NCT Number: NCT04183439
Modeling Technical Error and Adverse Outcomes
The investigators' objective was to develop a theoretical model exploring the relationship between technical errors and adverse patient outcomes. To achieve this aim, the investigators interviewed surgeons from a diverse group of surgical specialties, asking them about their adverse outcomes from surgery and their most granular surgical techniques. the investigators' focus was on adverse outcomes that could be predictably associated with imperfect surgical technique and therefore prevented with proper technique.
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About this study
Background:
Minute technical errors performed by the surgeon have the potential to lead to adverse patient outcomes. The objective was to gain a deeper understanding of this relationship through the development of an intraoperative model.
Materials and Methods:
The investigators used Constructivist Grounded Theory methodology, including a comprehensive review of the literature and interviews with surgeons, focusing on avoidance of technical errors. The investigators used the Observational Clinical Human Reliability Assessment system, which categorizes granular, technical intraoperative errors, as their conceptual framework. The investigators iteratively interviewed surgeons, from multiple adult and pediatric surgical specialties, refined our semi-structured interview, and developed a model. The model remained stable after interviewing 11 surgeons, and it was reviewed it with earlier interviewed surgeons.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Surgical teacher
Exclusion criteria
- None
Treatment and study plan
Primary outcomes
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Model of the relationship between minute, technical motions by a surgeon and intraoperative adverse events, and eventually adverse patient outcomes
Time frame: approximately 2 years
This is a qualitative study interviewing surgeons about the link between technical motions and adverse patient outcomes. Our primary outcome will be a model, developed from their answers.
Sponsors and collaborators
Lead sponsor
University of Missouri, Kansas City
Other
Registry information
Official study title
A Model of the Relationship Between Technical Error and Adverse Patient Outcome: A Constructive Grounded Theory Study
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Dec 3, 2019
- Registry last updated
- Dec 4, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.