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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04026698
Other study ID # 36220
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date September 30, 2022

Study information

Verified date May 2022
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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 and focus groups.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 116
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada University of Toronto Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University of Toronto Baycrest, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Pre-intervention and post-intervention- within 3 months after intervention completion
Secondary 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). Pre-intervention and post-intervention- within 3 months after intervention completion
Secondary 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). Pre-intervention and post-intervention- within 3 months after intervention completion
Secondary 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). Pre-intervention and post-intervention- within 3 months after intervention completion
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