ACP-Family Programme for Palliative Care Patients and Their Family Member
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACP-Family.
- Who it may be relevant to
- Registry conditions: Palliative Care. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other ACP-Family
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
Primary outcome measures
- Family's prediction accuracy of patient's treatment preferences [Time frame: 6 months]
Secondary outcome measures (8)
- Family's prediction accuracy of patient's treatment preferences [Time frame: 12 months]
- New ACP documentation [Time frame: 6 and 12 months]
- Family-reported perception of whether the patient's EOL care preference was respected [Time frame: 6 and 12 months]
- Patient's decisional conflict [Time frame: 6 and 12 months]
- Quality of communication [Time frame: 6 and 12 months]
- Family's decision-making confidence [Time frame: 6 and 12 months]
- Family's anxiety and depression [Time frame: 6 and 12 months]
- Satisfaction to the intervention [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Hong Kong · 3 centers
- Bradbury Hospice — Hong Kong
- Shatin Hospital — Hong Kong
- United Christian Hospital — Hong Kong
Publications
- 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
Identifiers
NCT: NCT05935540 · ACP2023