External Causes of Morbidity and MortalityNCT02646345
Surgical Checklist Success in Latin America
An observational study of External Causes of Morbidity and Mortality and External Causes of Morbidity (V00-Y99), run by Pontificia Universidad Catolica de Chile.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- External Causes of Morbidity and Mortality, External Causes of Morbidity (V00-Y99)
- What is being tested?
- Surgical checklist
- Type of treatment
- Surgery or procedure
- How many people
- 70,639 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All surgical patients age 15 and above
Who may be able to join
- All surgical patients
Who cannot join
- Obstetrical patients delivering vaginally
- Patients less than 15 years old
About this study
Official title: WHO Surgical Safety Checklist Implementation and Its Impact in Perioperative Morbidity and Mortality in an Academic Medical Center in Chile
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.
Read the detailed 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:
- 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.
- 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).
- Being tested
- Surgical checklist
- Keywords
- Checklist, Mortality, Latin America, Surgery, Morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical checklistProcedure or surgery
Use of the World Health Organization Surgical checklist
| Study group | Role | What they receive |
|---|---|---|
| Pre Checklist | All surgical encounters before surgical checklist implementation | |
| Post Checklist | All surgical encounters after surgical checklist implementation Receives: Procedure: Surgical checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
30 day postoperative mortality
Measured: Three years
Secondary outcomes (2)
Morbidity
30 day postoperative surgical site infection (measured in number of patients with surgical site infection)
Measured: Three years
Length of stay
Length of stay in days
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for External Causes of Morbidity and MortalityStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70,639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector J Lacassie, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646345
- Sponsor's protocol ID
- 12-218
- Status last verified
- Dec 2015
- First submitted
- 28 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19144931de 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.
PubMed 18519629Tscholl 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):948-956. doi: 10.1213/ANE.0000000000000671.
PubMed 25806399Schwarze 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.
PubMed 25692282Wachtel RE, Dexter F. Differentiating among hospitals performing physiologically complex operative procedures in the elderly. Anesthesiology. 2004 Jun;100(6):1552-61. doi: 10.1097/00000542-200406000-00031.
PubMed 15166578Urbach 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.
PubMed 24620866de 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.
PubMed 21067384Calland 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.
PubMed 21944620Leape LL. The checklist conundrum. N Engl J Med. 2014 Mar 13;370(11):1063-4. doi: 10.1056/NEJMe1315851. No abstract available.
PubMed 24620871Conley 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.
PubMed 21398154
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHO Surgical Safety Checklist Implementation and Its Impact in Perioperative Morbidity and Mortality in an Academic Medical Center in Chile
- ClinicalTrials.gov ID
- NCT02646345
- Acronym / sponsor ID
- 12-218
- Keywords
- Checklist, Mortality, Latin America, Surgery, Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,639 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Checklist | – | –All surgical encounters before surgical checklist implementation |
| Post Checklist | – | Procedure: Surgical checklistAll surgical encounters after surgical checklist implementation |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All surgical patients age 15 and above
Key inclusion criteria (1 listed)
- All surgical patients
Key exclusion criteria (2 listed)
- Obstetrical patients delivering vaginally
- Patients less than 15 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical checklistUse of the World Health Organization Surgical checklist | Procedure or surgery | Post Checklist |
Primary outcome
Mortality
Time frame: Three years
30 day postoperative mortality
2 secondary outcomes
Morbidity
Time frame: Three years
Length of stay
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 19144931Haynes 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.
- Background: PubMed 18519629de 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.
- Background: PubMed 25806399Tscholl 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):948-956. doi: 10.1213/ANE.0000000000000671.
- Background: PubMed 25692282Schwarze 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.
- Background: PubMed 15166578Wachtel RE, Dexter F. Differentiating among hospitals performing physiologically complex operative procedures in the elderly. Anesthesiology. 2004 Jun;100(6):1552-61. doi: 10.1097/00000542-200406000-00031.
- Background: PubMed 24620866Urbach 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.
- Background: PubMed 21067384de 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.
- Background: PubMed 21944620Calland 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.
- Background: PubMed 24620871Leape LL. The checklist conundrum. N Engl J Med. 2014 Mar 13;370(11):1063-4. doi: 10.1056/NEJMe1315851. No abstract available.
- Background: PubMed 21398154Conley 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector J Lacassie, MD principal investigator
Pontificia Universidad Catolica de Chile
Questions about this trial
What is this clinical trial studying?
An observational study of External Causes of Morbidity and Mortality and External Causes of Morbidity (V00-Y99), run by Pontificia Universidad Catolica de Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02646345, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.