Preparing Surrogates of Dementia Patients Through an Advance Care Planning Intervention

NCT06152120 | Completed

• 1 other identifier: 20212481
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.surrogates of both intervention and control groups will complete 3 surveys at different time points during their participation of the study.
3. 3.surrogate preparedness for decision-making,
4. 4.distress of surrogate and satisfaction with the care of loved one with dementia at the end-of-life,
5. 5.enrolment in Community Geriatric Assessment Team end-of-life care program,
6. 6.advanced care program documentation in medical record,
7. 7.patient comfort at end-of-life,
8. 8.hospitalizations in the last 6 months of life.

Conditions

Dementia

Keywords

dementia; advance care planning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• End-of-life care discussions with other family members

  Baseline, 2-month, 6-month

• Documentation of ACP discussions with medical providers

  Baseline, 2-month, 6-month

• Enrolment in Community Geriatric Assessment Team End-of-Life (CGAT EOL) care program

  2-month, 6-month

• Comfort Assessment in Dying with Dementia (CAD-EOLD)

  2-month, 6-month

• Unplanned hospital admissions and hospitalization days

  2-month, 6-month

Study Arms (2)

ACP Intervention arm

EXPERIMENTAL

The intervention consists of two components: 1. 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. 2. Structured nurse-facilitated post-discharge ACP consultations with use of video decisions aids * ACP 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

Usual care arm

NO INTERVENTION

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.

Interventions

Nurse-facilitated advance care planning intervention OTHER

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.

ACP Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.
• \- 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jacqueline Yuen, Dr

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff will be blinded to the study arm when collecting data from family surrogates by telephone at follow up time-points. The study biostatistician will also be blinded to the allocation of the study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The investigators will use a sequential mixed-methods approach including a pilot randomized controlled trial using a quantitative study to evaluate the effects of a structured nurse-facilitated ACP intervention and a qualitative study to explore the perceptions of the family surrogates and the ACP nurse facilitator on the ACP intervention. Each patient-family dyad will be randomized in a 1:1 ratio to ACP intervention vs. usual care before the baseline interview.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: June 15, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)