Clinical trial NCT06152120: Preparing Surrogates of Dementia Patients Through an Advance Care Planning Intervention
Official title: Preparing Surrogates of Dementia Patients for In-the-moment Decision Making Through a Structured Advance Care Planning Intervention: A Mixed-methods Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
advance care planning
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Family Member Decision-Making Self-efficacy Scale (FDMSE) - Chinese version
timeFrame: Baseline, 2-month, 6-month
measure: Family Distress in Advanced Dementia Scale (FDAD) Dementia Preparedness Subscale - Chinese version
timeFrame: Baseline, 2-month, 6-month
Secondary outcomes:
measure: End-of-life care discussions with other family members
timeFrame: Baseline, 2-month, 6-month
measure: Documentation of ACP discussions with medical providers
timeFrame: Baseline, 2-month, 6-month
measure: Enrolment in Community Geriatric Assessment Team End-of-Life (CGAT EOL) care program
timeFrame: 2-month, 6-month
measure: Comfort Assessment in Dying with Dementia (CAD-EOLD)
timeFrame: 2-month, 6-month
measure: Unplanned hospital admissions and hospitalization days
timeFrame: 2-month, 6-month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Jacqueline Yuen, Dr
role: PRINCIPAL_INVESTIGATOR
References: