Trials / Completed
CompletedNCT04183439
Modeling Technical Error and Adverse Outcomes
A Model of the Relationship Between Technical Error and Adverse Patient Outcome: A Constructive Grounded Theory Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 11 (actual)
- Sponsor
- University of Missouri, Kansas City · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2016-12-30
- Primary completion
- 2019-01-07
- Completion
- 2019-01-07
- First posted
- 2019-12-03
- Last updated
- 2019-12-04
Source: ClinicalTrials.gov record NCT04183439. Inclusion in this directory is not an endorsement.