Recruitment costs for a multi-center, randomized clinical trial for a behavioral intervention study [abstract] Abstract uri icon
  • Background and Aims: The pace of recruitment impacts resources, planned study tasks, timelines, and ultimately, costs. The Journey for Control of Diabetes: the IDEA Study, a randomized trial conducted in two healthcare settings (Minnesota and New Mexico) utilized different recruitment methods at each site. This presentation compares these recruitment methods with respect to recruitment efficiency and costs. Methods: Study inclusion criteria were patients with sub-optimally controlled type 2 diabetes, an A1c=>7, and diabetes education-naive within the last one to two years. Recruitment databases at each site were developed using electronic health data to identify potential participants. All patients were mailed recruitment letters and study brochures inviting them to participate. Site 1 mailed letters with an enclosed response form for the patient, if interested, to return to the study site; Site 2 mailed letters and subsequently attempted to contact all patients by telephone. Six months into the recruitment period, Site 1 also incorporated follow-up calls to potential patients who were mailed recruitment letters. Results: The enrolled sample was 623 patients: 147 (Site 1, Method 1), 190 (Site 1, Method 2), and 286 (Site 2). Recruitment efficiency rates based on number of enrolled participants per total recruitment letters mailed were 3.8% (147/3995 for Site 1, Method 1), 3.7% (190/5199 for Site 1, Method 2), and 6.9% (286/4128 for Site 2, Method 3). Cost of enrollment per patient ranged from $71.45 for Method 1 ($10,502/147), $81.90 for Method 2 ($15562/190), and $87.57 for Method 3 ($25,046/286). Total staff hours per patient were 1.58 for Method 1 (232.3/147), 2.51 for Method 2 (477.5/190), and 3.46 for Method 3 (990.4/286). Site 1, when combining data for Methods 1 and 2, recruited more subjects (337) within the 11 month recruitment period than Site 2 (286). Conclusions: Although recruitment efficiency rates were higher for Site 2, fewer staff hours were used at Site 1. Using the Site 2 methodology of contacting each patient may be more effective for studies with a higher risk of participation. Future studies should consider including a recruitment response form with the recruitment letter to save time and cost.

  • publication date
  • 2010
  • published in
  • Diabetes
  • Economics
  • Randomized Controlled Trials
  • Recruitment
  • Research Methods
  • Additional Document Info
  • 8
  • issue
  • 3-4