title: The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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/m2for 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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov: NCT01806727 . Registered on 5 March 2013.
authors.affiliation: Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27127, USA. valeffoe@gmail.com.|Department of Medicine, Morehouse School of Medicine, Atlanta, GA, USA. valeffoe@gmail.com.
authors.forename: Valery S
authors.initials: VS
authors.lastname: Effoe
authors.affiliation: Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Katula
authors.affiliation: Department of Family and Community Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Julienne K
authors.initials: JK
authors.lastname: Kirk
authors.affiliation: Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Carolyn F
authors.initials: CF
authors.lastname: Pedley
authors.affiliation: Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27127, USA.
authors.forename: Linda Y
authors.initials: LY
authors.lastname: Bollhalter
authors.affiliation: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: W Mark
authors.initials: WM
authors.lastname: Brown
authors.affiliation: Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27127, USA.
authors.forename: Margaret R
authors.initials: MR
authors.lastname: Savoca
authors.affiliation: Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27127, USA.
authors.forename: Stedman T
authors.initials: ST
authors.lastname: Jones
authors.affiliation: Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Baek
authors.affiliation: Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27127, USA.|Maya Angelou Center for Health Equity, Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Alain G
authors.initials: AG
authors.lastname: Bertoni
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000208:ethnology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000208:ethnology / Q000628:therapy*; D057286:Electronic Health Records; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009657:North Carolina / Q000453:epidemiology; D009765:Obesity / Q000175:diagnosis / Q000208:ethnology / Q000628:therapy*; D018579:Patient Selection; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012648:Self Care; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss; D055815:Young Adult
keywords: African Americans; Community-based interventions; Electronic medical records; Lifestyle interventions; Randomized controlled trial; Recruitment methods; Type 2 diabetes