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

NCT01872195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21000

Last updated 2015-06-11

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Complications
  • Complications of Surgical Procedures or Medical Care

Interventions

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).

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Eirik Søfteland, MD, PhD · Haukeland University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01872195 on ClinicalTrials.gov