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

NCT05935540 | Recruiting

• 1 other identifier: ACP2023
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

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.

Conditions

Palliative Care

Keywords

Advance care planning; palliative care; family; decision making

Outcome Measures

Primary Outcomes (1)

• Family's prediction accuracy of patient's treatment preferences

  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.

  6 months

Secondary Outcomes (8)

• 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

Study Arms (2)

ACP-Family

EXPERIMENTAL

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.

Other: ACP-Family

ACP-UC

NO INTERVENTION

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

Interventions

ACP-Family OTHER

It consists of two sessions (45-60 mins) to be delivered within one month in a face-to-face format as long as the patient is still in the hospital. The treatment will be continued in the patient's home if he/she is discharged before the two sessions are completed. The treatment will cover five elements in ACP, namely (1) patients' understanding of their illness, (2) patients' values and beliefs underpinning care preferences, (3) possible health conditions in the future, (4) introducing the idea of AD and its arrangement, and (5) construction of the role of substituted decision maker. A 3-min video on end-of-life treatment options will be shown to help patients and family members to clearly understand the related topic. However, there will be no restriction on the order of the five topics to be discussed during the intervention.

Also known as: Structured, family-supported, patient-centred ACP

ACP-Family

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Shatin Hospital: collaborator
• United Christian Hospital: collaborator

Study Sites (3)

Bradbury Hospice

Hong Kong, Hong Kong

NOT YET RECRUITING

Shatin Hospital

Hong Kong, Hong Kong

RECRUITING

United Christian Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Related Publications (1)

• Leung DYP, Chung JOK, Chan HYL, Lo RSK, Li K, Lam PT, Ng NHY. Effects of a structured, family-supported, and patient-centred advance care planning on end-of-life decision making among palliative care patients and their family members: protocol of a randomised controlled trial. BMC Palliat Care. 2024 Nov 7;23(1):257. doi: 10.1186/s12904-024-01588-z.

  PMID: 39511666 DERIVED

Study Officials

• Doris YP Leung, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris YP Leung, PhD

CONTACT

852 2766 6423; doris.yp.leung@polyu.edu.hk

Joyce OK Chung, PhD

CONTACT

852 2766 6322; okjoyce.chung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel, 2-armed RCT with follow-ups at 6 and 12 months

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: September 19, 2023
• Primary Completion: May 30, 2025
• Study Completion: November 30, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)