Quality of Quality Data

NCT01524484 | Completed

• 1 other identifier: KEK-ZH-Nr. 2011-0421
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

Data on quality of clinical anesthesia are important for the improvement of both quality and patient safety in this field. Routine quality data are often collected by professionals busy with patient care. This study examines the reliability of routinely collected quality data by comparing the electronic anesthesia record with the respective reports on quality-indicating events, i.e. whether events during the anesthetic (e.g., drop of blood pressure, irregular heart rhythm, and others) were actually reported or not. Additionally, interviews with reporting staff (physicians and nurses) are performed to gain insight in possible obstacles to reporting during the working process.

Conditions

Anesthesia

Keywords

Data quality; Anesthesia; Quality assurance

Outcome Measures

Primary Outcomes (1)

• Event reporting rate

  For defined events (hypotensive, hypertensive, bradycardic, tachycardic, and hypoxemic episodes), occurrence documented in the electronic anesthesia record is compared with their actual reporting in the reporting section of the record. From this, reporting rate is calculated for the various event types.

  Outcome measure is assessed at the end of each included anesthetic. Event reporting rate comprises reporting rate of defined events occurring during the given anesthetic. Durations of anesthetics are approximately between 0.5 and 5 hours.

Study Arms (2)

Anesthesia staff Interviewees

Staff entering quality data into the electronic anesthesia record are interviewed regarding working conditions and record layout

Anesthesia records

Anesthesia records (all types of procedures) are checked for correct reporting of defined events

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Anesthesia records: a) Pilot study: 50 consecutive cases of the year 2010. b) Main study: 200 cases of the year 2010, random sample (generated with a random number generator). All cases are of one hospital, no further restrictions. 2. anesthesia staff interviews: Physicians and nurses entering quality data into electronic anesthesia record

You may qualify if:

• consecutive cases for pilot study;
• anesthetic records of the year 2010 chosen as a random sample.
• all staff entering the quality data into the electronic anesthesia record (physicians, nurses)

You may not qualify if:

• participation of staff in this study,
• participation in quality data processing or assessment,
• longterm leave precluding the interview

Sponsors & Collaborators

• Johannes Wacker, MD: lead
• University of Zurich: collaborator
• University of Freiburg: collaborator

Study Sites (1)

Institute of Anesthesiology and Intensive Care, Klinik Hirslanden Zürich, Switzerland

Zurich, CH-8032, Switzerland

Location

Related Publications (1)

• Wacker J, Steurer J, Manser T, Leisinger E, Stocker R, Mols G. Perceived barriers to computerised quality documentation during anaesthesia: a survey of anaesthesia staff. BMC Anesthesiol. 2015 Jan 31;15:13. doi: 10.1186/1471-2253-15-13.

  PMID: 25971791 DERIVED

Study Officials

• Johannes Wacker, MD

  IFAI, Klinik Hirslanden, Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

• Georg Mols, MD, Prof.

  IFAI, Klinik Hirslanden Zürich, Switzerland

  STUDY DIRECTOR

• Reto Stocker, MD, Prof.

  IFAI, Klinik Hirslanden Zürich, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2012
• First Posted: February 2, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

CH (1)