Format

Send to

Choose Destination
Contemp Clin Trials. 2016 Mar;47:202-8. doi: 10.1016/j.cct.2016.01.010. Epub 2016 Jan 26.

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

Author information

1
Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA. Electronic address: mengt@med.umich.edu.
2
Division of General Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, MI, USA; Center for Clinical Management Research, VA Ann Arbor Healthcare System, USA.
3
Medical School Information Services, University of Michigan, Ann Arbor, MI, USA.
4
Division of General Pediatrics, Department of Pediatrics and Communicable Disease, University of Michigan, Ann Arbor, MI, USA.
5
Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, USA.

Abstract

BACKGROUND AND AIM:

A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR).

METHOD:

A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements.

RESULTS:

After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications.

CONCLUSION:

The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies.

KEYWORDS:

Diabetes mellitus; Patient recruitment; Research Registry

PMID:
26825022
PMCID:
PMC4818158
[Available on 2017-03-01]
DOI:
10.1016/j.cct.2016.01.010
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center