Team, Competence and Safety Climate in the Operating Room | NCT02329691

Studies
Team, Competence and Safety Climate in the Operating Room

NCT02329691

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Mar 21, 2017Actual

Enrollment

125Actual

Phase

Not provided

Conditions

Surgery

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2016Actual

First Submitted Date

Dec 18, 2014

First Submission Date that Met QC Criteria

Dec 27, 2014

First Posted Date

Jan 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2017

Last Update Posted Date

Mar 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eva Angenete, Senior Consultant Surgeon, Associate professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study will assess the underlying safety climate in one operating ward at Sahlgrenska University Hospital, Göteborg. The Safety Attitude Questionnaire (SAQ) Operating Room version will be used to assess baseline safety climate. The use of the WHO check list will be investigated and documented according to a pre-defined CRF (case record form).

After this evaluation, changes in the WHO checklist will be performed. The changes will include educational efforts and involving focus groups to receive suggestions on improvements of the WHO checklist. The revised version of the WHO checklist will be implemented. To evaluate effects of the changes the SAQ will once again be distributed to the involved personnel.

The main objective is to explore, describe, educate and thereby improve the safety climate in the operating room. The setting is one of the operating room departments in Sahlgrenska University Hospital Gothenburg. The project includes to following parts:

To assess baseline regarding the safety climate at a surgical ward at the Sahlgrenska University Hospital.
Educational efforts on safety climate, team work, communication, and WHO check list by lectures and focus group discussions involving the OR team members to get input and suggestions on improvements of the WHO checklist.
To explore differences in safety attitudes between different professions working in the OR.
To identify areas for improvement in team work, communication and other non-technical skills.
To re-implement the WHO check list with the aim to obtain more focus on the importance of teamwork and knowledge about the patient and procedure.
To compare results from SAQ after implementation of safety related objectives with SAQ baseline data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive change in the Safety Attitudes Questionnaire		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

All other health care personnel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Angenete	Sahlgrenska Universitetssjukhuset/Östra	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Surgery, Sahlgrenska University Hospital/Ostra		Gothenburg		SE 416 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28163786	Derived	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.