a Multifaceted Program for Improving Quality of Care in ICU

NCT00461461 | Completed DMC

• 1 other identifier: AOM04-108
• Study Type: interventional
• Target: 2,117
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• decreased of occured of iatrogenic event in ICU

  one month

Secondary Outcomes (2)

• severity of iatrogenic event

  one month

• preventability of iatrogenic event

  one month

Interventions

meeting nurses / physicians, quality improvement sessions PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients hospitalised in ICU

You may not qualify if:

• age under 18 years

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• The Outcomerea Group for Intensive Care Research: collaborator
• the Regional Direction of Clinical Research: collaborator
• the High Health Authority: collaborator

Study Sites (3)

Intensive Care Unit

Grenoble, 38043, France

Location

Medical and surgical Intensive Care unit

Paris, 75014, France

Location

Intensive Care Unit

Saint-Denis, 93200, France

Location

Related Publications (1)

• Garrouste-Orgeas M, Soufir L, Tabah A, Schwebel C, Vesin A, Adrie C, Thuong M, Timsit JF; Outcomerea Study Group. A multifaceted program for improving quality of care in intensive care units: IATROREF study. Crit Care Med. 2012 Feb;40(2):468-76. doi: 10.1097/CCM.0b013e318232d94d.

  PMID: 21963581 DERIVED

Related Links

• Outcomerea association

MeSH Terms

Interventions

Physicians

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Soufir Lilia, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

• Garrouste Maité, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

• Timsit Jean Francois, MD, PhD

  Unité INSERM U 823 - Equipe "Epidémiologie des cancers et affections graves"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 25, 2009

Record last verified: 2009-06

Locations

FR (3)