Patient SafetyNCT05365516
Medical Safety Huddles - a Multi-site QI Project
A study testing Implementing medical safety huddles in people with Patient Safety, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
This quality improvement project will implement and evaluate the impact of physician-specific huddles, termed "medical safety huddles" on patient safety within four programs/sites at Sinai Health Systems, St. John's Rehab (Sunnybrook) and University Health Network. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Safety
- What is being tested?
- Implementing medical safety huddles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Jun 2020to 30 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any staff physicians, residents or medical students working at the four programs/sites
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
St John's Rehab
Toronto, Ontario, M2M 2G1
Bridgepoint Active Health
Toronto, Ontario, M4M 2B5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Princess Margaret Hospital - UHN
Toronto, Ontario1, M5G2A2
About this study
Official title: Medical Safety Huddles - a Multi-site QI (Quality Improvement) Project
This quality improvement project will implement and evaluate the impact of physician-specific huddles, termed "medical safety huddles" on patient safety within four programs/sites at Sinai Health Systems, St. John's Rehab (Sunnybrook) and University Health Network.
- Conditions
- Patient Safety
- Being tested
- Implementing medical safety huddles
- Keywords
- Quality Improvement, Patient Safety, Physician Engagement, Huddles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementing medical safety huddlesOther
These short, virtual huddles are led by a huddle leader and occur on a weekly or once every two week basis. Each site will be adapting the Medical Safety Huddles for their context and workflow to specifically engage physicians.
| Study group | Role | What they receive |
|---|---|---|
| Medical Safety Huddles - Pre-implementation | No intervention | Not described |
| Medical Safety Huddles - Post-implementation | Experimental | Not described Receives: Other: Implementing medical safety huddles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
We will examine whether the huddles impact the frequency and severity of adverse events experienced by patients. We will also determine if the huddles specifically impact certain types of adverse events in terms of frequency and severity. We will also perform analysis specific for each program/site.
Measured: 19 months
Secondary outcomes (3)
Process measure - Attendance rate
The number of physicians attending each huddle will be monitored to ensure the fidelity of implementation
Measured: 15 months
Process measure - Safety issues
The type and number of safety issues brought up during huddles will be monitored on a monthly basis to ensure the fidelity of implementation
Measured: 15 months
Process measure - Actions taken to address safety issues
The number of actions taken to address safety issues will be monitored on a monthly basis to ensure the fidelity of implementation
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jun 2020
- Primary completion31 Oct 2022
- Study completion30 Jan 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 Patient SafetyStudies of the same condition, open and under way.
- More trials run by University Health Network, 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The multi-centre QI project will use a stepped wedge cluster randomized design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sinai Health System, Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Meiqi Guo, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365516
- Sponsor's protocol ID
- 19-6357
- Status last verified
- May 2023
- First submitted
- 20 Apr 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo M, Bayley M, Ye XY, Dunbar-Yaffe R, Fortin C, Go K, Macedo A, Matelski J, Mayo A, Pelc J, Robinson LR, Rotteau L, Wolfstadt J, Cram P, Linett L, Soong C. Impact of medical safety huddles on patient safety: a stepped-wedge cluster randomised study. BMJ Qual Saf. 2026 Apr 21;35(5):326-333. doi: 10.1136/bmjqs-2025-019170.
PubMed 41027730
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Safety Huddles - a Multi-site QI (Quality Improvement) Project
- ClinicalTrials.gov ID
- NCT05365516
- Acronym / sponsor ID
- 19-6357
- Conditions
- Patient Safety
- Keywords
- Quality Improvement, Patient Safety, Physician Engagement, Huddles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sinai Health System, Sunnybrook Health Sciences Centre
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 9 May 2022 (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 quality improvement project will implement and evaluate the impact of physician-specific huddles, termed "medical safety huddles" on patient safety within four programs/sites at Sinai Health Systems, St. John's Rehab (Sunnybrook) and University Health Network.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The multi-centre QI project will use a stepped wedge cluster randomized design
| Arm | Type | Receives |
|---|---|---|
| Medical Safety Huddles - Pre-implementation | No intervention | – |
| Medical Safety Huddles - Post-implementation | Experimental | Other: Implementing medical safety huddles |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any staff physicians, residents or medical students working at the four programs/sites
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Implementing medical safety huddlesThese short, virtual huddles are led by a huddle leader and occur on a weekly or once every two week basis. Each site will be adapting the Medical Safety Huddles for their context and workflow to specifically engage physicians. | Other | Medical Safety Huddles - Post-implementation |
Primary outcome
Adverse events
Time frame: 19 months
We will examine whether the huddles impact the frequency and severity of adverse events experienced by patients. We will also determine if the huddles specifically impact certain types of adverse events in terms of frequency and severity. We will also perform analysis specific for each program/site.
3 secondary outcomes
Process measure - Attendance rate
Time frame: 15 months
Process measure - Safety issues
Time frame: 15 months
Process measure - Actions taken to address safety issues
Time frame: 15 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 25 May 2023.
- Derived from this study: PubMed 41027730Guo M, Bayley M, Ye XY, Dunbar-Yaffe R, Fortin C, Go K, Macedo A, Matelski J, Mayo A, Pelc J, Robinson LR, Rotteau L, Wolfstadt J, Cram P, Linett L, Soong C. Impact of medical safety huddles on patient safety: a stepped-wedge cluster randomised study. BMJ Qual Saf. 2026 Apr 21;35(5):326-333. doi: 10.1136/bmjqs-2025-019170.
- 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.
Meiqi Guo, MD principal investigator
University Health Network, Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementing medical safety huddles in people with Patient Safety, run by University Health Network, Toronto at 4 sites 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 1 inclusion and 1 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 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Adverse events (time frame: 19 months). 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 NCT05365516, 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 25 May 2023.