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: Completed
• Conditions: Nosocomial Infection; Healthcare-Associated Infections (HAIs)
• Intervention / Treatment: Behavioral: 3-Step Hand Hygiene Technique; Behavioral: WHO 6-Step Hand Hygiene Technique

• Study Type: Interventional
• Enrollment (Actual): 1027
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • 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: No

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)

Number of Arms

2

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	Behavioral: 3-Step Hand Hygiene Technique; 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.	Behavioral: WHO 6-Step Hand Hygiene Technique; 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 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	Cases per 1,000 patient-days.	During hospitalization, up to 30 days
Cumulative Incidence of Healthcare-Associated Infections	Proportion of patients developing at least one HAI during follow-up.	During hospitalization, up to 30 days
Hand Hygiene Compliance	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: Fundación Clínica Shaio
• Investigators: Principal Investigator: Julia Alejandra Ortiz Aroca, M.Sc, Fundación Clínica Shaio

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cluster randomized trial; Patient safety; Intensive Care Units; Hospitalization; Infection prevention; Hand hygiene; Nosocomial infection; Healthcare-associated infection; Cross-over trial
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Cross Infection
• Other Study ID Numbers: DIB-25-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no current plan to make individual participant data available outside the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No