Trial of the Impact of the Electronic Frailty Integrated With Social Needs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 950 older adults (325 to eFRIEND, 625 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Community Health Worker (CHW)-Led Hybrid In-Person/Telehealth Program Pathway (eFRIEND) Participants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW. |
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.
|
| Active Comparator: Usual Care Usual care group will be monitored passively for outcomes under a waiver of informed consent |
Other: Usual Care
Routine treatment in primary care
|
Outcome Measures
Primary Outcome Measures
- Number of ED Visits or Inpatient Hospitalizations [Month 6]
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
- Number of ED Visits or Inpatient Hospitalizations [Month 12]
Healthcare encounters will be tracked using the Electronic Health Record (EHR)
Secondary Outcome Measures
- Number of Completed Medicare Annual Wellness Visits (AWVs) [Month 6 and Month 12]
Determined through data extraction from the EHR
- Usage of Advance Care Planning (ACP) [Month 6 and Month 12]
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.
- Acceptability of Program [Month 6 and Month 12]
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.
- Participant Uptake of Home Health Services--Total Number [Month 6 and Month 12]
Care at home survey measuring if patient received home health services with yes or no answer. Total number of participants who say yes.
- Participant Uptake of Home Health Services--Proportion [Month 6 and Month 12]
Care at home survey measuring if patient received home health services with yes or no answer. Proportion of participants who say yes.
- Proportion of eligible patients who interact with CHW [Month 6 and Month 12]
Shows feasibility of patient recruitment.
- Number of Annual Wellness Visits (AWV)s [Month 6 and Month 12]
- Percentage of Participants who Report Food Insecurity--Total Number [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included.
- Percentage of Participants who Report Food Insecurity--Proportion [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included.
- Percentage of Participants who Report Housing Instability--Total Number [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included.
- Percentage of Participants who Report Housing Instability--Proportion [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included.
- Percentage of Participants who Report Lack of Transportation--Total Number [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included.
- Percentage of Participants who Report Lack of Transportation--Proportion [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included.
- Percentage of Participants who Report Use of Social Services--Total Number [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included.
- Percentage of Participants who Report Use of Social Services--Proportion [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included.
- Percentage of Participants who Report Use of Home Health Services--Total Number [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included.
- Percentage of Participants who Report Use of Home Health Services--Proportion [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included.
- Percentage of Participants who Report Social Isolation--Total Number [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included.
- Percentage of Participants who Report Social Isolation--Proportion [Month 6 and Month 12]
Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Frail based on the electronic Frailty Index (eFI>0.21)
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Live in Forsyth County, NC
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Linked to any Accountable Care Organizations (ACO) registry
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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:
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Diagnosis code for dementia in the past 2 years
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Does not speak English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atrium Health Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Kathryn E. Callahan, MD, Atrium Health Wake Forest Baptist
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00079444