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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068651
• Other study ID #: 11120861
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: August 18, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Food and Health Bureau, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Food and Health BureauHong Kong: Hospital AuthorityHong Kong: The Chinese University of Hong Kong
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• Advance care planning programme
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.

Locations

Country	Name	City	State
Hong Kong	Haven of Hope Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Food and Health Bureau, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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 .	6 months	No
Secondary	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.	6 months	Yes