Patient-centered recruitment and retention for a randomized controlled study

Abstract

BackgroundRecruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial.MethodsThis is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients.ResultsWe recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians’ offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders’ advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge.ConclusionsWe have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies.Trial registrationClinicaltrials.gov, ID: NCT02032550. Registered on 22 November 2013.

Feasibility, Acceptability, and Preliminary Efficacy of VidaTalk™ Communication Application in Family Caregivers of Mechanically Ventilated ICU Patients

“…Therefore, we did not provide an active intervention such as communication training or instruction with the tablet to family caregivers beyond a simple instruction sheet. Despite best practices for participant retention strategies such as reminders, incentive payments, clear expectations of follow-up, and same interviewer used in throughout the study (Abshire et al, 2017;Chhatre et al, 2018;Dilworth-Anderson & Williams, 2004), our long-term retention rates were low. Family caregivers likely had competing priorities and this was confirmed during phone conversations with retained participants in which they revealed multiple caregiving responsibilities, serious financial concerns, rehospitalization, etc.…”

“…Additional participant retention strategies such as effective text reminders, increased amount of incentives, building relationship and identity, emphasizing study benefits, and contact/scheduling strategies (Chhatre et al, 2018;Dilworth-Anderson & Williams, 2004) should be considered in the future studies.…”

What influenced people with chronic breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study.

“…The qualitative interviews were analysed using Braun and Clarke's framework for thematic analysis [29] using NVIVO version 10 (QSR International (UK) Ltd.). Transcripts were read and re-read and then coded inductively for themes relating to; reasons to participate in the trial, reasons not to participate in the trial, reasons to remain in the trial and reasons to discontinue the trial.…”

“…There is an increasing literature around person centeredness in trials with growing evidence that involving patients at the research design stage can direct recruitment and retention strategies and improve enrolment (26)(27)(28). While studies evaluating person-centred care in trials remain limited, Chhatre et al applied a conceptual model of patient-centred recruitment and retention to a RCT of patients with newly diagnosed prostate cancer (29). The study identified strategies which may aid recruitment and retention, although acknowledged limitations due to time and resource constraints, with attrition of 26% at one of three sites (29).…”

“…While studies evaluating person-centred care in trials remain limited, Chhatre et al applied a conceptual model of patient-centred recruitment and retention to a RCT of patients with newly diagnosed prostate cancer (29). The study identified strategies which may aid recruitment and retention, although acknowledged limitations due to time and resource constraints, with attrition of 26% at one of three sites (29).…”