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

NCT ID: NCT03599310

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-07-31

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.

Conditions

End Stage Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Advance care planning

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: 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.

Interventions

Advance 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.

Intervention Type: BEHAVIORAL

Usual 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan Chai Hospital

OTHER

Sponsor Role: collaborator

Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Helen YL Chan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Y Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Yan Chai Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

14152631

Identifier Type: -

Identifier Source: org_study_id