Clinical trial NCT05935540: ACP-Family Programme for Palliative Care Patients and Their Family Member
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palliative Care
Keywords: Advance care planning
palliative care
family
decision making
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Shatin Hospital
name: United Christian Hospital
First posted: 2023-07-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel, 2-armed RCT with follow-ups at 6 and 12 months
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

Patient:

* 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:

* aged≥ 18
* 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.

Primary outcomes:
measure: Family's prediction accuracy of patient's treatment preferences
timeFrame: 6 months
Secondary outcomes:
measure: Family's prediction accuracy of patient's treatment preferences
timeFrame: 12 months
measure: New ACP documentation
timeFrame: 6 and 12 months
measure: Family-reported perception of whether the patient's EOL care preference was respected
timeFrame: 6 and 12 months
measure: Patient's decisional conflict
timeFrame: 6 and 12 months
measure: Quality of communication
timeFrame: 6 and 12 months
measure: Family's decision-making confidence
timeFrame: 6 and 12 months
measure: Family's anxiety and depression
timeFrame: 6 and 12 months
measure: Satisfaction to the intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Bradbury Hospice
city: Hong Kong
country: Hong Kong
facility: Shatin Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Doris YP Leung, PhD
role: PRINCIPAL_INVESTIGATOR
References: