NCT02329691

Brief Summary

The main objective is to explore and evaluate the effect of a change in the WHO checklist on the safety climate in the operating room at a University Hospital in Gothenburg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

December 18, 2014

Last Update Submit

March 20, 2017

Conditions

Surgery

Keywords

safety climatesurgery

Outcome Measures

Primary Outcomes (1)

  • Positive change in the Safety Attitudes Questionnaire

    1 year

Study Arms (1)

Changes in the WHO checklist

Specific changes in the WHO checklist will be performed after observational studies to enhance the WHO checklist at the specific institution

Eligibility Criteria

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

All health care personnel working in the OR at the general surgery department, Sahlgrenska University Hospital

You may qualify if:

  • Health care personnel working in the OR at Sahlgrenska University Hospital Östra, general surgery

You may not qualify if:

  • All other health care personnel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

Related Publications (1)

  • Erestam S, Haglind E, Bock D, Andersson AE, Angenete E. Changes in safety climate and teamwork in the operating room after implementation of a revised WHO checklist: a prospective interventional study. Patient Saf Surg. 2017 Jan 31;11:4. doi: 10.1186/s13037-017-0120-6. eCollection 2017.

    PMID: 28163786DERIVED

Study Officials

  • Eva Angenete

    Sahlgrenska Universitetssjukhuset/Östra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Surgeon, Associate professor

Study Record Dates

First Submitted

December 18, 2014

First Posted

January 1, 2015

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2016

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

SE(1)