An ounce of prevention: A pre-randomization protocol to improve retention in substance use disorder clinical trials |
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| Institution: | 1. Department of Family and Community Medicine, The University of Texas Health Science Center at Houston (UTHealth), McGovern Medical School, Houston, TX 77030, USA;2. Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9119, USA;3. Department of Psychiatry and Behavioral Sciences, UTHealth, McGovern Medical School, Houston, TX 77030, USA;1. Division of Alcohol and Drug Abuse, McLean Hospital, 115 Mill Street, Belmont, MA 02478, United States;2. Department of Psychiatry, Harvard Medical School, 401 Park Drive, Boston, MA 02155, United States;3. Partners HealthCare, 800 Boylston Street, Boston, MA 02199, United States;1. Department of Population Health, New York University School of Medicine, New York, NY, USA;2. Institute of Social and Medical Studies, H18, Lot 12B, Trung Yen 10 Street, Trung Hoa Ward, Cau Giay, Hanoi, Viet Nam;3. New York University Rory Meyers College of Nursing, USA;1. Department of Public Health, Graduate School, Yonsei University, Seoul, South Korea;2. Institute of Health Services Research, Yonsei University College of Medicine, Seoul, South Korea;3. Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, South Korea;4. Department of Biostatistics, Graduate School of Public Health, Yonsei University, Seoul, South Korea;2. Department of Psychology, University of Alabama at Birmingham, Campbell, Hall 415 1530 3rd Avenue South Birmingham, AL 35294-1170, USA;3. Department of Psychiatry, University of Alabama at Birmingham, Sparks, Center 1720 7th Avenue South Birmingham, AL 35294-0017, USA |
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| Abstract: | BackgroundMissing 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.Methods/designSTimulant 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 12 weeks followed by 1/week for 24 weeks. 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.ResultsIndividuals 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).DiscussionProactive 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. |
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