Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours

End Stage Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162912
• Other study ID #: 14168417
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Food and Health Bureau, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Disease

Intervention

Behavioral:
• Motivational Interviewing tailored Advance Care Planning
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.

Locations

Country	Name	City	State
Hong Kong	United Christian Hospital	Kwun Tong
Hong Kong	Haven of Hope Hospital	Tseung Kwan O

Sponsors (3)

Lead Sponsor	Collaborator
Food and Health Bureau, Hong Kong	Haven of Hope Hospital, United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decisional conflict	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
Secondary	Perceived stress	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
Secondary	Quality of life	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