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

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

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.

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.

Participants in the eFRIEND arm will receive regularly scheduled in-person and telehealth contacts with a CHW.

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.

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.

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.

Care at home survey measuring if patient received home health services with yes or no answer. Total number of participants who say yes.

Care at home survey measuring if patient received home health services with yes or no answer. Proportion of participants who say yes.

Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included.

Collected by yes/no response on questionnaire. Subjects who positively report food insecurity are included.

Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included.

Collected by yes/no response on questionnaire. Subjects who positively report housing instability are included.

Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included.

Collected by yes/no response on questionnaire. Subjects who positively report lack of transportation are included.

Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included.

Collected by yes/no response on questionnaire. Subjects who positively report use of social services are included.

Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included.

Collected by yes/no response on questionnaire. Subjects who positively report use of home health services are included.

Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included.

Collected by yes/no response on questionnaire. Subjects who positively report social isolation are included.

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

Our study, is a Pragmatic Trial of the impact of the Electronic Frailty Integrated with Social Needs (eFRIEND) on high cost, high burden healthcare use of older adults in Atrium Health Wake Forest Baptist, agrees to share study data that fulfill the ICMJE requirements starting after the first 3 months after our study has started and 36 months after our first article publication. We agree to provide data to researchers who can provide our lab with a methodologically sound proposal, and who need our data to help achieve aims outlined in their proposal. The study's data will be comprised of individual participant data that underlie the results reported in our publication. Participant data will be deidentified and can be used in text, tables, figures, and appendices, after approval from the study's primary investigator.

The requests must include a proposal with clear aims as to why and how the data will be used. If proposal is approved, a data access agreement will need to be signed and will only be accessible for a 36-month period. All requests to gain access to the data will need to be sent to the study's project manager, Renee Woodard, (renee.woodard@wakehealth.edu), with the study's primary investigator copied, Kate Callahan, MD, MS, (kecallah@wakehealth.edu).