Clinical trial NCT06008210: A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family
Official title: Effects of a Decision Support Intervention on End-of-life Care Planning in Patients With Advanced Chronic Obstructive Pulmonary Disease and Their Family Members: A Mixed Method Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Severe
Keywords: Advance Care Planning
Decision making
End-of-life care
Lead sponsor: Food and Health Bureau, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2023-08-23
Enrollment: 226
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel two-arm single-blinded randomised controlled trial will be conducted.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to support EOL decision-making in patients with advanced COPD and their family members. A parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. A total of 226 patients with advanced COPD and their designated family members will be recruited from hospital wards and outpatient clinics.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition. However, patients with advanced COPD and their family members generally are unprepared for end-of-life (EOL) situations. The Ottawa Decision Support Framework model is adopted to address the patients' decisional needs for the difficult decisions in EOL care. The participants will be randomly allocated to either the intervention group to receive the decision support intervention or the control group to receive general health coaching. Outcomes will be measured at baseline and 1- and 6-month post-allocation. Subsequently, a descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how the intervention influenced the study outcomes.

Eligibility criteria: Inclusion Criteria of patients:

* are aged 50 years or over
* have been diagnosed with COPD
* are cognitively sound (scored \> 5 on the validated Abbreviated Mental Test (Hong Kong version) \[AMT-HK\])
* meet at least two of the six specific clinical indicators related to advanced COPD in the Gold Standards Framework (GSF) Proactive Identification Guidance, 6th Edition
* can nominate a family member who would take part in their healthcare decision- making.

Inclusion Criteria of patients' family members:

* are aged 18 years or over,
* can communicate in Cantonese,
* have at least one personal contact per week with the patient in the past 6 months and
* are willing to join the study. Family members will be excluded if they score \< 6 on the AMT-HK or are expecting to leave Hong Kong within the next 6 months.

Exclusion Criteria:

* non-communicable due to a severe hearing impairment, dysphasia or a language barrier;
* are receiving palliative care services or
* have already completed ACP or an advance directive.

Primary outcomes:
measure: Decisional conflict at T0
timeFrame: Baseline
measure: Decisional conflict at T1
timeFrame: 1-month post allocation
measure: Decisional conflict at T2
timeFrame: 6-month post allocation
Secondary outcomes:
measure: Self-efficacy for ACP at T0
timeFrame: Baseline
measure: Self-efficacy for ACP at T1
timeFrame: 1-month post allocation
measure: Self-efficacy for ACP at T2
timeFrame: 6-month post allocation
measure: Readiness for ACP at T0
timeFrame: Baseline
measure: Readiness for ACP at T1
timeFrame: 1-month post allocation
measure: Readiness for ACP at T2
timeFrame: 6-month post allocation
measure: Family members' engagement in ACP at T0
timeFrame: Baseline
measure: Family members' engagement in ACP at T1
timeFrame: 1-month post allocation
measure: Family members' engagement in ACP at T2
timeFrame: 6-month post allocation
measure: End-of-life care preferences at T1
timeFrame: 1-month post allocation
measure: End-of-life care preferences at T2
timeFrame: 6-month post allocation
measure: Advance directives at T2
timeFrame: 6-month post allocation
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: Tai Po Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Helen Chan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: