- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06090240
Motivational Interviewing to Enhance Advance Care Planning for Older Adults and Caregivers After Emergency Visits
Maximizing Teachable Moments: Motivational Interviewing (MI) to Enhance Advance Care Planning (ACP) for Older Adults and Caregivers After Emergency Visits - A Mixed-Method Randomized Controlled Trial
This study aims to evaluate the effectiveness of a motivational interviewing (MI) intervention in enhancing advance care planning (ACP) among older adults who have visited the Emergency Room (ER) in the past six months and their family caregivers. The main question it aims to answer is: The effectiveness of the MI-based ACP intervention implemented within six months of an ER visit on improving older adults' advance directives (AD) completion rate.
Compared to participants in the control group who will only receive a self-education booklet, participants in the intervention group will receive a motivational interview educational intervention to see the effectiveness of an MI-based ACP intervention implemented within six months following an emergency room visit regarding the completion of AD for older adults.
Study Overview
Status
Intervention / Treatment
Detailed Description
Targeted issue: At present no feasible method exists to empower older adults following ER visits to engage in ACP in Hong Kong.
Population: The target group will be dyads comprising older adults who have had ER visits within the previous six months and their family caregivers.
Intervention: An MI-based ACP intervention our team developed.
Main study aim: To investigate the effectiveness of an MI-based ACP intervention implemented within six months following an emergency room visit on completion of AD for older adults compared to a self-education group.
Study method: Investigators will recruit eligible participants from two largest public hospitals, including the geriatric outpatient clinic of Queen Mary Hospital (IRB Ref: UW23-402) and the accident & emergency department of Queen Elizabeth Hospital (IRB Ref: KC/KE-23-0058/ER-1). A parallel RCT (allocation ratio= 1:1) with a post-trial qualitative study will be adopted and three follow-up time points at 3-, 6- and 12-month post-intervention. Participants in the intervention group will receive a motivational interview educational intervention, while participants in the comparison group will receive the pictorial ACP educational booklet for self-learning only. Completion of AD and health service utilization will be assessed at three follow-up time points. In addition, a post-intervention interview, regarding stakeholders' views on the relevance, effectiveness, and experience of the intervention., will be conducted.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chia-Chin LIN, PhD,FAAN,RN
- Phone Number: 852-3917-6600
- Email: cclin@hku.hk
Study Contact Backup
- Name: Tongyao Wang, PhD
- Phone Number: 852-3917-2790
- Email: tongyao1@hku.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- University of Hong Kong, School of Nursing
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Contact:
- Jialing Chen
- Phone Number: 39103442
- Email: jialing1@hku.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
The target group will be dyads comprising older adults who have had ER visits within the previous six months and their family caregivers. A dyad is defined as one older adult and one primary family caregiver of the older adult.
For older adults:
Inclusion Criteria:
- Aged 65 or older
- At least one episode of ER visit in the last six months
- Has a family caregiver to be present during the intervention
- Able to communicate in Chinese
Exclusion Criteria:
- Has completion of an AD
- Moderate to severe cognitive impairment or diagnosis of dementia, as identified in health records
- Communication problems (e.g., deafness or aphasia)
For family caregivers:
Inclusion Criteria:
- Aged 18 or above
- Immediate or extended family member or friend nominated by an eligible older adult participant as primary caregiver
- Able to communicate in Chinese
Exclusion Criteria:
- Moderate to severe cognitive impairment
- Communication problems (e.g., deafness or aphasia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational Interview
Older adult-family member dyads in this arm will receive an MI-based education intervention our team developed.
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Motivational Interviewing on Advance Care Planning Intervention: Dyads of older adults and family caregivers will receive three MI-based ACP counselling sessions: (1) a preparatory session, (2) motivation session, and (3) planning session.
The preparatory session will take 10-15 minutes, and the following two sessions in weeks 2 and 3 will last 30-45 minutes each.
Before each session, the nurse interventionist will first assess the dyad's readiness to engage in ACP based on the state of change algorithm.
Participants who have never thought about ACP will be in the pre-contemplation state, those who are willing to discuss EOL care and preferences to be in the contemplation state, those ready to talk about EOL planning to be in the preparation state, and those in the action state have a confirmed action plan on signing up their ADs.
Readiness-based ACP goals will be established, and state-matched MI counseling will be customized for each participant.
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No Intervention: Self-learning
Older adult-family member dyads in this arm will receive a self-learning ACP educational material developed by the Hong Kong Hospital Authority.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Completion of AD documentation at 3 Months
Time Frame: 3 months
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Completion of AD documentation will be measured by reviewing participants' medical records for a new AD document or self-reported AD completion at the 3-month follow-up time point.
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3 months
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Change from Baseline in Completion of AD documentation at 6 Months
Time Frame: 6 months
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Completion of AD documentation will be measured by reviewing participants' medical records for a new AD document or self-reported AD completion at the 6-month follow-up time point.
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6 months
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Change from Baseline in Completion of AD documentation at 12 Months
Time Frame: 12 months
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Completion of AD documentation will be measured by reviewing participants' medical records for a new AD document or self-reported AD completion at the 12-month follow-up time point.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chia-Chin LIN, PhD,FAAN,RN, University of Hong Kong, School of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2023-150, HKWC-2023-342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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