NCT01872195

Brief 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. 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. 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. 3.The sensitivity and specificity of ICD-10 coding vs. medical journal information is poor, with study results to be adjusted accordingly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

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

First Submitted

Initial submission to the registry

May 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

May 24, 2013

Last Update Submit

June 10, 2015

Conditions

Postoperative ComplicationsComplications of Surgical Procedures or Medical Care

Keywords

ChecklistIn-Hospital MortalityIn-Hospital Morbidity

Outcome Measures

Primary Outcomes (1)

  • Number of patients with complications or death, as a measure of checklist use

    Register number of patients with defined complications or peri- or postoperative death before and after checklist implementation.

    One year

Secondary Outcomes (1)

  • Discrepancies between patient information on complications registered as ICD-10 codes and information on complications documented in the actual electronic patient journal

    One year

Other Outcomes (1)

  • Length of hospital stay (days) as a measure of checklist use.

    One year

Study Arms (2)

* Before checklists

EXPERIMENTAL

The comprehensive patient safety checklist system

Other: The comprehensive patient safety checklist system

* After checklists

EXPERIMENTAL

Without the comprehensive patient safety checklist system

Other: The comprehensive patient safety checklist system

Interventions

The comprehensive patient safety checklist systemOTHER

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).

* After checklists* Before checklists

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (12)

  • Brown C, Hofer T, Johal A, Thomson R, Nicholl J, Franklin BD, Lilford RJ. An epistemology of patient safety research: a framework for study design and interpretation. Part 2. Study design. Qual Saf Health Care. 2008 Jun;17(3):163-9. doi: 10.1136/qshc.2007.023648.

    PMID: 18519621BACKGROUND

  • Birkmeyer JD. Strategies for improving surgical quality--checklists and beyond. N Engl J Med. 2010 Nov 11;363(20):1963-5. doi: 10.1056/NEJMe1009542. No abstract available.

    PMID: 21067390BACKGROUND

  • Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.

    PMID: 17092344BACKGROUND

  • de Vries EN, Eikens-Jansen MP, Hamersma AM, Smorenburg SM, Gouma DJ, Boermeester MA. Prevention of surgical malpractice claims by use of a surgical safety checklist. Ann Surg. 2011 Mar;253(3):624-8. doi: 10.1097/SLA.0b013e3182068880.

    PMID: 21209590BACKGROUND

  • de Vries EN, Prins HA, Crolla RM, den Outer AJ, van Andel G, van Helden SH, Schlack WS, van Putten MA, Gouma DJ, Dijkgraaf MG, Smorenburg SM, Boermeester MA; SURPASS Collaborative Group. Effect of a comprehensive surgical safety system on patient outcomes. N Engl J Med. 2010 Nov 11;363(20):1928-37. doi: 10.1056/NEJMsa0911535.

    PMID: 21067384BACKGROUND

  • de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008 Jun;17(3):216-23. doi: 10.1136/qshc.2007.023622.

    PMID: 18519629BACKGROUND

  • Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.

    PMID: 19144931BACKGROUND

  • Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009 Oct;62(10):e1-34. doi: 10.1016/j.jclinepi.2009.06.006. Epub 2009 Jul 23.

    PMID: 19631507BACKGROUND

  • Thygesen SK, Christiansen CF, Christensen S, Lash TL, Sorensen HT. The predictive value of ICD-10 diagnostic coding used to assess Charlson comorbidity index conditions in the population-based Danish National Registry of Patients. BMC Med Res Methodol. 2011 May 28;11:83. doi: 10.1186/1471-2288-11-83.

    PMID: 21619668BACKGROUND

  • van Klei WA, Hoff RG, van Aarnhem EE, Simmermacher RK, Regli LP, Kappen TH, van Wolfswinkel L, Kalkman CJ, Buhre WF, Peelen LM. Effects of the introduction of the WHO "Surgical Safety Checklist" on in-hospital mortality: a cohort study. Ann Surg. 2012 Jan;255(1):44-9. doi: 10.1097/SLA.0b013e31823779ae.

    PMID: 22123159BACKGROUND

  • Storesund A, Haugen AS, Flaatten H, Nortvedt MW, Eide GE, Boermeester MA, Sevdalis N, Tveiten O, Mahesparan R, Hjallen BM, Fevang JM, Storksen CH, Thornhill HF, Sjoen GH, Kolseth SM, Haaverstad R, Sandli OK, Softeland E. Clinical Efficacy of Combined Surgical Patient Safety System and the World Health Organization's Checklists in Surgery: A Nonrandomized Clinical Trial. JAMA Surg. 2020 Jul 1;155(7):562-570. doi: 10.1001/jamasurg.2020.0989.

    PMID: 32401293DERIVED

  • Storesund A, Haugen AS, Waehle HV, Mahesparan R, Boermeester MA, Nortvedt MW, Softeland E. Validation of a Norwegian version of SURgical PAtient Safety System (SURPASS) in combination with the World Health Organizations' Surgical Safety Checklist (WHO SSC). BMJ Open Qual. 2019 Jan 7;8(1):e000488. doi: 10.1136/bmjoq-2018-000488. eCollection 2019.

    PMID: 30687799DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eirik Søfteland, MD, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 7, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

NO(1)