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

Not Applicable

Completed

• Conditions: End Stage Disease
• Interventions: Behavioral: Usual care; Behavioral: Advance care planning

• Registration Number: NCT03599310
• Lead Sponsor: Food and Health Bureau, Hong Kong

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.

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-07-15
• Study First Submitted QC: 2018-07-15
• Study First Posted: 2018-07-26
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual care	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.
Advance care planning	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.

Primary Outcome Measures

Name	Time	Method
Documentation	3 months	Documentation of ACP discussion in medical record

Secondary Outcome Measures

Name	Time	Method
Family communication	3 months	Communication of end-of-life care preferences with family members
Self perceived quality-of-life of patients	3 months	Quality-of-life concerns at the end of life (QOLC-E)
Concordance of care	6 months	Concordance of care preferences and actual

Trial Locations

Locations (1)

Yan Chai Hospital; 🇭🇰 Hong Kong, Hong Kong