, 3987 (68%) of all 5877 invited participants consented to the registry linkage. Outcome measures Mental healthcare use and disorders from age 18–20 to 23–25 years (5 years). Methods Musculoskeletal pain was measured by the number of musculoskeletal pain sites. Multivariable logistic regression was used to explore the association with later mental healthcare use and disorders. Results Multisite adolescent musculoskeletal pain was significantly associated with an increase in mental healthcare use and mental health disorders in young adulthood. The relationship was stronger for anxiety and mood disorders, in both genders. Overall, the association between musculoskeletal pain and later mental health problems was attenuated after controlling for adolescent psychosocial and mental health problems, not by physical or sedentary activity. This could be due to confounding or mediation. However, when examining different mental health disorders, we found musculoskeletal pain to be significantly associated with anxiety disorders, and showing a strong trend in mood disorders, when adjusted for the adolescent factors. Conclusions Physicians should be aware that multisite adolescent pain is associated with mental health problems in adolescence, and that these adolescents are at increased risk of mental health disorders in young adulthood. As youth troubled by mental health problems commonly present physical symptoms it is important to examine for psychosocial problems in order to offer early interventions. PMID:28188150

Multisite musculoskeletal pain in adolescence as a predictor of medical and social welfare benefits in young adulthood: The Norwegian Arctic Adolescent Health Cohort Study.

PubMed

Eckhoff, C; Straume, B; Kvernmo, S

2017-11-01

Pain in adolescence is associated with mental health problems, the main reason for work disability in young adults. This study explores the relationship between multisite musculoskeletal pain in adolescence and later medical (sickness and medical rehabilitation benefits) and social welfare benefits, adjusted for sociodemographic, adolescent psychosocial and mental health problems. Data were obtained by linkage between the National Insurance Registry (2003-11) and the Norwegian Arctic Adolescent Health Study, a school-based survey in North Norway (2003-05), accepted by 3987 fifteen- to sixteen-year-olds (68% of the total population). The start of the follow-up time was July 1st of the corresponding year the participants responded to the health study. Musculoskeletal pain was measured by the number of musculoskeletal pain sites. We found a positive linear relationship between adolescent musculoskeletal pain sites and the occurrence of medical and social welfare benefits in young adulthood (p ≤ 0.001). Adolescent musculoskeletal pain was a significant predictor of sickness (p < 0.001) and social welfare benefits in females (p = 0.036), when adjusted for adolescent psychosocial and mental health problems. The most important adolescent psychosocial predictors were externalizing problems, less parental involvement and adverse life events. Adolescent multisite musculoskeletal pain was found to be an important predictor of later sickness and social welfare benefit receipt from adolescence to young adulthood. Adolescents with multisite musculoskeletal pain are at substantially increased risk of health and social difficulties into young adulthood. Identification and interventions for these adolescent problems could alleviate this risk and be a sound socioeconomic investment. © 2017 European Pain Federation - EFIC®.

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial

PubMed Central

2013-01-01

Background There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users’ readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Methods Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. Results The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants’ therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Conclusion Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. Trial registration ClinicalTrials.Gov.UK Identifier - NCT01132976 PMID:23414174

AIDS chief says nonoxynol-9 not effective against HIV.

PubMed

According to Dr. Peter Piot, executive director of the Joint UN Programme on HIV/AIDS (UNAIDS), the international multi-site trial of the spermicide nonoxynol-9 in gel form has shown that it is not effective in protecting women from HIV infection. This large-scale Phase III efficacy trial was conducted among female sex workers in Benin, Cote d'Ivoire, South Africa, and Thailand. Apart from receiving the trial microbicide or a placebo, participants also received classical HIV prevention support, such as free condoms, free treatment for sexually transmitted infections, counseling, and peer support. One positive outcome of the trial is that fewer of the sex workers who participated became infected with HIV, compared with the sex workers who did not participate at all in the study. However, Piot states that even if the results of the trials are disappointing, the search for an effective microbicide continues. To this effect, at least 36 compounds are at the preclinical testing stage, while 20 are ready for early safety trials in human volunteers and three additional compounds are being considered for large-scale trials.

Trial Readiness in Cavernous Angiomas With Symptomatic Hemorrhage (CASH).

PubMed

Polster, Sean P; Cao, Ying; Carroll, Timothy; Flemming, Kelly; Girard, Romuald; Hanley, Daniel; Hobson, Nicholas; Kim, Helen; Koenig, James; Koskimäki, Janne; Lane, Karen; Majersik, Jennifer J; McBee, Nichol; Morrison, Leslie; Shenkar, Robert; Stadnik, Agnieszka; Thompson, Richard E; Zabramski, Joseph; Zeineddine, Hussein A; Awad, Issam A

2018-04-11

Brain cavernous angiomas with symptomatic hemorrhage (CASH) are uncommon but exact a heavy burden of neurological disability from recurrent bleeding, for which there is no proven therapy. Candidate drugs to stabilize the CASH lesion and prevent rebleeding will ultimately require testing of safety and efficacy in multisite clinical trials. Much progress has been made in understanding the epidemiology of CASH, and novel biomarkers have been linked to the biological mechanisms and clinical activity in lesions. Yet, the ability to enroll and risk-stratify CASH subjects has never been assessed prospectively at multiple sites. Biomarkers and other outcomes have not been evaluated for their sensitivity and reliability, nor have they been harmonized across sites. To address knowledge gaps and establish a research network as infrastructure for future clinical trials, through the Trial Readiness grant mechanism, funded by National Institute of Neurological Disorders and Stroke/National Institutes of Health. This project includes an observational cohort study to assess (1) the feasibility of screening, enrollment rates, baseline disease categorization, and follow-up of CASH using common data elements at multiple sites, (2) the reliability of imaging biomarkers including quantitative susceptibility mapping and permeability measures that have been shown to correlate with lesion activity, and (3) the rates of recurrent hemorrhage and change in functional status and biomarker measurements during prospective follow-up. We propose a harmonized multisite assessment of enrollment rates of CASH, baseline features relevant to stratification in clinical trials, and follow-up assessments of functional outcomes in relation to clinical bleeds. We introduce novel biomarkers of vascular leak and hemorrhage, with firm mechanistic foundations, which have been linked to clinical disease activity. We shall test their reliability and validity at multiple sites, and assess their changes over time, with and without clinical rebleeds, hence their fitness as outcome instruments in clinical trials. The timing cannot be more opportune, with therapeutic targets identified, exceptional collaboration among researchers and the patient community, along with several drugs ready to benefit from development of a path to clinical testing using this network in the next 5 years.

Determination of emamectin benzoate in medicated fish feed: a multisite study.

PubMed

Farer, Leslie J

2005-01-01

A new method was developed for the quantitation of emamectin benzoate in medicated fish feed at levels between 1 and 30 ppm. The new procedure, based on a previously reported assay, consists of a wet methanolic extraction of ground feed, followed by solid-phase extraction and injection onto a gradient liquid chromatographic system. A multisite study involving 3 laboratories (the developing laboratory and 2 independent laboratories) was performed to evaluate precision, recovery, linearity, and sensitivity. Mean recove;ries for triplicate analyses at 3 levels, performed by 2 analysts per laboratory, were between 89 and 97%, with coefficients of variation ranging from 1.6 to 8.6%. Coefficients of determination (r2) obtained from the plotted data were > or =0.993. The precision of the method, determined from 6 replicate preparations from the same batch of medicated feed assayed in 3 separate trials per laboratory, was between 0.6 and 5.8%. The quantitation limit was established at 0.5 ppm. Specificity and robustness studies were performed by the developing laboratory.

Web-based alcohol screening and brief intervention for university students: a randomized trial.

PubMed

Kypri, Kypros; Vater, Tina; Bowe, Steven J; Saunders, John B; Cunningham, John A; Horton, Nicholas J; McCambridge, Jim

2014-03-26

Unhealthy alcohol use is a leading contributor to the global burden of disease, particularly among young people. Systematic reviews suggest efficacy of web-based alcohol screening and brief intervention and call for effectiveness trials in settings where it could be sustainably delivered. To evaluate a national web-based alcohol screening and brief intervention program. A multisite, double-blind, parallel-group, individually randomized trial was conducted at 7 New Zealand universities. In April and May of 2010, invitations containing hyperlinks to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screening test were e-mailed to 14,991 students aged 17 to 24 years. Participants who screened positive (AUDIT-C score ≥4) were randomized to undergo screening alone or to 10 minutes of assessment and feedback (including comparisons with medical guidelines and peer norms) on alcohol expenditure, peak blood alcohol concentration, alcohol dependence, and access to help and information. A fully automated 5-month follow-up assessment was conducted that measured 6 primary outcomes: consumption per typical occasion, drinking frequency, volume of alcohol consumed, an academic problems score, and whether participants exceeded medical guidelines for acute harm (binge drinking) and chronic harm (heavy drinking). A Bonferroni-corrected significance threshold of .0083 was used to account for the 6 comparisons and a sensitivity analysis was used to assess possible attrition bias. Of 5135 students screened, 3422 scored 4 or greater and were randomized, and 83% were followed up. There was a significant effect on 1 of the 6 prespecified outcomes. Relative to control participants, those who received intervention consumed less alcohol per typical drinking occasion (median 4 drinks [interquartile range {IQR}, 2-8] vs 5 drinks [IQR 2-8]; rate ratio [RR], 0.93 [99.17% CI, 0.86-1.00]; P = .005) but not less often (RR, 0.95 [99.17% CI, 0.88-1.03]; P = .08) or less overall (RR, 0.95 [99.17% CI, 0.81-1.10]; P = .33). Academic problem scores were not lower (RR, 0.91 [99.17% CI, 0.76-1.08]; P = .14) and effects on the risks of binge drinking (odds ratio [OR], 0.84 [99.17% CI, 0.67-1.05]; P = .04) and heavy drinking (OR, 0.77 [99.17% CI, 0.56-1.05]; P = .03) were not significantly significant. In a sensitivity analysis accounting for attrition, the effect on alcohol per typical drinking occasion was no longer statistically significant. A national web-based alcohol screening and brief intervention program produced no significant reductions in the frequency or overall volume of drinking or academic problems. There remains a possibility of a small reduction in the amount of alcohol consumed per typical drinking occasion. anzctr.org.au Identifier: ACTRN12610000279022.

Patterns of protective factors in an intervention for the prevention of suicide and alcohol abuse with Yup'ik Alaska Native youth.

PubMed

Henry, David; Allen, James; Fok, Carlotta Ching Ting; Rasmus, Stacy; Charles, Bill

2012-09-01

Community-based participatory research (CBPR) with American Indian and Alaska Native communities creates distinct interventions, complicating cross-setting comparisons. The objective of this study is to develop a method for quantifying intervention exposure in CBPR interventions that differ in their forms across communities, permitting multi-site evaluation. Attendance data from 195 youth from three Yup'ik communities were coded for the specific protective factor exposure of each youth, based on information from the intervention manual. The coded attendance data were then submitted to latent class analysis to obtain participation patterns. Five patterns of exposure to protective factors were obtained: Internal, External, Limits, Community/family, and Low Protection. Patterns differed significantly by community and youth age. Standardizing interventions by the functions an intervention serves (protective factors promoted) instead of their forms or components (specific activities) can assist in refining CBPR interventions and evaluating effects in culturally distinct settings.

The Alzheimer's Disease Neuroimaging Initiative (ADNI): MRI Methods

PubMed Central

Jack, Clifford R.; Bernstein, Matt A.; Fox, Nick C.; Thompson, Paul; Alexander, Gene; Harvey, Danielle; Borowski, Bret; Britson, Paula J.; Whitwell, Jennifer L.; Ward, Chadwick; Dale, Anders M.; Felmlee, Joel P.; Gunter, Jeffrey L.; Hill, Derek L.G.; Killiany, Ron; Schuff, Norbert; Fox-Bosetti, Sabrina; Lin, Chen; Studholme, Colin; DeCarli, Charles S.; Krueger, Gunnar; Ward, Heidi A.; Metzger, Gregory J.; Scott, Katherine T.; Mallozzi, Richard; Blezek, Daniel; Levy, Joshua; Debbins, Josef P.; Fleisher, Adam S.; Albert, Marilyn; Green, Robert; Bartzokis, George; Glover, Gary; Mugler, John; Weiner, Michael W.

2008-01-01

The Alzheimer's Disease Neuroimaging Initiative (ADNI) is a longitudinal multisite observational study of healthy elders, mild cognitive impairment (MCI), and Alzheimer's disease. Magnetic resonance imaging (MRI), (18F)-fluorode-oxyglucose positron emission tomography (FDG PET), urine serum, and cerebrospinal fluid (CSF) biomarkers, as well as clinical/psychometric assessments are acquiredat multiple time points. All data will be cross-linked and made available to the general scientific community. The purpose of this report is to describe the MRI methods employed in ADNI. The ADNI MRI core established specifications thatguided protocol development. A major effort was devoted toevaluating 3D T1-weighted sequences for morphometric analyses. Several options for this sequence were optimized for the relevant manufacturer platforms and then compared in a reduced-scale clinical trial. The protocol selected for the ADNI study includes: back-to-back 3D magnetization prepared rapid gradient echo (MP-RAGE) scans; B1-calibration scans when applicable; and an axial proton density-T2 dual contrast (i.e., echo) fast spin echo/turbo spin echo (FSE/TSE) for pathology detection. ADNI MRI methods seek to maximize scientific utility while minimizing the burden placed on participants. The approach taken in ADNI to standardization across sites and platforms of the MRI protocol, postacquisition corrections, and phantom-based monitoring of all scanners could be used as a model for other multisite trials. PMID:18302232

Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial.

PubMed

Kron, Frederick W; Fetters, Michael D; Scerbo, Mark W; White, Casey B; Lypson, Monica L; Padilla, Miguel A; Gliva-McConvey, Gayle A; Belfore, Lee A; West, Temple; Wallace, Amelia M; Guetterman, Timothy C; Schleicher, Lauren S; Kennedy, Rebecca A; Mangrulkar, Rajesh S; Cleary, James F; Marsella, Stacy C; Becker, Daniel M

2017-04-01

To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group's experiences and learning preferences. A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR's intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. MPathic-VR's virtual human simulation offers an effective and engaging means of advanced communication training. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial

PubMed Central

Kron, Frederick W.; Fetters, Michael D.; Scerbo, Mark W.; White, Casey B.; Lypson, Monica L.; Padilla, Miguel A.; Gliva-McConvey, Gayle A.; Belfore, Lee A.; West, Temple; Wallace, Amelia M.; Guetterman, Timothy C.; Schleicher, Lauren S.; Kennedy, Rebecca A.; Mangrulkar, Rajesh S.; Cleary, James F.; Marsella, Stacy C.; Becker, Daniel M.

2016-01-01

Objectives To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group’s experiences and learning preferences. Methods A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR’s intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. Secondary outcomes: student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. Results MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. Conclusions MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. Practice Implications MPathic-VR’s virtual human simulation offers an effective and engaging means of advanced communication training. PMID:27939846

Socioeconomic Status and Improvements in Lifestyle, Coronary Risk Factors, and Quality of Life: The Multisite Cardiac Lifestyle Intervention Program

PubMed Central

Govil, Sarah R.; Merritt-Worden, Terri; Ornish, Dean

2009-01-01

Objectives. We sought to clarify whether patients of low socioeconomic status (SES) can make lifestyle changes and show improved outcomes in coronary heart disease (CHD), similar to patients with higher SES. Methods. We examined lifestyle, risk factors, and quality of life over 3 months, by SES and gender, in 869 predominantly White, nonsmoking CHD patients (34% female) in the insurance-sponsored Multisite Cardiac Lifestyle Intervention Program. SES was defined primarily by education. Results. At baseline, less-educated participants were more likely to be disadvantaged (e.g., past smoking, sedentary lifestyle, high fat diet, overweight, depression) than were higher-SES participants. By 3 months, participants at all SES levels reported consuming 10% or less dietary fat, exercising 3.5 hours per week or more, and practicing stress management 5.5 hours per week or more. These self-reports were substantiated by improvements in risk factors (e.g., 5-kg weight loss, and improved blood pressure, low-density lipoprotein cholesterol, and exercise capacity; P < .001), and accompanied by improvements in well-being (e.g., depression, hostility, quality of life; P < .001). Conclusions. The observed benefits for CHD patients with low SES indicate that broadening accessibility of lifestyle programs through health insurance should be strongly encouraged. PMID:18923113

Informatics tools to improve clinical research study implementation.

PubMed

Brandt, Cynthia A; Argraves, Stephanie; Money, Roy; Ananth, Gowri; Trocky, Nina M; Nadkarni, Prakash M

2006-04-01

There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. We describe an approach that emphasizes the use of a variety of informatics tools that can facilitate study coordination, training, data checks and early identification and correction of faulty procedures and data problems. The paper focuses on informatics tools that can help in case report form design, procedures and training and data management. Informatics tools can be used to facilitate study coordination and implementation of clinical research trials.

How Can Multi-Site Evaluations Be Participatory?

ERIC Educational Resources Information Center

Lawrenz, Frances; Huffman, Douglas

2003-01-01

Multi-site evaluations are becoming increasingly common in federal funding portfolios. Although much thought has been given to multi-site evaluation, there has been little emphasis on how it might interact with participatory evaluation. Therefore, this paper reviews several National Science Foundation educational, multi-site evaluations for the…

A Mobile Health Strategy to Support Adherence to Antiretroviral Preexposure Prophylaxis.

PubMed

Fuchs, Jonathan D; Stojanovski, Kristefer; Vittinghoff, Eric; McMahan, Vanessa M; Hosek, Sybill G; Amico, K Rivet; Kouyate, Aminta; Gilmore, Hailey J; Buchbinder, Susan P; Lester, Richard T; Grant, Robert M; Liu, Albert Y

2018-03-01

Preexposure prophylaxis is a highly protective HIV prevention strategy, yet nonadherence can significantly reduce its effectiveness. We conducted a mixed methods evaluation of a mobile health intervention (iText) that utilized weekly bidirectional text or e-mail support messages to encourage preexposure prophylaxis (PrEP) adherence among participants in the multi-site iPrEx open-label extension study. A convenience sample of PrEP users from the San Francisco and Chicago sites participated in a 12-week pilot study. Fifty-six men who have sex with men were enrolled; a quarter of them were less than 30 years of age, 13% were black/African American, 11% were Latino, and most (88%) completed some college. Two-thirds opted for text message delivery. Of the 667 messages sent, only 1 individual requested support; initial nonresponse was observed in 22% and was higher among e-mail compared to text message recipients. Poststudy, a majority of participants would recommend the intervention to others, especially during PrEP initiation. Moreover, younger participants and men of color were more likely to report that they would use the iText strategy if it were available to them. Several participants commented that while they were aware that the messages were automated, they felt supported and encouraged that "someone was always there." Study staff reported that the intervention is feasible to administer and can be incorporated readily into clinic flow. A pre-post intervention regression discontinuity analysis using clinic-based pill counts showed a 50% reduction in missed doses [95% confidence interval (CI) 16-71; p = 0.008] and 77% (95% CI 33-92; p = 0.007) when comparing pill counts at quarterly visits just before and after iText enrollment. A mobile health intervention using weekly bidirectional messaging was highly acceptable and demonstrated promising effects on PrEP adherence warranting further evaluation for efficacy in a randomized controlled trial.

DIABETES, DEPRESSION, AND DEATH: A RANDOMIZED CONTROLLED TRIAL OF A DEPRESSION TREATMENT PROGRAM FOR OLDER ADULTS BASED IN PRIMARY CARE (PROSPECT)

PubMed Central

Bogner, Hillary R; Morales, Knashawn H; Post, Edward P; Bruce, Martha L

2009-01-01

OBJECTIVE Our a priori hypothesis was that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared to depressed patients with diabetes in usual care practices. RESEARCH DESIGN AND METHODS Multi-site practice-randomized controlled trial PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 5/99-8/01 and supplemented with a search of the National Death Index. Twenty primary care practices participated from New York City, Philadelphia, and Pittsburgh. In all, 584 participants who were identified though a two-stage, age-stratified (60-74; 75+) depression screening of randomly sampled patients and were classified as depressed with complete information on diabetes status are included in these analyses. Of all the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the Intervention Condition were less likely to have died during the 5-year follow-up interval than were depressed persons with diabetes in Usual Care after accounting for baseline differences among patients (adjusted hazard ratio 0.49, 95% CI [0.24, 0.98]). CONCLUSIONS Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than were depressed patients with diabetes in usual care practices. PMID:17717284

Hip kinetics during gait are clinically meaningful outcomes in young boys with Duchenne muscular dystrophy.

PubMed

Heberer, Kent; Fowler, Eileen; Staudt, Loretta; Sienko, Susan; Buckon, Cathleen E; Bagley, Anita; Sison-Williamson, Mitell; McDonald, Craig M; Sussman, Michael D

2016-07-01

Duchenne muscular dystrophy (DMD) is an X-linked genetic neuromuscular disorder characterized by progressive proximal to distal muscle weakness. The success of randomized clinical trials for novel therapeutics depends on outcome measurements that are sensitive to change. As the development of motor skills may lead to functional improvements in young boys with DMD, their inclusion may potentially confound clinical trials. Three-dimensional gait analysis is an under-utilized approach that can quantify joint moments and powers, which reflect functional muscle strength. In this study, gait kinetics, kinematics, spatial-temporal parameters, and timed functional tests were quantified over a one-year period for 21 boys between 4 and 8 years old who were enrolled in a multisite natural history study. At baseline, hip moments and powers were inadequate. Between the two visits, 12 boys began a corticosteroid regimen (mean duration 10.8±2.4 months) while 9 boys remained steroid-naïve. Significant between-group differences favoring steroid use were found for primary kinetic outcomes (peak hip extensor moments (p=.007), duration of hip extensor moments (p=.007), peak hip power generation (p=.028)), and spatial-temporal parameters (walking speed (p=.016) and cadence (p=.021)). Significant between-group differences were not found for kinematics or timed functional tests with the exception of the 10m walk test (p=.03), which improves in typically developing children within this age range. These results indicate that hip joint kinetics can be used to identify weakness in young boys with DMD and are sensitive to corticosteroid intervention. Inclusion of gait analysis may enhance detection of a treatment effect in clinical trials particularly for young boys with more preserved muscle function. Copyright © 2016 Elsevier B.V. All rights reserved.

Cigarette Smoking During Substance Use Disorder Treatment: Secondary Outcomes from a National Drug Abuse Treatment Clinical Trials Network study.

PubMed

McClure, Erin A; Campbell, Aimee N C; Pavlicova, Martina; Hu, Meichen; Winhusen, Theresa; Vandrey, Ryan G; Ruglass, Lesia M; Covey, Lirio S; Stitzer, Maxine L; Kyle, Tiffany L; Nunes, Edward V

2015-06-01

The majority of patients enrolled in treatment for substance use disorders (SUDs) also use tobacco. Many will continue to use tobacco even during abstinence from other drugs and alcohol, often leading to smoking-related illnesses. Despite this, little research has been conducted to assess the influence of being a smoker on SUD treatment outcomes and changes in smoking during a treatment episode. In this secondary analysis, cigarette smoking was evaluated in participants completing outpatient SUD treatment as part of a multi-site study conducted by the National Drug Abuse Treatment Clinical Trials Network. Analyses included the assessment of changes in smoking and nicotine dependence via the Fagerström Test for Nicotine Dependence during the 12-week study among all smokers (aim #1), specifically among those in the experimental treatment group (aim #2), and the moderating effect of being a smoker on treatment outcomes (aim #3). Participants generally did not reduce or quit smoking throughout the course of the study. Among a sub-set of participants with higher baseline nicotine dependence scores randomized to the control arm, scores at the end of treatment were lower compared to the experimental arm, though measures of smoking quantity did not appear to decrease. Further, being a smoker was associated with poorer treatment outcomes compared to non-smokers enrolled in the trial. This study provides evidence that patients enrolled in community-based SUD treatment continue to smoke, even when abstaining from drugs and alcohol. These results add to the growing literature encouraging the implementation of targeted, evidence-based interventions to promote abstinence from tobacco among SUD treatment patients. Copyright © 2015 Elsevier Inc. All rights reserved.

HIV salvage therapy does not require nucleoside reverse transcriptase inhibitors: a randomized trial

PubMed Central

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-01-01

Background Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral (ARV) regimens in treatment-experienced patients in the absence of data from randomized trials. Objective To compare treatment success between participants who omit versus Add NRTIs to an optimized ARV regimen of three or more agents. Design Multisite, randomized, controlled trial. Setting Outpatient HIV clinics. Participants HIV-infected patients with three-class ARV experience and/or viral resistance. Intervention Open-label optimized regimens (not including NRTIs) were selected based upon treatment history and susceptibility testing. Participants were randomized to Omit or Add NRTIs. Measurements The primary efficacy outcome was regimen failure through week 48, using a non-inferiority margin of 15%. The primary safety outcome was time to initial episode of severe sign/symptom or laboratory abnormality prior to discontinuation of NRTI assignment. Results 360 participants were randomized and 93% completed a week 48 visit. The cumulative probability of regimen failure was 29.8% in the Omit NRTI arm versus 25.9% in the Add NRTI arm (difference= 3.2%: 95% CI, −6.1 to 12.5). There were no significant differences in the primary safety endpoints or the proportion of participants with HIV RNA <50 copies/mL between arms. No deaths occurred in the Omit NRTIs arm, compared with 7 deaths in the Add NRTIs arm. Limitations Non-blinded study design and may not be applicable to resource poor settings. Conclusion HIV-infected treatment-experienced patients starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. PMID:26595748

Conducting a Multisite Education Research Project: Strategies to Overcome the Barriers to Achieve the Benefits.

PubMed

Beischel, Kelly P; Hart, Julie; Turkelson, Sandra L

2016-01-01

Multisite education research projects have many benefits as well as perceived barriers. In this article, we share our experiences with a multisite education research project and the barriers we overcame to reap the benefits. The outcome of our research resulted in increased rigor, role-modeling professional collaboration, and promotion of future multisite education studies. The strategies presented in this article will help alleviate perceived barriers and ameliorate the process of conducting multisite education research studies.

Can augmented physiotherapy input enhance recovery of mobility after stroke? A randomized controlled trial.

PubMed

2004-08-01

To discover if the provision of additional inpatient physiotherapy after stroke speeds the recovery of mobility. A multisite single-blind randomized controlled trial (RCT) comparing the effects of augmented physiotherapy input with normal input on the recovery of mobility after stroke. Three rehabilitation hospitals in North Glasgow, Scotland. Patients admitted to hospital with a clinical diagnosis of stroke, who were able to tolerate and benefit from mobility rehabilitation. We aimed to provide double the amount of physiotherapy to the augmented group. Primary outcomes were mobility milestones (ability to stand, step and walk), Rivermead Mobility Index (RMI) and walking speed. Seventy patients were recruited. The augmented therapy group received more direct contact with a physiotherapist (62 versus 35 minutes per weekday) and were more active (8.0% versus 4.8% time standing or walking) than normal therapy controls. The augmented group tended to achieve independent walking earlier (hazard ratio 1.48, 95% confidence interval 0.90-2.43; p=0.12) and had higher Rivermead Mobility Index scores at three months (mean difference 1.6; -0.1 to 3.3; p=0.068) but these differences did not reach statistical significance. There was no significant difference in any other outcome. A modest augmented physiotherapy programme resulted in patients having more direct physiotherapy time and being more active. The inability to show statistically significant changes in outcome measures could indicate either that this intervention is ineffective or that our study could not detect modest changes.

Effect of Escitalopram on Hot Flash Interference: A Randomized, Controlled Trial

PubMed Central

Carpenter, Janet S.; Guthrie, Katherine A.; Larson, Joseph C.; Freeman, Ellen W.; Joffe, Hadine; Reed, Susan D.; Ensrud, Kristine E.; LaCroix, Andrea Z.

2012-01-01

Objectives To estimate the effect of escitalopram 10–20 mg/day versus placebo for reducing hot flash interference in daily life and understand correlates and predictors of reductions in hot flash interference, a key measure of quality of life. Design Multi-site, randomized, double-blind, placebo-controlled clinical trial. Patients 205 midlife women (46% African-American) who met criteria participated. Setting MsFLASH clinical sites in Boston, Indianapolis, Oakland, and Philadelphia. Intervention After baseline, women were randomized to 1 pill of escitalopram 10 mg/day (n=104) or placebo (n=101) with follow-up at 4- and 8-weeks. At week 4, those not achieving 50% fewer hot flashes were increased to 2 pills daily (20 mg/day or 2 placebo pills). Main outcome measures The Hot Flash Related Daily Interference Scale; Correlates were variables from hot flash diaries; Predictors were baseline demographics, clinical variables, depression, anxiety, sleep quality, and hot flashes. Results Compared to placebo, escitalopram significantly reduced hot flash interference by 6.0 points at week 4 and 3.4 points at week 8 more than placebo (p=0.012). Reductions in hot flash interference correlated with changes in hot flash diary variables. However, baseline variables did not significantly predict reductions in hot flash interference. Conclusions Escitalopram 10–20mg/day for 8 weeks improves women’s quality of life and this benefit did not vary by demographic, clinical, mood, sleep, or hot flash variables. PMID:22480818

Results of a multisite randomized trial of supported employment interventions for individuals with severe mental illness.

PubMed

Cook, Judith A; Leff, H Stephen; Blyler, Crystal R; Gold, Paul B; Goldberg, Richard W; Mueser, Kim T; Toprac, Marcia G; McFarlane, William R; Shafer, Michael S; Blankertz, Laura E; Dudek, Ken; Razzano, Lisa A; Grey, Dennis D; Burke-Miller, Jane

2005-05-01

National probability surveys indicate that most individuals with schizophrenia and other severe mental illnesses are not employed. This multisite study tested the effectiveness of supported employment (SE) models combining clinical and vocational rehabilitation services to establish competitive employment. We randomly assigned 1273 outpatients with severe mental illness from 7 states in the United States to an experimental SE program or to a comparison or a services-as-usual condition, with follow-up for 24 months. Participants were interviewed semiannually, paid employment was tracked weekly, and vocational and clinical services were measured monthly. Mixed-effects random regression analysis was used to predict the likelihood of competitive employment, working 40 or more hours in a given month, and monthly earnings. Cumulative results during 24 months show that experimental group participants (359/648 [55%]) were more likely than those in the comparison programs (210/625 [34%]) to achieve competitive employment (chi(2) = 61.17; P<.001). Similarly, patients in experimental group programs (330/648 [51%]) were more likely than those in comparison programs (245/625 [39%]) to work 40 or more hours in a given month (chi(2) = 17.66; P<.001). Finally, participants in experimental group programs had significantly higher monthly earnings than those in the comparison programs (mean, US 122 dollars/mo [n=639] vs US 99 dollars/mo [n=622]); t(1259) = -2.04; P<.05). In the multivariate longitudinal analysis, experimental condition subjects were more likely than comparison group subjects to be competitively employed, work 40 or more hours in a given month, and have higher earnings, despite controlling for demographic, clinical, work history, disability beneficiary status, and study site confounders. Moreover, the advantage of experimental over comparison group participants increased during the 24-month study period. The SE models tailored by integrating clinical and vocational services were more effective than services as usual or unenhanced services.

Multisite evaluation of environmental cleanliness of high-touch surfaces in intensive care unit patient rooms.

PubMed

Hopman, Joost; Donskey, Curtis J; Boszczowski, Icaro; Alfa, Michelle J

2018-05-23

The efficacy of discharge cleaning and disinfection of high-touch surfaces of intensive care unit patient rooms in Brazil, Canada, the Netherlands, and the United States was evaluated and the effect of an educational intervention was determined. Significant site-to-site differences in cleaning regimens and baseline cleanliness levels were observed using ATP levels, colony-forming units, and reflective surface marker removal percent pass rates. An educational intervention that includes rapid feedback of the ATP measurements could significantly improve the quality of the cleaning and disinfection regimens. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

The National Trauma Institute: Lessons learned in the funding and conduct of 16 trauma research studies.

PubMed

Price, Michelle A; Beilman, Gregory J; Fabian, Timothy C; Hoyt, David B; Jurkovich, Gregory J; Knudson, M Margaret; MacKenzie, Ellen J; Marshall, Vivienne S; Overton, Kimberly E; Peitzman, Andrew B; Phillips, Monica J; Pruitt, Basil A; Smith, Sharon L; Stewart, Ronald M; Jenkins, Donald H

2016-09-01

To increase trauma-related research and elevate trauma on the national research agenda, the National Trauma Institute (NTI) issued calls for proposals, selected funding recipients, and coordinated 16 federally funded (Department of Defense) trauma research awards over a 4-year period. We sought to collect and describe the lessons learned from this activity to inform future researchers of barriers and facilitators. Fifteen principal investigators participated in semistructured interviews focused on study management issues such as securing institutional approvals, screening and enrollment, multisite trials management, project funding, staffing, and institutional support. NTI Science Committee meeting minutes and study management data were included in the analysis. Simple descriptive statistics were generated and textual data were analyzed for common themes. Principal investigators reported challenges in obtaining institutional approvals, delays in study initiation, screening and enrollment, multisite management, and study funding. Most were able to successfully resolve challenges and have been productive in terms of scholarly publications, securing additional research funding, and training future trauma investigators. Lessons learned in the conduct of the first two funding rounds managed by NTI are instructive in four key areas: regulatory processes, multisite coordination, adequate funding, and the importance of an established research infrastructure to ensure study success. Recommendations for addressing institution-related and investigator-related challenges are discussed along with ongoing advocacy efforts to secure sustained federal funding of a national trauma research program commensurate with the burden of injury.

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2014-02-01

updates on any changes to the IRB or submission process and to answer any questions. Attendance is prioritized to maintain a relationship with the...inclusion, which would assess areas related to social support and integration, use of prescription, drugs , readiness to engage in treatment, and...inclusion/exclusion criteria  (4) TBI, psychosis , cognitive impairment  (90) Ideation without attempt  (6) Not active duty, retired, or veteran  30

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2013-02-01

author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. 1...Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that...required, WRNMMC credentialing office will NOT renew privileges unless a peer review can be conducted. However, as it currently stands, peer review

Clinical Research That Matters: Designing Outcome-Based Research for Older Adults to Qualify for Systematic Reviews and Meta-Analyses.

PubMed

Lee, Jeannie K; Fosnight, Susan M; Estus, Erica L; Evans, Paula J; Pho, Victoria B; Reidt, Shannon; Reist, Jeffrey C; Ruby, Christine M; Sibicky, Stephanie L; Wheeler, Janel B

2018-01-01

Though older adults are more sensitive to the effects of medications than their younger counterparts, they are often excluded from manufacturer-based clinical studies. Practice-based research is a practical method to identify medication-related effects in older patients. This research also highlights the role of a pharmacist in improving care in this population. A single study rarely has strong enough evidence to change geriatric practice, unless it is a large-scale, multisite, randomized controlled trial that specifically targets older adults. It is important to design studies that may be used in systematic reviews or meta-analyses that build a stronger evidence base. Recent literature has documented a gap in advanced pharmacist training pertaining to research skills. In this paper, we hope to fill some of the educational gaps related to research in older adults. We define best practices when deciding on the type of study, inclusion and exclusion criteria, design of the intervention, how outcomes are measured, and how results are reported. Well-designed studies increase the pool of available data to further document the important role that pharmacists have in optimizing care of older patients.

The efficacy of gum chewing in reducing postoperative ileus: a multisite randomized controlled trial.

PubMed

Forrester, David Anthony Tony; Doyle-Munoz, Janet; McTigue, Toni; D'Andrea, Stephanie; Natale-Ryan, Angela

2014-01-01

The purpose of this prospective, attention-controlled, randomized study was to determine whether postoperative gum chewing reduces the duration of postoperative ileus symptoms following elective open or laparoscopic sigmoid colectomy when compared with standard care or an attention-control intervention. Forty-seven subjects scheduled for either an open or laparoscopic colon resection participated in the study. Subjects were recruited preoperatively at the preadmission learning centers of the 2 acute care medical centers that comprised the study settings. Subjects were randomized to 3 groups: (1) standard postoperative care (n = 18); (2) standard care and a silicone-adhesive patch applied to the deltoid region of the upper arm as an attention control (n = 16); and (3) standard care and gum chewing (n = 13). Standard postoperative care included removal of the nasogastric tube, early ambulation, nothing by mouth with ice chips only until the first passage of flatus, and then advancement of diet until tolerance of solid food. No statistically significant differences were found among the 3 study groups for the 4 postoperative outcome variables measured: (1) first passage of flatus; (2) first bowel movement; (3) return of hunger; and (4) ability to tolerate solid food for one meal. Postoperative gum chewing was not found to be more effective than standard postoperative care or our attention-control intervention in reducing the duration of postoperative ileus symptoms, length of stay, or complications among patients following open/laparoscopic sigmoid colectomy.

Trauma Collaborative Care Intervention: Effect on Surgeon Confidence in Managing Psychosocial Complications After Orthopaedic Trauma.

PubMed

Wegener, Stephen T; Carroll, Eben A; Gary, Joshua L; McKinley, Todd O; OʼToole, Robert V; Sietsema, Debra L; Castillo, Renan C; Frey, Katherine P; Scharfstein, Daniel O; Huang, Yanjie; Collins, Susan C J; MacKenzie, Ellen J

2017-08-01

The impact of the Trauma Collaborative Care (TCC) program on surgeon confidence in managing the psychosocial sequelae of orthopaedic trauma was evaluated as part of a larger prospective, multisite, cluster clinical trial. We compared confidence and perceived resource availability among surgeons practicing in trauma centers that implemented the TCC program with orthopaedic trauma surgeons in similar trauma centers that did not implement the TCC. Prospective cohort design. Level-I trauma centers. Attending surgeons and fellows (N = 95 Pre and N = 82 Post). Self-report 10-item measure of surgeon confidence in managing psychosocial issues associated with trauma and perceived availability of support resources. Analyses, performed on the entire sample and repeated on the subset of 52 surgeons who responded to the survey at both times points, found surgeons at intervention sites experienced a significantly greater positive improvement (P < 0.05) in their (1) belief that they have strategies to help orthopaedic trauma patients change their psychosocial situation; (2) confidence in making appropriate referrals for orthopaedic trauma patients with psychosocial problems; and (3) belief that they have access to information to guide the management of psychosocial issues related to recovery. Initial data suggest that the establishment of the TCC program can improve surgeons' perceived availability of resources and their confidence in managing the psychosocial sequelae after injury. Further studies will be required to determine if this translates into beneficial patient effects. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial.

PubMed

McMurran, Mary; Cox, W Miles; Whitham, Diane; Hedges, Lucy

2013-02-17

There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users' readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants' therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. ClinicalTrials.Gov.UK Identifier - NCT01132976.

Crew resource management training in the intensive care unit. A multisite controlled before-after study.

PubMed

Kemper, Peter F; de Bruijne, Martine; van Dyck, Cathy; So, Ralph L; Tangkau, Peter; Wagner, Cordula

2016-08-01

There is a growing awareness today that adverse events in the intensive care unit (ICU) are more often caused by problems related to non-technical skills than by a lack of technical, or clinical, expertise. Team training, such as crew resource management (CRM), aims to improve these non-technical skills. The present study evaluated the effectiveness of CRM in the ICU. Six ICUs participated in a paired controlled trial, with one pretest and two post-test measurements (after 3 and 12 months). Three ICUs received CRM training and were compared with a matched control unit. The 2-day classroom-based training was delivered to multidisciplinary groups (ie, ICU physicians, nurses, managers). All levels of Kirkpatrick's evaluation framework were assessed using a mixed method design, including questionnaires, observations and routinely administered patient outcome data. Level I-reaction: participants were very positive directly after the training. Level II-learning: attitudes towards behaviour aimed at optimising situational awareness were relatively high at baseline and remained stable. Level III-behaviour: self-reported behaviour aimed at optimising situational awareness improved in the intervention group. No changes were found in observed explicit professional oral communication. Level IV-organisation: patient outcomes were unaffected. Error management culture and job satisfaction improved in the intervention group. Patient safety culture improved in both control and intervention units. We can conclude that CRM, as delivered in the present study, does not change behaviour or patient outcomes by itself, yet changes how participants think about errors and risks. This indicates that CRM requires a combination with other initiatives in order to improve clinical outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Web-based treatment for substance use disorders: differential effects by primary substance.

PubMed

Cochran, Gerald; Stitzer, Maxine; Campbell, Aimee N C; Hu, Mei-Chen; Vandrey, Ryan; Nunes, Edward V

2015-06-01

This secondary analysis of data from a large, multi-site effectiveness trial (NCT01104805) sought to determine whether effects of a web-based behavioral treatment (Therapeutic Education System [TES]) differed by participants' self-identified primary drug of abuse. The all-comers sample of individuals entering outpatient psychosocial counseling treatment for substance abuse (N=497) cited cannabis (22.9%; n=114), stimulants (34.4%, n=171), opioids (21.7%, n=108), or alcohol (20.9%, n=104) as their primary substance of abuse. Participants were randomly assigned to receive treatment-as-usual (TAU) with or without TES substituted for approximately 2h of usual counseling. Multivariate analyses of abstinence outcomes examined interactions of treatment effects with primary substance. Adjusted odds ratios (AORs) demonstrated that primary stimulant users receiving TES were more likely to be abstinent in the final four weeks of treatment compared to stimulant users receiving TAU (AOR=3.59, 95% CI=1.25-10.27). Adjusted odds ratios for alcohol (AOR=3.15, 95% CI=0.85-11.65) and cannabis (AOR=2.64, 95% CI=0.73-9.52) also were of similar magnitude to stimulants but did not reach significance. Abstinence among primary opioid users was not improved by the TES intervention (AOR=0.35, 95% CI=0.09-1.47). This study supports the TES web-delivered treatment as a viable intervention for the majority of substance users entering outpatient counseling treatment, with demonstrated effectiveness among stimulant users and promising effects in alcohol and cannabis users but little or no effect in primary opioid users. Web-delivered treatments hold promise for expanding the availability of effective behavioral interventions for the majority of substance use disorders. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Juvenile Justice Behavioral Health Services Cascade: A New Framework for Measuring Unmet Substance Use Treatment Services Needs among Adolescent Offenders

PubMed Central

Knight, Danica; Wasserman, Gail A.; Dennis, Michael L.; Wiley, Tisha; Taxman, Faye S.; Oser, Carrie; Dembo, Richard; Robertson, Angela A.; Sales, Jessica

2017-01-01

Overview Substance use and substance use disorders are highly prevalent among youth under juvenile justice (JJ) supervision, and related to delinquency, psychopathology, social problems, risky sex and sexually transmitted infections, and health problems. However, numerous gaps exist in the identification of behavioral health (BH) problems and in the subsequent referral, initiation and retention in treatment for youth in community justice settings. This reflects both organizational and systems factors, including coordination between justice and BH agencies. Methods and Results This paper presents a new framework, the Juvenile Justice Behavioral Health Services Cascade (“Cascade”), for measuring unmet substance use treatment needs to illustrate how the cascade approach can be useful in understanding service delivery issues and identifying strategies to improve treatment engagement and outcomes for youth under community JJ supervision. We discuss the organizational and systems barriers for linking delinquent youth to BH services, and explain how the Cascade can help understand and address these barriers. We provide a detailed description of the sequential steps and measures of the Cascade, and then offer an example of its application from the Juvenile Justice – Translational Research on Interventions for Adolescents in the Legal System project (JJ-TRIALS), a multi-site research cooperative funded by the National Institute on Drug Abuse. Conclusion As illustrated with substance abuse treatment, the Cascade has potential for informing and guiding efforts to improve behavioral health service linkages for adolescent offenders, developing and testing interventions and policies to improve interagency and cross-systems coordination, and informing the development of measures and interventions for improving the implementation of treatment in complex multisystem service settings. PMID:28132705

Biphasic responses in multi-site phosphorylation systems.

PubMed

Suwanmajo, Thapanar; Krishnan, J

2013-12-06

Multi-site phosphorylation systems are repeatedly encountered in cellular biology and multi-site modification is a basic building block of post-translational modification. In this paper, we demonstrate how distributive multi-site modification mechanisms by a single kinase/phosphatase pair can lead to biphasic/partial biphasic dose-response characteristics for the maximally phosphorylated substrate at steady state. We use simulations and analysis to uncover a hidden competing effect which is responsible for this and analyse how it may be accentuated. We build on this to analyse different variants of multi-site phosphorylation mechanisms showing that some mechanisms are intrinsically not capable of displaying this behaviour. This provides both a consolidated understanding of how and under what conditions biphasic responses are obtained in multi-site phosphorylation and a basis for discriminating between different mechanisms based on this. We also demonstrate how this behaviour may be combined with other behaviour such as threshold and bistable responses, demonstrating the capacity of multi-site phosphorylation systems to act as complex molecular signal processors.

A Complier Average Causal Effect Analysis of the Stimulant Reduction Intervention using Dosed Exercise Study.

PubMed

Carmody, Thomas; Greer, Tracy L; Walker, Robrina; Rethorst, Chad D; Trivedi, Madhukar H

2018-06-01

Exercise is a promising treatment for substance use disorders, yet an intention-to-treat analysis of a large, multi-site study found no reduction in stimulant use for exercise versus health education. Exercise adherence was sub-optimal; therefore, secondary post-hoc complier average causal effects (CACE) analysis was conducted to determine the potential effectiveness of adequately dosed exercise. The STimulant use Reduction Intervention using Dosed Exercise study was a randomized controlled trial comparing a 12 kcal/kg/week (KKW) exercise dose versus a health education control conducted at nine residential substance use treatment settings across the U.S. that are affiliated with the National Drug Abuse Treatment Clinical Trials Network. Participants were sedentary but medically approved for exercise, used stimulants within 30 days prior to study entry, and received a DSM-IV stimulant abuse or dependence diagnosis within the past year. A CACE analysis adjusted to include only participants with a minimum threshold of adherence (at least 8.3 KKW) and using a negative-binomial hurdle model focused on 218 participants who were 36.2% female, mean age 39.4 years ( SD =11.1), and averaged 13.0 ( SD =9.2) stimulant use days in the 30 days before residential treatment. The outcome was days of stimulant use as assessed by the self-reported TimeLine Follow Back and urine drug screen results. The CACE-adjusted analysis found a significantly lower probability of relapse to stimulant use in the exercise group versus the health education group (41.0% vs. 55.7%, p <.01) and significantly lower days of stimulant use among those who relapsed (5.0 days vs. 9.9 days, p <.01). The CACE adjustment revealed significant, positive effects for exercise. Further research is warranted to develop strategies for exercise adherence that can ensure achievement of an exercise dose sufficient to produce a significant treatment effect.

The Effect of Telephone-Based Cognitive-Behavioral Therapy on Postnatal Depression: A Randomized Controlled Trial.

PubMed

Ngai, Fei-Wan; Wong, Paul Wai-Ching; Leung, Kwok-Yin; Chau, Pui-Hing; Chung, Ka-Fai

2015-01-01

Cognitive-behavioral therapy (CBT) is one of the most effective interventions for postnatal depression. However, few studies have evaluated the effect of CBT delivered via telephone for newborn mothers. The purpose of this study was to evaluate the efficacy of telephone-based CBT for postnatal depression at 6 weeks and 6 months postpartum. A multisite randomized controlled trial was conducted in the postnatal units at 3 regional hospitals in Hong Kong. A total of 397 women with an Edinburgh Postnatal Depression Scale (EPDS) score ≥10 on the second or third day postpartum were randomized to receive telephone-based CBT (n = 197) or standard care (n = 200). Primary outcome was the total EPDS score. A cutoff score of 9/10 on the EPDS was used to define women at risk of postnatal depression. Telephone-based CBT was associated with significantly lower depressive symptoms compared with standard care, when assessed at 6 weeks postpartum in the subgroups of mothers with minor depression (EPDS 10-12; difference = 1.90, 95% CI: 0.72-3.08; p = 0.002) and major depression (EPDS ≥13; difference = 5.00, 95% CI: 3.12-6.88; p < 0.001). The effect was sustained at 6 months postpartum in the subgroup with minor depression (difference = 1.20, 95% CI: 0.09-2.32; p = 0.034) but not significant in the subgroup with major depression (difference = 1.69, 95% CI: -0.10-3.47; p = 0.064). The proportion of women who satisfied our definition of postnatal depression was significantly lower in the intervention group at 6 weeks (difference = 23.3%, 95% CI: 13.7-33.0%; p < 0.001) and 6 months postpartum (difference = 11.4%, 95% CI: 1.9-20.8%; p = 0.019). Telephone-based CBT produced a significantly greater reduction in depressive symptoms than standard care during the postpartum period. © 2015 S. Karger AG, Basel.

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial.

PubMed

McMurran, Mary; Day, Florence; Reilly, Joseph; Delport, Juan; McCrone, Paul; Whitham, Diane; Tan, Wei; Duggan, Conor; Montgomery, Alan A; Williams, Hywel C; Adams, Clive E; Jin, Huajie; Moran, Paul; Crawford, Mike J

2017-12-01

We compared psychoeducation and problem solving (PEPS) therapy against usual treatment in a multisite randomized-controlled trial. The primary outcome was social functioning. We aimed to recruit 444 community-dwelling adults with personality disorder; however, safety concerns led to an early cessation of recruitment. A total of 154 people were randomized to PEPS and 152 to usual treatment. Follow-up at 72 weeks was completed for 68%. PEPS therapy was no more effective than usual treatment for improving social functioning (adjusted difference in mean Social Functioning Questionnaire scores = -0.73; 95% CI [-1.83, 0.38]; p = 0.19). PEPS therapy is not an effective treatment for improving social functioning of adults with personality disorder living in the community.

Developing a video intervention to model effective patient-physician communication and health-related decision-making skills for a multiethnic audience.

PubMed

Richter, D L; Greaney, M L; McKeown, R E; Cornell, C E; Littleton, M A; Pulley, L; Groff, J Y; Byrd, T L; Herman, C J

2001-01-01

The ENDOW study is a multisite, community-based project designed to improve decision-making and patient-physician communication skills for midlife African-American, white, and Hispanic women facing decisions about hysterectomy. Based on results of initial focus groups, a patient education video was developed in English and Spanish to serve as the centerpiece of various interventions. The video uses community women to model appropriate decision-making and patient-physician communication skills. Women in the target populations rated the video as useful to very useful and would recommend it to others. The use of theory-driven approaches and pilot testing of draft products resulted in the production of a well-accepted, useful video suitable for diverse populations in intervention sites in several states.

Health diplomacy the adaptation of global health interventions to local needs in sub-Saharan Africa and Thailand: Evaluating findings from Project Accept (HPTN 043)

PubMed Central

2012-01-01

Background Study-based global health interventions, especially those that are conducted on an international or multi-site basis, frequently require site-specific adaptations in order to (1) respond to socio-cultural differences in risk determinants, (2) to make interventions more relevant to target population needs, and (3) in recognition of ‘global health diplomacy' issues. We report on the adaptations development, approval and implementation process from the Project Accept voluntary counseling and testing, community mobilization and post-test support services intervention. Methods We reviewed all relevant documentation collected during the study intervention period (e.g. monthly progress reports; bi-annual steering committee presentations) and conducted a series of semi-structured interviews with project directors and between 12 and 23 field staff at each study site in South Africa, Zimbabwe, Thailand and Tanzania during 2009. Respondents were asked to describe (1) the adaptations development and approval process and (2) the most successful site-specific adaptations from the perspective of facilitating intervention implementation. Results Across sites, proposed adaptations were identified by field staff and submitted to project directors for review on a formally planned basis. The cross-site intervention sub-committee then ensured fidelity to the study protocol before approval. Successfully-implemented adaptations included: intervention delivery adaptations (e.g. development of tailored counseling messages for immigrant labour groups in South Africa) political, environmental and infrastructural adaptations (e.g. use of local community centers as VCT venues in Zimbabwe); religious adaptations (e.g. dividing clients by gender in Muslim areas of Tanzania); economic adaptations (e.g. co-provision of income generating skills classes in Zimbabwe); epidemiological adaptations (e.g. provision of ‘youth-friendly’ services in South Africa, Zimbabwe and Tanzania), and social adaptations (e.g. modification of terminology to local dialects in Thailand: and adjustment of service delivery schedules to suit seasonal and daily work schedules across sites). Conclusions Adaptation selection, development and approval during multi-site global health research studies should be a planned process that maintains fidelity to the study protocol. The successful implementation of appropriate site-specific adaptations may have important implications for intervention implementation, from both a service uptake and a global health diplomacy perspective. PMID:22716131

The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial.

PubMed

O'Dwyer, Susan Mary; MacHale, Elaine; Sulaiman, Imran; Holmes, Martin; Hughes, Cian; D'Arcy, Shona; Rapcan, Viliam; Taylor, Terence; Boland, Fiona; Bosnic-Anticevich, Sinthia; Reilly, Richard B; Ryder, Sheila A; Costello, Richard W

2016-05-04

Poor adherence to inhaled medication may lead to inadequate symptom control in patients with respiratory disease. In practice it can be difficult to identify poor adherence. We designed an acoustic recording device, the INCA® (INhaler Compliance Assessment) device, which, when attached to an inhaler, identifies and records the time and technique of inhaler use, thereby providing objective longitudinal data on an individual's adherence to inhaled medication. This study will test the hypothesis that providing objective, personalised, visual feedback on adherence to patients in combination with a tailored educational intervention in a community pharmacy setting, improves adherence more effectively than education alone. The study is a prospective, cluster randomised, parallel-group, multi-site study conducted over 6 months. The study is designed to compare current best practice in care (i.e. routine inhaler technique training) with the use of the INCA® device for respiratory patients in a community pharmacy setting. Pharmacies are the unit of randomisation and on enrolment to the study they will be allocated by the lead researcher to one of the three study groups (intervention, comparator or control groups) using a computer-generated list of random numbers. Given the nature of the intervention neither pharmacists nor participants can be blinded. The intervention group will receive feedback from the acoustic recording device on inhaler technique and adherence three times over a 6-month period along with inhaler technique training at each of these times. The comparator group will also receive training in inhaler use three times over the 6-month study period but no feedback on their habitual performance. The control group will receive usual care (i.e. the safe supply of medicines and advice on their use). The primary outcome is the rate of participant adherence to their inhaled medication, defined as the proportion of correctly taken doses of medication at the correct time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05. This clinical trial will establish whether providing personalised feedback to individuals on their inhaler use improves adherence. It may also be possible to enhance the role of pharmacists in clinical care by identifying patients in whom alteration of either therapy or inhaler device is appropriate. ClinicalTrials.gov NCT02203266 .

Efficacy vs effectiveness trial results of an indicated "model" substance abuse program: implications for public health.

PubMed

Hallfors, Denise; Cho, Hyunsan; Sanchez, Victoria; Khatapoush, Shereen; Kim, Hyung Min; Bauer, Daniel

2006-12-01

The US Department of Education requires schools to choose substance abuse and violence prevention programs that meet standards of effectiveness. The Substance Abuse and Mental Health Services Agency certifies "model" programs that meet this standard. We compared findings from a large, multisite effectiveness trial of 1 model program to its efficacy trial findings, upon which the certification was based. 1370 high-risk youths were randomized to experimental or control groups across 9 high schools in 2 large urban school districts. We used intent-to-treat and on-treatment approaches to examine baseline equivalence, attrition, and group differences in outcomes at the end of the program and at a 6-month follow-up. Positive efficacy trial findings were not replicated in the effectiveness trial. All main effects were either null or worse for the experimental than for the control group. These findings suggest that small efficacy trials conducted by developers provide insufficient evidence of effectiveness. Federal agencies and public health scientists must work together to raise the standards of evidence and ensure that data from new trials are incorporated into ongoing assessments of program effects.

Policies and Practices in the Delivery of HIV Services in Correctional Agencies and Facilities: Results from a Multi-Site Survey

PubMed Central

Belenko, Steven; Hiller, Matthew; Visher, Christy; Copenhaver, Michael; O’Connell, Daniel; Burdon, William; Pankow, Jennifer; Clarke, Jennifer; Oser, Carrie

2013-01-01

HIV risk is disproportionately high among incarcerated individuals. Corrections agencies have been slow to implement evidence-based guidelines and interventions for HIV prevention, testing, and treatment. The emerging field of implementation science focuses on organizational interventions to facilitate adoption and implementation of evidence-based practices. A survey of among CJ-DATS correctional agency partners revealed that HIV policies and practices in prevention, detection and medical care varied widely, with some corrections agencies and facilities closely matching national guidelines and/or implementing evidence-based interventions. Others, principally attributed to limited resources, had numerous gaps in delivery of best HIV service practices. A brief overview is provided of a new CJ-DATS cooperative research protocol, informed by the survey findings, to test an organization-level intervention to reduce HIV service delivery gaps in corrections. PMID:24078624

Multi-site pain and working conditions as predictors of work ability in a 4-year follow-up among food industry employees.

PubMed

Neupane, S; Virtanen, P; Leino-Arjas, P; Miranda, H; Siukola, A; Nygård, C-H

2013-03-01

We investigated the separate and joint effects of multi-site musculoskeletal pain and physical and psychosocial exposures at work on future work ability. A survey was conducted among employees of a Finnish food industry company in 2005 (n = 1201) and a follow-up survey in 2009 (n = 734). Information on self-assessed work ability (current work ability on a scale from 0 to 10; 7 = poor work ability), multi-site musculoskeletal pain (pain in at least two anatomical areas of four), leisure-time physical activity, body mass index and physical and psychosocial exposures was obtained by questionnaire. The separate and joint effects of multi-site pain and work exposures on work ability at follow-up, among subjects with good work ability at baseline, were assessed by logistic regression, and p-values for the interaction derived. Compared with subjects with neither multi-site pain nor adverse work exposure, multi-site pain at baseline increased the risk of poor work ability at follow-up, allowing for age, gender, occupational class, body mass index and leisure-time physical activity. The separate effects of the work exposures on work ability were somewhat smaller than those of multi-site pain. Multi-site pain had an interactive effect with work environment and awkward postures, such that no association of multi-site pain with poor work ability was seen when work environment was poor or awkward postures present. The decline in work ability connected with multi-site pain was not increased by exposure to adverse physical or psychosocial factors at work. © 2012 European Federation of International Association for the Study of Pain Chapters.

Identifying Depressed Older Adults in Primary Care: A Secondary Analysis of a Multisite Randomized Controlled Trial

PubMed Central

Voils, Corrine I.; Olsen, Maren K.; Williams, John W.; for the IMPACT Study Investigators

2008-01-01

Objective: To determine whether a subset of depressive symptoms could be identified to facilitate diagnosis of depression in older adults in primary care. Method: Secondary analysis was conducted on 898 participants aged 60 years or older with major depressive disorder and/or dysthymic disorder (according to DSM-IV criteria) who participated in the Improving Mood–Promoting Access to Collaborative Treatment (IMPACT) study, a multisite, randomized trial of collaborative care for depression (recruitment from July 1999 to August 2001). Linear regression was used to identify a core subset of depressive symptoms associated with decreased social, physical, and mental functioning. The sensitivity and specificity, adjusting for selection bias, were evaluated for these symptoms. The sensitivity and specificity of a second subset of 4 depressive symptoms previously validated in a midlife sample was also evaluated. Results: Psychomotor changes, fatigue, and suicidal ideation were associated with decreased functioning and served as the core set of symptoms. Adjusting for selection bias, the sensitivity of these 3 symptoms was 0.012 and specificity 0.994. The sensitivity of the 4 symptoms previously validated in a midlife sample was 0.019 and specificity was 0.997. Conclusion: We identified 3 depression symptoms that were highly specific for major depressive disorder in older adults. However, these symptoms and a previously identified subset were too insensitive for accurate diagnosis. Therefore, we recommend a full assessment of DSM-IV depression criteria for accurate diagnosis. PMID:18311416

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

PubMed Central

Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

2014-01-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761