Frontline Staff Working Within Personal Care Home FacilitiesSHIFTNCT06106087
Supporting Healthcare Improvement Through Facilitation & Training
A study testing Mixed methods quality improvement intervention in people with Frontline Staff Working Within Personal Care Home Facilities, run by University of Manitoba at 1 site in Canada.
Trial summary
SHIFT will support personal care home (PCH) staff to conduct quality improvement (QI) initiatives more purposefully and objectively in their regular care setting in ways that help to sustainably improve the quality of care and/or life of residents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frontline Staff Working Within Personal Care Home Facilities
- What is being tested?
- Mixed methods quality improvement intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2023to 9 Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Facility Inclusion Criteria:
- A personal care home (PCH) which provides 24-hour on-site housing and health care services care for older adults by professional (nursing) staff and others.
- Located in Manitoba.
- Licensed by the provincial government.
- 90% of residents aged 65 or over.
- Facility operations conducted in the English language.
Facility Exclusion Criteria:
- Chronic care facilities.
- Transition care facilities.
- Facilities that are expected to undergo major changes during the study intervention (e.g., where a unit is expected to close or the site is expected to undergo major renovations).
Individual Staff Inclusion Criteria:
- have worked on the unit for a minimum of three months.
- have worked at least 6 shifts per month on the unit.
- be able to travel to workshops and participate in relevant SHIFT activities.
- work well with other team members.
- have the respect of staff on the unit.
- be able to communicate effectively with colleagues.
Trial locations and contacts
1 site in 1 country.
About this study
SHIFT will support personal care home (PCH) staff to conduct quality improvement (QI) initiatives more purposefully and objectively in their regular care setting in ways that help to sustainably improve the quality of care and/or life of residents.
Read the detailed description
The SHIFT study will take place at approximately thirteen (13) residential long-term care facilities in Manitoba during a one-year period. These sites will be licensed by the provincial government and provide 24-hours on-site housing and health care services for older adults by professional (nursing) staff, allied health care professionals and unregulated staff.
In consultation with SHIFT research staff, a senior administrator at each facility will be identified to take on the role of Senior Sponsor (e.g. Director of Care, CEO) for the project. Quality improvement (QI) teams will be formed at each site and team formation will also occur in consultation with research staff. QI teams will have 5-6 participants comprised of a Team Sponsor (e.g. Unit Manager) and Team Members (e.g., Care Aides and Allied Staff).
The SHIFT intervention is comprised of three major components that include:
- PDSA (plan-do-study-act) Facilitation comprised of workshops interspersed with site-specific (i.e., context-sensitive) coaching sessions designed to help team members plan for and ably conduct their PDSA innovations;
- Readiness for Change Activities designed to help SHIFT team members more purposefully prepare for the intervention (e.g., by selecting PCH units with the appropriate personnel and context to participate in SHIFT, recruiting team members with the appropriate knowledge and social capital to help ensure project success); and,
- LeaderShift Modules designed to help Team Sponsors more effectively support front-line team members to plan, implement, and evaluate their SHIFT PDSA cycles.
- Being tested
- Mixed methods quality improvement intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed methods quality improvement interventionOther
Quality improvement training for frontline PCH staff
| Study group | Role | What they receive |
|---|---|---|
| QI Training | Other | Frontline staff in personal care homes will receive quality improvement training from an experienced quality advisor and support staff in making changes aimed to improve the quality of care for residents in the home. Receives: Other: Mixed methods quality improvement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Team fidelity to the quality improvement implementation process
Frontline teams will implement their change ideas using iterative plan-do-study-act (PDSA) cycles. Each team's progress will be captured by the SHIFT quality advisor during regular meetings. After each meeting the quality advisor will complete a structured diary that captures each team's PDSA process using a published scoring system (DOI: org/10.1186/s40814-022-00975-8). This tool measures the appropriateness of each team's aim statement (e.g., being specific, having timeframes), assesses their ability to properly measure and interpret data (e.g., documents pain reduction using run charts) to guide next PDSA steps, and reports the number of PDSA cycles they completed. As described in the aforementioned manuscript, multiple researchers will judge each team's progress independently and then meet to reach consensus opinion.
Measured: Through study completion, an average of 8 months
Level of readiness for change (R4C) among study participants
Each participant will complete a baseline survey to assess their R4C. This survey uses questions from existing tools modified for our target group. It will assess people's perceived R4C at the macro (e.g. "SHIFT aligns with our health system priorities"), meso (e.g. "SHIFT is viewed strongly by leaders at my site"), and micro level (e.g. "I have the skills to conduct SHIFT").
Team R4C scores will be correlated with results of Outcome Measure 1 (team fidelity to the implementation process) to descriptively assess if teams with higher baseline R4C scores make better PDSA progress.
Measured: Baseline
Identifying readiness for change (R4C) attributes that are precursors to PDSA implementation success.
While readiness for change (R4C) is a well-established concept, it is unclear if and how these processes help teams be more successful. At study start participants will engage in R4C discussions to understand their role in SHIFT, responsibilities and time required, and supports available.
During focus groups at study end, we will ask participants to (1) reflect on preparatory R4C activities, and (2) compare these to their SHIFT experiences including successes and challenges they encountered. During these focus groups people will suggest additional R4C activities that would have helped them to better prepare for SHIFT.
Measured: End of study (after an average of 8 months)
Value of the LeaderShift program from the perspective of participants
We are developing a novel leadership program (called LeaderShift) that teaches formal nursing home leaders how to help their staff conduct quality improvement initiatives more effectively. LeaderShift training includes four instructional workshops and two 1-1 coaching sessions throughout the study to help participants apply lessons during daily routines. Participants will discuss the value of LeaderShift with researchers in an end-of-project focus group to examine its value, to discuss components that were more and less effective, and to make suggestions for improving LeaderShift content. Following the principles employed by others (doi.org/10.1016/j.jcjq.2018.04.009) focus group data will be analyzed using qualitative constant comparative analysis to understand the extent, properties, and processes related to LeaderShift program success.
Measured: End of study (after an average of 8 months)
Participant Fidelity to the LeaderShift Program
LeaderShift is based on the LEADS framework that coaches people to lead in complex systems (DOI: 10.1108/LHS-02-2017-0002) and instructs people how to (1) develop key leadership characteristics (the domain of "Leading Self" in LEADS), (2) help others achieve their goals ("Engage Others"), and (3) create an environment of continuous improvement ("Systems Transformation"). Coaching will be provided during workshops and 1:1 sessions to discuss leadership change progress and to provide additional training where needed. After each session the LeaderShift coach will complete a semi structured diary documenting each participant's progress made with implementing these leadership principles. This will include a Likert Scale score of 0 (no success) to 9 (complete success) indicating the extent of participant progress and an explanation of the score provided. Researchers will review the diaries for each participant independently and develop a consensus score demonstrating overall success.
Measured: Through study completion, average of 8 months
Changes in leadership approaches witnessed by frontline teams
During end-of-study focus groups we will ask frontline team members if they noticed changes in their Team Sponsor's (direct supervisor's) leadership approach, to provide examples explaining these changes, and to discuss if and how this helped them to achieve PDSA success. Data will be presented aggregately across all SHIFT teams combined.
Measured: End of study (after an average of 8 months)
Secondary outcomes (1)
Improvement in resident care perceived by team members.
Each team will participate in an end-of-study focus group where members will be asked to reflect on their change ideas and discuss how these ideas improved resident care. Teams will be asked to provide examples illustrating how residents benefited from their change ideas. Following the principles employed by others (doi.org/10.1016/j.jcjq.2018.04.009) focus group data will be analyzed using a qualitative constant comparative analysis technique to understand the properties, processes, and causes of each team's perceived success.
Measured: End of study (after an average of 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start3 Nov 2023
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontline Staff Working Within Personal Care Home FacilitiesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Health
- Responsible party
- Principal investigator, Malcolm Doupe, University of Manitoba
- Investigators
- Malcolm Doupe, Phd, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106087
- Sponsor's protocol ID
- H2023:258
- Acronym
- SHIFT
- Status last verified
- Aug 2024
- First submitted
- 4 Oct 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Healthcare Improvement Through Facilitation & Training
- ClinicalTrials.gov ID
- NCT06106087
- Acronym / sponsor ID
- SHIFT / H2023:258
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Health
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 30 Oct 2023 (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.
SHIFT will support personal care home (PCH) staff to conduct quality improvement (QI) initiatives more purposefully and objectively in their regular care setting in ways that help to sustainably improve the quality of care and/or life of residents.
Detailed description
The SHIFT study will take place at approximately thirteen (13) residential long-term care facilities in Manitoba during a one-year period. These sites will be licensed by the provincial government and provide 24-hours on-site housing and health care services for older adults by professional (nursing) staff, allied health care professionals and unregulated staff.
In consultation with SHIFT research staff, a senior administrator at each facility will be identified to take on the role of Senior Sponsor (e.g. Director of Care, CEO) for the project. Quality improvement (QI) teams will be formed at each site and team formation will also occur in consultation with research staff. QI teams will have 5-6 participants comprised of a Team Sponsor (e.g. Unit Manager) and Team Members (e.g., Care Aides and Allied Staff).
The SHIFT intervention is comprised of three major components that include:
- PDSA (plan-do-study-act) Facilitation comprised of workshops interspersed with site-specific (i.e., context-sensitive) coaching sessions designed to help team members plan for and ably conduct their PDSA innovations;
- Readiness for Change Activities designed to help SHIFT team members more purposefully prepare for the intervention (e.g., by selecting PCH units with the appropriate personnel and context to participate in SHIFT, recruiting team members with the appropriate knowledge and social capital to help ensure project success); and,
- LeaderShift Modules designed to help Team Sponsors more effectively support front-line team members to plan, implement, and evaluate their SHIFT PDSA cycles.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QI Training | Other | Other: Mixed methods quality improvement interventionFrontline staff in personal care homes will receive quality improvement training from an experienced quality advisor and support staff in making changes aimed to improve the quality of care for residents in the home. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Mixed methods quality improvement interventionQuality improvement training for frontline PCH staff | Other | QI Training |
Primary outcome
Team fidelity to the quality improvement implementation process
Time frame: Through study completion, an average of 8 months
Frontline teams will implement their change ideas using iterative plan-do-study-act (PDSA) cycles. Each team's progress will be captured by the SHIFT quality advisor during regular meetings. After each meeting the quality advisor will complete a structured diary that captures each team's PDSA process using a published scoring system (DOI: org/10.1186/s40814-022-00975-8). This tool measures the appropriateness of each team's aim statement (e.g., being specific, having timeframes), assesses their ability to properly measure and interpret data (e.g., documents pain reduction using run charts) to guide next PDSA steps, and reports the number of PDSA cycles they completed. As described in the aforementioned manuscript, multiple researchers will judge each team's progress independently and then meet to reach consensus opinion.
Level of readiness for change (R4C) among study participants
Time frame: Baseline
Each participant will complete a baseline survey to assess their R4C. This survey uses questions from existing tools modified for our target group. It will assess people's perceived R4C at the macro (e.g. "SHIFT aligns with our health system priorities"), meso (e.g. "SHIFT is viewed strongly by leaders at my site"), and micro level (e.g. "I have the skills to conduct SHIFT"). Team R4C scores will be correlated with results of Outcome Measure 1 (team fidelity to the implementation process) to descriptively assess if teams with higher baseline R4C scores make better PDSA progress.
Identifying readiness for change (R4C) attributes that are precursors to PDSA implementation success.
Time frame: End of study (after an average of 8 months)
While readiness for change (R4C) is a well-established concept, it is unclear if and how these processes help teams be more successful. At study start participants will engage in R4C discussions to understand their role in SHIFT, responsibilities and time required, and supports available. During focus groups at study end, we will ask participants to (1) reflect on preparatory R4C activities, and (2) compare these to their SHIFT experiences including successes and challenges they encountered. During these focus groups people will suggest additional R4C activities that would have helped them to better prepare for SHIFT.
Value of the LeaderShift program from the perspective of participants
Time frame: End of study (after an average of 8 months)
We are developing a novel leadership program (called LeaderShift) that teaches formal nursing home leaders how to help their staff conduct quality improvement initiatives more effectively. LeaderShift training includes four instructional workshops and two 1-1 coaching sessions throughout the study to help participants apply lessons during daily routines. Participants will discuss the value of LeaderShift with researchers in an end-of-project focus group to examine its value, to discuss components that were more and less effective, and to make suggestions for improving LeaderShift content. Following the principles employed by others (doi.org/10.1016/j.jcjq.2018.04.009) focus group data will be analyzed using qualitative constant comparative analysis to understand the extent, properties, and processes related to LeaderShift program success.
Participant Fidelity to the LeaderShift Program
Time frame: Through study completion, average of 8 months
LeaderShift is based on the LEADS framework that coaches people to lead in complex systems (DOI: 10.1108/LHS-02-2017-0002) and instructs people how to (1) develop key leadership characteristics (the domain of "Leading Self" in LEADS), (2) help others achieve their goals ("Engage Others"), and (3) create an environment of continuous improvement ("Systems Transformation"). Coaching will be provided during workshops and 1:1 sessions to discuss leadership change progress and to provide additional training where needed. After each session the LeaderShift coach will complete a semi structured diary documenting each participant's progress made with implementing these leadership principles. This will include a Likert Scale score of 0 (no success) to 9 (complete success) indicating the extent of participant progress and an explanation of the score provided. Researchers will review the diaries for each participant independently and develop a consensus score demonstrating overall success.
Changes in leadership approaches witnessed by frontline teams
Time frame: End of study (after an average of 8 months)
During end-of-study focus groups we will ask frontline team members if they noticed changes in their Team Sponsor's (direct supervisor's) leadership approach, to provide examples explaining these changes, and to discuss if and how this helped them to achieve PDSA success. Data will be presented aggregately across all SHIFT teams combined.
1 secondary outcome
Improvement in resident care perceived by team members.
Time frame: End of study (after an average of 8 months)
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 15 Aug 2024.
- Individual participant dataSharing planned: No
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.
Malcolm Doupe, Phd principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed methods quality improvement intervention in people with Frontline Staff Working Within Personal Care Home Facilities, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 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?
Team fidelity to the quality improvement implementation process (time frame: Through study completion, an average of 8 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.