Clinical trial NCT06857825: Infection Control Link Nurses Program to Improve Compliance With Standard Precautions, Hand Hygiene, and Prevent Healthcare-Associated Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Standard Precautions
Hand Hygiene Behavior
Healthcare Associated Infections
Keywords: Infection Control Link Nurse
Nursing
Hand Hygiene
Standard Precautions
Healthcare-associated infections
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized control trial: all hospital wards and intensive care units of the promoting Center (i.e., n.8) will be divided in two parallel groups: 1) Intervention group (4 hospital units, implementation of one Infection Control Link Nurses per hospital unit); 2) Control group (4 hospital units, usual IPC practices) via cluster randomization.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Nurses' compliance with standard precautions
timeFrame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Secondary outcomes:
measure: Healthcare professionals' compliance with hand hygiene
timeFrame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
measure: Alchol-Based Hand Rub (ABHR) consumption
timeFrame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
measure: Incidence of Healthcare-Associated Infections (HAIs)
timeFrame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
Study officials:
affiliation: Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
name: Miriana D'Andrea, Master of Science in Nursing
role: PRINCIPAL_INVESTIGATOR
References:
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