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Effects of Checklists in Surgical Care - a Study on Complications, Death and Quality of Patient Administrative Data

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01872195
First received: May 24, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

This project aims to produce a systematic review on present knowledge on effects of using safety checklists in medicine. Implementation of a checklist system throughout surgical care may reduce patient morbidity and mortality. The reliability of patient data is crucial to make firm conclusions as to such effects. This project aims to investigate if such morbidity and mortality effects are obtainable in two Norwegian hospitals while at the same time making a crucial evaluation of the patient data used in this study itself.

We hypothesise

  1. An updated systematic review of the research literature provide evidence that safety checklists use does enhance safety and reduces patient mortality and morbidity
  2. Implementation of the patient safety checklist system will reduce patient mortality and morbidity in the checklist cohort, and subsequent effects on length of stay
  3. The sensitivity and specificity of ICD-10 coding vs. medical journal information is poor, with study results to be adjusted accordingly.

Condition Intervention
Postoperative Complications
Complications of Surgical Procedures or Medical Care
Other: The comprehensive patient safety checklist system

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Checklists in Surgical Care - a Study on Morbidity, Mortality and Data Quality

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Number of patients with complications or death, as a measure of checklist use [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Register number of patients with defined complications or peri- or postoperative death before and after checklist implementation.


Secondary Outcome Measures:
  • Discrepancies between patient information on complications registered as ICD-10 codes and information on complications documented in the actual electronic patient journal [ Time Frame: One year ] [ Designated as safety issue: No ]
    Registration of ICD-10 codes on complications and complications documented in the actual electronic patient journal will be registered separately and then compared as to discrepancies between these. This is done to evaluate and validate complication data (ICD-10 codes) used for primary outcome measures.


Other Outcome Measures:
  • Length of hospital stay (days) as a measure of checklist use. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Length of hospital stay will be measured both before and after checklist use to evaluate if such use may have effects on hospital stay.


Estimated Enrollment: 7400
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: * Before checklists
The comprehensive patient safety checklist system
Other: The comprehensive patient safety checklist system
The comprehensive patient safety checklist system follows each patient from admission to discharge with separate short checklists at each point of care: On admission to the hospital and ward (operating theatre nurse, ward doctor, surgeon, anaesthesiologist, ward nurse - 5 lists), in the operating theatre (here covered by the WHO-Safe Surgery checklist), at the recovery/ICU unit (nurse- 1 list), at discharge from the hospital (ward doctor, ward nurse - 2 lists).
Experimental: * After checklists
Without the comprehensive patient safety checklist system
Other: The comprehensive patient safety checklist system
The comprehensive patient safety checklist system follows each patient from admission to discharge with separate short checklists at each point of care: On admission to the hospital and ward (operating theatre nurse, ward doctor, surgeon, anaesthesiologist, ward nurse - 5 lists), in the operating theatre (here covered by the WHO-Safe Surgery checklist), at the recovery/ICU unit (nurse- 1 list), at discharge from the hospital (ward doctor, ward nurse - 2 lists).

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing a surgical procedure from the Orthopaedic Clinic, the Department of Gynaecology and Obstetrics and the Neurosurgical Department at Haukeland University Hospital.

Exclusion Criteria:

  • Radiology surgical interventions, donor surgery, out-patients and all patients who have made a written statement as to reservation to participate (use of patient data), and those who do not understand Norwegian spoken and written language will be excluded from data collection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872195

Contacts
Contact: Eirik Søfteland, MD, PhD +47 91342824 eirik.softeland@helse-bergen.no
Contact: Anette Storesund, RN, MCCN +47 99735274 anette.storesund@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Eirik Søfteland, MD, PhD    +47 91342824    eirik.softeland@helse-bergen.no   
Principal Investigator: Eirik Søfteland, MD, PhD         
Sub-Investigator: Anette Storesund, RN, MCCN         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Eirik Søfteland, MD, PhD Haukeland University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01872195     History of Changes
Other Study ID Numbers: REK Vest 2012/560, Regional Health Authority
Study First Received: May 24, 2013
Last Updated: March 19, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Checklist
In-Hospital Mortality
In-Hospital Morbidity

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014