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Completed

NCT Number: NCT06008210

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Severe

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decision Support Intervention

Behavioral

The participants will receive two 60-minute consultation sessions delivered by a trained nurse in four weeks at home. Participant's family members will be encouraged to attend the sessions. In the first session, the nurse will explore the participant's understanding of the current health condition, introduce the concept of advance care planning and discuss their decisional needs for end-of-life care decision-making. In the second session, the nurse will ask the participants to complete a value clarification exercise individually.

Health Coaching

Behavioral

The participants will receive two 60-minute health coaching sessions delivered by a trained nurse in four weeks at home. This intervention will focus on lifestyle modification and self-care management unrelated to the tested intervention content or outcomes.

Primary outcomes

  1. Decisional conflict at T0

    Time frame: Baseline

    Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.

  2. Decisional conflict at T1

    Time frame: 1-month post allocation

    Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.

  3. Decisional conflict at T2

    Time frame: 6-month post allocation

    Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.

Secondary outcomes

  1. Self-efficacy for ACP at T0

    Time frame: Baseline

    Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.

  2. Self-efficacy for ACP at T1

    Time frame: 1-month post allocation

    Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.

  3. Self-efficacy for ACP at T2

    Time frame: 6-month post allocation

    Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.

  4. Readiness for ACP at T0

    Time frame: Baseline

    Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.

  5. Readiness for ACP at T1

    Time frame: 1-month post allocation

    Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.

  6. Readiness for ACP at T2

    Time frame: 6-month post allocation

    Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.

  7. Family members' engagement in ACP at T0

    Time frame: Baseline

    Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.

  8. Family members' engagement in ACP at T1

    Time frame: 1-month post allocation

    Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.

  9. Family members' engagement in ACP at T2

    Time frame: 6-month post allocation

    Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.

  10. End-of-life care preferences at T1

    Time frame: 1-month post allocation

    End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.

  11. End-of-life care preferences at T2

    Time frame: 6-month post allocation

    End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.

  12. Advance directives at T2

    Time frame: 6-month post allocation

    Participants will be asked if they have completed advance directives in the past six months.

Sponsors and collaborators

Lead sponsor

Food and Health Bureau, Hong Kong

Other Gov

Collaborators

  • Hospital Authority, Hong Kong

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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