Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05700890

Conditions

Surgical Procedure, Unspecified

Communications Personnel

Tool Use Behavior

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05700890

Start date

Jan 27, 2023

Status verified date

Jan, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Perception of the HPC Toolkit [ Time Frame: the initial 8 weeks of interacting with the study site ]
  • Reduction rate of adverse events in patient [ Time Frame: Through study completion, and average of 1 year ]
  • SSC Attitudes and OR Culture [ Time Frame: Approximately the first and last 8 weeks interacting with the study site. ]
  • Patient Surgical Experiences Survey [ Time Frame: Approximately the first and last 8 weeks interacting with the study site. ]
  • User Experience Surveys [ Time Frame: Approximately the first and last 8 weeks interacting with the study site ]
  • CheckPOINT observation tool [ Time Frame: Approximately the first and last 8 weeks interacting with the study site ]
  • Semi-structured interviews [ Time Frame: Approximately the first and last 8 weeks interacting with the study site ]
  • Meeting observations [ Time Frame: up to 16 weeks ]

Central Contacts and Locations

Central contacts

Karolina Kogut

4034611190kkogut@ucalgary.ca

Nathan Turley

15876009765nturley@ucalgary.ca

Locations

Karolina Kogut

Recruiting

Calgary, Alberta, Canada, T2T 1L1

Contacts

Karolina Kogut

4034611190kkogut@ucalgary.ca

Nathan Turley

15876009765nturley@ucalgary.ca

Principal Investigator:

Mary Brindle, MD

More Information

Sponsor

University of Calgary

Last update posted

Jan 23, 2024

Last verified

Jan, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-01-23.