Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours

April 15, 2020 updated by: Dr. Helen YL Chan, Food and Health Bureau, Hong Kong

Effects of a Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours Among Patients With Palliative Care Needs: A Randomised Controlled Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kwun Tong, Hong Kong
        • United Christian Hospital
      • Tseung Kwan O, Hong Kong
        • Haven of Hope Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Participants in the experimental group will receive a MotivationaI Interviewing tailored ACP programme.
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.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advance Care Planning Behaviour
Time Frame: Baseline, 1 month and 3 months follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional conflict
Time Frame: Baseline, 1 month and 3 months follow up
Decisional conflict regarding end-of-life care is measured by the SURE test, a questionnaire with 4-item on knowledge and support for medical decision making. The higher score means the less decisional conflict.
Baseline, 1 month and 3 months follow up
Perceived stress
Time Frame: Baseline, 1 month and 3 months follow up
Perceived stress is measured by a 10-item Perceived Stress Scale, a questionnaire, using a 5-point Likert scale. The higher score means the higher level of stress.
Baseline, 1 month and 3 months follow up
Quality of life
Time Frame: Baseline, 1 month and 3 months follow up
Quality of life is measured by using a 23-item modified Quality of Life Concerns in the End of Life Questionnaire. The 23 items are rated on a 4-point Likert scale. The higher score means the better quality of life.
Baseline, 1 month and 3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helen N Chan, PhD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 14168417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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