Quality of LifeNCT04026698
Implementing an Intervention to Foster Resident and Family Engagement in Care Planning
A study testing Resident and Family Engagement Intervention in people with Quality of Life, run by University of Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Resident and Family Engagement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2019to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- residents with severe cognitive impairment
- residents who do not speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Resident and Family Engagement Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resident and Family Engagement InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resident and Family Engagement Intervention. | Experimental | 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. Receives: Behavioral: Resident and Family Engagement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life- a change is being assessed
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).
Measured: Pre-intervention and post-intervention- within 3 months after intervention completion
Secondary outcomes (3)
Resident satisfaction with care- a change is being assessed
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).
Measured: Pre-intervention and post-intervention- within 3 months after intervention completion
Family satisfaction with resident care- a change is being assessed
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).
Measured: Pre-intervention and post-intervention- within 3 months after intervention completion
Staff quality of work life- a change is being assessed
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).
Measured: Pre-intervention and post-intervention- within 3 months after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start15 Jan 2019
- Primary completion15 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This intervention study has a single group of participants who will receive the intervention. There is no control group or randomization.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Baycrest
- Responsible party
- Principal investigator, Dr. Lisa Cranley, University of Toronto
- Investigators
- Lisa A Cranley, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026698
- Sponsor's protocol ID
- 36220
- Status last verified
- Jun 2024
- First submitted
- 4 Jul 2019
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cranley LA, McGillis Hall L, Duggleby W, Helfenbaum S, Galessiere D, Meyer RM, Sivakumaran G, Just D, MacEachern L, McGilton KS. Resident- and family-led huddles for collaborative care planning in long-term care: a feasibility study. Innov Aging. 2025 Oct 23;9(11):igaf116. doi: 10.1093/geroni/igaf116. eCollection 2025.
PubMed 41334049
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Intervention to Foster Meaningful Engagement and Shared Decision-making in Long-term Care: A Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT04026698
- Acronym / sponsor ID
- 36220
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Baycrest
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This intervention study has a single group of participants who will receive the intervention. There is no control group or randomization.
| Arm | Type | Receives |
|---|---|---|
| Resident and Family Engagement Intervention. | Experimental | Behavioral: Resident and Family Engagement InterventionThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- residents with severe cognitive impairment
- residents who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resident and Family Engagement InterventionThe 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. | Behavioural | Resident and Family Engagement Intervention. |
Primary outcome
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).
3 secondary outcomes
Resident satisfaction with care- a change is being assessed
Time frame: 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
Staff quality of work life- a change is being assessed
Time frame: Pre-intervention and post-intervention- within 3 months after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 41334049Cranley LA, McGillis Hall L, Duggleby W, Helfenbaum S, Galessiere D, Meyer RM, Sivakumaran G, Just D, MacEachern L, McGilton KS. Resident- and family-led huddles for collaborative care planning in long-term care: a feasibility study. Innov Aging. 2025 Oct 23;9(11):igaf116. doi: 10.1093/geroni/igaf116. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa A Cranley, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resident and Family Engagement Intervention in people with Quality of Life, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life- a change is being assessed (time frame: Pre-intervention and post-intervention- within 3 months after intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.