Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms (PROPECS)
Communication in the operating room (OR) is a key factor to prevent deleterious events for the patient. French national health authority made the implementation of safety checklist mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key elements for better patient outcomes. Observational studies in the OR showed low compliance to this checklist, either on the way it is used or on the information implemented.
The primary objective of this project is to assess the efficacy of a simulation-based curriculum involving OR medical and non-medical personnel in order to improve communication in the OR.
調査の概要
詳細な説明
Operating theater is a complex system where efficient communication is critical to patient safety. Patient safety check-list are used worldwide as a way to improve communication and teamwork in the operating room in order to decrease perioperative morbidity and mortality. Previous studies have shown that communication failure in the OR may be associated with adverse events. The improvement of safety culture (including communication and team work) may be obtained by simulation based training.
The primary objective of this before-after study is to assess the efficacy of a simulation-based curriculum involving OR medical and non medical personnel in order to improve communication in the OR.
In brief, in a first period, an audit to assess communication efficacy and teamwork will be realized during 125 surgical procedures. Communication failures and consequences will be recorded using a standardized form filled by trained personnel. In a second phase, all the OR personnel (surgeon, anesthesiologist, nurses) will be invited to participate to a special training on communication and teamwork. This curriculum will include formal presentations and also simulation-based training. Scenarios are built to improve the ability to communicate in specific situations (fire in the OR, haemorrhage, wrong side, anaphylaxis).
In a third phase, an audit on communication and teamwork, similar to the first phase will be realized. The primary endpoint is the frequency of surgical interventions having at least one communication failure with a consequence. The investigators expect a significant decrease in the rate of communication failures between phase 1 and 3. A fourth phase will consist in a last audit two years after phase 1 to evaluate long-term effect of this curriculum.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Grenoble、フランス、38000
- Operating rooms of Grenoble University Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- All surgical interventions occuring in Grenoble University Hospital, North site, between November and January
Exclusion Criteria:
- Interventions supposed to last more than 4 hours
- Interventions in situations of vital emergencies
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Before simulation-based curriculum
125 surgical interventions will be observed and outcomes will be measured before simulation-based curriculum
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After simulation-based curriculum
125 surgical interventions will be observed and outcomes will be measured after simulation-based curriculum
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Operating room medical and non-medical members will be asked to carry out a simulation session preceded by an educational maze with videos.
Outcomes will be compared and correlated after and before this curriculum
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Frequency of surgical interventions having at least on communication failure with a consequence
時間枠:After 3 months of audit
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After 3 months of audit
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二次結果の測定
結果測定 |
時間枠 |
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Compliance to the safety checklist in the operating room
時間枠:measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
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measured during each surgical intervention, before anesthesia, before incision and at the end of surgery
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6 items survey estimating teamwork quality
時間枠:measured at the end of each surgical intervention, an average of 2.5 hours
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measured at the end of each surgical intervention, an average of 2.5 hours
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Number of adverse events occuring in the OR declared to the institution
時間枠:After 3 months of audit
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After 3 months of audit
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Surgical Apgar score
時間枠:measured at the end of each surgical intervention, an average of 2.5 hours
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measured at the end of each surgical intervention, an average of 2.5 hours
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Nature of communication failure and consequences
時間枠:measured during each surgical procedure, for an average of 2.5 hours
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measured during each surgical procedure, for an average of 2.5 hours
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rate of communication failures
時間枠:measured during each surgical procedure, for an average of 2.5 hours
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measured during each surgical procedure, for an average of 2.5 hours
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Survey on safety culture for employees working in the OR
時間枠:After 3 months of audit
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After 3 months of audit
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Count of team members and number of passage in the OR
時間枠:measured during each surgical procedure, for an average of 2.5 hours
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measured during each surgical procedure, for an average of 2.5 hours
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協力者と研究者
捜査官
- 主任研究者:Pierre Albaladejo, MD, PhD、University Hospital, Grenoble
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2013-32 (AP HM)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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