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CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials
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). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago’s So...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10624358/ https://www.ncbi.nlm.nih.gov/pubmed/37864258 http://dx.doi.org/10.1186/s13063-023-07697-z |
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author | Abramsohn, Emily M. De Ornelas, MariaDelSol Borson, Soo Frazier, Cristianne R. M. Fuller, Charles M. Grana, Mellissa Huang, Elbert S. Jagai, Jyotsna S. Makelarski, Jennifer A. Miller, Doriane Schulman-Green, Dena Shiu, Eva Thompson, Katherine Winslow, Victoria Wroblewski, Kristen Lindau, Stacy Tessler |
author_facet | Abramsohn, Emily M. De Ornelas, MariaDelSol Borson, Soo Frazier, Cristianne R. M. Fuller, Charles M. Grana, Mellissa Huang, Elbert S. Jagai, Jyotsna S. Makelarski, Jennifer A. Miller, Doriane Schulman-Green, Dena Shiu, Eva Thompson, Katherine Winslow, Victoria Wroblewski, Kristen Lindau, Stacy Tessler |
author_sort | Abramsohn, Emily M. |
collection | PubMed |
description | 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). 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 FINDINGS: CommunityRx 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. DISCUSSION: Our 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 REGISTRATION: ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07697-z. |
format | Online Article Text |
id | pubmed-10624358 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-106243582023-11-04 CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials Abramsohn, Emily M. De Ornelas, MariaDelSol Borson, Soo Frazier, Cristianne R. M. Fuller, Charles M. Grana, Mellissa Huang, Elbert S. Jagai, Jyotsna S. Makelarski, Jennifer A. Miller, Doriane Schulman-Green, Dena Shiu, Eva Thompson, Katherine Winslow, Victoria Wroblewski, Kristen Lindau, Stacy Tessler Trials Study Protocol 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). 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 FINDINGS: CommunityRx 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. DISCUSSION: Our 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 REGISTRATION: ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07697-z. BioMed Central 2023-10-21 /pmc/articles/PMC10624358/ /pubmed/37864258 http://dx.doi.org/10.1186/s13063-023-07697-z Text en © BioMed Central Ltd., part of Springer Nature 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Abramsohn, Emily M. De Ornelas, MariaDelSol Borson, Soo Frazier, Cristianne R. M. Fuller, Charles M. Grana, Mellissa Huang, Elbert S. Jagai, Jyotsna S. Makelarski, Jennifer A. Miller, Doriane Schulman-Green, Dena Shiu, Eva Thompson, Katherine Winslow, Victoria Wroblewski, Kristen Lindau, Stacy Tessler CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials |
title | CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials |
title_full | CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials |
title_fullStr | CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials |
title_full_unstemmed | CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials |
title_short | CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials |
title_sort | communityrx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10624358/ https://www.ncbi.nlm.nih.gov/pubmed/37864258 http://dx.doi.org/10.1186/s13063-023-07697-z |
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