Infection Control Link Nurses Program to Improve Compliance With Standard Precautions, Hand Hygiene, and Prevent Healthcare-Associated Infections (INFECTION)

April 3, 2025 updated by: Centro Cardiologico Monzino

Effectiveness of Implementing an Infection Control Link Nurses Program to Improve Nurses' Compliance With Standard Precautions, Healthcare Professionals' Compliance With Hand Hygiene, and to Prevent Healthcare-Associated Infections: a Cluster Randomized Controlled Trial

The goal of this clinical trial is to learn if Infection Control Link Nurses (i.e., clinical nurses providing direct patient care with an interest and expertise in infection control practices) are effective in improving nurses' compliance with standard precaution measures, healthcare professional's compliance with hand hygiene practices and in reducing healthcare-associated infections. The main questions it aims to answer are:

  • Are Infection Control Link Nurses effective in improving nurses' compliance with standard precautions?
  • Are Infection Control Link Nurses effective in improving healthcare professionals' compliance with hand hygiene practices?
  • Are Infection Control Link Nurses effective in improving alcohol-based hand rub consumption?
  • Are Infection Control Link Nurses effective in reducing healthcare-associated infections? In this study, a total of 8 hospital units will be randomized in two groups: 1) Intervention group, where in 4 hospital units will be selected and trained 4 Infection Control Link Nurses; and 2) Control group, where in 4 hospital units will continue usual IPC practice.

Training of Infection Control Link Nurses will be 12 months-long, with regular monthly scheduled meetings.

Researchers will compare Intervention group with the Control group to see if nurses' compliance with standard precautions and healthcare professionals' compliance with hand hygiene will improve in the Intervention group, and if overall healthcare-associated infection incidence will decrease.

Participants will be nurses working full time in the selected hospital units, for a total of 100 nurses. They will sign an Informed Consent form and they will fill out a validated instrument named "Compliance with Standard Precautions Scale-Italian Version", to measure their adherence to standard precautions measures (i.e., use of protective device, disposal of sharp, disposal of waste etc). Concurrently, evaluation of healthcare professionals' compliance with hand hygiene will be done via direct observation, following World Health Organization's Technical Manual, by hospital staff who did not participate in the conception and design of the study. Lastly, data regarding alcohol-based hand rub consumption and healthcare-associated infections will be collected by experienced personnel who routinely perform these activities. The study will last 12 months, data collection will be carried out at baseline (pre-implementation of infection control link nurses) and after 12 months (after infection control link nurses implementation).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this cluster RCT, all medical-surgical wards and ICUs of the Center where the study will be conducted, will be selected. Subsequently, cluster randomization will divide those hospital units in two arms: (1) Intervention group - 1 ICLN per ward/ICU will be identified and formed; (2) Control group - wards and ICU that will continue standard IPC practice.

Assessment, data collection, and intervention will be administered within the hospital facility. Since this hospital comprises in total 6 medical-surgical wards and 2 ICUs, each study group (i.e., Intervention group and Control group) will comprise 4 hospital units.

Data will be collected in presence at baseline (T0 - before ICLNs' implementation) and after 12 months (T1).

  • Primary endpoint will be nurses' compliance with standard precautions, using a validated instrument ("Compliance with Standard Precaution Scale-Italian version; CSPS-It)
  • Secondary outcomes (i.e., healthcare professionals' hand hygiene compliance, healthcare professionals' alchol-based hand rub consumption and healthcare-associated infections incidence rate) will be evaluated for all healthcare professionals working in the promoting center.

Signing of Informed Consent will only be required by nursing staff who fill-out the CSPS-It, whereas all other data collected (hand hygiene compliance, alchol-based hand rub consumption consumption and HAIs incidence) are part of usual intra-hospital surveillance practices and do not involve the collection of any personal data.

For this reason, nurses working in the selected units will be asked to participate in the study, and they will be asked to sign an Informed Consent form and will be consecutively enrolled until the sample size is reached (i.e., 100 nurses).

After cluster randomization is performed, recruitment of potential participants will begin. 4 ICLNs will be selected and every clinical nurse working full-time in the selected hospital units will be asked to participate in the present RCT. After signing the Informed Consent, baseline data collection will begin.

At baseline (T0) socio-demographic data and job-related informations (e.g., time in years of clinical experience as a nurse, study degree) will be collected. Afterward, participants will be asked to fill out a validated instrument aiming to measure compliance with standard precautions (i.e., CSPS-it). Sample size is composed only by nurses because CSPS-It is validated only for registered nurses and nursing students.

Concurrently, data regarding healthcare professionals' (i.e., doctors, nurses, support personnel, technicians) compliance with hand hygiene (HH), Alcohol-Based Hand Rub (ABHR) consumption, and Healthcare-Associated Infections (HAIs)' incidence rate will be collected.

During the 12-month ICLNs implementation program, ICLNs will be continuously supported in their activities by hospital management and by their colleagues, and they will be asked to participate in monthly educational meetings covering core elements on HAIs prevention and control, standard and isolation precaution measures, and hand hygiene paired with flexible times useful for ICLNs to create debates, reflect on barriers, and analyze situations together.

After 12 months (T1), the same data collection at baseline (T0) will be performed (i.e., CSPS-it, HH compliance, ABHR consumption, HAIs' incidence rate).

Data collection will be carried out by research assistants trained to the present protocol, HH compliance direct observations will be performed by hospital personnel not involved in this RCT, data related to AHRB consumption and HAIs rate will be collected by trained personnel working in the hospital facility.

To ensure privacy, data at baseline and follow-up will be collected, analyzed and presented exclusively in aggregate form (i.e., for the intervention group and control group).

Study Type

Interventional

Enrollment (Estimated)

100

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

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20138
        • Recruiting
        • Centro Cardiologico Monzino, IRCCS
        • Contact:
        • Contact:
        • Contact:
          • Miriana D'Andrea, Master of Science in Nursing
        • Contact:
          • Claudio Bassi, Master of Science in Nursing
        • Contact:
          • Monica Perazzani, Registered Nurse
        • Contact:
          • Arianna Galotta, Biostatistics
        • Contact:
          • Mariangela Alberti, Registered Nurse
        • Contact:
          • Alessia M Trenta, PhD in Nursing
        • Contact:
          • Alice Bonomi, PhD in Biostatistics

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Nursing staff working full time in the hospital wards and intensive care units partecipating in the study

Exclusion Criteria:

  • Nurses unavailable to sign informed consent

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
In the Control group, 4 hospital medical-surgical wards and intensive care units will continue their normal practice, following usual IPC measures
Experimental: Infection Control Link Nurses
In the Intervention group, in the 4 hospital medical-surgical wards and intensive care units randomized, will be implemented one infection control link nurse (ICLN) per hospital unit, for a total of 4 ICLNs They will receive ongoing education and they will be responsible for peer education about infection control practice, standard precaution measures, isolation measures, compliance with hand hygiene, promotion of evidence-based practice during patient care. They will act as a link between the IPC team and clinical practice, educating collegues and students on infection control guidelines
Behavioral: Implementation of Infection Control Link Nurses (ICLNs)

Infection Control Link Nurses (ICLNs) are clinical nurses, working in direct nursing care, with an interest and expertise on infection control practice. They work with constant and direct support by the IPC hospital team, and they are required to follow a training course with numerous scheduled meetings about IPC-related issues.

They will be selected via spontaneous application or identified by their Head Nurses. All ICLNs activities are to be completed during working hours, they still maintain their clinical nursing role, but in addition they implement and translate IPC-measures into clinical practice by observing, monitoring and analyzing data on compliance with hand hygiene, compliance with standard and isolation precautions, healthcare-associated infections and other IPC-related issues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nurses' compliance with standard precautions
Time Frame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Standard Precautions are measure that healthcare professionals need to apply into practice with dual aim: to protect themselves from contamination during direct patient care, and to prevent/reduce healthcare-associated infections in patients. It will be measured via the Compliance with Standard Precaution Scale, Italian version (CSPS-It). Written approval and permission to use the scale have been obtained both by the original author and by the author of the Italian-validated version. CSPS-It is a 20-item instrument, validated for registered nurses and nursing students, aiming to assess nursing staff's compliance with standard precautions measures (e.g., use of protective device, disposal of sharp, disposal of waste). It comprises 20 items, both positively and negatively worded, answerable with a 4-point Likert scale ranging from 1 ("never") to 4 ("always"). Scoring ranges between 0 and 20, with higher scores reflecting better compliance with standard precautions
Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare professionals' compliance with hand hygiene
Time Frame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Healthcare professionals' hand hygiene compliance will be evaluated via direct observation, following the World Health Organization - Hand Hygiene Technical Reference Manual. This Manual explains in detail how an observer should conduct the evaluation, following the 5 moments for hand hygiene (1. Before touching a patient; 2. Before clean/aseptic procedure; 3. After body fluid exposure risk; 4. After touching a patient; 5. After touching patient surroundings) defined by WHO to clean healthcare professionals' hands with soap and water or AHRB. WHO Technical Reference Manual contains a specific part (i.e., Part III - Observing hand hygiene practices) that guides step by step direct observations of HH. Calculation % of HH compliance of the observed staff is based on the following formula: Compliance (%)= (Performed actions/Opportunities) x 100.
Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Alchol-Based Hand Rub (ABHR) consumption
Time Frame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Alchol-based hand rub (ABHR) consumption is a proxy measure of hand hygiene. It involves measuring the quantity of hydro-alcoholic hand sanitizing solution used by healthcare professionals in a set period of time, through consumption flows. ABHR consumption will be analyzed via the following equation, proposed by WHO: (ABHR consumption)/(1000 patient-days). WHO proposes a rate of ABHR consumption >=20 Liters/1000 patient-days as the desirable standard.
Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Incidence of Healthcare-Associated Infections (HAIs)
Time Frame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)

Incidence of the following Healthcare-Associated Infections (HAIs) will be calculated: catheterization-associated urinary tract infections (CAUTIs), mechanical ventilation-associated pneumonia (VAPs), surgical site infections (SSIs) and bloodstream infections (BSIs). The incidence rate of VAP, CAUTI, SSI, and BSI will be calculated as per the usual reporting of positive culture specimens by the CCM Medical Laboratory. All first positive culture samples associated with a specific hospital unit will be considered. Individual cases will then be analyzed, by experienced personnel who routinely perform these activities, based on the Atlanta Center of Disease Control Guidelines, identifying hospital HAIs. Incidence of each HAI (i.e., VAP, CAUTI, SSI, BSI) will be calculated using the following equation:

Incidence rate= (Number of first positive cultures per patient / Number of unit's admissions) x 1000 patient-days
Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)

Collaborators and Investigators

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

Sponsor

Centro Cardiologico Monzino

Investigators

  • Principal Investigator: Miriana D'Andrea, Master of Science in Nursing, Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

March 20, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCM L2-284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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