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

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.

Study Overview

• Status: Completed
• Conditions: Caregiver Burnout
• Intervention / Treatment: Behavioral: Collaborative Healthcare Encounters with Caregivers (CHEC); Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caregiver Checklist (CHEC); 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); CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.
Active Comparator: Usual care; Attendance at primary care appointments as usual.	Behavioral: Usual Care; Attendance at primary care appointments as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Catherine Riffin, PhD, Weill Medical College of Cornell University; Principal Investigator: Karl Pillemer, PhD, Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): August 27, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Primary care; Screening; Caregiver; Older adult
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 21-04023513; 5K01AG061275 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No