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

NCT ID: NCT05935540

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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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

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Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel, 2-armed RCT with follow-ups at 6 and 12 months
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ACP-Family

Intervention Type 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.

ACP-UC

Usual care that is available to all palliative care patients in the hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 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.

Intervention Type OTHER

Other Intervention Names

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Structured, family-supported, patient-centred ACP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shatin Hospital

OTHER

Sponsor Role collaborator

United Christian Hospital

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doris YP Leung, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Bradbury Hospice

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Shatin Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

United Christian Hospital

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Countries

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Hong Kong

Central Contacts

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Doris YP Leung, PhD

Role: CONTACT

852 2766 6423

Joyce OK Chung, PhD

Role: CONTACT

852 2766 6322

Facility Contacts

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See-kit Raymond Lo

Role: primary

Raymond SK Lo, MD

Role: primary

852 3919 7500

Kevin CT Li, MD

Role: backup

852 6134 7676

Po Tin Lam

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39511666 (View on PubMed)

Other Identifiers

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ACP2023

Identifier Type: -

Identifier Source: org_study_id

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