Clinical trial NCT03599310: Effects of a Structured Advance Care Planning Guide Among Patients With Advanced Illness in Hospital Care Settings
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Disease
Keywords: Advance care planning
Communication
Nurse
End-of-life
Lead sponsor: Food and Health Bureau, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Yan Chai Hospital
First posted: 2018-07-26
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Documentation
timeFrame: 3 months
Secondary outcomes:
measure: Family communication
timeFrame: 3 months
measure: Self perceived quality-of-life of patients
timeFrame: 3 months
measure: Concordance of care
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Yan Chai Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Helen Y Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: