Healthcare-Associated Infections (HAIs)EASY HANDSNCT07593417
Easy Hands: Impact of a 3-Step Versus WHO 6-Step Hand Hygiene Technique on Healthcare-Associated Infections in Intensive Care and Hospitalization Units.
A study testing 3-Step Hand Hygiene Technique and WHO 6-Step Hand Hygiene Technique in people with Healthcare-Associated Infections (HAIs) and Nosocomial Infection, run by Fundación Clínica Shaio at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthcare-Associated Infections (HAIs), Nosocomial Infection
- What is being tested?
- 3-Step Hand Hygiene Technique and WHO 6-Step Hand Hygiene Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,027 participants
- Where
- 1 siteColombia
- Study dates
- 1 Sep 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Admission to Emergency Department or Operating Rooms.
- HAI present at baseline (t0).
- HAI occurring during the first two hospital days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- 3-Step Hand Hygiene Technique, WHO 6-Step Hand Hygiene Technique
- Keywords
- Hand hygiene, Healthcare-associated infection, Nosocomial infection, Cluster randomized trial, Cross-over trial, Infection prevention, Patient safety, Intensive Care Units, Hospitalization
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Step Hand Hygiene TechniqueBehavioural
Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period.
WHO 6-Step Hand Hygiene TechniqueBehavioural
Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period.
| Study group | Role | What they receive |
|---|---|---|
| 3-Step Hand Hygiene Technique | Experimental | Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period Receives: Behavioral: 3-Step Hand Hygiene Technique |
| WHO 6-Step Hand Hygiene Technique | Active comparator | Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period. Receives: Behavioral: WHO 6-Step Hand Hygiene Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Healthcare-Associated Infection
Time from hospital admission to first documented healthcare-associated infection according to institutional surveillance criteria.
Measured: During hospitalization, up to 30 days
Secondary outcomes (3)
Incidence Density of Healthcare-Associated Infections
Cases per 1,000 patient-days.
Measured: During hospitalization, up to 30 days
Cumulative Incidence of Healthcare-Associated Infections
Proportion of patients developing at least one HAI during follow-up.
Measured: 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.
Measured: During hospitalization, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Sep 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare-Associated Infections (HAIs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Clínica Shaio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Alejandra Ortiz Aroca, M.Sc, Principal investigator, Fundación Clínica Shaio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593417
- Sponsor's protocol ID
- DIB-25-29
- Acronym
- EASY HANDS
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to make individual participant data available outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07593417
- Acronym / sponsor ID
- EASY HANDS / DIB-25-29
- Keywords
- Hand hygiene, Healthcare-associated infection, Nosocomial infection, Cluster randomized trial, Cross-over trial, Infection prevention, Patient safety, Intensive Care Units
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Fundación Clínica ShaioUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3-Step Hand Hygiene Technique | Experimental | Behavioral: 3-Step Hand Hygiene TechniqueSimplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period |
| WHO 6-Step Hand Hygiene Technique | Active comparator | Behavioral: WHO 6-Step Hand Hygiene TechniqueStandard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Admission to Emergency Department or Operating Rooms.
- HAI present at baseline (t0).
- HAI occurring during the first two hospital days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Step Hand Hygiene TechniqueSimplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period. | Behavioural | 3-Step Hand Hygiene Technique |
| WHO 6-Step Hand Hygiene TechniqueStandard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period. | Behavioural | WHO 6-Step Hand Hygiene Technique |
Primary outcome
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.
3 secondary outcomes
Incidence Density of Healthcare-Associated Infections
Time frame: During hospitalization, up to 30 days
Cumulative Incidence of Healthcare-Associated Infections
Time frame: During hospitalization, up to 30 days
Hand Hygiene Compliance
Time frame: During hospitalization, up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. There is no current plan to make individual participant data available outside the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Alejandra Ortiz Aroca, M.Sc principal investigator
Fundación Clínica Shaio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-Step Hand Hygiene Technique and WHO 6-Step Hand Hygiene Technique in people with Healthcare-Associated Infections (HAIs) and Nosocomial Infection, run by Fundación Clínica Shaio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Healthcare-Associated Infection (time frame: During hospitalization, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.