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

NCT04946942 | Completed Results

• 2 other identifiers: 21-040235135K01AG061275
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caregiver Burnout

Keywords

Caregiver; Older adult; Primary care; Screening

Outcome Measures

Primary Outcomes (7)

• The Number of Caregivers Who Complete the Checklist

  The number of caregivers who complete the checklist

  Through study completion, up to 1 year

• Acceptable Length of CHEC, as Measured by the Number of Caregivers Who Report That the Checklist is an Acceptable Length

  Acceptable length of CHEC, as measured by the number of caregivers who report that the checklist is an acceptable length

  Post intervention, at 1 week

• CHEC's Ease of Use, as Measured by the Number of Caregivers Who Report That the Checklist is Easy to Use

  CHEC's ease of use, as measured by the number of caregivers who report that the checklist is easy to use

  Post intervention, at 1 week

• CHEC's Helpfulness in Identify Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Identifying Their Needs

  CHEC's helpfulness in identify caregivers' needs, as measured by the number of caregivers who report that the checklist is helpful in identifying their needs

  Post intervention, at 1 week

• CHEC's Helpfulness in Starting a Conversation With Health Care Providers About Caregivers' Needs, as Measured by the Number 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 number of caregivers who report that the checklist is helpful in starting a conversation with providers about their needs

  Post intervention, at 1 week

• 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

• 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

Study Arms (2)

Caregiver Checklist (CHEC)

EXPERIMENTAL

CHEC is composed of two elements: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older adults (aged 65+) to their primary care visits and 2) Tip Sheet for clinicians.

Behavioral: Collaborative Healthcare Encounters with Caregivers (CHEC)

Usual care

ACTIVE COMPARATOR

Attendance at primary care appointments as usual.

Behavioral: Usual Care

Interventions

Collaborative Healthcare Encounters with Caregivers (CHEC) BEHAVIORAL

CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.

Caregiver Checklist (CHEC)

Usual Care BEHAVIORAL

Attendance at primary care appointments as usual.

Usual care

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (2)

• Neprash HT, Everhart A, McAlpine D, Smith LB, Sheridan B, Cross DA. Measuring Primary Care Exam Length Using Electronic Health Record Data. Med Care. 2021 Jan;59(1):62-66. doi: 10.1097/MLR.0000000000001450.

  PMID: 33301282 BACKGROUND

• Riffin C, Brody L, Wolff JL, Pillemer KA. A Pilot Trial Evaluating Collaborative Healthcare Encounters With Caregivers: A Checklist-Based Intervention for Primary Care. J Appl Gerontol. 2025 Dec;44(12):2006-2014. doi: 10.1177/07334648251323688. Epub 2025 Feb 27.

  PMID: 40015556 DERIVED

MeSH Terms

Conditions

Caregiver Burden

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

As a small feasibility trial, the study was not powered to conduct multivariable analyses that account for caregiver characteristics or to evaluate treatment effects by time. Additionally, findings may not generalize to mainstream primary care practice, given that recruitment occurred at a single academic geriatrics clinic with generous appointment lengths that may have enabled greater discussion of caregiver concerns.

Results Point of Contact

• Title: Catherine Riffin, PhD
• Organization: Weill Medical College of Cornell University

acr2213@med.cornell.edu

(203) 303-4904

Study Officials

• Catherine Riffin, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Karl Pillemer, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: August 30, 2021
• Primary Completion: August 27, 2024
• Study Completion: December 10, 2024
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)