SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study)

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04187040

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Hand hygiene is one of the most important measures to prevent healthcare associated infections. A hand hygiene technique consisting of three steps may be superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique. Therefore, the aim of this study is to compare compliance with hand hygiene indications and technique between a 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Condition or Disease	Intervention/Treatment	Phase
Hand Hygiene	Procedure: Study intervention: 3-step hand hygiene technique Procedure: Control intervention: 6-step hand hygiene technique	N/A

Detailed Description

Hand hygiene is one of the most important measures to prevent transmission of pathogens between healthcare workers and patients, and ultimately, healthcare-associated infections. However, compliance with both hand hygiene indications and technique (outlining the steps for applying hand rub to ensure coverage of all surfaces of the hands) remains insufficient at most institutions worldwide. It was previously demonstrated that a hand hygiene technique consisting of three steps is superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique in a single center study. Furthermore, the 3-step technique was non-inferior regarding microbiological efficacy in two experimental studies and during daily clinical practice. To further investigate the external validity and generalizability of these findings to different settings, this study compares both compliance with hand hygiene indications and technique between the 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All participating wards will be randomly assigned with a 1:1 allocation to either the intervention (3-step hand hygiene technique) or the control group (6-step hand hygiene technique). Randomization will be stratified by participating institution for balanced allocation. Within each stratum, block randomization will be applied to assign wards to the two study groups. Blocking will be used to ensure close balance of the number of wards assigned to each group at any time during the study. Stratified randomization will be performed to ensure balance of the two groups within each institution.All participating wards will be randomly assigned with a 1:1 allocation to either the intervention (3-step hand hygiene technique) or the control group (6-step hand hygiene technique). Randomization will be stratified by participating institution for balanced allocation. Within each stratum, block randomization will be applied to assign wards to the two study groups. Blocking will be used to ensure close balance of the number of wards assigned to each group at any time during the study. Stratified randomization will be performed to ensure balance of the two groups within each institution.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene - an International Multicenter Cluster Randomized Trial (SIMPLIFY Study)

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3-step hand hygiene technique Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 3-step hand hygiene technique.	Procedure: Study intervention: 3-step hand hygiene technique 3-step hand hygiene technique: Covering all surfaces of the hands (based on own judgement) Rotational rubbing of fingertips in the palm of the alternate hand Rotational rubbing of both thumbs
Active Comparator: 6-step hand hygiene technique Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 6-step hand hygiene technique.	Procedure: Control intervention: 6-step hand hygiene technique 6-step hand hygiene technique (according to the WHO Guidelines on Hand Hygiene in Health Care, First Global Patient Safety Challenge): Rubbing hands palm to palm Palm to palm with fingers interlaced Right palm over left dorsum with interlaced fingers and vice versa Back of fingers to opposing palms with fingers interlocked Rotational rubbing of left thumb clasped in right palm and vice versa Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa

Arm

Intervention/Treatment

Active Comparator: 3-step hand hygiene technique

Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 3-step hand hygiene technique.

Procedure: Study intervention: 3-step hand hygiene technique

3-step hand hygiene technique: Covering all surfaces of the hands (based on own judgement) Rotational rubbing of fingertips in the palm of the alternate hand Rotational rubbing of both thumbs

Active Comparator: 6-step hand hygiene technique

Wards assigned to this study arm will receive instructions, educational materials and tutorials about the 6-step hand hygiene technique.

Procedure: Control intervention: 6-step hand hygiene technique

6-step hand hygiene technique (according to the WHO Guidelines on Hand Hygiene in Health Care, First Global Patient Safety Challenge): Rubbing hands palm to palm Palm to palm with fingers interlaced Right palm over left dorsum with interlaced fingers and vice versa Back of fingers to opposing palms with fingers interlocked Rotational rubbing of left thumb clasped in right palm and vice versa Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa

Outcome Measures

Primary Outcome Measures

Compliance with hand hygiene indications [Up to one year]
Compliance with the five hand hygiene indications defined by the WHO: before touching a patient before clean/aseptic procedures after body fluid exposure risk after touching a patient after touching patient surroundings
Compliance with the assigned hand hygiene technique [Up to one year]
Compliance with the assigned technique, defined as performance of the proposed three steps in the intervention group and of all six steps in the control group.

Secondary Outcome Measures

Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips [Up to one year]
Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips, which are part of both the 3-step and the 6-step technique for applying hand rub.
Duration of the hand hygiene action [Up to one year]
Duration of the hand hygiene action, the time spent for the application of hand rub will be measured and compared between the two assignments.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe

Exclusion Criteria:

Individuals, who are no HCWs

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Sarah Tschudin Sutter, Prof.Dr.med., University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT04187040

Other Study ID Numbers:

2019-01071;me19Tschudinsutter2

First Posted:

Dec 5, 2019

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Basel, Switzerland

WHO-guideline on hand hygiene in healthcare

3-step hand hygiene technique

6-step hand hygiene technique

Study Results

No Results Posted as of Jul 27, 2022