NCT02068651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

February 13, 2014

Last Update Submit

August 18, 2016

Conditions

Chronic Disease

Keywords

End-of-life careTreatment decision makingAdvance care planning

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Level of certainty about future care

    6 months

  • Health care utilization

    6 months

Study Arms (2)

Advance care planning programme

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Advance care planning programmeBEHAVIORAL

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.

Advance care planning programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haven of Hope Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 21, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)