American journal of health promotion : AJHP · 2016
A Randomized Controlled Trial of Opt-In Versus Opt-Out Enrollment Into a Diabetes Behavioral Intervention.
СтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод пока не подготовлен
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Aysola Jaya, Tahirovic Emin, Troxel Andrea B, Asch David A, Gangemi Kelsey, Hodlofski Amanda T, Zhu Jingsan, Volpp Kevin
Аннотация
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.
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.