NCT06238063

Brief Summary

The goal of this cluster randomized controlled trial is to examine the effectiveness of a nurse-led advance care planning (ACP) intervention on improving ACP discussion uptake in residential care homes (RCHs). The main question it aims to answer is: The effectiveness of nurse-led advance care planning (ACP) interventions implemented on eligible residents in residential care homes on improving ACP discussion uptake in this population. Compared to participants in the control group who will only receive usual care with no ACP intervention, residents and their family members in the intervention group will be invited to attend the ICP meeting with ACP discussion. The ACP discussion will be guided by the established protocol, which was developed by the expert panel and delivered by trained nurses.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3.3 years

First QC Date

March 23, 2023

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in Chart review at post-intervention

    The medical records of all RCH residents will be audited at baseline (T0), post-intervention (T1; after the ACP intervention), 1-year follow-up (T2; 1 year after the launch of the ACP intervention at the RCH), and 2-year follow-up (T3; 2 years after the launch of the ACP intervention at the RCH). The following information will be extracted: ACP documentation (primary outcome; i.e., new documentation related to ACP and EOL care); designated surrogate decision-maker; AD completion; and healthcare utilization (i.e., number of inpatient hospitalizations, emergency department visits, intensive care unit admissions and length of stay, mechanical intubation rates and in-hospital cardiopulmonary resuscitation rates during the 6 months before death, place of death). The information specific to ACP intervention will only be extracted in residents who participated in ACP intervention: concordance on EOL preferences ; and concordance between preferred and actual outcomes of EOL care.

    baseline and immediately after the intervention

  • Change from Baseline in Chart review at 1-year follow-up time point.

    The medical records of all RCH residents will be audited at baseline (T0), post-intervention (T1; after the ACP intervention), 1-year follow-up (T2; 1 year after the launch of the ACP intervention at the RCH), and 2-year follow-up (T3; 2 years after the launch of the ACP intervention at the RCH). The following information will be extracted: ACP documentation (primary outcome; i.e., new documentation related to ACP and EOL care); designated surrogate decision-maker; AD completion; and healthcare utilization (i.e., number of inpatient hospitalizations, emergency department visits, intensive care unit admissions and length of stay, mechanical intubation rates and in-hospital cardiopulmonary resuscitation rates during the 6 months before death, place of death). The information specific to ACP intervention will only be extracted in residents who participated in ACP intervention: concordance on EOL preferences ; and concordance between preferred and actual outcomes of EOL care.

    1-year follow-up (i.e., 1 year after the launch of the ACP intervention)

  • Change from Baseline in Chart review at 2-year follow-up time point.

    The medical records of all RCH residents will be audited at baseline (T0), post-intervention (T1; after the ACP intervention), 1-year follow-up (T2; 1 year after the launch of the ACP intervention at the RCH), and 2-year follow-up (T3; 2 years after the launch of the ACP intervention at the RCH). The following information will be extracted: ACP documentation (primary outcome; i.e., new documentation related to ACP and EOL care); designated surrogate decision-maker; AD completion; and healthcare utilization (i.e., number of inpatient hospitalizations, emergency department visits, intensive care unit admissions and length of stay, mechanical intubation rates and in-hospital cardiopulmonary resuscitation rates during the 6 months before death, place of death). The information specific to ACP intervention will only be extracted in residents who participated in ACP intervention: concordance on EOL preferences ; and concordance between preferred and actual outcomes of EOL care.

    2-year follow-up (i.e., 2 years after the launch of the ACP intervention at the RCH).

Other Outcomes (5)

  • Quality about End-of-life Communication (QOC)

    immediately after the intervention and 2 years after the launch of intervention.

  • Caregiver quality-of-life (QOL)

    baseline, immediately after the intervention, and 2 years after the launch of intervention.

  • Qualitative interviews

    immediately after the intervention and 1 year after the launch of intervention

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The ACP intervention, which was developed by the expert panel, will be delivered by trained nurses in each RCH during a mandatory annual individual care planning (ICP) meeting. Eligible residents and their family members will be invited to attend the ICP meeting with ACP discussion.

Behavioral: Nurse-led Advance Care Planning (ACP) Intervention

Control

NO INTERVENTION

Participants in the control arm will receive usual care with no ACP intervention.

Interventions

An ACP discussion between the participating resident, family members, and the trained nurse will be incorporated into the annual review. The proposed ACP intervention will be divided into three parts (three weekly sessions, 1.5 hours each): 1) preparatory, 2) discussion, and 3) follow-up sessions.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Eligible participants have to be age 65 or older and be able to communicate in Cantonese or Mandarin.
  • Participants will also be invited to identify family members involved in making decisions about their care to participate in the intervention. For residents who have moderate or severe cognitive impairment (as determined by a score of less than 19 in the Hong Kong version of the Montreal Cognitive Assessment), the participation of family members is mandatory.

You may not qualify if:

  • They have a moderate or severe significant cognitive impairment but do not have family members, or
  • They have prior ACP experience (e.g., AD completed).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Wang T, Cheung DST, Chu C, Chen J, Lin CC. Evaluation of a train-the-trainer implementation strategy on providers' competency, opportunity and motivation for advance care planning in residential care homes: a mixed-methods study. BMC Geriatr. 2026 Jan 3. doi: 10.1186/s12877-025-06898-2. Online ahead of print.

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Chia-Chin Lin, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Chin Lin, PhD

CONTACT

Tongyao Wang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

February 2, 2024

Study Start

July 1, 2022

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

July 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations