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

September 13, 2023 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

Individuals, who are no HCWs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:

  1. Covering all surfaces of the hands (based on own judgement)
  2. Rotational rubbing of fingertips in the palm of the alternate hand
  3. 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):

  1. Rubbing hands palm to palm
  2. Palm to palm with fingers interlaced
  3. Right palm over left dorsum with interlaced fingers and vice versa
  4. Back of fingers to opposing palms with fingers interlocked
  5. Rotational rubbing of left thumb clasped in right palm and vice versa
  6. Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with hand hygiene indications
Time Frame: 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
Up to one year
Compliance with the assigned hand hygiene technique
Time Frame: 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.
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with performance of the two steps for applying hand rub to the thumbs and the fingertips
Time Frame: 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.
Up to one year
Duration of the hand hygiene action
Time Frame: 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.
Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-01071;me19Tschudinsutter2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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