Device Briefing Tool and Surgical Safety Checklist Implementation
NCT ID: NCT05123495
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
294 participants
OBSERVATIONAL
2019-11-01
2021-06-30
Brief Summary
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Detailed Description
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Group II does not receive the DBT alone; these teams continue with their usual care, and then receive the DBT and SSC package.
Device-related interruptions, non-technical skills of surgical teams, and Culture of Safety Survey will be measured pre- and post-implementation of the SSC and DBT interventions, with specific timing depended on group allocation. OR teams at each hospital will be observed longitudinally to assess the effects of the DBT and SSC interventions.
Target Population for the Quality Improvement Initiative Participants will be members of the OR team at each participating hospital. These members include practicing surgeons, anesthesiologists, OR nurses, and OR staff. Hospitals will be participating institutions of SingHealth and NUHS hospital clusters. J\&J device sales representatives ("reps") will serve as key trainers during the multidisciplinary trainings to use the DBT during an operation. A separate implementation team will be trained by Ariadne Labs to execute the SSC at each eligible hospital. Hospital leadership will be key stakeholders to engage at each hospital in order to implement the DBT, team training, and SSC program.
Interventions Device Briefing Tool: a 4-item mini-checklist focused on raising OR team awareness to the nuances of a new surgical device.
Trained J\&J sales reps will be responsible for training OR teams to use the DBT with the new surgical device. Ariadne Labs will provide initial training to the J\&J reps and be available for ongoing training support.
Safe Surgery Checklist: Developed with the World Health Organization, the SSC is a 19-item checklist consisting of verbal confirmation by surgical teams of the completion of the basic steps for ensuring the safe delivery of anesthesia, prophylaxis against infection, effective teamwork, among other essential practices in surgery. As described elsewhere in greater detail, it is used at 3 critical junctures of care: before anesthesia is administered, immediately before incision is made, and before the patient is taken out of the operating room. A successful implementation of the SSC is a labor-intensive iterative process that includes 4 phases: prepare, own, expand, and improve.
Ariadne Labs will provide the specialists needed to implement the SSC and to support local hospitals' implementation teams. Please refer to the SSC Implementation Guide for process details in the Supplemental Materials.
Outcomes to Study Device-related interruptions: Any interruption in the surgical team's workflow as the result of the use of the study device.
Non-technical skills: Evaluation of OR team performance for non-technical skills (situation awareness, decision-making, cooperation and teamwork, and leadership), using the NOTECHS assessment, a validated rating system for intraoperative OR team behavior.
Perception of safety, i.e. "safety culture": The perception of safety among members of the OR team will be measured using the Culture of Safety Survey.
Site readiness assessment: We will evaluate the readiness capacity of institutions to implement the DBT/SSC intervention using the Readiness Assessment Tool.
Goal: Determine if the pre-intervention Readiness Assessment Tool is predictive (R2 \> 0.7) of implementation success as gauged by the post-intervention Implementation Survey.
Feasibility of scale: The scale of this project will be measured by the number of personnel trained, the number of hospitals at which the DBT, team training, and SSC intervention is implemented, and adherence rates to the intervention.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Device Briefing Tool Implementation
Surgical departments which receive training on use of the Device Briefing Tool
Device Briefing Tool
A 4-item supplement to the WHO Surgical Safety Checklist designed to improve teamwork and communication around new/complex surgical devices
Surgical Safety Checklist
Reimplementation of the WHO Surgical Safety Checklist to improve adherence and utility of the checklist
Comparator
Surgical departments that do not receive training on use of the Device Briefing Tool
Surgical Safety Checklist
Reimplementation of the WHO Surgical Safety Checklist to improve adherence and utility of the checklist
Interventions
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Device Briefing Tool
A 4-item supplement to the WHO Surgical Safety Checklist designed to improve teamwork and communication around new/complex surgical devices
Surgical Safety Checklist
Reimplementation of the WHO Surgical Safety Checklist to improve adherence and utility of the checklist
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Note - there are NO specific age criteria, since the unit of analysis is the surgical team rather than the patient. It is highly unlikely that any surgical team member would be less than 18 years of age or greater than 89 years of age, but there are no explicit age-based exclusions.
ALL
Yes
Sponsors
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Singapore General Hospital
OTHER
James Etheridge
OTHER
Responsible Party
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James Etheridge
Safe Surgery Research Fellow
Principal Investigators
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Joaquim Havens, MD
Role: PRINCIPAL_INVESTIGATOR
Ariadne Labs
Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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IRB19-0389
Identifier Type: -
Identifier Source: org_study_id