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Clinical Trials/NCT05143255
NCT05143255
Active, Not Recruiting
N/A

Developing a Communication Intervention to Help People With Memory Challenges and Their Care Partners Engage in Advance Care Planning

Weill Medical College of Cornell University1 site in 1 country90 target enrollmentDecember 9, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Weill Medical College of Cornell University
Enrollment
90
Locations
1
Primary Endpoint
Change in advance care planning preparedness, as measured by the Advance Care Planning Engagement Survey: Process Measures
Status
Active, Not Recruiting
Last Updated
8 months ago

Overview

Brief Summary

The proposed research is consistent with broader public health goals focused on improving communication regarding end-of-life care and the Centers for Medicare and Medicaid Services' (CMS) call for increased patient engagement in advance care planning (ACP) as part of standard care. The proposed study will address this public health issue by developing a communication-based intervention designed to improve Alzheimer's Disease and Related Dementias (ADRD) patients' and care partners' engagement in ACP, distress and care partner burden, and completion of advance directives and receipt of goal-concordant care at the end-of-life. Therefore, this study is aligned with the National Institute on Aging's long-term goal to improve the quality of care for ADRD patients and CMS's goal to increase engagement in ACP.

Detailed Description

The goals of this study are to: (1) develop a communication-based intervention, called KNow the Optimal Way (KNOW) for Alzheimer's Disease and Related Dementias (ADRD) patients and care partners that includes theoretically grounded communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention; and (3) test the preliminary efficacy of the intervention on ADRD patients' and care partners' preparedness for and engagement in advance care planning (ACP), and completion of advance directives (primary outcomes) as well as patient-care partner concordance on the person with dementia (PWD)'s healthcare values, perceived need for ACP, psychological distress, communication quality, and care partner burden (secondary outcomes).

Registry
clinicaltrials.gov
Start Date
December 9, 2024
End Date
January 31, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in advance care planning preparedness, as measured by the Advance Care Planning Engagement Survey: Process Measures

Time Frame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

Change in advance care planning preparedness will be assessed in patients and care partners using the reliable and valid Advance Care Planning Engagement Survey: Process Measures (31-items). Response options range from 1=never to 5=a lot. Questions include those asking about knowledge of advance care planning, degree of contemplation about advance care planning, and self-efficacy and readiness to engage in advance care planning. Overall scores can range from 31 to 155, with higher scores indicating more engagement in advance care planning.

Change in care partners' engagement in advance care planning, as measured by the Van Scoy and Sudore measure which adapts the Decision Maker subscale of the Advance Care Planning Engagement Survey

Time Frame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

Change in care partner engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to care partners. Response options range from 1=never to 5=a lot. Scores can range from 4 to 20, with higher scores indicating more decisions have been made.

Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures

Time Frame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options range from 1=never to 5= a lot. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Scores can range from 4 to 20, with higher scores indicating that more decisions have been made around advance care planning.

Change in discussion of advance directives

Time Frame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

Discussion of advance directives will be assessed with an 8-item measure that asks persons with ADRD and care partner whether the patient has discussed end-of-life care, living will, health care proxy, and DNR orders with family/patient and doctor/patient's doctor. Response options are yes or no. A total score is created by adding up the number of discussions, which can range from 0 to 8, with 0 meaning no discussions have occurred (low score) to 8, meaning all discussions have occurred (high score).

Change in the number of patients who have completed advance directives

Time Frame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up

Completion of advance directives will be assessed by asking patients whether they have completed a do-not-resuscitate order, a living will, and/or or identified a health care proxy; data will be verified through the patient's electronic health record. Completion will be scored a 0 if the patient has completed none and 1 if they have completed one or more of the advance directives. Additional analyses will be done on each individual advance directive (e.g., 0 if no DNR order, 1 if yes to completing DNR order).

Secondary Outcomes

  • Change in perceived need for advanced care planning (ACP), as measured by the Decisional Balance scale(Baseline, Post-Intervention (within 2 weeks), 3-month follow up)
  • Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline, Post-Intervention (within 2 weeks), 3-month follow up)
  • Change in care partner burden (care partner only), as measured by the Zarit Burden Interview(Baseline, Post-Intervention (within 2 weeks), 3-month follow up)
  • Change in psychological distress/depression, as measured by the Center for Epidemiological Studies Depression Scale(Baseline, Post-Intervention (within 2 weeks), 3-month follow up)
  • Change in concordance on healthcare values, as measured by the Health Care Values Rating Scale(Baseline, Post-Intervention (within 2 weeks), 3-month follow up)
  • Change in communication quality, as measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF)(Baseline, Post-Intervention (within 2 weeks), 3-month follow up)

Study Sites (1)

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