Recruitment of Nursing Home Residents for Randomized Control Study: Challenges and Strategies

TL;DR

This paper discusses the challenges and strategies used to recruit and retain nursing home residents in a clinical trial during the pandemic.

Contribution

The paper presents practical strategies for adapting clinical trial protocols to the dynamic nursing home environment.

Findings

160 out of 217 residents from 23 nursing homes completed the study.

Success was achieved by tailoring protocols to address pandemic-related challenges and engaging facility staff.

Corporate endorsement and staff involvement were key to recruitment and retention.

Abstract

Numerous studies attest to the challenges of recruiting and retaining nursing home (NH) residents in clinical trials. In this presentation, we present methods we used to recruit and retain NH residents in a randomized, double-blinded, comparative study that assessed the effects of the Shingrix vaccine on the innate immune system residents (age 65-XXX) during the COVID-19 pandemic. The protocol was quite complex (1) recruitment/consent, (2) Baseline blood draw and 1st injection, and (3) a second injection/blood draw (3 months later). The post-treatment control group had the same number of visits but had two additional visits to receive the vaccine. Of the 217 residents enrolled in the study, 160 residents from 23 NHs completed the study. Our success relied upon working alongside corporate and facility leaders to tailor our protocols to the ever-evolving clinical landscape, which included (1) fluctuating trends in staff/resident outbreaks, (2) weather emergencies, (3) the introduction of new local/federal government regulations (i.e., regular COVID testing, rules governing entry into a facility), and (4) introduction of the COVID vaccine/vaccine hesitancy. While corporate endorsement helped the team to gain entrance, our strategies enabled nursing home staff to become vested in the research. Recognizing the value, both socially and medically, the protocols had for their clients, they worked with us to recruit and retain resident research participants.