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Completed

NCT Number: NCT03599310

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

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.

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Key information

Conditions

End Stage Disease Behavior Communication Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yan Chai Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advance care planning

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. Documentation

    Time frame: 3 months

    Documentation of ACP discussion in medical record

Secondary outcomes

  1. Family communication

    Time frame: 3 months

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

  2. Self perceived quality-of-life of patients

    Time frame: 3 months

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

  3. Concordance of care

    Time frame: 6 months

    Concordance of care preferences and actual

Sponsors and collaborators

Lead sponsor

Food and Health Bureau, Hong Kong

Other Gov

Collaborators

  • Yan Chai Hospital

Registry information

Official study title

Effects of a Structured Advance Care Planning Guide Among Patients With Advanced Illness in Hospital Care Settings: a Stepped-wedge Cluster Randomised Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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