Strengthen Family Members' Understanding of Advance Care Planning With a Nurse-led, Motivational Interview

June 13, 2023 updated by: The University of Hong Kong

Strengthen Family Members' Understanding of Advance Care Planning With a Nurse-led, Motivational Interview Educational Intervention: A Mixed-method Feasibility Study

The goal of this clinical trial is to strengthen the understanding of advance care planning (ACP) in family members of older adults in residential care homes with a nurse-led, motivational interview (MI) educational intervention.The main question it aims to answer is: The feasibility of the nurse-led, motivational interview educational intervention to promote family members' understanding of ACP.

Participants will receive a nurse-led, motivational interview educational intervention to see if the nurse-led, motivational interview educational intervention works in strengthening family members' knowledge on ACP and readiness for initiating conversations on ACP with their loved ones.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Targeted issue: Lack of feasible method exists to empower family members of older adults in residential care homes to engage in advance care planning (ACP).

Population: Family members who are identified by a resident aged above 65 years old in residential care homes.

Intervention: A nurse-led, stage-tailored, motivational interview (MI) educational intervention.

Study aim: To evaluate the preliminary feasibility of the nurse-led, motivational interview educational intervention to promote family members' understanding of ACP.

Study method: This is a mixed-methods design, including an intervention trial and qualitative process evaluation interview. Participants will receive a nurse-led, motivational interview educational intervention and research staff will track their readiness for ACP at three-time points (before the intervention [T0], 2-week [T1], 3-week [T2] post-intervention). In addition, a post-intervention interview, regarding participants' experience of receiving the intervention, will be conducted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 and above
  • Identified by a resident aged above 65 years old in the residential care home as family member by the HA's definition
  • Able to read and write in Chinese

Exclusion Criteria:

  • Moderate to severe cognitive impairment
  • Severe hearing impairment, defined as unable to participate in a telephone conversation
  • Primary language other than Cantonese or Mandarin
  • No access to telephone
  • Cannot read or write in Chinese

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motivational Interview
Participants will receive the nurse-led, motivational interview educational intervention in this group.
Other: a Nurse-led, Motivational Interview
Family member participants will receive three counselling sessions: (1) preparatory session, (2) motivation session, and (3) planning session. The preparatory session will take 10-15 minutes, and the following two sessions at weeks 2 & 3, with 30-45 min, respectively. The sessions can be delivered via face-to-face, zoom meeting, or telephones. Before each session, the nurse will first assess the family member's readiness to engage in ACP based on the State to Change algorithm. Family members who have never thought about ACP will be in the pre-contemplation state. Family members who are willing to discuss end-of-life care will be in the contemplation state. Those who are ready to talk about end-of-life planning will be in the planning state. Readiness-based ACP goals will be established, and state-matched motivational interview counseling will be customized for each participant.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Family Members' Readiness for ACP at 2 Weeks
Time Frame: 2 weeks
Family members' readiness for ACP will be measured by the researcher-developed family caregivers' ACP engagement survey (FACP-10), which consists of 10 items rated on a 5-point Likert scale. The survey assesses family caregivers' self-reported levels of ACP knowledge, readiness to discuss ACP with a loved one, self-efficacy in initiating ACP conversations with a loved one and barriers to such initiation, and emotional perceptions of and attitudes toward ACP, as well as whether having the necessary communication tools for ACP conversations. The scale scores range from 10 (the lowest) to 50 (the highest).Higher score indicates a higher readiness for ACP. Investigator developed the instrument based on the key domains reported in the Advance Care Planning Engagement Survey (ACPES) and the constructs identified in a systematic review of family caregivers' roles in ACP. The pilot data demonstrated adequate reliability of the scale in Hong Kong family caregivers.
2 weeks
Change from Baseline in Family Members' Readiness for ACP at 3 Weeks
Time Frame: 3 weeks
Family members' readiness for ACP will be measured by the researcher-developed family caregivers' ACP engagement survey (FACP-10), which consists of 10 items rated on a 5-point Likert scale. The survey assesses family caregivers' self-reported levels of ACP knowledge, readiness to discuss ACP with a loved one, self-efficacy in initiating ACP conversations with a loved one and barriers to such initiation, and emotional perceptions of and attitudes toward ACP, as well as whether having the necessary communication tools for ACP conversations. The scale scores range from 10 (the lowest) to 50 (the highest). Higher score indicates a higher readiness for ACP. Investigator developed the instrument based on the key domains reported in the Advance Care Planning Engagement Survey (ACPES) and the constructs identified in a systematic review of family caregivers' roles in ACP. The pilot data demonstrated adequate reliability of the scale in Hong Kong family caregivers.
3 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chia-Chin LIN, PhD,FAAN,RN, University of Hong Kong, School of Nursing

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW 22-586

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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