Easy Hands: Impact of a 3-Step Versus WHO 6-Step Hand Hygiene Technique on Healthcare-Associated Infections in Intensive Care and Hospitalization Units. (EASY HANDS)
Easy Hands: A Cluster Randomized Cross-Over Trial Evaluating a Simplified 3-Step Hand Hygiene Technique Versus the WHO 6-Step Technique on the Incidence of Healthcare-Associated Infections.
Healthcare-associated infections (HAIs) remain a major cause of morbidity, mortality, and healthcare costs worldwide. Hand hygiene is the cornerstone of infection prevention; however, adherence to the full WHO 6-step hand hygiene technique may be limited in routine clinical practice due to time constraints and workflow barriers. Simplified hand hygiene approaches may improve compliance while preserving clinical effectiveness.
The Easy Hands study is a pragmatic cluster randomized cross-over trial designed to compare a simplified 3-step hand hygiene technique with the standard WHO 6-step technique in clinical care units. Hospital services were randomized to one of two sequences of intervention and crossed over after the first study period. The primary objective is to evaluate whether the simplified 3-step technique is associated with differences in time to first healthcare-associated infection among hospitalized patients.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bogota D.C.
-
Bogotá, Bogota D.C., Colombia, 110121
- Fundación Clínica Shaio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Admission to a participating cluster during an active intervention period.
- Adult or pediatric hospitalized patient.
- Availability of admission and discharge dates.
- Eligibility for institutional infection surveillance.
Exclusion Criteria:
- Admission to Emergency Department or Operating Rooms.
- HAI present at baseline (t0).
- HAI occurring during the first two hospital days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3-Step Hand Hygiene Technique
Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period
|
Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period.
|
|
Active Comparator: WHO 6-Step Hand Hygiene Technique
Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period.
|
Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Healthcare-Associated Infection
Time Frame: During hospitalization, up to 30 days
|
Time from hospital admission to first documented healthcare-associated infection according to institutional surveillance criteria.
|
During hospitalization, up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence Density of Healthcare-Associated Infections
Time Frame: During hospitalization, up to 30 days
|
Cases per 1,000 patient-days.
|
During hospitalization, up to 30 days
|
|
Cumulative Incidence of Healthcare-Associated Infections
Time Frame: During hospitalization, up to 30 days
|
Proportion of patients developing at least one HAI during follow-up.
|
During hospitalization, up to 30 days
|
|
Hand Hygiene Compliance
Time Frame: During hospitalization, up to 30 days
|
Percentage adherence to the assigned hand hygiene technique measured through direct observational audits using institutional hand hygiene monitoring procedures.
|
During hospitalization, up to 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia Alejandra Ortiz Aroca, M.Sc, Fundación Clínica Shaio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIB-25-29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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