Implementing an Intervention to Foster Resident and Family Engagement in Care Planning

June 24, 2024 updated by: Dr. Lisa Cranley, University of Toronto

Implementing an Intervention to Foster Meaningful Engagement and Shared Decision-making in Long-term Care: A Mixed Methods Approach

This study is a pilot test of an intervention to engage residents and their family and the healthcare team in a collaborative approach to decisions about care planning in long-term care. The intervention includes leadership coaching with the management team, an educational bundle that includes a one-day education session for staff and managers on communication strategies and ways to engage family and residents in care planning and follow-up visits, and a series of resident and family led huddles (brief, 15 minute meetings) to discuss a care related topic with staff to foster proactive communication and information sharing for care planning.

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

This study is a pilot test of an intervention to engage residents and their family and the healthcare team in a collaborative approach to decisions about care planning in long-term care. The intervention includes leadership coaching with the management team, an educational bundle that includes a one-day education session for staff and managers on communication strategies and ways to engage family and residents in care planning and follow-up visits, and a series of resident and family led huddles (brief, 15 minute meetings) to discuss a care related topic with staff to foster proactive communication and information sharing and care planning.

The study aims are to describe the feasibility and acceptability of the resident and family engagement intervention, and to evaluate the following outcomes: resident quality of life, resident and family satisfaction with care, and staff quality of work life. The investigators aim to recruit 20 staff, the leadership team, and 12 resident-family dyads from four long-term care facilities who will receive the intervention and complete the survey measures. The expected outcome from this study is an increased understanding of how to engage residents and family in care decisions impacting quality of life.

Amendment: Due to the COVID-19 pandemic, the anticipated sample size is smaller and as a result, our outcomes will be explored qualitatively through interviews.

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.
110

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1P8
        • University of Toronto

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Residents:

  • residents who can communicate in English
  • residents (aged 65 or older) who have a visiting family member who is their substitute decision maker- both the resident and their family member will participate in the huddles

Exclusion Criteria:

  • residents with severe cognitive impairment
  • residents who do not speak English

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: Health Services Research
  • 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: Resident and Family Engagement Intervention.
The intervention has three components: leadership coaching for managers, administrators/ directors of care in long-term care settings; a one-day in-person training session for staff and managers; and resident and family led huddles (brief, 15 minute meetings) with staff.
Behavioral: Resident and Family Engagement Intervention

The leadership coaching component targets managers, administrators/ directors of care in long-term care settings. These sessions involve selecting a subset of relevant performance outcomes from the quality improvement plan that align with leadership vision and priorities for staff performance which leaders can monitor, reinforce and encourage.

The education component involves a one-day in-person training session for staff and managers on communication strategies and ways to engage family and residents in care planning, and includes follow-up visits.

The huddle component involves a series of resident and family led huddles (brief, 15 minute meetings) to discuss a care related topic with staff to foster proactive communication and information sharing. Resident-family dyads will participate in the huddles, along with the staff and management team who received the training. The huddles will be scheduled for 15 minutes once/month for up to 3 months.

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
Quality of life- a change is being assessed
Time Frame: Pre-intervention and post-intervention- within 3 months after intervention completion
The dementia quality of life DEMQOL (28-items) and DEMQOL-Proxy (31-items) are measures that assess health-related quality of life of people with dementia. The questions are interviewer-administered to obtain self (person with dementia) and caregiver perspectives. Response options range from 1=a lot to 4=not at all (with higher scores indicating a higher perceived health-related quality of life). A total score is calculated by summing scores from the 28 items (minimum score 28, maximum score 112).
Pre-intervention and post-intervention- within 3 months after intervention completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resident satisfaction with care- a change is being assessed
Time Frame: Pre-intervention and post-intervention- within 3 months after intervention completion
Resident satisfaction with care will be assessed using the Resident Satisfaction with the Nursing Home questionnaire, a 29-item measure that has been used with residents with cognitive impairment. The questions are interviewer-administered to obtain self-reported data from the resident using Yes/No response options (with a Yes response indicating satisfaction).
Pre-intervention and post-intervention- within 3 months after intervention completion
Family satisfaction with resident care- a change is being assessed
Time Frame: Pre-intervention and post-intervention- within 3 months after intervention completion
Family satisfaction with resident care will be assessed using the Nursing Facility Family Satisfaction Questionnaire, a 20-item measure that uses a visual analogue scale ranging from 1 (very poor) to 10 (excellent).
Pre-intervention and post-intervention- within 3 months after intervention completion
Staff quality of work life- a change is being assessed
Time Frame: Pre-intervention and post-intervention- within 3 months after intervention completion
Staff quality of work life will be assessed using a 16-item need-satisfaction measure on a five-point Likert scale ranging from 1=strongly disagree to 5=strongly agree (with higher scores indicating a higher perception of quality of work life).
Pre-intervention and post-intervention- within 3 months after intervention completion

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.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Baycrest

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: Lisa A Cranley, PhD, University of Toronto

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.
January 15, 2019

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.
December 15, 2022

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.
April 30, 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).
July 4, 2019

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.
July 17, 2019

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.
July 19, 2019

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 26, 2024

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 24, 2024

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, 2024

More Information

Terms related to this study

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.
  • 36220

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.

Clinical Trials on Quality of Life

Clinical Trials on Resident and Family Engagement Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings