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| Name | Class |
|---|---|
| Shatin Hospital | OTHER |
| United Christian Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| ACP-UC | No Intervention | Usual care that is available to all palliative care patients in the hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patient:
Family member:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Doris YP Leung, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bradbury Hospice | Not yet recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39511666 | Derived | 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. |
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Individual participant data are not readily shared because permission to use the data by other researchers has to seek approval from the ethical committee. Requests to access IPD should be directed to PI for further consideration and seeking approval from ethical committee.
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A parallel, 2-armed RCT with follow-ups at 6 and 12 months
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| 12 months |
| New ACP documentation | 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. | 6 and 12 months |
| Family-reported perception of whether the patient's EOL care preference was respected | 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. | 6 and 12 months |
| Patient's decisional conflict | 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. | 6 and 12 months |
| Quality of communication | 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. | 6 and 12 months |
| Family's decision-making confidence | 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. | 6 and 12 months |
| Family's anxiety and depression | 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 | 6 and 12 months |
| Satisfaction to the intervention | 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 | 6 months |
| Shatin Hospital | Recruiting | Hong Kong | Hong Kong |
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| United Christian Hospital | Not yet recruiting | Hong Kong | Hong Kong |
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