Healthcare-Associated Infections (HAIs), Nosocomial Infection
Conditions
Keywords
Hand hygiene, Healthcare-associated infection, Nosocomial infection, Cluster randomized trial, Cross-over trial, Infection prevention, Patient safety, Intensive Care Units, Hospitalization
Brief summary
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.
Interventions
BEHAVIORAL3-Step Hand Hygiene Technique
Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period.
BEHAVIORALWHO 6-Step Hand Hygiene Technique
Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period.
Sponsors
Fundación Clínica Shaio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Masking description
None (Open Label)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Healthcare-Associated Infection | During hospitalization, up to 30 days | Time from hospital admission to first documented healthcare-associated infection according to institutional surveillance criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Density of Healthcare-Associated Infections | During hospitalization, up to 30 days | Cases per 1,000 patient-days. |
| Cumulative Incidence of Healthcare-Associated Infections | During hospitalization, up to 30 days | Proportion of patients developing at least one HAI during follow-up. |
| Hand Hygiene Compliance | 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. |
Countries
Colombia
Contacts
PRINCIPAL_INVESTIGATORJulia Alejandra Ortiz Aroca, M.Sc
Fundación Clínica Shaio
Outcome results
None listed