Trial of the Impact of the Electronic Frailty Integrated With Social Needs
Pragmatic Trial of the Impact of the Electronic Frailty Integrated With Social Needs (eFRIEND) on High Cost, High Burden Healthcare Use of Older Adults
1 other identifier
interventional
2,050
1 country
1
Brief Summary
Participants in Electronic Frailty Integrated with Social Needs (eFRIEND) will randomize to receive regularly scheduled in-person and telehealth contacts with a community health worker (CHW) or continue to receive standard of care. The purpose of this research is to use CHW to help older adults because there may be some resources that could benefit them that they are not aware of or for which they need help applying.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedStudy Start
First participant enrolled
September 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2024
CompletedJuly 3, 2024
April 1, 2024
1.7 years
March 14, 2022
June 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of ED Visits or Inpatient Hospitalizations
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
Month 6
Number of ED Visits or Inpatient Hospitalizations
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
Month 12
Secondary Outcomes (19)
Number of Completed Medicare Annual Wellness Visits (AWVs)
Month 6 and Month 12
Usage of Advance Care Planning (ACP)
Month 6 and Month 12
Acceptability of Program
Month 6 and Month 12
Participant Uptake of Home Health Services--Total Number
Month 6 and Month 12
Participant Uptake of Home Health Services--Proportion
Month 6 and Month 12
- +14 more secondary outcomes
Study Arms (2)
Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND)
EXPERIMENTALParticipants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW.
Usual Care
ACTIVE COMPARATORUsual care group will be monitored passively for outcomes under a waiver of informed consent
Interventions
eFRIEND is a 6-month CWH-led intervention. All CHW will be part of the research team to ensure successful recruitment and interaction with patients, and all CHW will be certified and have participated in the North Carolina Community Health Worker Standardized Core Competency Training.
Eligibility Criteria
You may qualify if:
- Frail based on the electronic Frailty Index (eFI\>0.21)
- Live in Forsyth County, NC
- Linked to any Accountable Care Organizations (ACO) registry
- Have a Primary Care Provider (PCP) in Atrium Health Wake Forest Baptist (AHWFB) system, and have seen their PCP or someone else in the clinic of their PCP within the last 12 months
You may not qualify if:
- Diagnosis code for dementia in the past 2 years
- Does not speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atrium Health Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn E. Callahan, MD
Atrium Health Wake Forest Baptist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 24, 2022
Study Start
September 6, 2022
Primary Completion
May 12, 2024
Study Completion
May 12, 2024
Last Updated
July 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 9 months and ending 36 months following article publication
- Access Criteria
- The requests must include a proposal with clear aims as to why and how the data will be used. If proposal is approved, a data access agreement will need to be signed and will only be accessible for a 36-month period. All requests to gain access to the data will need to be sent to the study's project manager, Renee Woodard, (renee.woodard@wakehealth.edu), with the study's primary investigator copied, Kate Callahan, MD, MS, (kecallah@wakehealth.edu).
Our study, is a Pragmatic Trial of the impact of the Electronic Frailty Integrated with Social Needs (eFRIEND) on high cost, high burden healthcare use of older adults in Atrium Health Wake Forest Baptist, agrees to share study data that fulfill the ICMJE requirements starting after the first 3 months after our study has started and 36 months after our first article publication. We agree to provide data to researchers who can provide our lab with a methodologically sound proposal, and who need our data to help achieve aims outlined in their proposal. The study's data will be comprised of individual participant data that underlie the results reported in our publication. Participant data will be deidentified and can be used in text, tables, figures, and appendices, after approval from the study's primary investigator.