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Clinical Trials/NCT05935540
NCT05935540
Recruiting
N/A

Effects of a Structured, Family-supported, Patient-centred Advance Care Planning for End-of-life Decision Among Palliative Care Patients and Their Family Members: a Randomized Controlled Trial

The Hong Kong Polytechnic University3 sites in 1 country170 target enrollmentSeptember 19, 2023
ConditionsPalliative Care

Overview

Phase
N/A
Intervention
Not specified
Conditions
Palliative Care
Sponsor
The Hong Kong Polytechnic University
Enrollment
170
Locations
3
Primary Endpoint
Family's prediction accuracy of patient's treatment preferences
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to test the effectiveness of a structured, family-supported, patient-centred advance care planning (ACP) in palliative care patients and their family members. The main question it aims to answer is: • the effectiveness of the ACP intervention on promoting end-of-life decision making and psychological outcomes in patients and family members. Participants will be assigned to either the ACP-Family group (ACP-Family) to receive a structured, family-supported, patient-centred ACP intervention or usual palliative care (ACP-UC) at the hospital. Researchers will compare the ACP-Family and ACP-UC groups to see if the ACP-Family group will produce better outcomes than the ACP-UC group.

Detailed Description

This is a two-arm parallel randomized controlled trial with follow-ups at 6 and 12 months, aiming to examine the effectiveness of a structured, family-supported, patient-centred ACP programme for adult palliative care patients and their families. This study will randomize 170 palliative care patients and their family members to the structured, family-supported, patient-centred ACP programme (ACP-Family) or ACP service under usual care (ACP-UC). Within one month, they will receive two 60-90 minute sessions of the family-supported, patient-centred ACP programme covering five elements in ACP discussions delivered by a trained ACP facilitator; or usual care provided by the respective hospital. All discussion sessions in the ACP group will be recorded for quality checking. It is hypothesized that, as compare to ACP-UC, the ACP-Family group will significantly improve EOL decision making outcomes including (i) prediction accuracy of patient's treatment preferences between palliative care patients and their family members, (ii) new ACP documentation in palliative care patients, and (iii) family-reported patient's EOL care preferences was respected for deceased patients; and 2. psychological outcomes including family member's decision-making confidence, anxiety, depression, and quality of communication regarding EOL, and patient's decisional conflict, and perceived quality of communication regarding EOL. In addition, 3. we also explore the potential moderating effect of type of hospital setting on the effectiveness of the ACP-Family on these patient and family outcomes.

Registry
clinicaltrials.gov
Start Date
September 19, 2023
End Date
November 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • aged ≥ 18,
  • receiving palliative care at the study hospitals,
  • able to communicate in Cantonese, and
  • cognitively intact (Abbreviated Mental Test (AMT) score ≥ 7)13 at the time of recruitment
  • Family member:
  • able to communicate in Cantonese, and
  • nominated by the patient who is likely to make substituted decisions for the patient in future health care issues.

Exclusion Criteria

  • are engaging in ACP discussion with healthcare professionals in the hospital at the time of recruitment.

Outcomes

Primary Outcomes

Family's prediction accuracy of patient's treatment preferences

Time Frame: 6 months

Patients and family members will be asked independently to indicate patient's preferences regarding three life-sustaining treatments (cardiopulmonary resuscitation, mechanical ventilator and tube feeding) based on three options (want to attempt, refuse or uncertain) in two hypothetical EOL scenarios (being terminally ill and in persistent vegetative state or a state of irreversible coma). An accuracy score will be calculated by summing the number of treatment decisions for which responses from the patient and family member are identical, and then dividing by the total number of decisions (n = 6), all equally weighted.

Secondary Outcomes

  • Family's prediction accuracy of patient's treatment preferences(12 months)
  • New ACP documentation(6 and 12 months)
  • Family-reported perception of whether the patient's EOL care preference was respected(6 and 12 months)
  • Patient's decisional conflict(6 and 12 months)
  • Quality of communication(6 and 12 months)
  • Family's decision-making confidence(6 and 12 months)
  • Family's anxiety and depression(6 and 12 months)
  • Satisfaction to the intervention(6 months)

Study Sites (3)

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