Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study

Caregiver Burnout Clinical Trial

Official title:

Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946942
• Other study ID #: 21-04023513
• Secondary ID: 5K01AG061275
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Weill Medical College of Cornell University
• Contact: Catherine Riffin, PhD
• Phone: 781.454.6126
• Email: acr2213[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this project is to pilot test CHEC (Collaborative Healthcare Encounters with Caregivers) in primary care. CHEC is brief intervention with two components: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older patients (aged 65+) to their primary care visits and 2) accompanying Tip Sheet for clinicians.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

Inclusion Criteria:

Patients

• Age 65-89

• English speaking

• Women and men

• Of varying race/ethnicity

• Accompanied to primary care visits at the Center on Aging by a family caregiver (family caregiver also consents to participating in this study)

• Sufficient cognitive capacity to consent themselves or through a legal representative

Caregivers

• Age 21+

• English speaking

• Women and men

• Of varying race/ethnicity

• Accompany an older adult to his or her primary care visits at the Center on Aging (Older adult also consents to participating in this study)

• Cognitively intact (on basis of a 6-item cognitive screen)

Clinicians

• Age 21+

• Women and men

• Of varying race/ethnicity

• Treat patients at the Center on Aging

Exclusion Criteria:

• Patients, caregivers, and clinicians that do not meet the inclusion criteria.

• Patients and caregivers who are deaf or have hearing impairments that limit their ability to answer telephone queries.

• Caregivers who are visually impaired and cannot see well enough to read large print and complete paper-based surveys.

• Patients and/or caregivers whose dyad counterpart does not consent to take part in the study (i.e., Patients gives consent and their caregiver does not).

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout

Intervention

Behavioral:
• Collaborative Healthcare Encounters with Caregivers (CHEC)
CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.
• Usual Care
Attendance at primary care appointments as usual.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate, as measured by the number of caregivers who complete the checklist	Accrual rate, as measured by the number of caregivers who complete the checklist	Through study completion, up to 1 year
Primary	Acceptable length of CHEC, as measured by the proportion of caregivers who report that the checklist is an acceptable length	Acceptable length of CHEC, as measured by the proportion of caregivers who report that the checklist is an acceptable length	Post intervention, at 1 week
Primary	CHEC's ease of use, as measured by the proportion of caregivers who report that the checklist is easy to use	CHEC's ease of use, as measured by the proportion of caregivers who report that the checklist is easy to use	Post intervention, at 1 week
Primary	CHEC's helpfulness in identify caregivers' needs, as measured by the proportion of caregivers who report that the checklist is helpful in identifying their needs	CHEC's helpfulness in identify caregivers' needs, as measured by the proportion of caregivers who report that the checklist is helpful in identifying their needs	Post intervention, at 1 week
Primary	CHEC's helpfulness in starting a conversation with health care providers about caregivers' needs, as measured by the proportion of caregivers who report that the checklist is helpful in starting a conversation with providers about their needs	CHEC's helpfulness in starting a conversation with health care providers about caregivers' needs, as measured by the proportion of caregivers who report that the checklist is helpful in starting a conversation with providers about their needs	Post intervention, at 1 week
Primary	Desire to continue use, as measured by the number caregivers who report that they desire to continue using the checklist in the future	Desire to continue use, as measured by the number caregivers who report that they desire to continue using the checklist in the future	Post intervention, at 1 week
Primary	Discussion of caregivers' needs, as measured by the number of completed checklists that result in a conversation with providers about caregiver needs/concerns	Discussion of caregivers' needs, as measured by the number of completed checklists that result in a conversation with providers about caregiver needs/concerns	Post intervention, at 1 week