Trial Outcomes & Findings for Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study (NCT NCT04946942)
NCT ID: NCT04946942
Last Updated: 2025-07-03
Results Overview
The number of caregivers who complete the checklist
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
Through study completion, up to 1 year
Results posted on
2025-07-03
Participant Flow
The trial was conducted at an academic affiliated geriatrics practice in New York City.
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.
Participant milestones
| Measure |
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.
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.
Usual Care: Attendance at primary care appointments as usual.
|
Clinicians
Participating physicians of the patients
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
48
|
7
|
|
Overall Study
COMPLETED
|
52
|
46
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
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.
Usual Care: Attendance at primary care appointments as usual.
|
Clinicians
Participating physicians of the patients
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
0
|
Baseline Characteristics
Age was not collected for the 7 primary care physicians.
Baseline characteristics by cohort
| Measure |
Caregiver Checklist (CHEC): Caregivers
n=29 Participants
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.
|
Caregiver Checklist (CHEC): Patient
n=29 Participants
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.
|
Usual Care: Caregiver
n=24 Participants
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
Usual Care: Patient
n=24 Participants
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
Clinicians
n=7 Participants
Participating physicians of the patients
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 11.4 • n=29 Participants • Age was not collected for the 7 primary care physicians.
|
86.9 years
STANDARD_DEVIATION 8.1 • n=29 Participants • Age was not collected for the 7 primary care physicians.
|
61.7 years
STANDARD_DEVIATION 13.0 • n=24 Participants • Age was not collected for the 7 primary care physicians.
|
86.2 years
STANDARD_DEVIATION 5.4 • n=24 Participants • Age was not collected for the 7 primary care physicians.
|
—
|
75.3 years
STANDARD_DEVIATION 15.0 • n=106 Participants • Age was not collected for the 7 primary care physicians.
|
|
Sex: Female, Male
Female
|
27 Participants
n=29 Participants
|
14 Participants
n=29 Participants
|
15 Participants
n=24 Participants
|
18 Participants
n=24 Participants
|
4 Participants
n=7 Participants
|
78 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=29 Participants
|
15 Participants
n=29 Participants
|
9 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=7 Participants
|
35 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=29 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=29 Participants
|
23 Participants
n=29 Participants
|
21 Participants
n=24 Participants
|
20 Participants
n=24 Participants
|
7 Participants
n=7 Participants
|
97 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
4 Participants
n=29 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=29 Participants
|
3 Participants
n=29 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=29 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=29 Participants
|
18 Participants
n=29 Participants
|
20 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
5 Participants
n=7 Participants
|
78 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=29 Participants
|
5 Participants
n=29 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=29 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=113 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
29 participants
n=29 Participants
|
24 participants
n=24 Participants
|
24 participants
n=24 Participants
|
7 participants
n=7 Participants
|
113 participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 1 yearPopulation: 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.
The number of caregivers who complete the checklist
Outcome measures
| Measure |
Caregiver Checklist (CHEC)
n=28 Participants
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.
|
Usual Care
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|
|
The Number of Caregivers Who Complete the Checklist
|
28 Participants
|
—
|
PRIMARY outcome
Timeframe: Post intervention, at 1 weekPopulation: 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.
Acceptable length of CHEC, as measured by the number of caregivers who report that the checklist is an acceptable length
Outcome measures
| Measure |
Caregiver Checklist (CHEC)
n=28 Participants
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.
|
Usual Care
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|
|
Acceptable Length of CHEC, as Measured by the Number of Caregivers Who Report That the Checklist is an Acceptable Length
|
23 Participants
|
—
|
PRIMARY outcome
Timeframe: Post intervention, at 1 weekPopulation: 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.
CHEC's ease of use, as measured by the number of caregivers who report that the checklist is easy to use
Outcome measures
| Measure |
Caregiver Checklist (CHEC)
n=28 Participants
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.
|
Usual Care
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|
|
CHEC's Ease of Use, as Measured by the Number of Caregivers Who Report That the Checklist is Easy to Use
|
25 Participants
|
—
|
PRIMARY outcome
Timeframe: Post intervention, at 1 weekPopulation: 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.
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
Outcome measures
| Measure |
Caregiver Checklist (CHEC)
n=28 Participants
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.
|
Usual Care
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|
|
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
|
20 Participants
|
—
|
PRIMARY outcome
Timeframe: Post intervention, at 1 weekPopulation: 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.
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
Outcome measures
| Measure |
Caregiver Checklist (CHEC)
n=28 Participants
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.
|
Usual Care
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|
|
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
|
22 Participants
|
—
|
PRIMARY outcome
Timeframe: Post intervention, at 1 weekPopulation: 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.
Desire to continue use, as measured by the number caregivers who report that they desire to continue using the checklist in the future
Outcome measures
| Measure |
Caregiver Checklist (CHEC)
n=28 Participants
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.
|
Usual Care
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|
|
Desire to Continue Use, as Measured by the Number Caregivers Who Report That They Desire to Continue Using the Checklist in the Future
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: Post intervention, at 1 weekPopulation: 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.
Discussion of caregivers' needs, as measured by the number of completed checklists that result in a conversation with providers about caregiver needs/concerns
Outcome measures
| Measure |
Caregiver Checklist (CHEC)
n=28 Participants
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.
|
Usual Care
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|
|
Discussion of Caregivers' Needs, as Measured by the Number of Completed Checklists That Result in a Conversation With Providers About Caregiver Needs/Concerns
|
22 checklists
|
—
|
Adverse Events
Caregiver Checklist (CHEC): Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregiver Checklist (CHEC): Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care: Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care: Patient
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caregiver Checklist (CHEC): Caregiver
n=29 participants at risk
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.
|
Caregiver Checklist (CHEC): Patient
n=29 participants at risk
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.
|
Usual Care: Caregiver
n=24 participants at risk
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
Usual Care: Patient
n=24 participants at risk
Attendance at primary care appointments as usual.
Usual Care: Attendance at primary care appointments as usual.
|
|---|---|---|---|---|
|
Social circumstances
Patient/care recipient abuse
|
0.00%
0/29 • 6 months
Clinicians were not assessed for adverse events.
|
0.00%
0/29 • 6 months
Clinicians were not assessed for adverse events.
|
0.00%
0/24 • 6 months
Clinicians were not assessed for adverse events.
|
4.2%
1/24 • 6 months
Clinicians were not assessed for adverse events.
|
Additional Information
Catherine Riffin, PhD
Weill Medical College of Cornell University
Phone: (203) 303-4904
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place