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a Multifaceted Program for Improving Quality of Care in ICU
This study is currently recruiting participants.
Verified by Groupe Hospitalier Paris Saint Joseph, April 2007
Sponsors and Collaborators: Groupe Hospitalier Paris Saint Joseph
The Outcomerea Group for Intensive Care Research
the Regional Direction of Clinical Research
the High Health Authority
Information provided by: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT00461461
  Purpose

Medical errors that affect patient safety have generated huge concern since the publication of “To Err Is Human” 6 years ago [1]. Given the complexity of management in the intensive care unit (ICU) and the nature of human activities, critically ill patients are exposed to adverse events (AEs) induced by medical errors. A large number of studies have focused on AEs and medical errors in ICUs [2-6], one of their main goals being to identify strategies for preventing AEs and thereby improving patient outcomes. Choosing the best AE to serve as an indicator for the risk of medical error is challenging. In 2005, our group conducted a systematic literature review and presented the results to 30 national experts with clinical backgrounds in internal, emergency, and intensive care medicine. Using the Delphi technique, these experts selected 14 AEs that had the following characteristics: high frequency, easy and reproducible definition, association with morbidity and mortality, and ease of reporting without fear of punishment (Iatroref I study) (ref abstract). These AEs were used in a French multicenter study (75 ICUs) for a weeklong incidence evaluation (Iatroref II study) (ref abstract). Preliminary evaluation of the results allowed us to choose the following AEs for the current Iatroref III study: error in insulin administration, error in anticoagulant administration, error in anticoagulant prescription, unplanned extubation, and unplanned removal of central venous catheter. Evidence suggests that guidelines alone without reinforcing strategies may be insufficient to change provider behavior and that the most effective interventions may be multifaceted rather than single-component strategies ([7]). This study will test a composite intervention program. The objectives of the study are to determine whether the introduction of a composite intervention program decreases the predefined AEs.

Study hypothesis: The intervention program will decrease the incidence of the predefined AEs.


Condition Intervention
Adverse Event
Indicator
Intensive Care Units
Procedure: meeting nurses / physicians, quality improvement sessions

U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study
Official Title: IATROREF III: a Multifaceted Program for Improving Quality of Care in Critically Ill Patients

Further study details as provided by Groupe Hospitalier Paris Saint Joseph:

Primary Outcome Measures:
  • decreased of occured of iatrogenic event in ICU

Estimated Enrollment: 2000
Study Start Date: March 2007
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients hospitalised in ICU

Exclusion Criteria:

  • age under 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461461

Contacts
Contact: Soufir Lilia, MD 00 33 1 44123640 lsoufir@hpsj.fr

Locations
France
Medical and surgical Intensive Care unit Recruiting
Paris, France, 75014
Contact: Soufir Lilia, MD     0033144123640     lsoufir@hpsj.fr    
Contact: Garrouste-Orgeas Maité, MD     0033144123415     mgarrouste@hpsj.fr    
Sub-Investigator: Tabah Alexis, MD            
Sub-Investigator: Garrouste-Orgeas Maité, MD            
Sub-Investigator: Soufir Lilia, MD            
Intensive Care Unit Recruiting
Grenoble, France, 38043
Contact: Timsit Jean Francois, MD, PhD     0033476768731     jftimsit@chu-grenoble.fr    
Sub-Investigator: Timsit jean Francois, MD, PhD            
Intensive Care Unit Recruiting
Saint Denis, France, 93200
Contact: Adrie Christophe, MD, PhD     00331 42 35 61 40     christophe.adrie@wanadoo.fr    
Sub-Investigator: Adrie Christophe, MD, PhD            
Sub-Investigator: Thuong Marie, MD            
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
The Outcomerea Group for Intensive Care Research
the Regional Direction of Clinical Research
the High Health Authority
Investigators
Principal Investigator: Soufir Lilia, MD Groupe Hospitalier Paris Saint Joseph
Principal Investigator: Garrouste Maité, MD Groupe Hospitalier Paris Saint Joseph
Principal Investigator: Timsit Jean Francois, MD, PhD Unité INSERM U 823 - Equipe "Epidémiologie des cancers et affections graves"
  More Information

Outcomerea association  This link exits the ClinicalTrials.gov site

Study ID Numbers: AOM04-108
Study First Received: April 17, 2007
Last Updated: April 17, 2007
ClinicalTrials.gov Identifier: NCT00461461  
Health Authority: France: Ministry of Health

Study placed in the following topic categories:
Critical Illness

ClinicalTrials.gov processed this record on January 16, 2009