Developing a Communication Intervention for People With Memory Challenges and Their Care Partners

NCT05143255 | Completed

• 2 other identifiers: 21-04023598R21AG070501
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia

Keywords

caregiving; advance care planning; communication

Outcome Measures

Primary Outcomes (5)

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

  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.

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

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

  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.

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

• 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

  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.

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

• Change in discussion of advance directives

  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).

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

• Change in the number of patients who have completed advance directives

  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).

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

Secondary Outcomes (6)

• 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 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/depression, as measured by the Center for Epidemiological Studies Depression 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 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 Arms (1)

KNOW Intervention

EXPERIMENTAL

Behavioral: KNOW

Interventions

KNOW BEHAVIORAL

KNow the Optimal Way (KNOW) is a manualized ADRD patient-care partner intervention designed to increase engagement in advance care planning (ACP) and completion of advance directives among early stage ADRD patients and their care partners using theoretically grounded distress tolerance techniques (inhibitory learning theory) and communication skills (cognitive-social processing theory) consistent with recommended guidelines for discussions about ACP in ADRD care.

KNOW Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• not fluent in English;
• ≤17 years of age;
• too ill or weak to complete the interviews (per the interviewer);
• presence of significant sensory, language, or motor deficit (e.g., visual or hearing loss, paralysis, aphasia) (per self report, the interviewer or medical record); or
• patient is in the late stage of dementia (i.e., severe cognitive impairment), is bed-bound, or has a nursing home admission planned within 12 months per CP report or the medical record.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Communication

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Sara Czaja, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 3, 2021
• Study Start: December 9, 2024
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)