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Completed

NCT Number: NCT05293730

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

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.

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Key information

Conditions

Aging Behavior Helping Behavior Social Behavior

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eFRIEND

Behavioral

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.

Usual Care

Other

Routine treatment in primary care

Primary outcomes

  1. Number of ED Visits or Inpatient Hospitalizations

    Time frame: Month 6

    Healthcare encounters will be tracked using the Electronic Health Record (EHR)

  2. Number of ED Visits or Inpatient Hospitalizations

    Time frame: Month 12

    Healthcare encounters will be tracked using the Electronic Health Record (EHR)

Secondary outcomes

  1. Number of Completed Medicare Annual Wellness Visits (AWVs)

    Time frame: Month 6 and Month 12

    Determined through data extraction from the EHR

  2. Usage of Advance Care Planning (ACP)

    Time frame: 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.

  3. Acceptability of Program

    Time frame: 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.

  4. Participant Uptake of Home Health Services--Total Number

    Time frame: 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.

  5. Participant Uptake of Home Health Services--Proportion

    Time frame: 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.

  6. Proportion of eligible patients who interact with CHW

    Time frame: Month 6 and Month 12

    Shows feasibility of patient recruitment.

  7. Number of Annual Wellness Visits (AWV)s

    Time frame: Month 6 and Month 12

  8. Percentage of Participants who Report Food Insecurity--Total Number

    Time frame: Month 6 and Month 12

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

  9. Percentage of Participants who Report Food Insecurity--Proportion

    Time frame: Month 6 and Month 12

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

  10. Percentage of Participants who Report Housing Instability--Total Number

    Time frame: Month 6 and Month 12

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

  11. Percentage of Participants who Report Housing Instability--Proportion

    Time frame: Month 6 and Month 12

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

  12. Percentage of Participants who Report Lack of Transportation--Total Number

    Time frame: Month 6 and Month 12

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

  13. Percentage of Participants who Report Lack of Transportation--Proportion

    Time frame: Month 6 and Month 12

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

  14. Percentage of Participants who Report Use of Social Services--Total Number

    Time frame: Month 6 and Month 12

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

  15. Percentage of Participants who Report Use of Social Services--Proportion

    Time frame: Month 6 and Month 12

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

  16. Percentage of Participants who Report Use of Home Health Services--Total Number

    Time frame: Month 6 and Month 12

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

  17. Percentage of Participants who Report Use of Home Health Services--Proportion

    Time frame: Month 6 and Month 12

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

  18. Percentage of Participants who Report Social Isolation--Total Number

    Time frame: Month 6 and Month 12

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

  19. Percentage of Participants who Report Social Isolation--Proportion

    Time frame: Month 6 and Month 12

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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