Trial of the Impact of the Electronic Frailty Integrated With Social Needs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2024-05-12

Brief Summary

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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.

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Detailed Description

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The study team will conduct a pragmatic randomized pilot trial of a CHW-led hybrid in-person/telehealth program pathway (eFRIEND) for frail older adults. Using Zelen's effectiveness design, the study team will identify eligible frail older adults via the Electronic Health Record (EHR). Eligible participants will be randomized to the eFRIEND pathway or usual care. The study team will randomize 2050 older adults (1050 to eFRIEND, 1000 to usual care), with the randomization stratified by primary care clinic. Eligible participants randomized to the eFRIEND pathway will be contacted by phone to discuss study procedures and obtain verbal informed consent. eFRIEND comprises a 6-month intervention. All CHW will be certified and have participated in the North Carolina Community Health Worker Standardized Core Competency Training. CHW are trusted members of the community and are utilized as part of routine care to assist patients. At the first visit, the CHW will assess if the participants have any unmet social and/or functional needs (baseline survey). The frequency and amount of time of each point of contact will be at the discretion of the CHW.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND)

Participants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW.

Group Type EXPERIMENTAL

eFRIEND

Intervention Type BEHAVIORAL

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.

Usual Care

Usual care group will be monitored passively for outcomes under a waiver of informed consent

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Routine treatment in primary care

Interventions

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eFRIEND

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.

Intervention Type BEHAVIORAL

Usual Care

Routine treatment in primary care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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