Surgical Procedure, UnspecifiedNCT05700890
The Surgical Safety Checklist Revisited
An observational study of Surgical Procedure, Unspecified and Communications Personnel, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this study is to develop and iteratively improve a toolkit - the "High-Performance Checklist" (HPC) toolkit - that provides clinicians with evidence-informed strategies for improving their Modification, Implementation, Training on, and Evaluation of the Surgical Safety Checklist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified, Communications Personnel, Tool Use Behavior
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2023to May 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are three types of participants in this study: 1. The Implementation Team includes physicians, nurses, administrators, and patient advocates 2. The OR Team 3. Surgical patients
Who may be able to join
- surgeons, anesthesiologists, nurses and administrator will be included in the study
- surgical patients that have undergone surgery within the last three months at the Peter Lougheed Centre
Who cannot join
- Patients that are unable to fill out a survey or participate in a semi structured interview
- Patients that surgery was done more than 3 months ago
- Surgical patients that are under the age of 18
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Karolina Kogut
Calgary, Alberta, T2T 1L1
Karolina Kogut, 4034611190, kkogut@ucalgary.ca
Nathan Turley, 15876009765, nturley@ucalgary.ca
About this study
Official title: Adaptation of the World Health Organization Surgical Safety Checklist to High-Income Healthcare Settings - Phase III: Site Testing Study
The goal of this study is to develop and iteratively improve a toolkit - the "High-Performance Checklist" (HPC) toolkit - that provides clinicians with evidence-informed strategies for improving their Modification, Implementation, Training on, and Evaluation of the Surgical Safety Checklist.
The study team will test the toolkit in the operating rooms of Calgary's Peter Lougheed Centre and collect feedback via surveys and questionnaires. This feedback will be used to iteratively improve the toolkit.
Read more
By improving clinicians' ability to modify their SSC, the study team hopes to see improvements in its uptake and surgical outcomes for patients.
Participants will be surgical clinical staff members and hospital administration, as well as participants over the age of 18, who have undergone a surgery in the last 90 days. They will all complete the following tasks:
Online or paper questionnaire Semi structured interviews Team meetings
Read the detailed description
This study is the third phase of a multi-year, multi-stage research project aimed at successful use of the World Health Organization's Safe Surgery Checklist. The study's first stage involved collecting perceptions of the SSC from surgical personnel in five high-income countries: Australia, the United States, Canada, the United Kingdom, and New Zealand. In that stage, interviews and surveys were conducted with individuals who use the SSC. Our results showed barriers and facilitators to the SSC's use and highlighted clinicians' attitudes towards it. The first stage of our study identified the need to better tailor the SSC checklists to meet contextual needs and ongoing gaps in leadership and team performance.
The study's second stage involved building a toolkit aimed at addressing four areas (Modification, Implementation, Training, and Evaluation) through the creation of working groups for each area. These working groups comprised Subject-Matter Experts (SMEs) from the consensus meeting and individuals from the surgical safety field. The output generated by these groups through a consensus-building process is the "High-Performance Checklist" Toolkit ("Toolkit"). The Toolkit is built using the Explore, Prepare, Implement, and Sustain (EPIS) framework and provides clinicians a mechanism for effectively customizing their SSC to their needs.
The third stage of the study involves pilot testing the Toolkit at three different sites and assessing its impact and usefulness in helping implementation teams at these sites. The three sites selected for this study are facilities of different size and scale, for which impact, outcomes, and clinician feedback from Implementation Teams from each site will be compared. The first site is the Peter Lougheed Centre in Calgary, Alberta, then the team intend to run the study at the University of Alberta Hospital and the hospital in Fort McMurray, Alberta.
At each site, three types of participants will be recruited: Implementation team ("ImT") members, operating room ("OR") personnel, and surgical patients. The ImT members will work through the Toolkit to customize their SSC, then the OR personnel will use the modified SSC. The patients will participate in Focus Groups to explore their perceptions of the SSC's use at each site.
From there, we will endeavour to make alterations to the toolkit, if necessary, before rolling it out on a larger scale.
The anticipated result is that clinicians' use of this toolkit will enhance their ability to effectively modify, implement, train, and evaluate their SSC, improve their use of SSC to reduce the rate of adverse events with patients in the OR. It is predicted that the Toolkit will have a positive impact on the culture of patient safety and staff members' perception of psychological safety in the OR.
This study aims to fill the gap in effective checklist modification, training, implementation, and evaluation that was observed during data gathering stage. The study team will gain insight on the utility of a tool designed for improving surgical teams' use of the SSC: how it works, users' perceptions of it, areas for improvement, and ideas for spreading the tool's usage.
Methods: During this stage of the study, the Toolkit will be implemented at the aforementioned Albertan sites. Using an effectiveness-implementation hybrid design, a mixed-methods approach will be applied to assess the implementation of the Toolkit and users' experiences with it. The impact of the toolkit's use on clinical outcomes will also be assessed through the collection of health systems data. Through a series of surveys, interviews, and observations of the toolkit being used, the toolkit's usability, feasibility, and acceptability, and impact on safety culture will be measured before, during, and after the toolkit's implementation. Throughout the study, ratings of the SSC's performance will be taken to assess the toolkit's impact on OR participants' teamwork and SSC engagement.
Operationally, this stage of the study comprises four phases: initial introductions and pre-study data collection, use of the Toolkit by completing the EPIS elements, post-implementation data collection, and a three-months post-implementation follow-up. Data will be collected during each phase to assess the impact of the toolkit and the experience of its users.
Data analysis: survey, health systems data, and SSC performance ratings will be analyzed using SPSS and qualitative data from the observations and interviews will be analyzed thematically using NVIVO.
- Keywords
- Surgical Safety Checklist, Patient Safety, Quality improvement, Teamwork, Psychological safety
- Medical subject headings
- Communication, Tool Use Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Team | The Implementation Group will complete two surveys at the beginning of the study, then at five different points during the HPC Toolkit's use, and again three months post-intervention. The surveys are the Safe Surgery Checklist Culture Survey and the SSC Use and Attitudes Survey and a series of user experience surveys. They will also do interviews pre- and post-HPC toolkit, and we will observe the Implementation Team's meetings as they work through the toolkit. | |
| OR Team | The OR members will complete the same pre- and post-intervention surveys (Safe Surgery Checklist Culture Survey and the SSC Use and Attitudes Survey) and do interviews before and after the IT has worked through the HPC toolkit. | |
| Surgical Patients | Surgical patients will be invited to participate in focus groups on their experiences from the time they enter the hospital on the day of their surgery to the moment they are put under anaesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of the HPC Toolkit
We will assess if the clinicians use of the HPC toolkit foster improvement in their use of the SSC. Surveys and semi-structured interviews will be collected at baseline, after the HPC introduction and at follow-up to assess if the HPC toolkit is sustained.
Measured: the initial 8 weeks of interacting with the study site
Reduction rate of adverse events in patient
We will assess if the clinicians use of the HPC toolkit reduces the rate of adverse events in patients
Measured: Through study completion, and average of 1 year
SSC Attitudes and OR Culture
The Implementation Team ("ImT") and OR Team's perceptions of the SSC and OR Culture will be measured through surveys at3 points in time.
Measured: Approximately the first and last 8 weeks interacting with the study site.
Patient Surgical Experiences Survey
Patients' experiences with surgery before and after the HPC Toolkit's implementation.
Measured: Approximately the first and last 8 weeks interacting with the study site.
User Experience Surveys
The ImT's experiences with the HPC Toolkit: ease of use, intuitiveness, layout, etc.
Measured: Approximately the first and last 8 weeks interacting with the study site
CheckPOINT observation tool
In situ observations of the SSC's use in the OR; measures SSC use in practice. Captured by the ImT and OR Team participants.
Measured: Approximately the first and last 8 weeks interacting with the study site
Semi-structured interviews
Participants' perceptions of the SSC and the HPC Toolkit's impact on it
Measured: Approximately the first and last 8 weeks interacting with the study site
Meeting observations
The Implementation Team's use of the HPC Toolkit
Measured: up to 16 weeks
Secondary outcomes (3)
Healthcare system data collection
AHS data analytics will be collected to assess the HPC toolkit's impact on patient safety and clinical throughput.
Measured: Up to 2 years
Measures of surgical safety
Health systems data will be collected to look at the following perioperative events:a. Surgical Site Infection Rate (%) b. 30-Day In Hospital Mortality after major surgery (crude and risk adjusted) c. 30-Day re-admission after surgery (crude rate and risk adjusted rate) d. Unplanned ED visit within 30 days after surgery (%) e. Unplanned Re-Operative events (%) - within 24 hours? f. Peri-operative venous thromboembolism (VTE) diagnosis (%)
Measured: Up to 2 years
Effectiveness of SSC practice
Errors averted by using the safe Surgery Checklist (Provincial Data):a. Site/Side/Location/Procedure - Incomplete or incorrect b. Pre op prep/lab/meds - incomplete or incorrect c. Equipment/Supplies - Missing or incorrect d. Allergies/Contraindications - to medication/equipment e. Documentation/history - incomplete or incorrect f. Wrong patient g. Not specified These data will be collected before and after implementation of the High Performance Toolkit to demonstrate the effectiveness of SSC practice.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start27 Jan 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ariadne Labs, National Aeronautics and Space Administration (NASA)
- Responsible party
- Sponsor
- Investigators
- Mary Brindle, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700890
- Sponsor's protocol ID
- REB21-0099
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007 Aug;42(4):1758-72. doi: 10.1111/j.1475-6773.2006.00684.x.
PubMed 17286625Campbell S, Greenwood M, Prior S, Shearer T, Walkem K, Young S, Bywaters D, Walker K. Purposive sampling: complex or simple? Research case examples. J Res Nurs. 2020 Dec;25(8):652-661. doi: 10.1177/1744987120927206. Epub 2020 Jun 18.
PubMed 34394687Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Delisle M, Pradarelli JC, Panda N, Koritsanszky L, Sonnay Y, Lipsitz S, Pearse R, Harrison EM, Biccard B, Weiser TG, Haynes AB; Surgical Outcomes Study Groups and GlobalSurg Collaborative. Variation in global uptake of the Surgical Safety Checklist. Br J Surg. 2020 Jan;107(2):e151-e160. doi: 10.1002/bjs.11321.
PubMed 31903586Devcich DA, Weller J, Mitchell SJ, McLaughlin S, Barker L, Rudolph JW, Raemer DB, Zammert M, Singer SJ, Torrie J, Frampton CM, Merry AF. A behaviourally anchored rating scale for evaluating the use of the WHO surgical safety checklist: development and initial evaluation of the WHOBARS. BMJ Qual Saf. 2016 Oct;25(10):778-86. doi: 10.1136/bmjqs-2015-004448. Epub 2015 Nov 20.
PubMed 26590200Dixon E, Vollmer CM Jr, Bathe O, Sutherland F. Training, practice, and referral patterns in hepatobiliary and pancreatic surgery: survey of general surgeons. J Gastrointest Surg. 2005 Jan;9(1):109-14. doi: 10.1016/j.gassur.2004.03.008.
PubMed 15623451Fourcade A, Blache JL, Grenier C, Bourgain JL, Minvielle E. Barriers to staff adoption of a surgical safety checklist. BMJ Qual Saf. 2012 Mar;21(3):191-7. doi: 10.1136/bmjqs-2011-000094. Epub 2011 Nov 7.
PubMed 22069112Halcomb EJ, Davidson PM. Is verbatim transcription of interview data always necessary? Appl Nurs Res. 2006 Feb;19(1):38-42. doi: 10.1016/j.apnr.2005.06.001.
PubMed 16455440Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.
PubMed 19144931Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Dziekan G, Herbosa T, Kibatala PL, Lapitan MC, Merry AF, Reznick RK, Taylor B, Vats A, Gawande AA; Safe Surgery Saves Lives Study Group. Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. BMJ Qual Saf. 2011 Jan;20(1):102-7. doi: 10.1136/bmjqs.2009.040022.
PubMed 21228082King DK, Shoup JA, Raebel MA, Anderson CB, Wagner NM, Ritzwoller DP, Bender BG. Planning for Implementation Success Using RE-AIM and CFIR Frameworks: A Qualitative Study. Front Public Health. 2020 Mar 3;8:59. doi: 10.3389/fpubh.2020.00059. eCollection 2020.
PubMed 32195217Laugaland K, Aase K, Waring J. Hospital discharge of the elderly--an observational case study of functions, variability and performance-shaping factors. BMC Health Serv Res. 2014 Aug 30;14:365. doi: 10.1186/1472-6963-14-365.
PubMed 25175924Lepanluoma M, Takala R, Kotkansalo A, Rahi M, Ikonen TS. Surgical safety checklist is associated with improved operating room safety culture, reduced wound complications, and unplanned readmissions in a pilot study in neurosurgery. Scand J Surg. 2014 Mar;103(1):66-72. doi: 10.1177/1457496913482255. Epub 2013 Dec 17.
PubMed 24345978Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6.
PubMed 30611302
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the World Health Organization Surgical Safety Checklist to High-Income Healthcare Settings - Phase III: Site Testing Study
- ClinicalTrials.gov ID
- NCT05700890
- Acronym / sponsor ID
- REB21-0099
- Keywords
- Surgical Safety Checklist, Patient Safety, Quality improvement, Teamwork, Psychological safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ariadne Labs, National Aeronautics and Space Administration (NASA)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 26 Jan 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.
The goal of this study is to develop and iteratively improve a toolkit - the "High-Performance Checklist" (HPC) toolkit - that provides clinicians with evidence-informed strategies for improving their Modification, Implementation, Training on, and Evaluation of the Surgical Safety Checklist.
The study team will test the toolkit in the operating rooms of Calgary's Peter Lougheed Centre and collect feedback via surveys and questionnaires. This feedback will be used to iteratively improve the toolkit.
By improving clinicians' ability to modify their SSC, the study team hopes to see improvements in its uptake and surgical outcomes for patients.
Participants will be surgical clinical staff members and hospital administration, as well as participants over the age of 18, who have undergone a surgery in the last 90 days. They will all complete the following tasks:
Online or paper questionnaire Semi structured interviews Team meetings
Detailed description
This study is the third phase of a multi-year, multi-stage research project aimed at successful use of the World Health Organization's Safe Surgery Checklist. The study's first stage involved collecting perceptions of the SSC from surgical personnel in five high-income countries: Australia, the United States, Canada, the United Kingdom, and New Zealand. In that stage, interviews and surveys were conducted with individuals who use the SSC. Our results showed barriers and facilitators to the SSC's use and highlighted clinicians' attitudes towards it. The first stage of our study identified the need to better tailor the SSC checklists to meet contextual needs and ongoing gaps in leadership and team performance.
The study's second stage involved building a toolkit aimed at addressing four areas (Modification, Implementation, Training, and Evaluation) through the creation of working groups for each area. These working groups comprised Subject-Matter Experts (SMEs) from the consensus meeting and individuals from the surgical safety field. The output generated by these groups through a consensus-building process is the "High-Performance Checklist" Toolkit ("Toolkit"). The Toolkit is built using the Explore, Prepare, Implement, and Sustain (EPIS) framework and provides clinicians a mechanism for effectively customizing their SSC to their needs.
The third stage of the study involves pilot testing the Toolkit at three different sites and assessing its impact and usefulness in helping implementation teams at these sites. The three sites selected for this study are facilities of different size and scale, for which impact, outcomes, and clinician feedback from Implementation Teams from each site will be compared. The first site is the Peter Lougheed Centre in Calgary, Alberta, then the team intend to run the study at the University of Alberta Hospital and the hospital in Fort McMurray, Alberta.
At each site, three types of participants will be recruited: Implementation team ("ImT") members, operating room ("OR") personnel, and surgical patients. The ImT members will work through the Toolkit to customize their SSC, then the OR personnel will use the modified SSC. The patients will participate in Focus Groups to explore their perceptions of the SSC's use at each site.
From there, we will endeavour to make alterations to the toolkit, if necessary, before rolling it out on a larger scale.
The anticipated result is that clinicians' use of this toolkit will enhance their ability to effectively modify, implement, train, and evaluate their SSC, improve their use of SSC to reduce the rate of adverse events with patients in the OR. It is predicted that the Toolkit will have a positive impact on the culture of patient safety and staff members' perception of psychological safety in the OR.
This study aims to fill the gap in effective checklist modification, training, implementation, and evaluation that was observed during data gathering stage. The study team will gain insight on the utility of a tool designed for improving surgical teams' use of the SSC: how it works, users' perceptions of it, areas for improvement, and ideas for spreading the tool's usage.
Methods: During this stage of the study, the Toolkit will be implemented at the aforementioned Albertan sites. Using an effectiveness-implementation hybrid design, a mixed-methods approach will be applied to assess the implementation of the Toolkit and users' experiences with it. The impact of the toolkit's use on clinical outcomes will also be assessed through the collection of health systems data. Through a series of surveys, interviews, and observations of the toolkit being used, the toolkit's usability, feasibility, and acceptability, and impact on safety culture will be measured before, during, and after the toolkit's implementation. Throughout the study, ratings of the SSC's performance will be taken to assess the toolkit's impact on OR participants' teamwork and SSC engagement.
Operationally, this stage of the study comprises four phases: initial introductions and pre-study data collection, use of the Toolkit by completing the EPIS elements, post-implementation data collection, and a three-months post-implementation follow-up. Data will be collected during each phase to assess the impact of the toolkit and the experience of its users.
Data analysis: survey, health systems data, and SSC performance ratings will be analyzed using SPSS and qualitative data from the observations and interviews will be analyzed thematically using NVIVO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implementation Team | – | –The Implementation Group will complete two surveys at the beginning of the study, then at five different points during the HPC Toolkit's use, and again three months post-intervention. The surveys are the Safe Surgery Checklist Culture Survey and the SSC Use and Attitudes Survey and a series of user experience surveys. They will also do interviews pre- and post-HPC toolkit, and we will observe the Implementation Team's meetings as they work through the toolkit. |
| OR Team | – | –The OR members will complete the same pre- and post-intervention surveys (Safe Surgery Checklist Culture Survey and the SSC Use and Attitudes Survey) and do interviews before and after the IT has worked through the HPC toolkit. |
| Surgical Patients | – | –Surgical patients will be invited to participate in focus groups on their experiences from the time they enter the hospital on the day of their surgery to the moment they are put under anaesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are three types of participants in this study: 1. The Implementation Team includes physicians, nurses, administrators, and patient advocates 2. The OR Team 3. Surgical patients
Key inclusion criteria (2 listed)
- surgeons, anesthesiologists, nurses and administrator will be included in the study
- surgical patients that have undergone surgery within the last three months at the Peter Lougheed Centre
Key exclusion criteria (3 listed)
- Patients that are unable to fill out a survey or participate in a semi structured interview
- Patients that surgery was done more than 3 months ago
- Surgical patients that are under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perception of the HPC Toolkit
Time frame: the initial 8 weeks of interacting with the study site
We will assess if the clinicians use of the HPC toolkit foster improvement in their use of the SSC. Surveys and semi-structured interviews will be collected at baseline, after the HPC introduction and at follow-up to assess if the HPC toolkit is sustained.
Reduction rate of adverse events in patient
Time frame: Through study completion, and average of 1 year
We will assess if the clinicians use of the HPC toolkit reduces the rate of adverse events in patients
SSC Attitudes and OR Culture
Time frame: Approximately the first and last 8 weeks interacting with the study site.
The Implementation Team ("ImT") and OR Team's perceptions of the SSC and OR Culture will be measured through surveys at3 points in time.
Patient Surgical Experiences Survey
Time frame: Approximately the first and last 8 weeks interacting with the study site.
Patients' experiences with surgery before and after the HPC Toolkit's implementation.
User Experience Surveys
Time frame: Approximately the first and last 8 weeks interacting with the study site
The ImT's experiences with the HPC Toolkit: ease of use, intuitiveness, layout, etc.
CheckPOINT observation tool
Time frame: Approximately the first and last 8 weeks interacting with the study site
In situ observations of the SSC's use in the OR; measures SSC use in practice. Captured by the ImT and OR Team participants.
Semi-structured interviews
Time frame: Approximately the first and last 8 weeks interacting with the study site
Participants' perceptions of the SSC and the HPC Toolkit's impact on it
Meeting observations
Time frame: up to 16 weeks
The Implementation Team's use of the HPC Toolkit
3 secondary outcomes
Healthcare system data collection
Time frame: Up to 2 years
Measures of surgical safety
Time frame: Up to 2 years
Effectiveness of SSC practice
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 17286625Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007 Aug;42(4):1758-72. doi: 10.1111/j.1475-6773.2006.00684.x.
- Background: PubMed 34394687Campbell S, Greenwood M, Prior S, Shearer T, Walkem K, Young S, Bywaters D, Walker K. Purposive sampling: complex or simple? Research case examples. J Res Nurs. 2020 Dec;25(8):652-661. doi: 10.1177/1744987120927206. Epub 2020 Jun 18.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Background: PubMed 31903586Delisle M, Pradarelli JC, Panda N, Koritsanszky L, Sonnay Y, Lipsitz S, Pearse R, Harrison EM, Biccard B, Weiser TG, Haynes AB; Surgical Outcomes Study Groups and GlobalSurg Collaborative. Variation in global uptake of the Surgical Safety Checklist. Br J Surg. 2020 Jan;107(2):e151-e160. doi: 10.1002/bjs.11321.
- Background: PubMed 26590200Devcich DA, Weller J, Mitchell SJ, McLaughlin S, Barker L, Rudolph JW, Raemer DB, Zammert M, Singer SJ, Torrie J, Frampton CM, Merry AF. A behaviourally anchored rating scale for evaluating the use of the WHO surgical safety checklist: development and initial evaluation of the WHOBARS. BMJ Qual Saf. 2016 Oct;25(10):778-86. doi: 10.1136/bmjqs-2015-004448. Epub 2015 Nov 20.
- Background: PubMed 15623451Dixon E, Vollmer CM Jr, Bathe O, Sutherland F. Training, practice, and referral patterns in hepatobiliary and pancreatic surgery: survey of general surgeons. J Gastrointest Surg. 2005 Jan;9(1):109-14. doi: 10.1016/j.gassur.2004.03.008.
- Background: PubMed 22069112Fourcade A, Blache JL, Grenier C, Bourgain JL, Minvielle E. Barriers to staff adoption of a surgical safety checklist. BMJ Qual Saf. 2012 Mar;21(3):191-7. doi: 10.1136/bmjqs-2011-000094. Epub 2011 Nov 7.
- Background: PubMed 16455440Halcomb EJ, Davidson PM. Is verbatim transcription of interview data always necessary? Appl Nurs Res. 2006 Feb;19(1):38-42. doi: 10.1016/j.apnr.2005.06.001.
- Background: PubMed 19144931Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.
- Background: PubMed 21228082Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Dziekan G, Herbosa T, Kibatala PL, Lapitan MC, Merry AF, Reznick RK, Taylor B, Vats A, Gawande AA; Safe Surgery Saves Lives Study Group. Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. BMJ Qual Saf. 2011 Jan;20(1):102-7. doi: 10.1136/bmjqs.2009.040022.
- Background: PubMed 32195217King DK, Shoup JA, Raebel MA, Anderson CB, Wagner NM, Ritzwoller DP, Bender BG. Planning for Implementation Success Using RE-AIM and CFIR Frameworks: A Qualitative Study. Front Public Health. 2020 Mar 3;8:59. doi: 10.3389/fpubh.2020.00059. eCollection 2020.
- Individual participant dataSharing planned: No
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Recruiting
Improving Surgical Communication for Patients in Wisconsin
Surgeons, Surgical Procedure, Unspecified
Active, not recruitingObservational study
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC
Surgical Procedure, Unspecified, Intensive Care Units (ICUs)
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
Not yet recruitingPhase 4
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified
Recruiting
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Critical Illness, Surgical Procedure, Unspecified
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.
Mary Brindle, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified and Communications Personnel, run by University of Calgary 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 3 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: status not confirmed, as of the sponsor's last update on 23 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karolina Kogut (4034611190, kkogut@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of the HPC Toolkit (time frame: the initial 8 weeks of interacting with the study site). The study lists 8 primary outcomes in all. 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 NCT05700890, which also lists 31 linked publications.
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 23 Jan 2024.