ACP-Family Programme for Palliative Care Patients and Their Family Member
- Conditions
- Palliative Care
- Interventions
- Other: ACP-Family
- Registration Number
- NCT05935540
- Lead Sponsor
- The Hong Kong Polytechnic University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
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.
- are engaging in ACP discussion with healthcare professionals in the hospital at the time of recruitment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACP-Family ACP-Family 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.
- Primary Outcome Measures
Name Time Method Family's prediction accuracy of patient's treatment preferences 6 months 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.
- Secondary Outcome Measures
Name Time Method Family's prediction accuracy of patient's treatment preferences 12 months 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.
New ACP documentation 6 and 12 months Advance directives will be retrieved from medical record or ACP discussion recorded reported by the patients or family member. A composite variable of any ACP documentation (forms and/or discussion) will be created.
Family-reported perception of whether the patient's EOL care preference was respected 6 and 12 months For deceased patients, their family members will be asked to respond to two items (whether EOL wishes were discussed and whether they were met) and a binary variable will be generated.
Patient's decisional conflict 6 and 12 months Patient's decisional conflict in making decisions related to future care will be measured by the SURE test scale. Patients will be asked to rate their future care on four items using a Yes/No format.
Quality of communication 6 and 12 months Patient-healthcare provider and family-healthcare provider quality of communication about EOL care will be measured using the corresponding subscale of the validated Quality of Communication Questionnaire. Patients and family members will be asked to rate how good their physician is at each of the 7 communication skills about EOL discussion.
Family's decision-making confidence 6 and 12 months Family's decision-making confidence in EOL decision making for their patients will be measured by the 5-item Decision Making Confidence Scale. Family members will be asked to indicate their level of comfort in the surrogate role on a 5-point Likert scale.
Family's anxiety and depression 6 and 12 months Family's anxiety and depression will be assessed by the widely used 14-item Hospital Anxiety and Depression Scale (HADS). The HADS consists of two subscales: anxiety (7 items) and depression (7 items) with scores range 0-21
Satisfaction to the intervention 6 months Patients and family members in the ACP-Family arm will be asked to rate their satisfaction about the discussion, the video shown, the ACP facilitator and the involvement of the family member (for patient only) using one item on a 0-10 VAS scale separately
Trial Locations
- Locations (3)
Bradbury Hospice
🇭🇰Hong Kong, Hong Kong
United Christian Hospital
🇭🇰Hong Kong, Hong Kong
Shatin Hospital
🇭🇰Hong Kong, Hong Kong