SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study)

Study Overview
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Brief Summary
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Hand hygiene is one of the most important measures to prevent healthcare associated infections. A hand hygiene technique consisting of three steps may be superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique. Therefore, the aim of this study is to compare compliance with hand hygiene indications and technique between a 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Detailed Description
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Hand hygiene is one of the most important measures to prevent transmission of pathogens between healthcare workers and patients, and ultimately, healthcare-associated infections. However, compliance with both hand hygiene indications and technique (outlining the steps for applying hand rub to ensure coverage of all surfaces of the hands) remains insufficient at most institutions worldwide. It was previously demonstrated that a hand hygiene technique consisting of three steps is superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique in a single center study. Furthermore, the 3-step technique was non-inferior regarding microbiological efficacy in two experimental studies and during daily clinical practice. To further investigate the external validity and generalizability of these findings to different settings, this study compares both compliance with hand hygiene indications and technique between the 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Official Title
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SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene - an International Multicenter Cluster Randomized Trial (SIMPLIFY Study)

Conditions
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Hand Hygiene

Intervention / Treatment
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* Procedure: Study intervention: 3-step hand hygiene technique
* Procedure: Control intervention: 6-step hand hygiene technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe Exclusion Criteria: Individuals, who are no HCWs
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participating wards will be randomly assigned with a 1:1 allocation to either the intervention (3-step hand hygiene technique) or the control group (6-step hand hygiene technique). Randomization will be stratified by participating institution for balanced allocation. Within each stratum, block randomization will be applied to assign wards to the two study groups. Blocking will be used to ensure close balance of the number of wards assigned to each group at any time during the study. Stratified randomization will be performed to ensure balance of the two groups within each institution.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3-step hand hygiene technique<br>Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 3-step hand hygiene technique. | Procedure: Study intervention: 3-step hand hygiene technique<br>* 3-step hand hygiene technique: Covering all surfaces of the hands (based on own judgement) Rotational rubbing of fingertips in the palm of the alternate hand Rotational rubbing of both thumbs<br>|
| Active Comparator: 6-step hand hygiene technique<br>Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 6-step hand hygiene technique. | Procedure: Control intervention: 6-step hand hygiene technique<br>* 6-step hand hygiene technique (according to the WHO Guidelines on Hand Hygiene in Health Care, First Global Patient Safety Challenge): Rubbing hands palm to palm Palm to palm with fingers interlaced Right palm over left dorsum with interlaced fingers and vice versa Back of fingers to opposing palms with fingers interlocked Rotational rubbing of left thumb clasped in right palm and vice versa Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with hand hygiene indications | Compliance with the five hand hygiene indications defined by the WHO: before touching a patient before clean/aseptic procedures after body fluid exposure risk after touching a patient after touching patient surroundings | Up to one year | 
| Compliance with the assigned hand hygiene technique | Compliance with the assigned technique, defined as performance of the proposed three steps in the intervention group and of all six steps in the control group. | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips | Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips, which are part of both the 3-step and the 6-step technique for applying hand rub. | Up to one year | 
| Duration of the hand hygiene action | Duration of the hand hygiene action, the time spent for the application of hand rub will be measured and compared between the two assignments. | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WHO-guideline on hand hygiene in healthcare, 3-step hand hygiene technique, 6-step hand hygiene technique