Clinical trial NCT05113147: Disruptive Behavior in the Operating Room
Official title: Disruptive Behavior in the Operating Room: Systemic Over Individual Determinants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disruptive Behavior
Keywords: Disruptive Behavior
Patient Safety
Operating Room
Surgeons
Effective Teamwork
Organizational Culture
Qualitative Study
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty participants included (surgeons n = 12, anesthetists n = 2, residents n = 2, nurses n = 2, technicians n = 2).

Brief summary: Background: The operating room (OR) environment presents specific conditions that put stress on work dynamics. Disruptive behavior (DB) among members of the health team is recognized to affect work dynamics and patient outcomes. The objective was to explore the perceptions of different members of the health team, including surgeons, about the occurrence of DB and the work dynamics in the OR.

Study design: Qualitative exploratory study, based on semi structured individual interviews. Twenty participants were sampled until data saturation, including surgeons, anesthetists, nurses among other. Data extraction from verbatim transcriptions was performed by investigators via qualitative analysis software, using grounded theory framework.

Detailed description: METHODS

A qualitative exploratory study was carried out within an analytical and relational framework of the contents \[19,20\]. The study was approved by a Scientific Ethics Committee (project ID: 15-340) and meets the quality standards for reporting qualitative Research (COREQ checklist).

Selection of participants Intentional theoretical sampling was performed, which considered the representation of different members of the health team to seek maximum heterogeneity.

The inclusion criterion was that the health members had at least one year of experience in the operating room. Participants were included until achieving data saturation from the information obtained.

Data collection In-depth individual interviews were based on a semistructured script designed to investigate the perceptions of the participants about the activity they performed, the ideal working conditions, the presence of disruptive behaviors, and their management. The final version of the script was reached after the first four interviews. Once the adjustments were made, the same script was used with the other participants.

The interviews were conducted by two interviewers (DZ and MC) with experience in this collection technique and who were not linked to the activities of the health team that was the subject of this study. The information was collected in 2017 and 2018. The participants were invited by email, and once they signed an informed consent, which explained the research´s goal and information about their participation. Once they agreed to participate, the interviewers interviewed an office face-to-face to guarantee privacy and confidentiality. Interviews lasted an average of 45 minutes, and all were audio-recorded and later transcribed verbatim.

Data analysis The participants' responses were analyzed with open and axial coding, based on the grounded theory model to relate the categories emerging from the responses.

Grounded theory is based on the analysis of the narrative contained in the interviews. This in turn leads to the development of codes, categories and themes based on the descriptions to culminate in hypotheses of how these themes interact. Atlas.ti v8.0 software was used for the data analysis (ATLAS.ti Scientific Software Development GmbH, Lietzenburger Str. 75, D-10719 Berlin, Germany).

Six researchers from the team collaborated in the analysis of the transcripts through an iterative process of intersubjective data triangulation sessions until definitive categories and guiding questions were reached regarding the phenomenon under study.

After the analysis, all participants received an email, who explained the findings and asked for feedback (member checking).

Eligibility criteria: Inclusion Criteria:

* Health members working in the operating room.

Exclusion Criteria:

* Less than one year of experience in the operating room.

Primary outcomes:
measure: Perceptions about the occurrence of disruptive behaviors and the work dynamics in the operating room
timeFrame: Up to 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: María-Jesús Lira
state: Santiago Metropolitan
Study officials:
References: