Jaya Aysola1,2, Emin Tahirovic3, Andrea B Troxel2,3, David A Asch1,2,4,5, Kelsey Gangemi2, Amanda T Hodlofski2, Jingsan Zhu2, Kevin Volpp1,2,4,5,6. 1. 1 Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 2. 2 Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA. 3. 3 Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics (CCEB), University of Pennsylvania, Philadelphia, PA, USA. 4. 4 Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA. 5. 5 Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, USA. 6. 6 University of Pennsylvania Prevention Research Center, Philadelphia, PA, USA.
Abstract
PURPOSE: To examine the effect of an opt-out default recruitment strategy compared to a conventional opt-in strategy on enrollment and adherence to a behavioral intervention for poorly controlled diabetic patients. DESIGN: Randomized controlled trial. SETTING:University of Pennsylvania primary care practices. PARTICIPANTS: Participants of this trial included those with (1) age 18 to 80 years; (2) diabetes diagnosis; and (3) a measured hemoglobin A1c (HbA1c) greater than 8% in the past 12 months. INTERVENTION: We randomized eligible patients into opt-in and opt-out arms prior to enrollment. Those in the opt-out arm received a letter stating that they were enrolled into a diabetes research study with the option to opt out, and those in the opt-in arm received a standard recruitment letter. MEASURES: Main end points include enrollment rate, defined as the proportion of participants who attended the baseline visit, and adherence to daily glycemic monitoring. ANALYSIS: We powered our study to detect a 20% difference in adherence to device usage between arms and account for a 10% attrition rate. RESULTS: Of the 569 eligible participants who received a recruitment letter, 496 were randomized to the opt-in arm and 73 to the opt-out arm. Enrollment rates were 38% in the opt-out arm and 13% in the opt-in arm ( P < .001). CONCLUSIONS: Opt-out defaults, where clinically appropriate, could be a useful approach for increasing the generalizability of low-risk trials testing behavioral interventions in clinical settings.
RCT Entities:
PURPOSE: To examine the effect of an opt-out default recruitment strategy compared to a conventional opt-in strategy on enrollment and adherence to a behavioral intervention for poorly controlled diabeticpatients. DESIGN: Randomized controlled trial. SETTING: University of Pennsylvania primary care practices. PARTICIPANTS: Participants of this trial included those with (1) age 18 to 80 years; (2) diabetes diagnosis; and (3) a measured hemoglobin A1c (HbA1c) greater than 8% in the past 12 months. INTERVENTION: We randomized eligible patients into opt-in and opt-out arms prior to enrollment. Those in the opt-out arm received a letter stating that they were enrolled into a diabetes research study with the option to opt out, and those in the opt-in arm received a standard recruitment letter. MEASURES: Main end points include enrollment rate, defined as the proportion of participants who attended the baseline visit, and adherence to daily glycemic monitoring. ANALYSIS: We powered our study to detect a 20% difference in adherence to device usage between arms and account for a 10% attrition rate. RESULTS: Of the 569 eligible participants who received a recruitment letter, 496 were randomized to the opt-in arm and 73 to the opt-out arm. Enrollment rates were 38% in the opt-out arm and 13% in the opt-in arm ( P < .001). CONCLUSIONS:Opt-out defaults, where clinically appropriate, could be a useful approach for increasing the generalizability of low-risk trials testing behavioral interventions in clinical settings.
Entities:
Keywords:
behavioral economics; behavioral interventions; medical self-care
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