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- Title
The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial.
- Authors
Effoe, Valery S; Katula, Jeffrey A; Kirk, Julienne K; Pedley, Carolyn F; Bollhalter, Linda Y; Brown, W Mark; Savoca, Margaret R; Jones, Stedman T; Baek, Janet; Bertoni, Alain G; LIFT Diabetes Research Team
- Abstract
<bold>Background: </bold>The use of the electronic medical record (EMR) system in recruitment in clinical trials has the potential for providing a very reliable and cost-effective recruiting methodology which may improve participant recruitment in clinical trials. We examined a recruitment approach centered on the use of the EMR, as well as other traditional methods, in the Lifestyle Intervention for Treatment of Diabetes (LIFT Diabetes) trial.<bold>Methods: </bold>LIFT Diabetes is a randomized controlled trial designed to investigate the effects of two contrasting interventions on cardiovascular disease risk: a community-based intensive lifestyle program aimed at achieving weight loss and a clinic-based enhanced diabetes self-management program. Eligible participants were overweight/obese (body mass index, BMI ≥25 kg/m2) patients with type 2 diabetes who were aged 21 years or older. Recruitment strategies included the use of the EMR system (primary), direct referrals, media advertisements, and community screenings.<bold>Results: </bold>A total of 1102 telephone screens were conducted, resulting in randomization of 260 participants (61.5 % from EMR, mean age 56.3 years, 66.2 % women, 48.1 % non-Hispanic blacks) over a 21-month period, with a yield of 23.6 %. Recruitment yields differed by recruitment method, with referrals having the highest yield (27.5 %). A history of cardiovascular disease was the main health reason for exclusion from the study (16.5 %). An additional 8.9 % were excluded for BMI <25 kg/m2 (<27 kg/m2 for insulin users), 5.4 % could not exercise, 5.2 % had an HbA1c >11 %, and 34.9 % were excluded for other non-medical reasons. Exclusion criteria did not appear to differentially affect enrollment in terms of race or ethnicity.<bold>Conclusions: </bold>Future clinical studies should tailor their recruitment strategies based on the participant demographics of interest. Efficient methods such as using the EMR system and referrals should be prioritized over labor-intensive, low-yielding methods such as community screenings and mass mailings.<bold>Trial Registration: </bold>ClinicalTrials.gov: NCT01806727 . Registered on 5 March 2013.
- Subjects
NORTH Carolina; CARDIOVASCULAR disease diagnosis; CARDIOVASCULAR disease prevention; TYPE 2 diabetes diagnosis; TYPE 2 diabetes treatment; OBESITY treatment; BEHAVIOR; CARDIOVASCULAR diseases; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; TYPE 2 diabetes; OBESITY; RESEARCH; RESEARCH funding; HEALTH self-care; TIME; WEIGHT loss; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; PATIENT selection; DIAGNOSIS
- Publication
Trials, 2016, Vol 11, p496
- ISSN
1745-6215
- Publication type
journal article