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

Wake Forest University (WFU)

Status: Completed

Conditions: Aging

Treatments: Other: Usual Care; Behavioral: eFRIEND

Study type: Interventional

Funder types: Other

Identifiers

NCT05293730

IRB00079444

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,050 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Diagnosis code for dementia in the past 2 years
• Does not speak English

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,050 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Behavioral: eFRIEND

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care