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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.
- Abstract
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
- Subjects
TREATMENT of diabetes; ELECTRONIC health records; RANDOMIZED controlled trials; TYPE 2 diabetes; COMMUNITY-based social services
- Publication
Trials, 2016, Vol 11, p1
- ISSN
1745-6215
- Publication type
Article
- DOI
10.1186/s13063-016-1631-7