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

Aging Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05293730
• Other study ID #: IRB00079444
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2050
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Frailty

Intervention

Behavioral:
• 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.

Other:
• Usual Care
Routine treatment in primary care

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ED Visits or Inpatient Hospitalizations	Healthcare encounters will be tracked using the Electronic Health Record (EHR)	Month 6
Primary	Number of ED Visits or Inpatient Hospitalizations	Healthcare encounters will be tracked using the Electronic Health Record (EHR)	Month 12
Secondary	Number of Completed Medicare Annual Wellness Visits (AWVs)	Determined through data extraction from the EHR	Month 6 and Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of eligible patients who interact with CHW	Shows feasibility of patient recruitment.	Month 6 and Month 12
Secondary	Number of Annual Wellness Visits (AWV)s		Month 6 and Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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