NCT03599310

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

July 15, 2018

Last Update Submit

November 11, 2019

Conditions

End Stage Disease

Keywords

Advance care planningCommunicationNurseEnd-of-life

Outcome Measures

Primary Outcomes (1)

  • Documentation

    Documentation of ACP discussion in medical record

    3 months

Secondary Outcomes (3)

  • Family communication

    3 months

  • Self perceived quality-of-life of patients

    3 months

  • Concordance of care

    6 months

Study Arms (2)

Advance care planning

EXPERIMENTAL

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

Usual care

PLACEBO COMPARATOR

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

Advance care planningBEHAVIORAL

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.

Advance care planning
Usual careBEHAVIORAL

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.

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yan Chai Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

CommunicationDeath

Interventions

Advance Care Planning

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Helen Y Chan, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 15, 2018

First Posted

July 26, 2018

Study Start

August 1, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Health conditions only

Locations

HK(1)