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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04946942
Enrollment
113
Registered
2021-07-01
Start date
2021-08-30
Completion date
2024-12-10
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burnout

Keywords

Caregiver, Older adult, Primary care, Screening

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.

Interventions

BEHAVIORALCollaborative Healthcare Encounters with Caregivers (CHEC)

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

BEHAVIORALUsual Care

Attendance at primary care appointments as usual.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
The Number of Caregivers Who Complete the ChecklistThrough study completion, up to 1 yearThe number of caregivers who complete the checklist
Acceptable Length of CHEC, as Measured by the Number of Caregivers Who Report That the Checklist is an Acceptable LengthPost intervention, at 1 weekAcceptable length of CHEC, as measured by the number of caregivers who report that the checklist is an acceptable length
CHEC's Ease of Use, as Measured by the Number of Caregivers Who Report That the Checklist is Easy to UsePost intervention, at 1 weekCHEC's ease of use, as measured by the number of caregivers who report that the checklist is easy to use
CHEC's Helpfulness in Identify Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Identifying Their NeedsPost intervention, at 1 weekCHEC'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 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 NeedsPost intervention, at 1 weekCHEC'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
Desire to Continue Use, as Measured by the Number Caregivers Who Report That They Desire to Continue Using the Checklist in the FuturePost intervention, at 1 weekDesire to continue use, as measured by the number caregivers who report that they desire to continue using the checklist in the future
Discussion of Caregivers' Needs, as Measured by the Number of Completed Checklists That Result in a Conversation With Providers About Caregiver Needs/ConcernsPost intervention, at 1 weekDiscussion of caregivers' needs, as measured by the number of completed checklists that result in a conversation with providers about caregiver needs/concerns

Countries

United States

Participant flow

Recruitment details

The trial was conducted at an academic affiliated geriatrics practice in New York City.

Pre-assignment details

Participants included primary care physicians, patients, and their accompanying family caregivers. Physicians were were randomized 1:1 to CHEC or usual care using a computer-assisted algorithm to ensure unbiased allocation. Patient-caregiver dyads of participating physicians were allocated to CHEC or usual care based on the randomization of their assigned physician. The counts below for the CHEC and Usual Care arms include patients and caregivers.

Participants by arm

ArmCount
Caregiver Checklist (CHEC): Caregivers
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. Collaborative Healthcare Encounters with Caregivers (CHEC): CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.
29
Caregiver Checklist (CHEC): Patient
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. Collaborative Healthcare Encounters with Caregivers (CHEC): CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.
29
Usual Care: Caregiver
Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual.
24
Usual Care: Patient
Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual.
24
Clinicians
Participating physicians of the patients
7
Total113

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up620

Baseline characteristics

CharacteristicCaregiver Checklist (CHEC): CaregiversTotalUsual Care: PatientUsual Care: CaregiverCaregiver Checklist (CHEC): PatientClinicians
Age, Continuous65.4 years
STANDARD_DEVIATION 11.4
75.3 years
STANDARD_DEVIATION 15
86.2 years
STANDARD_DEVIATION 5.4
61.7 years
STANDARD_DEVIATION 13
86.9 years
STANDARD_DEVIATION 8.1
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants7 Participants0 Participants2 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants97 Participants20 Participants21 Participants23 Participants7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants9 Participants4 Participants1 Participants4 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants8 Participants0 Participants0 Participants3 Participants2 Participants
Race (NIH/OMB)
Black or African American
2 Participants9 Participants3 Participants2 Participants2 Participants0 Participants
Race (NIH/OMB)
More than one race
3 Participants12 Participants3 Participants1 Participants5 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants5 Participants2 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
19 Participants78 Participants16 Participants20 Participants18 Participants5 Participants
Region of Enrollment
United States
29 participants113 participants24 participants24 participants29 participants7 participants
Sex: Female, Male
Female
27 Participants78 Participants18 Participants15 Participants14 Participants4 Participants
Sex: Female, Male
Male
2 Participants35 Participants6 Participants9 Participants15 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 290 / 240 / 24
other
Total, other adverse events
0 / 290 / 290 / 241 / 24
serious
Total, serious adverse events
0 / 290 / 290 / 240 / 24

Outcome results

Primary

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

Time frame: Post intervention, at 1 week

Population: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Caregiver Checklist (CHEC)Acceptable Length of CHEC, as Measured by the Number of Caregivers Who Report That the Checklist is an Acceptable Length23 Participants
Primary

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

Time frame: Post intervention, at 1 week

Population: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Caregiver Checklist (CHEC)CHEC's Ease of Use, as Measured by the Number of Caregivers Who Report That the Checklist is Easy to Use25 Participants
Primary

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

Time frame: Post intervention, at 1 week

Population: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Caregiver Checklist (CHEC)CHEC's Helpfulness in Identify Caregivers' Needs, as Measured by the Number of Caregivers Who Report That the Checklist is Helpful in Identifying Their Needs20 Participants
Primary

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

Time frame: Post intervention, at 1 week

Population: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Caregiver Checklist (CHEC)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 Needs22 Participants
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

Time frame: Post intervention, at 1 week

Population: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Caregiver Checklist (CHEC)Desire to Continue Use, as Measured by the Number Caregivers Who Report That They Desire to Continue Using the Checklist in the Future15 Participants
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

Time frame: Post intervention, at 1 week

Population: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

ArmMeasureValue (NUMBER)
Caregiver Checklist (CHEC)Discussion of Caregivers' Needs, as Measured by the Number of Completed Checklists That Result in a Conversation With Providers About Caregiver Needs/Concerns22 checklists
Primary

The Number of Caregivers Who Complete the Checklist

The number of caregivers who complete the checklist

Time frame: Through study completion, up to 1 year

Population: Only caregivers assigned to the CHEC condition (n=28) were analyzed for this outcome measure. The patients from these dyads were not assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Caregiver Checklist (CHEC)The Number of Caregivers Who Complete the Checklist28 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026