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

Study Overview
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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.

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 1400 older adults (700 to eFRIEND, 700 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.

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

Conditions
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Aging

Intervention / Treatment
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* Behavioral: eFRIEND
* Other: Usual Care


Participation Criteria
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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 Exclusion Criteria: Diagnosis code for dementia in the past 2 years Does not speak English

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND)<br>Participants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW. | Behavioral: eFRIEND<br>* 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.<br>|
| Active Comparator: Usual Care<br>Usual care group will be monitored passively for outcomes under a waiver of informed consent | Other: Usual Care<br>* Routine treatment in primary care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Completed Medicare Annual Wellness Visits (AWVs) | Determined through data extraction from the EHR | Month 6 and Month 12 | 
| Usage of Advance Care Planning (ACP) | Total number of patients who completed ACP based on billing codes (99497 and 99498) from the EHR. The listed billing codes indicate that ACP has been completed at a patient's appointment. | Month 6 and Month 12 | 
| Acceptability of Program | Survey by clinicians at the participating sites. Mean score on the program acceptability survey Acceptability survey is comprised of the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Scores range from 12-60, with higher scores indicating greater acceptability. | Month 6 and Month 12 | 
| Participant Uptake of Home Health Services--Total Number | Care at home survey measuring if patient received home health services with yes or no answer. Total number of participants who say yes. | Month 6 and Month 12 | 
| Participant Uptake of Home Health Services--Proportion | Care at home survey measuring if patient received home health services with yes or no answer. Proportion of participants who say yes. | Month 6 and Month 12 | 
| Proportion of eligible patients who interact with CHW | Shows feasibility of patient recruitment. | Month 6 and Month 12 | 
| Number of Annual Wellness Visits (AWV)s |  | Month 6 and Month 12 | 
| Percentage of Participants who Report Food Insecurity--Total Number | Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Food Insecurity--Proportion | Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Housing Instability--Total Number | Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Housing Instability--Proportion | Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Lack of Transportation--Total Number | Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Lack of Transportation--Proportion | Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Use of Social Services--Total Number | Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Use of Social Services--Proportion | Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Use of Home Health Services--Total Number | Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Use of Home Health Services--Proportion | Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Social Isolation--Total Number | Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included. | Month 6 and Month 12 | 
| Percentage of Participants who Report Social Isolation--Proportion | Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included. | Month 6 and Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, Community Health Care Worker, assistance, at home care