ACP-Family Programme for Palliative Care Patients and Their Family Member

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Palliative Care

Treatments: Other: ACP-Family

Study type: Interventional

Funder types: Other

Identifiers

NCT05935540

ACP2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

ACP-Family

Experimental group

Description:

It is a ACP discussion intervention consisting of two sessions (45-60 mins) and to be delivered within one month in a face-to-face format as long as the patient is still in the hospital by a trained ACP facilitator.

Treatment:

Other: ACP-Family

ACP-UC

No Intervention group

Description:

Usual care that is available to all palliative care patients in the hospital.