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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Bogota D.C.
-
Bogotá, Bogota D.C., Colombia, 110121
- Fundación Clínica Shaio
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to First Healthcare-Associated Infection
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence Density of Healthcare-Associated Infections
Tidsramme: During hospitalization, up to 30 days
|
Cases per 1,000 patient-days.
|
During hospitalization, up to 30 days
|
|
Cumulative Incidence of Healthcare-Associated Infections
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Julia Alejandra Ortiz Aroca, M.Sc, Fundación Clínica Shaio
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DIB-25-29
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .