A Multifaceted Intervention to Improve Hand Hygiene

Study Overview
=================
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.

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.

Official Title
-----------------
Cluster Randomized Controlled Trial of a Multifaceted Intervention to Improve Hand Hygiene Among Healthcare Workers

Conditions
-----------------
Handwashing, Infection

Intervention / Treatment
-----------------
* Behavioral: feedback
* Behavioral: Education
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand hygiene<br>Hand hygiene promotion | Behavioral: feedback<br> <br> Behavioral: Education<br> <br> |
| Active Comparator: Usual care<br>usual care | Other: usual care<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MRSA |  | 12 months | 
| Adherence to hand hygiene |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of multi-resistant bacteria other than MRSA |  | 12 months | 
| Catheter-related blood stream infections |  | 12 months | 
| Clostridium difficile related diarrhea |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hand washing, cluster randomized trial, performance feedback, healthcare workers, Hand hygiene, hand washing adherence