The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial

Trials. 2016 Oct 13;17(1):496. doi: 10.1186/s13063-016-1631-7.


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.

Trial registration: NCT01806727 . Registered on 5 March 2013.

Keywords: African Americans; Community-based interventions; Electronic medical records; Lifestyle interventions; Randomized controlled trial; Recruitment methods; Type 2 diabetes.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Aged
  • Cardiovascular Diseases / diagnosis
  • Cardiovascular Diseases / ethnology
  • Cardiovascular Diseases / prevention & control*
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / ethnology
  • Diabetes Mellitus, Type 2 / therapy*
  • Electronic Health Records*
  • Female
  • Humans
  • Male
  • Middle Aged
  • North Carolina / epidemiology
  • Obesity / diagnosis
  • Obesity / ethnology
  • Obesity / therapy*
  • Patient Selection*
  • Risk Factors
  • Risk Reduction Behavior*
  • Self Care*
  • Time Factors
  • Treatment Outcome
  • Weight Loss
  • Young Adult

Associated data