Improving the Statistical Power of Hospice Research: Lessons from Two Clinical Trials (GP132)

Outcomes 1. Identify recruitment strategies for successful participant recruitment in hospice clinical trials including the implementation of IRB supported HIPAA waivers, agency support for automated referral into research, and management protocols for recruitment goal monitoring.2. Create a protocol for participant recruitment using the electronic medical record in hospice clinical trials including required approvals, written processes and consideration for referral reports, and monitoring statistics to evaluate impact of the design. Key Message Recruitment one of the most challenging aspects of research in the hospice setting. Hospice staff can become gatekeepers and are overwhelmed with caseloads and burnout which can interfere with study referral. We report on two clinical trials which took staff out of the referral process and measured the results. Importance 1. Hospice clinical trials are rare and can suffer from inadequate sample sizes2. Ongoing evaluation of recruitment statistics can help researchers identify problems and solutions to assure sampling targets are met. Objective(s) The research questions for this study include: 1) What is the impact of using electronic medical records to identify hospice caregivers and patients for clinical research? 2) How does the referral and consent rate differ between hospice agencies participating in electronic record referral as compared to those who do not? 3) What are the challenges associated with electronic record referral to research? Scientific Methods Utilized A separate data base on referral activity was maintained in two clinical trials providing data for this project. Recruitment statistics were compared between referral protocols to identify the most effective recruitment methods. Average numbers of referrals, consents, consent rates, phone calls from recruiters, data completion, and reasons for refusal to participate were compared between groups and between studies. Results Nearly 1000 (rural and urban) hospice caregivers were recruited into two clinical trials over four years (including the COVID-19 pandemic), achieving their necessary sample size and analytic power. Hospice agencies who agreed to recruit from their electronic medical records (EMR) identified significantly more potential participants and had more consenting participants than those who did not use the EMR. Recruitment with the EMR required a similar effort by recruitment staff to those obtained without the EMR. Finally, the reasons for lack of consent into the trials was similar for both groups. Conclusion(s) Removing hospice staff from the research study recruitment process results in the identification of more research subjects. While the percentage of potential participants consented into a trial is less, the number available is higher and thus recruitment is more successful. Similarly, the cost of staff recruitment time is comparable regardless of where the referrals is generated. Impact For numerous reasons hospice clinicians struggle with the recruitment of hospice patients and family into clinical trials. Automatic screening of potential research participants through medical record reporting and supported by HIPAA waivers, is a research friendly strategy for recruitment. For hospice clinical research to continue to expand with large clinical trials, the implementation of recruitment strategies, such as electronic medical record referrals, are critical. While these recruitment methods are not innovative in other health care settings (hospitals and clinics) they are unique to research in hospice agencies. Hospice researchers should embrace opportunities to measure outcomes of recruitment strategies as we seek to build hospice research.