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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 |
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Information provided by: | Groupe Hospitalier Paris Saint Joseph |
ClinicalTrials.gov Identifier: | NCT00461461 |
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 |
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Adverse Event Indicator Intensive Care Units |
Procedure: meeting nurses / physicians, quality improvement sessions |
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 |
Estimated Enrollment: | 2000 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Soufir Lilia, MD | 00 33 1 44123640 | lsoufir@hpsj.fr |
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 |
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" |
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 |
Critical Illness |