Trial record 14 of 16 for:    "Advance Directives" | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Food and Health Bureau, Hong Kong
Sponsor:
Information provided by (Responsible Party):
Dr. Helen YL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02068651
First received: February 13, 2014
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Chronic Disease
Behavioral: Advance care planning programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Community-based Advance Care Planning Programme to Improve End-of-life Care in Patients With Advanced Disease: A Mixed-method Approach

Resource links provided by NLM:


Further study details as provided by Food and Health Bureau, Hong Kong:

Primary Outcome Measures:
  • End-of-life care preferences [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 240
Study Start Date: March 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advance care planning programme
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.
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.
No Intervention: Usual care
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068651

Contacts
Contact: Helen Chan, RN PhD 852-3943-8099 helencyl@cuhk.edu.hk

Locations
Hong Kong
Haven of Hope Hospital Not yet recruiting
Hong Kong, Hong Kong
Principal Investigator: KS Chan, MBBS         
Sub-Investigator: Jeffrey Ng, MBBS         
Sub-Investigator: LN Chan, RN MSc MBA         
Sub-Investigator: PS Ko, RN MN         
Sponsors and Collaborators
Food and Health Bureau, Hong Kong
Investigators
Principal Investigator: Helen Chan, RN PhD The Nethersole School of Nursing, The Chinese University of Hong Kong
Principal Investigator: Diana Lee, RN PhD The Nethersole School of Nursing, The Chinese University of Hong Kong
Principal Investigator: Carmen Chan, RN PhD The Nethersole School of Nursing, The Chinese University of Hong Kong
Principal Investigator: Iris Lee, RN PhD The Nethersole School of Nursing, The Chinese University of Hong Kong
Principal Investigator: Doris Leung, PhD The Nethersole School of Nursing, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr. Helen YL Chan, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02068651     History of Changes
Other Study ID Numbers: 11120861
Study First Received: February 13, 2014
Last Updated: February 19, 2014
Health Authority: Hong Kong: Food and Health Bureau
Hong Kong: Hospital Authority
Hong Kong: The Chinese University of Hong Kong

Keywords provided by Food and Health Bureau, Hong Kong:
End-of-life care
Treatment decision making
Advance care planning

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014