A Community-based Advance Care Planning Programme for Patients With Advanced Disease

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Advance care planning programme

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring End-of-life care, Treatment decision making, Advance care planning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

aged 18 or above
meet one of the three triggers for supportive /palliative care as suggested in the Gold Standards Framework
living at home
being communicable

Exclusion Criteria:

mentally incompetent
cannot nominate a family carer
have already signed an advance directive
have been referred to palliative care service

Sites / Locations

Haven of Hope Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Advance care planning programme

Usual care

Arm Description

Participants in the experimental group will receive a structured advance care planning programme, namely Let Me Talk, delivered by a trained nurse facilitator. The programme will be conducted on individual basis through three one-hour home visits, once weekly. Family carers of the participants will be invited to all sessions.

Participants in the control group will receive three weekly home visits with basic health assessment and education provided by the trained nurse facilitator. If they request advance care planning information or assistance, an advance directive form, which is available on the Internet for public access, will be provided to them for their information.

Outcomes

Primary Outcome Measures

End-of-life care preferences

In this study, end-of-life care preferences include goal for end-of-life care and decisions over the use of life-sustaining treatments relevant to individual's anticipated health changes. So, whether the patients' end-of-life care preferences is known at different timepoints will be determined based on (1) the congruence between patients' end-of-life care preferences and family carers' predicted end-of-life care preferences for patients; and (2) whether patients' end-of-life preferences are documented in their medical record.

Secondary Outcome Measures

Level of certainty about future care

The SURE test (Legare, Kearing, Clay, Gagnon, D'Amours, Rousseau & O'Connor, 2010) will be used to measure the patient's level of decisional conflict in making decisions related to future care. Patients will be asked to rate their certainty in their future care on four items by using a dichotomous response format: yes or no. Good construct validity and reliability were demonstrated. It has previously been translated into Chinese and tested among local older people .

Health care utilization

Patient's medical records will be retrieved retrospectively six months after their enrolment to review their health care utilization over the study period, including the number of visits to the emergency department, unplanned admission, length of hospital stay, as well as investigation, procedures and treatment received.

Full Information

NCT ID

NCT02068651

First Posted

February 13, 2014

Last Updated

August 18, 2016

Sponsor

Food and Health Bureau, Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT02068651

Brief Title

A Community-based Advance Care Planning Programme for Patients With Advanced Disease

Official Title

A Community-based Advance Care Planning Programme to Improve End-of-life Care in Patients With Advanced Disease: A Mixed-method Approach

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Food and Health Bureau, Hong Kong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Advance care planning has been recommended as an integral part of care for patients with life-limiting disease, but relevant development in Hong Kong is still in its infancy. This proposed study attempts to address this service gap by promoting advance care planning to patients with advanced disease. It is hypothesized that the proportion of patients whose end-of-life care preferences were known in the experimental group will be significantly higher than that in the control group.

Detailed Description

This study aims to evaluate the impacts of a community-based advance care planning programme on end-of-life care of patients with advanced disease. A mixed-method approach, including a randomized controlled trial and qualitative interviews, will be used. Participants in the experimental group will received a structured advance care planning programme delivered by a trained facilitator. It includes an educational component, reflection and a family meeting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Disease

Keywords

End-of-life care, Treatment decision making, Advance care planning

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Advance care planning programme

Arm Type

Experimental

Arm Description

Participants in the experimental group will receive a structured advance care planning programme, namely Let Me Talk, delivered by a trained nurse facilitator. The programme will be conducted on individual basis through three one-hour home visits, once weekly. Family carers of the participants will be invited to all sessions.

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Participants in the control group will receive three weekly home visits with basic health assessment and education provided by the trained nurse facilitator. If they request advance care planning information or assistance, an advance directive form, which is available on the Internet for public access, will be provided to them for their information.

Intervention Type

Behavioral

Intervention Name(s)

Advance care planning programme

Intervention Description

It is a multi-faceted programme which includes an educational component with support of multimedia materials, reflection on personal values and a facilitated discussion between patient and family carer over future care. It will be delivered to each pair of participant and family carer on individual basis. By the end of the programme, each participant will have a personal workbook summarising the advance care planning process for record.

Primary Outcome Measure Information:

Title

End-of-life care preferences

Description

In this study, end-of-life care preferences include goal for end-of-life care and decisions over the use of life-sustaining treatments relevant to individual's anticipated health changes. So, whether the patients' end-of-life care preferences is known at different timepoints will be determined based on (1) the congruence between patients' end-of-life care preferences and family carers' predicted end-of-life care preferences for patients; and (2) whether patients' end-of-life preferences are documented in their medical record.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Level of certainty about future care

Description

The SURE test (Legare, Kearing, Clay, Gagnon, D'Amours, Rousseau & O'Connor, 2010) will be used to measure the patient's level of decisional conflict in making decisions related to future care. Patients will be asked to rate their certainty in their future care on four items by using a dichotomous response format: yes or no. Good construct validity and reliability were demonstrated. It has previously been translated into Chinese and tested among local older people .

Time Frame

6 months

Title

Health care utilization

Description

Patient's medical records will be retrieved retrospectively six months after their enrolment to review their health care utilization over the study period, including the number of visits to the emergency department, unplanned admission, length of hospital stay, as well as investigation, procedures and treatment received.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: aged 18 or above meet one of the three triggers for supportive /palliative care as suggested in the Gold Standards Framework living at home being communicable Exclusion Criteria: mentally incompetent cannot nominate a family carer have already signed an advance directive have been referred to palliative care service

Overall Study Officials: