Surgical Site InfectionsNCT02414191
Feedback on Perioperative Temperature Management and Patient Outcomes: Three-arm Trial to Compare Feedback
A study testing Benchmarked Feedback and Ranked Feedback in people with Surgical Site Infections and Hypothermia, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The investigators aim to assess the impact of benchmarked and ranked feedback on anesthesiologists' perioperative temperature management and subsequent patient outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infections, Hypothermia
- What is being tested?
- Benchmarked Feedback and Ranked Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to 6 Apr 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Staff Anesthesiologists at The Ottawa Hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Audit and Feedback on Physicians' Perioperative Temperature Management and Patient Outcomes: A Three-arm Cluster Randomized Controlled Trial to Compare Benchmarked and Ranked Feedback
The investigators aim to assess the impact of benchmarked and ranked feedback on anesthesiologists' perioperative temperature management and subsequent patient outcomes.
- Conditions
- Surgical Site Infections, Hypothermia
- Being tested
- Benchmarked Feedback, Ranked Feedback
- Keywords
- Feedback, Temperature management, Anesthesia
- Medical subject headings
- Surgical Wound Infection, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benchmarked FeedbackBehavioural
Participants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of benchmarked feedback, which is the measure of their performance in comparison the standard set by the hospital.
Ranked FeedbackBehavioural
Participants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of ranked feedback, which is the measure of their performance in comparison to their peers.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this study arm will receive no form of feedback. |
| Benchmarked Feedback | Other | Participants in this study arm will receive benchmarked feedback regarding their perioperative temperature management. Receives: Behavioral: Benchmarked Feedback |
| Ranked Feedback | Other | Participants in this study arm will receive ranked feedback regarding their perioperative temperature management. Receives: Behavioral: Ranked Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient peri-operative temperature
Measured: Within the 30 minutes immediately before or the 15 minutes immediately after anesthesia end time.
Secondary outcomes (2)
Intraoperative warming device usage perioperative
Measured: intraoperative
Patient post-operative surgical site infection (SSI) rate
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
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 Surgical Site InfectionsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Boet, MD, PhD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414191
- Sponsor's protocol ID
- 20140117-01H
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Boet S, Bryson GL, Taljaard M, Pigford AA, McIsaac DI, Brehaut J, Forster A, Mohamed K, Clavel N, Pysyk C, Grimshaw JM; Canadian Perioperative Anesthesia Clinical Trials Group. Effect of audit and feedback on physicians' intraoperative temperature management and patient outcomes: a three-arm cluster randomized-controlled trial comparing benchmarked and ranked feedback. Can J Anaesth. 2018 Nov;65(11):1196-1209. doi: 10.1007/s12630-018-1205-0. Epub 2018 Aug 29.
PubMed 30159716
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Audit and Feedback on Physicians' Perioperative Temperature Management and Patient Outcomes: A Three-arm Cluster Randomized Controlled Trial to Compare Benchmarked and Ranked Feedback
- ClinicalTrials.gov ID
- NCT02414191
- Acronym / sponsor ID
- 20140117-01H
- Conditions
- Surgical Site Infections, Hypothermia
- Keywords
- Feedback, Temperature management, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 10 Apr 2015 (estimated)
- 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.
The investigators aim to assess the impact of benchmarked and ranked feedback on anesthesiologists' perioperative temperature management and subsequent patient outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this study arm will receive no form of feedback. |
| Benchmarked Feedback | Other | Behavioral: Benchmarked FeedbackParticipants in this study arm will receive benchmarked feedback regarding their perioperative temperature management. |
| Ranked Feedback | Other | Behavioral: Ranked FeedbackParticipants in this study arm will receive ranked feedback regarding their perioperative temperature management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Staff Anesthesiologists at The Ottawa Hospital
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 |
|---|---|---|
| Benchmarked FeedbackParticipants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of benchmarked feedback, which is the measure of their performance in comparison the standard set by the hospital. | Behavioural | Benchmarked Feedback |
| Ranked FeedbackParticipants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of ranked feedback, which is the measure of their performance in comparison to their peers. | Behavioural | Ranked Feedback |
Primary outcome
Patient peri-operative temperature
Time frame: Within the 30 minutes immediately before or the 15 minutes immediately after anesthesia end time.
2 secondary outcomes
Intraoperative warming device usage perioperative
Time frame: intraoperative
Patient post-operative surgical site infection (SSI) rate
Time frame: Within 30 days of surgery
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 24 Mar 2020.
- Derived from this study: PubMed 30159716Boet S, Bryson GL, Taljaard M, Pigford AA, McIsaac DI, Brehaut J, Forster A, Mohamed K, Clavel N, Pysyk C, Grimshaw JM; Canadian Perioperative Anesthesia Clinical Trials Group. Effect of audit and feedback on physicians' intraoperative temperature management and patient outcomes: a three-arm cluster randomized-controlled trial comparing benchmarked and ranked feedback. Can J Anaesth. 2018 Nov;65(11):1196-1209. doi: 10.1007/s12630-018-1205-0. Epub 2018 Aug 29.
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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.
Sylvain Boet, MD, PhD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benchmarked Feedback and Ranked Feedback in people with Surgical Site Infections and Hypothermia, run by Ottawa Hospital Research Institute 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 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 24 Mar 2020. 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?
Patient peri-operative temperature (time frame: Within the 30 minutes immediately before or the 15 minutes immediately after anesthesia end time.). 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 NCT02414191, 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 24 Mar 2020.