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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-Step Hand Hygiene Technique | Experimental | Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period |
|
| WHO 6-Step Hand Hygiene Technique | Active Comparator | Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-Step Hand Hygiene Technique | Behavioral | Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Alejandra Ortiz Aroca, M.Sc | Fundación ClÃnica Shaio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación ClÃnica Shaio | Bogotá | Bogota D.C. | 110121 | Colombia |
There is no current plan to make individual participant data available outside the study team.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2026 |
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The Easy Hands study was conducted in inpatient clinical units, including intensive care and hospitalization wards. Participating units (clusters) were randomly assigned to one of two intervention sequences:
Sequence AB: 3-step technique followed by 6-step technique Sequence BA: 6-step technique followed by 3-step technique
Each intervention period lasted according to the predefined implementation schedule, after which clusters crossed over to the alternate technique.
Patients admitted to participating units during active study periods were included consecutively and followed until first HAI, discharge, death, or administrative censoring. The study uses time-to-event methods, accounting for cluster effects, crossover design, period effects, and time-varying clinical exposures.
The study hypothesis is that the simplified 3-step technique does not increase the hazard of HAI compared with the WHO 6-step standard technique.
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None (Open Label)
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| WHO 6-Step Hand Hygiene Technique | Behavioral | Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period. |
|
| 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 |
| May 8, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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