Clinical Trials Directory

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.