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

End Stage Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599310
• Other study ID #: 14152631
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: November 2019
• Source: Food and Health Bureau, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Disease

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Yan Chai Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Food and Health Bureau, Hong Kong	Yan Chai Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation	Documentation of ACP discussion in medical record	3 months
Secondary	Family communication	Communication of end-of-life care preferences with family members	3 months
Secondary	Self perceived quality-of-life of patients	Quality-of-life concerns at the end of life (QOLC-E)	3 months
Secondary	Concordance of care	Concordance of care preferences and actual	6 months