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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease Severe
• Intervention / Treatment: Behavioral: Decision Support Intervention; Behavioral: Health Coaching

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.

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Chan, Ph.D.; Phone Number: 39438099; Email: helencyl@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Decision Support Intervention	Behavioral: Decision Support Intervention; 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.
Active Comparator: Control Group; Health coaching	Behavioral: Health Coaching; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Food and Health Bureau, Hong Kong
• Collaborators: Hospital Authority, Hong Kong
• Investigators: Principal Investigator: Helen Chan, Ph.D., Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Decision making; Advance Care Planning; End-of-life care
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Death
• Other Study ID Numbers: 14118622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No