The Surgical Safety Checklist Revisited

NCT05700890 | Unknown

• 1 other identifier: REB21-0099
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Surgical Procedure, Unspecified; Communications Personnel; Tool Use Behavior

Keywords

Surgical Safety Checklist; Patient Safety; Quality improvement; Teamwork; Psychological safety

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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.

  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.

  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.

  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

  Approximately the first and last 8 weeks interacting with the study site

• Meeting observations

  The Implementation Team's use of the HPC Toolkit

  up to 16 weeks

Secondary Outcomes (3)

• Healthcare system data collection

  Up to 2 years

• Measures of surgical safety

  Up to 2 years

• Effectiveness of SSC practice

  Up to 2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Ariadne Labs: collaborator
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (1)

Karolina Kogut

Calgary, Alberta, T2T 1L1, Canada

RECRUITING

Related Publications (31)

• 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.

  PMID: 17286625 BACKGROUND

• Campbell 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.

  PMID: 34394687 BACKGROUND

• Curran 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.

  PMID: 22310560 BACKGROUND

• Damschroder 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.

  PMID: 19664226 BACKGROUND

• Delisle 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.

  PMID: 31903586 BACKGROUND

• Devcich 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.

  PMID: 26590200 BACKGROUND

• Dixon 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.

  PMID: 15623451 BACKGROUND

• Fourcade 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.

  PMID: 22069112 BACKGROUND

• Halcomb 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.

  PMID: 16455440 BACKGROUND

• Haynes 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.

  PMID: 19144931 BACKGROUND

• Haynes 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.

  PMID: 21228082 BACKGROUND

• King 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.

  PMID: 32195217 BACKGROUND

• Laugaland 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.

  PMID: 25175924 BACKGROUND

• Lepanluoma 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.

  PMID: 24345978 BACKGROUND

• Moullin 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.

  PMID: 30611302 BACKGROUND

• Russ SJ, Sevdalis N, Moorthy K, Mayer EK, Rout S, Caris J, Mansell J, Davies R, Vincent C, Darzi A. A qualitative evaluation of the barriers and facilitators toward implementation of the WHO surgical safety checklist across hospitals in England: lessons from the "Surgical Checklist Implementation Project". Ann Surg. 2015 Jan;261(1):81-91. doi: 10.1097/SLA.0000000000000793.

  PMID: 25072435 BACKGROUND

• Solsky I, Berry W, Edmondson L, Lagoo J, Baugh J, Blair A, Singer S, Haynes AB. World Health Organization Surgical Safety Checklist Modification: Do Changes Emphasize Communication and Teamwork? J Surg Res. 2020 Feb;246:614-622. doi: 10.1016/j.jss.2018.09.035. Epub 2018 Oct 24.

  PMID: 30528925 BACKGROUND

• Stelfox HT, Crimi C, Berra L, Noto A, Schmidt U, Bigatello LM, Hess D. Determinants of tracheostomy decannulation: an international survey. Crit Care. 2008;12(1):R26. doi: 10.1186/cc6802. Epub 2008 Feb 26.

  PMID: 18302759 BACKGROUND

• Taylor MJ, McNicholas C, Nicolay C, Darzi A, Bell D, Reed JE. Systematic review of the application of the plan-do-study-act method to improve quality in healthcare. BMJ Qual Saf. 2014 Apr;23(4):290-8. doi: 10.1136/bmjqs-2013-001862. Epub 2013 Sep 11.

  PMID: 24025320 BACKGROUND

• Urbach DR, Govindarajan A, Saskin R, Wilton AS, Baxter NN. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med. 2014 Mar 13;370(11):1029-38. doi: 10.1056/NEJMsa1308261.

  PMID: 24620866 BACKGROUND

• Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J. National trends in patient safety for four common conditions, 2005-2011. N Engl J Med. 2014 Jan 23;370(4):341-51. doi: 10.1056/NEJMsa1300991.

  PMID: 24450892 BACKGROUND

• AHRQ (2022). "What is Patient Safety Culture?". Agency for Healthcare Research and Quality. Accessed on August 25, 2022.

  BACKGROUND

• AHS (2021). "Safe Surgery Checklist: Surgery SCN". Alberta Health Services. Accessed on December 21, 2021.

  BACKGROUND

• DeWalt, K. M., & DeWalt, Billie R. (2011). Participant observation a guide for fieldworkers. Lanham, Md.: Rowman & Littlefield.

  BACKGROUND

• Laugwitz, B., Held, T, & Schrepp, M. (2008). Construction and Evaluation of a User Experience Questionnaire. USAB 2008. 5298. 63-76. 10.1007/978-3-540-89350-9_6.

  BACKGROUND

• Lund, A. (2001). Measuring Usability with the USE Questionnaire. Usability and User Experience Newsletter of the STC Usability SIG. 8

  BACKGROUND

• Miles, M. B., & Huberman, A. M. (1994). Qualitative data analysis: an expanded sourcebook. Thousand Oaks, Calif.: Sage.

  BACKGROUND

• Minge, M., Thuering, M., Wagner, I., & Kuhr, C. (2017). The meCUE Questionnaire: A Modular Tool for Measuring User Experience. 486. 115-128. 10.1007/978-3-319-41685-4_11.

  BACKGROUND

• Touchette, A. (2020, May 21). "The Consolidated Framework for Implementation Research (CFIR)". CHI KT Platform. Accessed on February 17, 2022.

  BACKGROUND

• Urban D, Burian BK, Patel K, Turley NW, Elam M, MacRobie AG, Merry AF, Kumar M, Hannenberg A, Haynes AB, Brindle ME. Surgical Teams' Attitudes About Surgical Safety and the Surgical Safety Checklist at 10 Years: A Multinational Survey. Ann Surg Open. 2021 Jul 6;2(3):e075. doi: 10.1097/AS9.0000000000000075. eCollection 2021 Sep.

  PMID: 36590849 BACKGROUND

• Arber A. "Pain talk" in hospice and palliative care team meetings: an ethnography. Int J Nurs Stud. 2007 Aug;44(6):916-26. doi: 10.1016/j.ijnurstu.2006.04.002. Epub 2006 Jun 9.

  PMID: 16764880 RESULT

MeSH Terms

Conditions

Communication; Tool Use Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Study Officials

• Mary Brindle, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Kogut

CONTACT

4034611190; kkogut@ucalgary.ca

Nathan Turley

CONTACT

15876009765; nturley@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: January 26, 2023
• Study Start: January 27, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)