a Multifaceted Program for Improving Quality of Care in ICU
|ClinicalTrials.gov Identifier: NCT00461461|
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : June 25, 2009
Medical errors that affect patient safety have generated huge concern since the publication of "To Err Is Human" 6 years ago . 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 (). 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 or disease||Intervention/treatment||Phase|
|Adverse Event Indicator Intensive Care Units||Procedure: meeting nurses / physicians, quality improvement sessions||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2117 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||IATROREF III: a Multifaceted Program for Improving Quality of Care in Critically Ill Patients|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||June 2008|
Procedure: meeting nurses / physicians, quality improvement sessions
- Meeting with the ICU staff to discuss the epidemiology of patients on each theme.
- Pocket card with guidelines on the theme and ICU protocol in each study ICU.
- Feedback meeting twice a month on errors in the unit, preventability, and appropriate changes in procedures on the subject.
For each iatrogenic indicator, the interventions are:
- decreased of occured of iatrogenic event in ICU [ Time Frame: one month ]
- severity of iatrogenic event [ Time Frame: one month ]
- preventability of iatrogenic event [ Time Frame: one month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461461
|Intensive Care Unit|
|Grenoble, France, 38043|
|Medical and surgical Intensive Care unit|
|Paris, France, 75014|
|Intensive Care Unit|
|Saint Denis, France, 93200|
|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"|