A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family

Food and Health Bureau, Hong Kong

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease Severe

Treatments: Behavioral: Health Coaching; Behavioral: Decision Support Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06008210

14118622

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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226 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Decision Support Intervention

Treatment:

Behavioral: Decision Support Intervention

Control Group

Active Comparator group

Description:

Health coaching

Treatment:

Behavioral: Health Coaching