Clinical trial NCT05293730: Trial of the Impact of the Electronic Frailty Integrated With Social Needs
Official title: Pragmatic Trial of the Impact of the Electronic Frailty Integrated With Social Needs (eFRIEND) on High Cost, High Burden Healthcare Use of Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Community Health Care Worker
elderly
assistance
at home care
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 2050
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of ED Visits or Inpatient Hospitalizations
timeFrame: Month 6
measure: Number of ED Visits or Inpatient Hospitalizations
timeFrame: Month 12
Secondary outcomes:
measure: Number of Completed Medicare Annual Wellness Visits (AWVs)
timeFrame: Month 6 and Month 12
measure: Usage of Advance Care Planning (ACP)
timeFrame: Month 6 and Month 12
measure: Acceptability of Program
timeFrame: Month 6 and Month 12
measure: Participant Uptake of Home Health Services--Total Number
timeFrame: Month 6 and Month 12
measure: Participant Uptake of Home Health Services--Proportion
timeFrame: Month 6 and Month 12
measure: Proportion of eligible patients who interact with CHW
timeFrame: Month 6 and Month 12
measure: Number of Annual Wellness Visits (AWV)s
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Food Insecurity--Total Number
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Food Insecurity--Proportion
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Housing Instability--Total Number
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Housing Instability--Proportion
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Lack of Transportation--Total Number
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Lack of Transportation--Proportion
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Use of Social Services--Total Number
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Use of Social Services--Proportion
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Use of Home Health Services--Total Number
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Use of Home Health Services--Proportion
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Social Isolation--Total Number
timeFrame: Month 6 and Month 12
measure: Percentage of Participants who Report Social Isolation--Proportion
timeFrame: Month 6 and Month 12
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Kathryn E. Callahan, MD
role: PRINCIPAL_INVESTIGATOR
References: