Evaluating the Efficacy of a Registry linked to a Consent to Re-Contact Program and Communication Strategies for Recruiting and Enrolling Participants into Clinical Trials

Elizabeth Flood-Grady, Virginia C Clark, Angie Bauer, Lauren Morelli, Patrick Horne, Janice L Krieger, David R Nelson, Elizabeth Flood-Grady, Virginia C Clark, Angie Bauer, Lauren Morelli, Patrick Horne, Janice L Krieger, David R Nelson

Abstract

Introduction: Although registries can rapidly identify clinical study participants, it is unknown which follow up methods for recruiting are most effective. Our goal is to examine the efficacy of three communication strategies for recruiting and enrolling patients who were identified via a contact registry (i.e., registry linked to a consent to re-contact program).

Methods: Patients who met the study criteria were identified via the contact registry and targeted for recruitment. In condition 1, patients established in the university hepatology specialty clinics were contacted one time via phone call by the study coordinator and asked to participate (C1). In condition 2, non-established specialty clinic patients were mailed an IRB-approved letter with study information and instructions for calling the study coordinator to participate (C2). Condition 2A included patients who called within two weeks of receiving the letter (C2A); condition 2B included patients who did not call after receiving the letter but were subsequently contacted via phone call.

Results: A registry identified 1,060 patients, of which 661were eligible and targeted for recruiting. All 37 patients were reached in C1 and 17 (45.9%) were recruited. Nineteen of the 624 patients in C2A were reached and 10 were recruited whereas 120 of the 605 patients in C2B were reached and 53 (8.7%) were recruited. Seventy patients enrolled with C2B being the most effective (total, cost) recruitment strategy (n = 50) (p < .001).

Conclusion: The efficacy of enrolling patients identified via a contact registry into clinical trials varies based on the communication strategies used for recruiting.

Keywords: broad consent; communication; patient recruitment; registry.

Figures

Fig. 1
Fig. 1
Process identifying, recruiting, and enrolling patients. Note: All patients were identified via the contact registry (i.e., IDR and Consent2Share). C1: Specialty clinic patients contacted via coordinator initiated phone call; C2A: Non-specialty clinic patients mailed a letter, patient initiated the phone call; C2B: Non-specialty clinic patients mailed a letter, contacted via coordinator initiated phone call after two weeks of no reply.

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Source: PubMed

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