Prospective Clinical Surveillance With Application of Trigger Tools in Critically Ill Patients

NCT03781713 | Completed Phase 2 DMC

• 1 other identifier: CONEP 1.487.682
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the impact of prospective clinical surveillance with the use of triggers to identify risk of adverse events with prompt adoption of interventions on the stabilization time of critically ill patients.

Conditions

Critical Illness

Keywords

prospective; surveillance; trigger; stabilization

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of prospective trigger tools and near real time interventions on the stabilization time of critically ill patients.

  For the calculation of the stabilization time, the long-term risk rating of the Epimed Performance software (Epimed solutions) will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.

  3 months

Study Arms (2)

STUDY GROUP

ACTIVE COMPARATOR

patients who triggered triggers and had interventions. Kdigo: interventions to prevent renal replacement therapy Delta SOFA: interventions to improve SOFA score Hypoglycemia: Interventions to prevent new episodes of hypoglycemia in the next 24 hours Drug interaction risk D or X - Intervention in the therapeutic plan in order to avoid adverse drug reactions. Antimicrobial stewardship: optimization of antimicrobial therapy based on Gram stain, MALDI TOF, MIC, antimicrobial susceptibility

Other: KDIGO; Other: Delta SOFA; Combination Product: Hypoglycemia; Drug: Drug interaction risk D or X; Drug: Antimicrobial stewardship

CONTROL GROUP

NO INTERVENTION

patients who did not triggered triggers

Interventions

KDIGO OTHER

Interventions to prevent renal replacement therapy

STUDY GROUP

Delta SOFA OTHER

interventions to improve SOFA score

STUDY GROUP

Hypoglycemia COMBINATION_PRODUCT

Interventions to prevent new episodes of hypoglycemia in the next 24 hours

STUDY GROUP

Drug interaction risk D or X DRUG

Intervention in the therapeutic plan in order to avoid adverse drug reactions.

STUDY GROUP

Antimicrobial stewardship DRUG

Optimization of anticrobial therapy based on Gram stain, MALDI TOF, MIC and antimicrobial susceptibility

STUDY GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (2)

Hospital Sao Domingos

São Luís, Maranhão, 65060-642, Brazil

Location

Hospital São Domingos

São Luís, Maranhão, 65060-645, Brazil

Location

Related Publications (11)

• Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010 Nov 25;363(22):2124-34. doi: 10.1056/NEJMsa1004404.

  PMID: 21105794 BACKGROUND

• Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/

  PMID: 25077248 RESULT

• Griffin FA, Classen DC. Detection of adverse events in surgical patients using the Trigger Tool approach. Qual Saf Health Care. 2008 Aug;17(4):253-8. doi: 10.1136/qshc.2007.025080.

  PMID: 18678721 RESULT

• 4. Griffin FA, Resar RK. IHI global trigger tool for measuring adverse events. 2nd edn. Cambridge, Massachusetts Institute for Healthcare Improvement, 2009.

  RESULT

• 5. Shimada S, Rivard PE, Mull J, et al. Triggers and Targeted Injury Detection Systems: Aiming for the Right Target With the Appropriate Tool. 2009.

  RESULT

• Franklin BD, Birch S, Schachter M, Barber N. Testing a trigger tool as a method of detecting harm from medication errors in a UK hospital: a pilot study. Int J Pharm Pract. 2010 Oct;18(5):305-11. doi: 10.1111/j.2042-7174.2010.00058.x.

  PMID: 20840687 RESULT

• Carnevali L, Krug B, Amant F, Van Pee D, Gerard V, de Bethune X, Spinewine A. Performance of the adverse drug event trigger tool and the global trigger tool for identifying adverse drug events: experience in a Belgian hospital. Ann Pharmacother. 2013 Nov;47(11):1414-9. doi: 10.1177/1060028013500939.

  PMID: 24285758 RESULT

• Forster AJ, Worthington JR, Hawken S, Bourke M, Rubens F, Shojania K, van Walraven C. Using prospective clinical surveillance to identify adverse events in hospital. BMJ Qual Saf. 2011 Sep;20(9):756-63. doi: 10.1136/bmjqs.2010.048694. Epub 2011 Mar 1.

  PMID: 21367769 RESULT

• Wong BM, Dyal S, Etchells EE, Knowles S, Gerard L, Diamantouros A, Mehta R, Liu B, Baker GR, Shojania KG. Application of a trigger tool in near real time to inform quality improvement activities: a prospective study in a general medicine ward. BMJ Qual Saf. 2015 Apr;24(4):272-81. doi: 10.1136/bmjqs-2014-003432. Epub 2015 Mar 6.

  PMID: 25749028 RESULT

• 10. Kdigo Clinical Practice Guideline for acute kidney injury. Kidney International 2012; 2 9Suppl 1).

  RESULT

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 RESULT

MeSH Terms

Conditions

Critical Illness

Interventions

Hig1 protein, mouse; Antimicrobial Stewardship

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Utilization Review; Drug Utilization; Pharmacy Administration; Organization and Administration; Health Services Administration; Utilization Review; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• JOSE R AZEVEDO, MD. PhD

  Hospital Sao Domingos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Model Details: To evaluate the impact of the tool on the time of stabilization of patients, two groups will be compared: the first will be composed of patients who did not triggered triggers and the second by patients who triggered triggers and had interventions. For the calculation of the stabilization time, the long-term risk rating of the Epimed Performance software will be used, which allows us to estimate the length of ICU stay of the patients individually using more than 60 variables.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: November 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 10, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)