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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03599310
Enrollment
350
Registered
2018-07-26
Start date
2017-08-01
Completion date
2019-07-31
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Disease

Keywords

Advance care planning, Communication, Nurse, End-of-life

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.

Interventions

BEHAVIORALAdvance 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.

BEHAVIORALUsual 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.

Sponsors

Yan Chai Hospital
CollaboratorOTHER
Food and Health Bureau, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Documentation3 monthsDocumentation of ACP discussion in medical record

Secondary

MeasureTime frameDescription
Family communication3 monthsCommunication of end-of-life care preferences with family members
Self perceived quality-of-life of patients3 monthsQuality-of-life concerns at the end of life (QOLC-E)
Concordance of care6 monthsConcordance of care preferences and actual

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026