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| ID | Type | Description | Link |
|---|---|---|---|
| 5K01AG061275 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | Active Comparator | Attendance at primary care appointments as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative Healthcare Encounters with Caregivers (CHEC) | Behavioral | CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns. |
|
| 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 |
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Inclusion Criteria:
Patients
Caregivers
Clinicians
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Riffin, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Karl Pillemer, PhD | Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33301282 | Background | 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. | |
| 40015556 | Derived | 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. |
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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.
The trial was conducted at an academic affiliated geriatrics practice in New York City.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual. |
| FG002 | Clinicians | Participating physicians of the patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Age was not collected for the 7 primary care physicians.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not collected for the 7 primary care physicians. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Caregivers Who Complete the Checklist | The number of caregivers who complete the checklist | 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. | Posted | Count of Participants | Participants | Through study completion, up to 1 year |
|
6 months
Clinicians were not assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caregiver Checklist (CHEC): Caregiver | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient/care recipient abuse | Social circumstances | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Riffin, PhD | Weill Medical College of Cornell University | (203) 303-4904 | acr2213@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2024 | Apr 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Usual Care | Behavioral | 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 |
| 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 |
| BG001 | 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. |
| BG002 | Usual Care: Caregiver | Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual. |
| BG003 | Usual Care: Patient | Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual. |
| BG004 | Clinicians | Participating physicians of the patients |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Usual Care |
Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual. |
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Post intervention, at 1 week |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Post intervention, at 1 week |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Post intervention, at 1 week |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Post intervention, at 1 week |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Post intervention, at 1 week |
|
|
|
| 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 | 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. | Posted | Number | checklists | Post intervention, at 1 week |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Usual Care: Caregiver | Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Usual Care: Patient | Attendance at primary care appointments as usual. Usual Care: Attendance at primary care appointments as usual. | 0 | 24 | 0 | 24 | 1 | 24 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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