Device Briefing Tool and Surgical Safety Checklist Implementation

NCT05123495 | Completed

• 1 other identifier: IRB19-0389
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to implement a quality improvement initiative using the device briefing tool (DBT) and the Safe Surgery Checklist (SSC) and to evaluate its effect on patient safety measures and on safety culture with the introduction of a new surgical device in Singapore hospitals. Within eligible hospitals, J\&J and Ariadne Labs staff will train local implementation teams to, in turn, train operating room teams to use the DBT and SSC. Project-specific outcomes will be measured by neutral observers and via survey data. Throughout the quality improvement initiative, hospitals will receive ongoing training and coaching on their interventions and feedback on their outcomes.

Conditions

Clinical Skills

Keywords

Non-technical skills

Outcome Measures

Primary Outcomes (1)

• Oxford NOTECHS scale

  Measure of non-technical skills of surgical teams assessed by neutral observers. Scored 12-48 with higher scores indicating better non-technical skills.

  Change in NOTECHS scores will be assessed from baseline to immediately after DBT implementation and 2-months after SSC implementation

Secondary Outcomes (2)

• Device-related interruptions (DRIs)

  Change in DRIs will be assessed from baseline to immediately after DBT implementation and 2-months after SSC implementation

• Culture of safety

  Change in safety culture from baseline will be assessed 2-months post-SSC

Study Arms (2)

Device Briefing Tool Implementation

Surgical departments which receive training on use of the Device Briefing Tool

Behavioral: Device Briefing Tool; Behavioral: Surgical Safety Checklist

Comparator

Surgical departments that do not receive training on use of the Device Briefing Tool

Behavioral: Surgical Safety Checklist

Interventions

Device Briefing Tool BEHAVIORAL

A 4-item supplement to the WHO Surgical Safety Checklist designed to improve teamwork and communication around new/complex surgical devices

Device Briefing Tool Implementation

Surgical Safety Checklist BEHAVIORAL

Reimplementation of the WHO Surgical Safety Checklist to improve adherence and utility of the checklist

Comparator; Device Briefing Tool Implementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All surgical teams operating in participating SingHealth hospitals will be eligible. Surgical teams include surgeons, anesthetists, nurses, and (in some cases) ancillary providers. The patient is not included as a member of the surgical team. Patients are not being evaluated as part of this study.

You may qualify if:

• Surgical teams in SingHealth hospitals

You may not qualify if:

• Refusal by any team member to participate

Sponsors & Collaborators

• James Etheridge: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Study Officials

• Joaquim Havens, MD

  Ariadne Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Safe Surgery Research Fellow

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 17, 2021
• Study Start: November 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)