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Clinical Trials/NCT05293730
NCT05293730CompletedNot Applicable

Pragmatic Trial of the Impact of the Electronic Frailty Integrated With Social Needs (eFRIEND) on High Cost, High Burden Healthcare Use of Older Adults

Wake Forest University Health Sciences2 sites in 1 country2,050 target enrollmentStarted: September 6, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,050
Locations
2
Primary Endpoint
Number of ED Visits or Inpatient Hospitalizations

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Number of ED Visits or Inpatient Hospitalizations

Time Frame: Month 12

Healthcare encounters will be tracked using the Electronic Health Record (EHR)

Secondary Outcomes

  • Number of Completed Medicare Annual Wellness Visits (AWVs)(Month 6 and Month 12)
  • Usage of Advance Care Planning (ACP)(Month 6 and Month 12)
  • Number of Annual Wellness Visits (AWV)s(Month 6 and Month 12)
  • Percentage of Participants who Report Social Isolation--Total Number(Month 6 and Month 12)
  • Participant Uptake of Home Health Services--Total Number(Month 6 and Month 12)
  • Percentage of Participants who Report Lack of Transportation--Proportion(Month 6 and Month 12)
  • Percentage of Participants who Report Use of Social Services--Proportion(Month 6 and Month 12)
  • Percentage of Participants who Report Use of Home Health Services--Proportion(Month 6 and Month 12)
  • Percentage of Participants who Report Housing Instability--Total Number(Month 6 and Month 12)
  • Percentage of Participants who Report Lack of Transportation--Total Number(Month 6 and Month 12)
  • Percentage of Participants who Report Use of Home Health Services--Total Number(Month 6 and Month 12)
  • Percentage of Participants who Report Use of Social Services--Total Number(Month 6 and Month 12)
  • Acceptability of Program(Month 6 and Month 12)
  • Participant Uptake of Home Health Services--Proportion(Month 6 and Month 12)
  • Proportion of eligible patients who interact with CHW(Month 6 and Month 12)
  • Percentage of Participants who Report Food Insecurity--Total Number(Month 6 and Month 12)
  • Percentage of Participants who Report Food Insecurity--Proportion(Month 6 and Month 12)
  • Percentage of Participants who Report Housing Instability--Proportion(Month 6 and Month 12)
  • Percentage of Participants who Report Social Isolation--Proportion(Month 6 and Month 12)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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