Mack T Ruffin1, Donald E Nease. 1. Department of Family Medicine, The University of Michigan, USA. mruffin@umich.edu
Abstract
PURPOSE: To report using electronic medical record (EMR) data to identify patients eligible for a clinical trial and the impact of providing an honorarium and deadline on accrual. METHODS: Six practices using a common EMR participated in a cluster-randomized trial testing a self-administered, web-based familial risk assessment tool. EMR-derived lists of eligible patients were made available for provider review. An honorarium and deadline for responding in the patient recruitment letter were implemented in the last half of the recruitment process. RESULTS: We identified 22,376 potentially eligible patients. Lists not returned by providers accounted for 9840 (44%) patients. We mailed invitations to 11,956 patients; 2398 (20%) requested more information and a consent document, 1489 (12.5%) consented to participate, and 1305 (11%) completed the baseline data collection. Patients receiving the additional $2 and a deadline compared with those receiving the personal invitation alone had significantly higher interest in participating (25% vs. 17%, P = .0001) but were less likely to complete baseline data collection (57% vs. 65% P = .01). Once consented, 85% completed the study with no significant difference by recruitment approach. CONCLUSIONS: Using EMR data reduces the burden to identify potentially eligible patients. However, some providers still did not review and return the lists. Adding a $2 incentive and deadline for responding did not improve the rate of eligible patients consenting and completing the study. Other patient recruitment methods to get better response by providers and population from primary care offices must be explored.
RCT Entities:
PURPOSE: To report using electronic medical record (EMR) data to identify patients eligible for a clinical trial and the impact of providing an honorarium and deadline on accrual. METHODS: Six practices using a common EMR participated in a cluster-randomized trial testing a self-administered, web-based familial risk assessment tool. EMR-derived lists of eligible patients were made available for provider review. An honorarium and deadline for responding in the patient recruitment letter were implemented in the last half of the recruitment process. RESULTS: We identified 22,376 potentially eligible patients. Lists not returned by providers accounted for 9840 (44%) patients. We mailed invitations to 11,956 patients; 2398 (20%) requested more information and a consent document, 1489 (12.5%) consented to participate, and 1305 (11%) completed the baseline data collection. Patients receiving the additional $2 and a deadline compared with those receiving the personal invitation alone had significantly higher interest in participating (25% vs. 17%, P = .0001) but were less likely to complete baseline data collection (57% vs. 65% P = .01). Once consented, 85% completed the study with no significant difference by recruitment approach. CONCLUSIONS: Using EMR data reduces the burden to identify potentially eligible patients. However, some providers still did not review and return the lists. Adding a $2 incentive and deadline for responding did not improve the rate of eligible patients consenting and completing the study. Other patient recruitment methods to get better response by providers and population from primary care offices must be explored.
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