CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials

Trials

Study Protocol

Dena Schulman-Green¹  Kristen Wroblewski²  Doriane Miller²  Katherine Thompson²  Charles M. Fuller²  Elbert S. Huang²  Stacy Tessler Lindau²  Emily M. Abramsohn²  Eva Shiu²  Cristianne R. M. Frazier²  Victoria Winslow²  Jennifer A. Makelarski²  MariaDelSol De Ornelas²  Mellissa Grana²  Jyotsna S. Jagai²  Soo Borson³ 

[1] New York University, 433 1St Ave, 10010, New York, NY, USA;University of Chicago, 5841 S. Maryland Ave., MC 2050, 60637, Chicago, IL, USA;University of Southern California, 1975 Zonal Ave, 90033, Los Angeles, CA, USA;

关键词: Randomized controlled trial;    Trial design;    Innovation;    Health-related socioeconomic risk factors;    Informational intervention;    Community resources;    Caregivers;   

DOI  :  10.1186/s13063-023-07697-z

 received in 2023-01-10, accepted in 2023-10-03,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundCommunityRx 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). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago’s South Side, a predominantly African American/Black community. CommunityRx-Hunger is a double-blind RCT enrolling caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT enrolling caregivers of community-residing people with dementia. RCTs with caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify caregivers in clinical settings. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the protocols from in-person to remote operations. This study describes these protocols and methods used for successful iteration to overcome barriers.Methods and findingsCommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two in-person RCT protocols were pre-tested. In March 2020, when pandemic conditions prohibited face-to-face clinical enrollment, 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. Enabled by engaged Community Advisory Boards and ARCTICS, both RCTs quickly adapted to remote operations. To accommodate these adaptations, launch was delayed 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 the first 12 months than originally projected for in-person enrollment.DiscussionOur asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration of in-person trials to remote 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 registrationClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019).

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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