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Palliative CareNCT05935540

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

A study testing ACP-Family in people with Palliative Care, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Palliative Care
What is being tested?
ACP-Family
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
3 sitesHong Kong
Study dates
19 Sep 2023to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

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

Hong Kong3 sites, 3 recruiting

  • Bradbury Hospice

    Hong Kong

    See-kit Raymond Lo, losk@ha.org.hk

    Not yet recruiting

  • Shatin Hospital

    Hong Kong

    Raymond SK Lo, MD, 852 3919 7500, losk@ha.org.hk

    Kevin CT Li, MD, 852 6134 7676, lkc447@ha.org.hk

    Recruiting

  • United Christian Hospital

    Hong Kong

    Po Tin Lam, lampt@ha.org.hk

    Not yet recruiting

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Conditions
Palliative Care
Being tested
ACP-Family
Keywords
Advance care planning, palliative care, family, decision making

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACP-FamilyOther

    Also called Structured, family-supported, patient-centred ACP

    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.

Study groups in NCT05935540
Study groupRoleWhat they receive
ACP-FamilyExperimentalIt 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.
Receives: Other: ACP-Family
ACP-UCNo interventionUsual care that is available to all palliative care patients in the hospital.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (8)

  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.

    Measured: 12 months

  2. 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.

    Measured: 6 and 12 months

  3. 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.

    Measured: 6 and 12 months

  4. 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.

    Measured: 6 and 12 months

  5. 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.

    Measured: 6 and 12 months

  6. 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.

    Measured: 6 and 12 months

  7. 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

    Measured: 6 and 12 months

  8. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start19 Sep 2023
  3. Primary completion30 May 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A parallel, 2-armed RCT with follow-ups at 6 and 12 months
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05935540
Sponsor's protocol ID
ACP2023
Status last verified
Aug 2024
First submitted
29 Jun 2023
Last updated
10 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 39511666

Questions about this trial

What is this clinical trial studying?

A study testing ACP-Family in people with Palliative Care, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Doris YP Leung, PhD (852 2766 6423, doris.yp.leung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Family's prediction accuracy of patient's treatment preferences (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05935540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.

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