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

Primary Purpose

Caregiver Burnout

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Healthcare Encounters with Caregivers (CHEC)
Usual Care
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Caregiver Burnout focused on measuring Caregiver, Older adult, Primary care, Screening

Eligibility Criteria

21 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Caregiver Checklist (CHEC)

Usual care

Arm Description

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.

Attendance at primary care appointments as usual.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 23, 2021
Last Updated
May 30, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04946942
Brief Title
Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study
Official Title
Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout
Keywords
Caregiver, Older adult, Primary care, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caregiver Checklist (CHEC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Attendance at primary care appointments as usual.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Healthcare Encounters with Caregivers (CHEC)
Intervention Description
CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Attendance at primary care appointments as usual.
Primary Outcome Measure Information:
Title
Accrual rate, as measured by the number of caregivers who complete the checklist
Description
Accrual rate, as measured by the number of caregivers who complete the checklist
Time Frame
Through study completion, up to 1 year
Title
Acceptable length of CHEC, as measured by the proportion of caregivers who report that the checklist is an acceptable length
Description
Acceptable length of CHEC, as measured by the proportion of caregivers who report that the checklist is an acceptable length
Time Frame
Post intervention, at 1 week
Title
CHEC's ease of use, as measured by the proportion of caregivers who report that the checklist is easy to use
Description
CHEC's ease of use, as measured by the proportion of caregivers who report that the checklist is easy to use
Time Frame
Post intervention, at 1 week
Title
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
Description
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
Time Frame
Post intervention, at 1 week
Title
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
Description
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
Time Frame
Post intervention, at 1 week
Title
Desire to continue use, as measured by the number caregivers who report that they desire to continue using the checklist in the future
Description
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
Title
Discussion of caregivers' needs, as measured by the number of completed checklists that result in a conversation with providers about caregiver needs/concerns
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Riffin, PhD
Phone
781.454.6126
Email
acr2213@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lilla Brody, BA
Phone
310-696-9442
Email
lab4012@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Riffin, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Pillemer, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Riffin, PhD
Phone
781-454-6126
Email
acr2213@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Catherine Riffin

12. IPD Sharing Statement

Plan to Share IPD
No

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

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