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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease Severe

Intervention / Treatment
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* Behavioral: Decision Support Intervention
* Behavioral: Health Coaching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel two-arm single-blinded randomised controlled trial will be conducted.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Decision Support Intervention | Behavioral: Decision Support Intervention<br>* 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.<br>|
| Active Comparator: Control Group<br>Health coaching | Behavioral: Health Coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict at T0 | 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. | Baseline | 
| Decisional conflict at T1 | 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. | 1-month post allocation | 
| Decisional conflict at T2 | 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. | 6-month post allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for ACP at T0 | 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. | Baseline | 
| Self-efficacy for ACP at T1 | 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. | 1-month post allocation | 
| Self-efficacy for ACP at T2 | 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. | 6-month post allocation | 
| Readiness for ACP at T0 | 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. | Baseline | 
| Readiness for ACP at T1 | 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. | 1-month post allocation | 
| Readiness for ACP at T2 | 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-month post allocation | 
| Family members' engagement in ACP at T0 | 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. | Baseline | 
| Family members' engagement in ACP at T1 | 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. | 1-month post allocation | 
| Family members' engagement in ACP at T2 | 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. | 6-month post allocation | 
| End-of-life care preferences at T1 | 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. | 1-month post allocation | 
| End-of-life care preferences at T2 | 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. | 6-month post allocation | 
| Advance directives at T2 | Participants will be asked if they have completed advance directives in the past six months. | 6-month post allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advance Care Planning, Decision making, End-of-life care