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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Family's prediction accuracy of patient's treatment preferences [Срок оценки: 6 months]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Гонконг · 3 центра

• Bradbury Hospice — Гонконг
• Shatin Hospital — Гонконг
• United Christian Hospital — Гонконг

Публикации

• 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

Идентификаторы

NCT: NCT05935540 · ACP2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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