Clinical trial NCT05143255: Developing a Communication Intervention for People With Memory Challenges and Their Care Partners
Official title: Developing a Communication Intervention to Help People With Memory Challenges and Their Care Partners Engage in Advance Care Planning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: caregiving
advance care planning
communication
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: Patient Inclusion Criteria:

1. Montreal Cognitive Assessment (MoCA) score of ≥11-21
2. score of ≥9 on the University of California-San Diego Brief Assessment of Capacity to Consent,
3. score of ≥11 on the capacity to execute a Health Care Proxy Guideline,
4. identification of an informal CP.
5. age ≥ 65
6. impaired autonomy in memory function, ADLs, or IADLs per the care partner's report.

Care Partner Inclusion Criteria:

1. the person whom the patient indicates provides their informal (unpaid) care
2. MoCA score of ≥26

Exclusion Criteria for Patient or Care Partner:

* 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)
* 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
* has a diagnosis of Major Depressive Disorder, Bipolar Disorder, current psychotic disorder or substance abuse disorder per self-report or the medical record
* patient-care partner dyads who have completed advance directives, due to the lack of need for an intervention

Primary outcomes:
measure: Change in advance care planning preparedness, as measured by the Advance Care Planning Engagement Survey: Process Measures
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: 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
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in discussion of advance directives
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in the number of patients who have completed advance directives
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in knowledge about dementia trajectory, as measured by the Alzheimer's Disease Knowledge Scale
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Secondary outcomes:
measure: Change in concordance on healthcare values, as measured by the Health Care Values Rating Scale
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in perceived need for advanced care planning (ACP), as measured by the Decisional Balance scale
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in psychological distress/depression, as measured by the Center for Epidemiological Studies Depression Scale
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in communication quality, as measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF)
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
measure: Change in care partner burden (care partner only), as measured by the Zarit Burden Interview
timeFrame: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sara Czaja, PhD
role: PRINCIPAL_INVESTIGATOR
References: