Preparing Surrogates of Dementia Patients Through an Advance Care Planning Intervention

Preparing Surrogates of Dementia Patients for In-the-moment Decision Making Through a Structured Advance Care Planning Intervention: A Mixed-methods Pilot Study

The goal of this clinical trial is to evaluate the effects of a nurse-facilitated post-discharge advance care planning intervention with family surrogates of dementia patients on outcomes that reflect the preparedness of surrogates in decision-making.

The main question it aims to answer is, whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.

Participants will be randomized to ACP intervention vs. usual care.

1. patients of the Intervention group will be assessed on palliative care needs, and surrogates of the Intervention group will participate in 2-3 nurse-led ACP consultations;
2. surrogates of both intervention and control groups will complete 3 surveys at different time points during their participation of the study.

Researchers will compare the intervention group and control group to see any differences in:

1. surrogate preparedness for decision-making,
2. distress of surrogate and satisfaction with the care of loved one with dementia at the end-of-life,
3. enrolment in Community Geriatric Assessment Team end-of-life care program,
4. advanced care program documentation in medical record,
5. patient comfort at end-of-life,
6. hospitalizations in the last 6 months of life.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: Nurse-facilitated advance care planning intervention

Detailed Description

In order to test the ACP interventions that aim to engage surrogates' participation in ACP and improve their preparedness for decision-making rather than on documentation of advance care plans alone, the research team has developed a pilot structured, nurse-facilitated post-discharge ACP intervention with the aim to improve surrogates' preparedness for in-the-moment decision-making.

It does so by incorporating best practices for ACP communication, drawing from prior work of the research team and existing literature, combined with a focus on developing surrogates' self-efficacy for decision-making guided by Bandura's Social Cognitive Theory.

This application aims to test the intervention's effects on surrogate outcomes (decision-making self-efficacy and distress), patient outcomes (patient comfort and healthcare utilization), as well as process outcomes (ACP documentation, end-of-life care discussions between family members, and enrolment in end-of-life care programs).

The research hypotheses to be tested are as follows: the investigators will test whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Dyads of patients with dementia admitted for an unplanned hospital admission and their family surrogate will be eligible for the study.

Inclusion Criteria of patients:

- Patient (a) at or above the age of 60 years old, (b) with diagnosis of dementia based on DSM-5 Criteria for Major Neurocognitive Disorder and Stage 6d or above on the Functional Assessment Staging Tool (FAST), (c) residing in a residential care home that is participating in Hospital Authority Enhanced Community Geriatric Assessment Team End-of-Life (CGAT EOL) Care program and (d) has an eligible family decision-maker.

Exclusion Criteria of patients:

- Patient with (i) prior completed advance directive, (ii) On tube feeding at the time of index admission, (iii) currently enrolled in an end-of-life care program or palliative care service, or (iv) with family members who lack consensus on the primary family surrogate decision-maker.

Inclusion Criteria of surrogates:

- Surrogate (a) at or above the age of 18 years old, (b) identified as the patient's next of kin or legal guardian who is the 'key decision maker' in hospital records, and (c) able to provide informed consent for him/herself and the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACP Intervention arm; The intervention consists of two components: Palliative care needs assessment During the patient's hospitalization, the ACP nurse facilitator will conduct a palliative care needs assessment including assessment of patient's dementia severity (using the FAST scale), symptoms, clinical condition, nutritional and functional status, as well as psychosocial information.; Structured nurse-facilitated post-discharge ACP consultations with use of video decisions aidsACP consultation 1 (1-2 weeks post discharge)Video decision aids (Between consultations 1 and 2)ACP consultation 2 (2-3 weeks post discharge)ACP consultation 3 (3-4 weeks post discharge), if needed At the completion of the ACP intervention, the ACP nurse facilitator may refer patients to the CGAT EOL program via the link nurse if fulfill the program criteria and agreed by the family surrogate(s).	Other: Nurse-facilitated advance care planning intervention; The intervention consists of two components: Component 1. Palliative care needs assessment - The research nurse will conduct a palliative care needs assessment and also review related information from the medical chart, which will enable the nurse to provide tailored information on the patient's illness, prognosis, and palliative care needs during subsequent ACP consultations. Component 2: Structured nurse-facilitated ACP consultations - The research nurse will conduct post-discharge ACP consultations with the family surrogate, with content that includes: assess readiness for discussions, introduce video decision aides to provide related ACP information and share examples of family surrogates with similar experiences.
No Intervention: Usual care arm; Patient and family surrogate dyads will receive usual hospital and post-discharge care. A publicly available information leaflet on advance care planning from the Hospital Authority's website will be given to control family surrogates after randomization. If a surrogate seeks assistance in discussing advance care planning, the research staff will advise the surrogate to speak with the patient's medical providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Family Member Decision-Making Self-efficacy Scale (FDMSE) - Chinese version	This is a modified 17-item version of the FDMSE, a valid and reliable scale that quantifies a family member's confidence (0-100, where 100 = greatest self-efficacy) in end-of-life care decision-making for a loved one.	Baseline, 2-month, 6-month
Family Distress in Advanced Dementia Scale (FDAD) Dementia Preparedness Subscale - Chinese version	The FDAD is a validated 21-item scale rated on a 1-5 scale, with higher scores indicating greater family distress. The scale assesses three domains of distress of family members of nursing home residents with dementia: Emotional Distress, Dementia Preparedness, and Clinician Relations. The Chinese version of the FDAD has high content validity (CVI = 0.95). It has good internal consistency (Cronbach's alpha 0.83) and moderate test-retest reliability (ICC = 0.64). We will use the 5-item Dementia Preparedness subscale to evaluate family distress associated with lack of knowledge of the course of dementia and surrogate medical decision making.	Baseline, 2-month, 6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-of-life care discussions with other family members	The number of conversations which the surrogate has with other family members regarding end-of-life care decisions for the patient with advanced dementia.	Baseline, 2-month, 6-month
Documentation of ACP discussions with medical providers	Information on the date of ACP discussion, type of clinician(s) involved, and care decisions in the Hospital Authority Clinical Management System.	Baseline, 2-month, 6-month
Enrolment in Community Geriatric Assessment Team End-of-Life (CGAT EOL) care program	Occurrence and date of new enrolment in the CGAT EOL care program in the Hospital Authority Clinical Management System.	2-month, 6-month
Comfort Assessment in Dying with Dementia (CAD-EOLD)	Measure of common symptoms and conditions to assess comfort of advanced dementia patients across 4 domains: Physical Distress, Emotional Distress, Well Being, and Dying Symptoms.	2-month, 6-month
Unplanned hospital admissions and hospitalization days	The number of unplanned hospital admissions and hospitalization days in public and private hospitals.	2-month, 6-month

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Jacqueline Yuen, Dr, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: dementia; advance care planning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 20212481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No