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临床试验/NCT05123495
NCT05123495已完成不适用

Safe Introduction of a New Surgical Device With the Device Briefing Tool and Surgical Safety Checklist in Singapore

James Etheridge1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
1
主要终点
Oxford NOTECHS scale

研究概览

简要总结

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.

详细描述

Design of Quality Improvement Initiative Using a prospective observational implementation design, surgical teams will be assigned to 1 of 2 groups. Group I will receive the complete intervention, which includes implementation of the DBT from the start, and then the DBT and SSC package.

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Surgical teams in SingHealth hospitals

排除标准

  • Refusal by any team member to participate
  • 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.

结局指标

主要结局

Oxford NOTECHS scale

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

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

次要结局

  • Culture of safety(Change in safety culture from baseline will be assessed 2-months post-SSC)
  • Device-related interruptions (DRIs)(Change in DRIs will be assessed from baseline to immediately after DBT implementation and 2-months after SSC implementation)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

James Etheridge

Safe Surgery Research Fellow

Ariadne Labs

研究点 (1)

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