- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04026698
Implementing an Intervention to Foster Resident and Family Engagement in Care Planning
Implementing an Intervention to Foster Meaningful Engagement and Shared Decision-making in Long-term Care: A Mixed Methods Approach
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 1P8
- University of Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Lisa A Cranley, PhD, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 36220
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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