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Clinical Trials/NCT06008210
NCT06008210
Completed
Not Applicable

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

Food and Health Bureau, Hong Kong2 sites in 1 country226 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Decision Support Intervention
Conditions
Chronic Obstructive Pulmonary Disease Severe
Sponsor
Food and Health Bureau, Hong Kong
Enrollment
226
Locations
2
Primary Endpoint
Decisional conflict at T0
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
August 31, 2025
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Food and Health Bureau, Hong Kong
Responsible Party
Principal Investigator
Principal Investigator

Helen YL Chan

Professor

Chinese University of Hong Kong

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

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.

Arms & Interventions

Intervention Group

Decision Support Intervention

Intervention: Decision Support Intervention

Control Group

Health coaching

Intervention: Health Coaching

Outcomes

Primary Outcomes

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.

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.

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

  • Self-efficacy for ACP at T1(1-month post allocation)
  • Readiness for ACP at T1(1-month post allocation)
  • Readiness for ACP at T2(6-month post allocation)
  • Advance directives at T2(6-month post allocation)
  • Self-efficacy for ACP at T0(Baseline)
  • Family members' engagement in ACP at T0(Baseline)
  • End-of-life care preferences at T1(1-month post allocation)
  • Readiness for ACP at T0(Baseline)
  • Self-efficacy for ACP at T2(6-month post allocation)
  • Family members' engagement in ACP at T1(1-month post allocation)
  • End-of-life care preferences at T2(6-month post allocation)
  • Family members' engagement in ACP at T2(6-month post allocation)

Study Sites (2)

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