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a Multifaceted Program for Improving Quality of Care in ICU

This study has been completed.
Sponsor:
Collaborators:
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
First received: April 17, 2007
Last updated: June 24, 2009
Last verified: June 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
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 [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • severity of iatrogenic event [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • preventability of iatrogenic event [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Enrollment: 2117
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: meeting nurses / physicians, quality improvement sessions

    For each iatrogenic indicator, the interventions are:

    1. Meeting with the ICU staff to discuss the epidemiology of patients on each theme.
    2. Pocket card with guidelines on the theme and ICU protocol in each study ICU.
    3. Feedback meeting twice a month on errors in the unit, preventability, and appropriate changes in procedures on the subject.
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  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

Locations
France
Intensive Care Unit
Grenoble, France, 38043
Medical and surgical Intensive Care unit
Paris, France, 75014
Intensive Care Unit
Saint Denis, France, 93200
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

Additional Information:
Outcomerea association  This link exits the ClinicalTrials.gov site

No publications provided by Groupe Hospitalier Paris Saint Joseph

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00461461     History of Changes
Other Study ID Numbers: AOM04-108
Study First Received: April 17, 2007
Last Updated: June 24, 2009
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013