Effectiveness of clinical trial recruitment strategies in a safety-net hospital
Abstract
BACKGROUND
Recruitment of underserved populations into clinical trials is difficult. Understanding which recruitment methods are most effective is essential to increasing recruitment yields. Moreover, knowledge of how many contact attempts should be conducted before a patient is considered non-responsive is also of interest as it can guide prioritization of patient outreach.
METHODS
The Improving Diabetes Equity and Advancing care study is a randomized controlled trial of diabetes management strategies among Black and/or Latine patients. Patients were recruited using four methods (in-person, phone, flyer, community health worker [CHW] referral). We calculated enrollment rates, number of contact attempts needed to enroll, and sociodemographic differences by recruitment method.
RESULTS
We screened 30,772 patients for eligibility, contacted 789 patients who met eligibility criteria, and enrolled 104 patients into the study for an enrollment rate of 13.2%. Twenty-nine percent, 8%, 14%, 14%, and 7% of patients were enrolled in the study in-person, by phone, by a combination of methods, by flyer, and by CHW referral, respectively. Two-thirds of enrolled patients enrolled on the first or second contact attempt. Latine patients and patients of low socioeconomic status were more likely to be recruited in person.
CONCLUSIONS
In-person recruitment had the highest rate of enrollment success. The combination approach was less effective than in-person alone, and flyer and CHW referral…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30,772 participants or records.
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