The use of electronic medical records for recruitment in clinical trials

Findings from the Lifestyle Intervention for Treatment of Diabetes trial

Valery S. Effoe, Jeffrey A. Katula, Julienne K. Kirk, Carolyn F. Pedley, Linda Y. Bollhalter, W. Mark Brown, Margaret R. Savoca, Stedman T. Jones, Janet Baek, Alain G. Bertoni, Andrea Mathieux, Ashley Dassa, Benedicte Crudgington, Benyam Yoseph, Caroline S. Blackwell, Carolyn Pedley, Danae Rosendall, Denise Faust, Emily Gower, Erika Griffith & 22 others Helen Yearley, Jackie Lynn Kiger, Joi Spaulding, Julienne Kirk, Karein Freehill, Katerra Logan, Kimberly Dezern, Kristen Puhlman, Leigh Anderson, Madison LeCroy, Margaret Savoca, Mark Brown, Megan Jenkins, Melissa Moran, Patricia Davis, Ronny A. Bell, Sarah Langdon, Stedman Jones, Stephanie Leger, Tim Holland, William Brown, the LIFT Diabetes Research Team

Research output: Contribution to journalArticle

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. Trial registration: ClinicalTrials.gov: NCT01806727. Registered on 5 March 2013.

Original languageEnglish (US)
Article number496
JournalTrials
Volume17
Issue number1
DOIs
StatePublished - Oct 13 2016
Externally publishedYes

Fingerprint

Electronic Health Records
Life Style
Clinical Trials
Referral and Consultation
Cardiovascular Diseases
Therapeutics
Mass Screening
Self Care
Random Allocation
Telephone
Type 2 Diabetes Mellitus
Weight Loss
Body Mass Index
Randomized Controlled Trials
Demography
Costs and Cost Analysis
Health

Keywords

  • African Americans
  • Community-based interventions
  • Electronic medical records
  • Lifestyle interventions
  • Randomized controlled trial
  • Recruitment methods
  • Type 2 diabetes

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Effoe, V. S., Katula, J. A., Kirk, J. K., Pedley, C. F., Bollhalter, L. Y., Brown, W. M., ... the LIFT Diabetes Research Team (2016). The use of electronic medical records for recruitment in clinical trials: Findings from the Lifestyle Intervention for Treatment of Diabetes trial. Trials, 17(1), [496]. https://doi.org/10.1186/s13063-016-1631-7

The use of electronic medical records for recruitment in clinical trials : Findings from the Lifestyle Intervention for Treatment of Diabetes trial. / 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.; Mathieux, Andrea; Dassa, Ashley; Crudgington, Benedicte; Yoseph, Benyam; Blackwell, Caroline S.; Pedley, Carolyn; Rosendall, Danae; Faust, Denise; Gower, Emily; Griffith, Erika; Yearley, Helen; Kiger, Jackie Lynn; Spaulding, Joi; Kirk, Julienne; Freehill, Karein; Logan, Katerra; Dezern, Kimberly; Puhlman, Kristen; Anderson, Leigh; LeCroy, Madison; Savoca, Margaret; Brown, Mark; Jenkins, Megan; Moran, Melissa; Davis, Patricia; Bell, Ronny A.; Langdon, Sarah; Jones, Stedman; Leger, Stephanie; Holland, Tim; Brown, William; the LIFT Diabetes Research Team.

In: Trials, Vol. 17, No. 1, 496, 13.10.2016.

Research output: Contribution to journalArticle

Effoe, VS, Katula, JA, Kirk, JK, Pedley, CF, Bollhalter, LY, Brown, WM, Savoca, MR, Jones, ST, Baek, J, Bertoni, AG, Mathieux, A, Dassa, A, Crudgington, B, Yoseph, B, Blackwell, CS, Pedley, C, Rosendall, D, Faust, D, Gower, E, Griffith, E, Yearley, H, Kiger, JL, Spaulding, J, Kirk, J, Freehill, K, Logan, K, Dezern, K, Puhlman, K, Anderson, L, LeCroy, M, Savoca, M, Brown, M, Jenkins, M, Moran, M, Davis, P, Bell, RA, Langdon, S, Jones, S, Leger, S, Holland, T, Brown, W & the LIFT Diabetes Research Team 2016, 'The use of electronic medical records for recruitment in clinical trials: Findings from the Lifestyle Intervention for Treatment of Diabetes trial', Trials, vol. 17, no. 1, 496. https://doi.org/10.1186/s13063-016-1631-7
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. ; Mathieux, Andrea ; Dassa, Ashley ; Crudgington, Benedicte ; Yoseph, Benyam ; Blackwell, Caroline S. ; Pedley, Carolyn ; Rosendall, Danae ; Faust, Denise ; Gower, Emily ; Griffith, Erika ; Yearley, Helen ; Kiger, Jackie Lynn ; Spaulding, Joi ; Kirk, Julienne ; Freehill, Karein ; Logan, Katerra ; Dezern, Kimberly ; Puhlman, Kristen ; Anderson, Leigh ; LeCroy, Madison ; Savoca, Margaret ; Brown, Mark ; Jenkins, Megan ; Moran, Melissa ; Davis, Patricia ; Bell, Ronny A. ; Langdon, Sarah ; Jones, Stedman ; Leger, Stephanie ; Holland, Tim ; Brown, William ; the LIFT Diabetes Research Team. / The use of electronic medical records for recruitment in clinical trials : Findings from the Lifestyle Intervention for Treatment of Diabetes trial. In: Trials. 2016 ; Vol. 17, No. 1.
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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. Trial registration: ClinicalTrials.gov: 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",
author = "Effoe, {Valery S.} and Katula, {Jeffrey A.} and Kirk, {Julienne K.} and Pedley, {Carolyn F.} and Bollhalter, {Linda Y.} and Brown, {W. Mark} and Savoca, {Margaret R.} and Jones, {Stedman T.} and Janet Baek and Bertoni, {Alain G.} and Andrea Mathieux and Ashley Dassa and Benedicte Crudgington and Benyam Yoseph and Blackwell, {Caroline S.} and Carolyn Pedley and Danae Rosendall and Denise Faust and Emily Gower and Erika Griffith and Helen Yearley and Kiger, {Jackie Lynn} and Joi Spaulding and Julienne Kirk and Karein Freehill and Katerra Logan and Kimberly Dezern and Kristen Puhlman and Leigh Anderson and Madison LeCroy and Margaret Savoca and Mark Brown and Megan Jenkins and Melissa Moran and Patricia Davis and Bell, {Ronny A.} and Sarah Langdon and Stedman Jones and Stephanie Leger and Tim Holland and William Brown and {the LIFT Diabetes Research Team}",
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TY - JOUR

T1 - The use of electronic medical records for recruitment in clinical trials

T2 - Findings from the Lifestyle Intervention for Treatment of Diabetes trial

AU - Effoe, Valery S.

AU - Katula, Jeffrey A.

AU - Kirk, Julienne K.

AU - Pedley, Carolyn F.

AU - Bollhalter, Linda Y.

AU - Brown, W. Mark

AU - Savoca, Margaret R.

AU - Jones, Stedman T.

AU - Baek, Janet

AU - Bertoni, Alain G.

AU - Mathieux, Andrea

AU - Dassa, Ashley

AU - Crudgington, Benedicte

AU - Yoseph, Benyam

AU - Blackwell, Caroline S.

AU - Pedley, Carolyn

AU - Rosendall, Danae

AU - Faust, Denise

AU - Gower, Emily

AU - Griffith, Erika

AU - Yearley, Helen

AU - Kiger, Jackie Lynn

AU - Spaulding, Joi

AU - Kirk, Julienne

AU - Freehill, Karein

AU - Logan, Katerra

AU - Dezern, Kimberly

AU - Puhlman, Kristen

AU - Anderson, Leigh

AU - LeCroy, Madison

AU - Savoca, Margaret

AU - Brown, Mark

AU - Jenkins, Megan

AU - Moran, Melissa

AU - Davis, Patricia

AU - Bell, Ronny A.

AU - Langdon, Sarah

AU - Jones, Stedman

AU - Leger, Stephanie

AU - Holland, Tim

AU - Brown, William

AU - the LIFT Diabetes Research Team

PY - 2016/10/13

Y1 - 2016/10/13

N2 - 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: ClinicalTrials.gov: NCT01806727. Registered on 5 March 2013.

AB - 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: ClinicalTrials.gov: NCT01806727. Registered on 5 March 2013.

KW - African Americans

KW - Community-based interventions

KW - Electronic medical records

KW - Lifestyle interventions

KW - Randomized controlled trial

KW - Recruitment methods

KW - Type 2 diabetes

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