Surgical Checklist Success in Latin America

External Causes of Morbidity and Mortality Clinical Trial

Official title:

WHO Surgical Safety Checklist Implementation and Its Impact in Perioperative Morbidity and Mortality in an Academic Medical Center in Chile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646345
• Other study ID #: 12-218
• Status: Completed
• Phase: N/A
• First received: December 28, 2015
• Last updated: December 31, 2015
• Start date: July 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Observational

Clinical Trial Summary

Limited information is available about surgical checklist effectiveness in Latin America. We plan to compare the pre and post surgical checklist implementation in a tertiary healthcare center in terms of morbidity (length of stay and surgical site infection rate) and in-hospital mortality rate.

Description:

The purpose was to determine the impact of the implementation of the World Health Organization (WHO) Surgical Safety Checklist in terms of morbidity and mortality in adult surgical patients in a tertiary healthcare institution in Chile.

After Institutional Review Board (IRB) approval (Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile), a retrospective analysis of all surgical encounters on patients age 15 and above from January 2005 to December 2012 at our center will be reviewed.

Encounter data will include up to 14 diagnostic and procedure International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes, demographic data, date of admission and discharge, emergency status, healthcare system used and in-hospital death. A 5-level "high risk" variable was created in order to account for surgical complexity and associated in-hospital mortality (level 1, surgeries with <1% in-hospital mortality; level 2, 1% to <5%; level 3, 5% to <10%; level 4, 10% to <15%; level 5, > or = 15%)6.

Surgical heterogeneity will be calculated by the Internal Herfindahl Index, which represents the diversity or comprehensiveness of the types of procedures performed at a facility.

Statistics:

Propensity score (PS) analysis will be used to control for differences in baseline characteristics. The PS is the conditional probability of receiving an exposure (e.g. checklist) given a set of measured covariates. To estimate the PS, a logistic regression model will be used in which "treatment" status (checklist performed vs. not performed) will be regressed on the baseline (pre-treatment) characteristics.

PS analysis will be implemented in two ways to control for confounding:

1. PS matching: matching will be performed using a one-to-one nearest neighbor caliper matching without replacement with a caliper size of 0.2 standard deviations. Balances in the distribution of baseline covariates will be assessed by estimating absolute standardized differences of the covariates between the two groups before and after matching. Any imbalanced covariates (standardized difference >10%) after matching will be adjusted for in the final analysis. As the PS matched sample does not consist of independent observations, we will use a marginal regression model with robust standard errors.

2. PS weighting: the entire sample will be weighted by the inverse probability of the treatment weights derived from the PS. If a subject has a higher probability of being in a group, it will be considered over-represented and therefore will be assigned a lower weight. Conversely, if the subject has a smaller probability, it will be considered as under-represented and will be assigned a higher weight. We then will fit a weighted linear regression model using an indicator variable representing checklist intervention status as the sole predictor, and mortality as our outcome variable.

Data will be expressed as mean (SD; standard deviation) or median (IQR, interquartile range) unless otherwise stated. A two-sided p value less than 0.05 will be considered significant. The analyses will be performed using STATA v.12.0 (StataCorp, College Station, TX).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70639
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All surgical patients

Exclusion Criteria:

• Obstetrical patients delivering vaginally

• Patients less than 15 years old

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• External Causes of Morbidity (V00-Y99)
• External Causes of Morbidity and Mortality

Intervention

Procedure:
• Surgical checklist
Use of the World Health Organization Surgical checklist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

References & Publications (10)

Calland JF, Turrentine FE, Guerlain S, Bovbjerg V, Poole GR, Lebeau K, Peugh J, Adams RB. The surgical safety checklist: lessons learned during implementation. Am Surg. 2011 Sep;77(9):1131-7. — View Citation

Conley DM, Singer SJ, Edmondson L, Berry WR, Gawande AA. Effective surgical safety checklist implementation. J Am Coll Surg. 2011 May;212(5):873-9. doi: 10.1016/j.jamcollsurg.2011.01.052. Epub 2011 Mar 12. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Leape LL. The checklist conundrum. N Engl J Med. 2014 Mar 13;370(11):1063-4. doi: 10.1056/NEJMe1315851. — View Citation

Schwarze ML, Barnato AE, Rathouz PJ, Zhao Q, Neuman HB, Winslow ER, Kennedy GD, Hu YY, Dodgion CM, Kwok AC, Greenberg CC. Development of a list of high-risk operations for patients 65 years and older. JAMA Surg. 2015 Apr;150(4):325-31. doi: 10.1001/jamasurg.2014.1819. — View Citation

Tscholl DW, Weiss M, Kolbe M, Staender S, Seifert B, Landert D, Grande B, Spahn DR, Noethiger CB. An Anesthesia Preinduction Checklist to Improve Information Exchange, Knowledge of Critical Information, Perception of Safety, and Possibly Perception of Teamwork in Anesthesia Teams. Anesth Analg. 2015 Oct;121(4):948-56. doi: 10.1213/ANE.0000000000000671. — View Citation

Urbach DR, Govindarajan A, Saskin R, Wilton AS, Baxter NN. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med. 2014 Mar 13;370(11):1029-38. doi: 10.1056/NEJMsa1308261. — View Citation

Wachtel RE, Dexter F. Differentiating among hospitals performing physiologically complex operative procedures in the elderly. Anesthesiology. 2004 Jun;100(6):1552-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	30 day postoperative mortality	Three years	No
Secondary	Morbidity	30 day postoperative surgical site infection (measured in number of patients with surgical site infection)	Three years	Yes
Secondary	Length of stay	Length of stay in days	Three years	Yes