search
Back to results

Motivational Interviewing to Enhance Advance Care Planning for Older Adults and Caregivers After Emergency Visits

Primary Purpose

Older Adults, Advance Care Planning, Advance Directives

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MI-based ACP intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Older Adults

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Motivational Interview

    Self-learning

    Arm Description

    Older adult-family member dyads in this arm will receive an MI-based education intervention our team developed.

    Older adult-family member dyads in this arm will receive a self-learning ACP educational material developed by the Hong Kong Hospital Authority.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Completion of AD documentation at 3 Months
    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.
    Change from Baseline in Completion of AD documentation at 6 Months
    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.
    Change from Baseline in Completion of AD documentation at 12 Months
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 18, 2023
    Sponsor
    The University of Hong Kong
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06090240
    Brief Title
    Motivational Interviewing to Enhance Advance Care Planning for Older Adults and Caregivers After Emergency Visits
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    October 19, 2024 (Anticipated)
    Study Completion Date
    January 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Older Adults, Advance Care Planning, Advance Directives, Family Members

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    376 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motivational Interview
    Arm Type
    Experimental
    Arm Description
    Older adult-family member dyads in this arm will receive an MI-based education intervention our team developed.
    Arm Title
    Self-learning
    Arm Type
    No Intervention
    Arm Description
    Older adult-family member dyads in this arm will receive a self-learning ACP educational material developed by the Hong Kong Hospital Authority.
    Intervention Type
    Other
    Intervention Name(s)
    MI-based ACP intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Completion of AD documentation at 3 Months
    Description
    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.
    Time Frame
    3 months
    Title
    Change from Baseline in Completion of AD documentation at 6 Months
    Description
    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.
    Time Frame
    6 months
    Title
    Change from Baseline in Completion of AD documentation at 12 Months
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chia-Chin LIN, PhD,FAAN,RN
    Phone
    852-3917-6600
    Email
    cclin@hku.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tongyao Wang, PhD
    Phone
    852-3917-2790
    Email
    tongyao1@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chia-Chin LIN, PhD,FAAN,RN
    Organizational Affiliation
    University of Hong Kong, School of Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Motivational Interviewing to Enhance Advance Care Planning for Older Adults and Caregivers After Emergency Visits

    We'll reach out to this number within 24 hrs