NCT01334411

Brief Summary

Aim: To identify examples of surgeons good and poor intraoperative behaviours related to safe and efficient surgery. Methods: Ten observations will undertaken in the operating theatres of Rigshospitalet and Herlev Hospital with the researchers taking field notes. This provides the Ph.d student with empirical background knowledge of observed surgical behaviour as well as an understanding of surgical culture. The knowledge will be used to qualify the interviewguide. 8 semi-structured group interviews and 3 individual interviews will be conducted and tape recorded. The interviews will be led by the Ph.d student with an anesthesia nurse present as a co-moderator. The groups will contain 4 - 12 participants. The interview guide will be developed with a Scottish behavioural marker system as a framework, drawing upon the literature as well as the observations. It will contain questions regarding leadership, communication, teamwork, situation awareness and decision making to facilitate a discussion about surgeons' good and poor behaviours. Material: Data will be collected in two hospitals in the capital Region of Denmark, Rigshospitalet and Herlev Hospital. Each hospital will provide four focus groups, one containing consultant surgeons in general surgery, one trainee surgeons, one scrub nurses and one containing a mixture of anesthetists and anesthesia nurses. The two latter focus groups is included to get the perspectives of the surgeons' team members since international studies have demonstrated differences of opinion regarding the perceived quality of teamwork amongst operating theatre staff. This study will be the first to build in the opinions of the team members into a behavioural marker system. 3 individual interviews with surgeons will afterwards conducted in one of the hospitals to get a more in-depth discussion. Data analysis and statistics: The interviews will be fully transcribed and analysed using qualitative method of systematic text condensation. Power calculations are not relevant in this qualitative study. Accepted guidelines state that the number of participants in each group should range between 5 and 15 and the data are from two large university hospitals receiving different patient categories to ensure a certain representative sample of informants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2011

First QC Date

April 1, 2011

Last Update Submit

April 12, 2011

Conditions

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The interview informants are health care personell in two Danish Hospitals as described in the project description

You may qualify if:

  • medical professionals at Rigshospitalet and Herlev Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Institute for Medical Simulation

Herlev, 2730, Denmark

Location

Related Publications (1)

  • Spanager L, Lyk-Jensen HT, Dieckmann P, Wettergren A, Rosenberg J, Ostergaard D. Customization of a tool to assess Danish surgeons non-technical skills in the operating room. Dan Med J. 2012 Nov;59(11):A4526.

Study Officials

  • Doris Ostergaard, M.D

    Danish Institute for Medical Simulation

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 13, 2011

Study Start

September 1, 2010

Study Completion

March 1, 2011

Last Updated

April 13, 2011

Record last verified: 2011-04

Locations