Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care.

Autor:	Abramsohn EM; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., De Ornelas M; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Borson S; University of Southern California., Frazier CR; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Fuller CM; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Grana M; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Huang ES; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Jagai JS; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Makelarski JA; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Miller D; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Schulman-Green D; New York University Rory Meyers College of Nursing., Shiu E; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Thompson K; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Winslow V; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Wroblewski K; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences., Lindau ST; University of Chicago Biological Sciences Division: University of Chicago Division of the Biological Sciences.
Jazyk:	angličtina
Zdroj:	Research square [Res Sq] 2023 Mar 01. Date of Electronic Publication: 2023 Mar 01.
DOI:	10.21203/rs.3.rs-2464681/v1
Abstrakt:	Background: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). CommunityRx-Hunger is a double-blind randomized controlled trial (RCT) that enrolls caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT that enrolls caregivers of community-residing people with dementia. Clinical trials that enroll caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify and track caregivers. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the CommunityRx protocols from in-person to remote operations. This study describes the novel methods used to iterate existing RCT protocols and factors contributing to their successful iteration. Methods: CommunityRx uses individual-level data to generate personalized community resource referrals for basic, health and caregiving needs. Our research program uses an asset-based, community-engaged approach including study-specific community advisory boards (CABs). In early 2020, both RCT protocols were pre-tested in-person. In March 2020, when pandemic conditions prohibited enrollment during clinical encounters, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Results: Enabled by engaged CABs and ARCTICS, both RCTs quickly adapted to remote operations. Designed before the pandemic, we had planned to launch both trials by March 2020 and complete enrollment by December 2021. The pandemic postponed launch until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in 12 months than originally projected in-person. Conclusions: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration to remote trial operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. Trial Status: Both studies are registered on ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999); CommunityRx for Caregivers (NCT04146545); My Diabetes My Community (NCT04970810). Competing Interests: Under the terms of Grant Number 1C1CMS330997-01-00 (ST Lindau, PI) from the Department of Health and Human Services, Centers for Medicare & Medicaid Services, we were expected to develop a sustainable business model which will continue and support the model that we tested after award funding ends. Dr. Stacy Lindau was the founder and owner of a social impact company, NowPow, LLC, which was acquired by Unite Us, LLC in 2021. Dr. Lindau is a paid advisor to and holds stock in Unite Us, LLC. Dr. Lindau is an editor on Female Sexual Dysfunction for UpToDate and received royalties <$100/year in 2019, 2020 for this work. Subsequent royalties have been paid to the University of Chicago. Neither the University of Chicago nor UChicago Medicine is endorsing or promoting Unite Us or its business, products, or services. All other authors have no competing interests to disclose.Consent for publication: Not applicable
Databáze:	MEDLINE
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