a Multifaceted Program for Improving Quality of Care in ICU

Summary

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.

Conditions

• Adverse Event
• Indicator
• Intensive Care Units

Interventions

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.

Sponsors & Collaborators

• The Outcomerea Group for Intensive Care Research

  collaborator UNKNOWN

• the Regional Direction of Clinical Research

  collaborator UNKNOWN

• the High Health Authority

  collaborator UNKNOWN

• Fondation Hôpital Saint-Joseph

  lead OTHER

Principal Investigators

• Soufir Lilia, MD · Fondation Hôpital Saint-Joseph

• Garrouste Maité, MD · Fondation Hôpital Saint-Joseph

• Timsit Jean Francois, MD, PhD · Unité INSERM U 823 - Equipe "Epidémiologie des cancers et affections graves"

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2008-01-31

Completion

2008-06-30

Countries

• France

Study Locations