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CompletedNCT03599310Updated Nov 13, 2019

Effects of a Structured Advance Care Planning Guide Among Patients With Advanced Illness in Hospital Care Settings

An interventional study of Advance care planning and Usual care in End Stage Disease, sponsored by Food and Health Bureau, Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Food and Health Bureau, Hong Kong · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2017, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Objective: To examine the effects of a structured advance care planning (ACP) guide among patients with advanced illness in hospital care setting.

Methods: This is a 24-month stepped-wedge cluster randomised controlled trial to be conducted in the Department of Medicine in an acute hospital. Patients are eligible to the study if they are aged 18 or over, are communicable, and meet the indicators of health deterioration or advanced condition in the Supportive and Palliative Care Indicators Tool (SPICT). Ward nurses will be trained to be interventionists to conduct ACP by means of a structured ACP guide. The guide is adapted from a culturally sensitive ACP programme developed in the local context with reference to the format of the Serious Illness Communication Guide, which is an evidence-based best practice in end-of-life care communication to support the ACP process.

Main outcome measures: Data will be collected at baseline (T0), one week (T1), three months (T2) and six months (T3) after intervention. The primary study outcome is the documentation of ACP discussion in medical records and completion of advance directives. Secondary outcomes are communicating end-of-life care preferences with family carers, quality of life and concordance of care preferences and treatment provided.

Read the detailed description

Advance care planning (ACP) is defined as a communication process among patients, their family members and healthcare providers about end-of-life care, before the patients lose their capacity to decide for themselves. The main purpose of this study is to embed ACP into the usual care process in acute hospital setting through building staff capacity to conduct ACP. This will be a 24-month stepped-wedge cluster randomised controlled trial, with randomization built into the phasing of intervention implementation. This crossover design enables all study venues sequentially switched from control to experimental. This study will be conducted in all eight wards of the medical department of an 800-bed acute hospital. The ACP in this study is a facilitator-based intervention with a structured communication guide as a tool to aid the interventionists in broaching end-of-life care issues and eliciting patients' values and preferences in a consistent manner. The primary study outcome is the documentation of ACP discussion in medical records. Secondary outcomes are communicating end-of-life care preferences with family carers, quality of life and concordance of care preferences and treatment provided. Data collection will be conducted at baseline, one week, three months and six months after intervention.

02

Conditions studied

  • End Stage Disease

Keywords

  • Advance care planning
  • Communication
  • Nurse
  • End-of-life
03

In context

Lead sponsor

Food and Health Bureau, Hong Kong is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aged 18 years or over;
  • meet either two general indicators of health deterioration or one clinical indicator of an advanced illness condition in the Supportive and Palliative Care Indicators Tool (SPICT); and
  • able to communicate in Cantonese.

Exclusion criteria

Exclusion Criteria:

  • mentally incompetent or unable to communicate;
  • receiving psychiatric treatment; or
  • have been referred to the palliative care service at the time of recruitment.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
350 participants (actual)

Study arms

  • Experimental
    Advance care planning

    The intervention is a facilitator-based ACP process with a structured guide as a communication tool to aid the interventionists in broaching end-of-life care issues and eliciting patients' values and preferences in a consistent manner.

    Behavioral: Advance care planning

  • Placebo comparator
    Usual care

    A leaflet covering the concept of ACP and advance directives (AD), purposes and potential benefits will be distributed to all participants as part of usual information support to standardize the information provided. The health care team will encourage patients to discuss the matters with their family carers and/or significant others.

    Behavioral: Usual care

Interventions

  • BehavioralAdvance care planning

    The ACP guide is adapted from the Serious Illness Communication Guide and a culturally-sensitive ACP programme developed in the local context. The trained ACP facilitators will initiate the conversation by introducing the concepts of ACP with the support of the guide and assessing the patient's illness understanding and readiness to think about end-of-life care issues.

  • BehavioralUsual care

    In the current practice, patients will have to take the initiative themselves if they would like to discuss their end-of-life care or make an advance directive.

06

What researchers measure

Primary outcomes

  1. Documentation

    Documentation of ACP discussion in medical record

    Time frame: 3 months

Secondary outcomes

  1. Family communication

    Communication of end-of-life care preferences with family members

    Time frame: 3 months

  2. Self perceived quality-of-life of patients

    Quality-of-life concerns at the end of life (QOLC-E)

    Time frame: 3 months

  3. Concordance of care

    Concordance of care preferences and actual

    Time frame: 6 months

07

Study locations

1 site
  • Yan Chai Hospital
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No — Health conditions only

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03599310
Lead sponsor
Food and Health Bureau, Hong Kong
Collaborators
Yan Chai Hospital
Responsible party
Dr. Helen YL Chan (Associate Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jul 26, 2018
Start date
Aug 1, 2017
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Nov 13, 2019

Study contacts

Helen Y Chan, PhD
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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