NCT04162912

Brief Summary

This proposed study is designed to test the effects of motivational interviewing (MI) in increasing the uptake of ACP behaviours among patients with palliative care needs. A randomised controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of a MI-tailored ACP (MI-ACP) programme on palliative care patients recruited from the outpatient palliative care clinics and home palliative care services of two hospitals. A total of 204 patients will be recruited and randomly assigned to experimental and control groups. The patients in the experimental group will receive a MI-ACP programme facilitated by a trained nurse, whereas the patients in the control group will receive usual care. Primary outcome is the behavioural changes in ACP. Secondary outcomes are perceived stress, decisional conflict and quality of life. Study outcomes will be measured at baseline, 1 month and 3 months after enrolment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

November 11, 2019

Last Update Submit

April 15, 2020

Conditions

End Stage Disease

Keywords

Advance Care PlanningMotivational InterviewingPallative Care

Outcome Measures

Primary Outcomes (1)

  • Advance Care Planning Behaviour

    Behaviour changes in ACP behaviours measured using a questionnaire. It included 4 items about different ACP behavior on a 5-point Likert scale. The higher score means the higher level of readiness for the behaviours.

    Baseline, 1 month and 3 months follow up

Secondary Outcomes (3)

  • Decisional conflict

    Baseline, 1 month and 3 months follow up

  • Perceived stress

    Baseline, 1 month and 3 months follow up

  • Quality of life

    Baseline, 1 month and 3 months follow up

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants in the experimental group will receive a MotivationaI Interviewing tailored ACP programme.

Behavioral: Motivational Interviewing tailored Advance Care Planning

Control group

NO INTERVENTION

The participants in the control group will receive usual care offered by the palliative care team under study and its affiliated day care centres, home care team and outpatient clinics.

Interventions

Motivational Interviewing tailored Advance Care PlanningBEHAVIORAL

The trained interventionist who is experienced in MI techniques will explore their illness experiences, emotions and beliefs about their health conditions and future care in an empathetic manner and explore their ambivalence for ACP behaviours.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • years of age or over
  • newly referred to palliative care services
  • with a palliative performance scale (PPS) score of 60 or above; and
  • with full level of consciousness

You may not qualify if:

  • uncommunicable because of sensory impairment or language barrier
  • cognitively impaired
  • are receiving active psychiatric treatment
  • already had signed an advance directive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

United Christian Hospital

Kwun Tong, Hong Kong

Location

Haven of Hope Hospital

Tseung Kwan O, Hong Kong

Location

Related Publications (1)

  • Chan HY, Leung DY, Lam PT, Ko PP, Lam RW, Chan KS. Effect of motivational interviewing to promote advance care planning among palliative care patients in ambulatory care setting: a randomized controlled trial. BMC Palliat Care. 2025 Jan 31;24(1):31. doi: 10.1186/s12904-025-01667-9.

    PMID: 39891169DERIVED

Study Officials

  • Helen N Chan, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 14, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)