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A Multifaceted Intervention to Improve Hand Hygiene

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ClinicalTrials.gov Identifier: NCT00375037
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : September 22, 2008
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University

Brief Summary:
This randomized controlled trial will evaluate the effect of a multifaceted intervention including performance feedback on adherence to hand hygiene among healthcare workers. A key component of the study is to demonstrate whether improved adherence to hand hygiene leads to a reduction in rates of infection.

Condition or disease Intervention/treatment
Handwashing Infection Behavioral: feedback Behavioral: Education Other: usual care

Detailed Description:
A cluster randomized controlled trial of the intervention will be conducted where hospital units (wards) in three hospitals will be allocated to either the intervention or usual practise. We will stratify by hospital site in order to minimize confounding by hospital-level factors. The unit of allocation, intervention, and analysis will be at the level of the hospital unit. Thirty hospital units will be randomized to either the intervention or comparison arm. We will compare adherence to hand hygiene, MRSA rates, and other outcomes between the two study arms.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cluster Randomized Controlled Trial of a Multifaceted Intervention to Improve Hand Hygiene Among Healthcare Workers
Study Start Date : January 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Hand hygiene promotion
Behavioral: feedback Behavioral: Education
Active Comparator: 2
usual care
Other: usual care

Primary Outcome Measures :
  1. Incidence of MRSA [ Time Frame: 12 months ]
  2. Adherence to hand hygiene [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Incidence of multi-resistant bacteria other than MRSA [ Time Frame: 12 months ]
  2. Catheter-related blood stream infections [ Time Frame: 12 months ]
  3. Clostridium difficile related diarrhea [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

A. Study units Inclusion: Medical and subspecialty units, surgical units, critical care units

Exclusion: pediatric units, neonatal intensive care units

B. Healthcare workers

Inclusion: any hospital staff with direct patient care who are affiliated with a single unit (includes registered nurses, nursing assistants, environmental aides, allied health professionals (occupational, physical, and respiratory therapists), and some physicians

C. Patients Clinical outcomes will be measured in patients on study units.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375037

Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Henderson Hospital
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Physicians' Services Incorporated Foundation
Principal Investigator: Mark B Loeb, MD, MSc Hamilton Health Sciences- McMaster University

Responsible Party: Dr. Mark Loeb, McMaster University
ClinicalTrials.gov Identifier: NCT00375037     History of Changes
Other Study ID Numbers: 05-277
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: September 22, 2008
Last Verified: September 2008

Keywords provided by McMaster University:
hand washing
cluster randomized trial
performance feedback
healthcare workers
Hand hygiene
hand washing adherence