Standard PrecautionsINFECTIONNCT06857825
Infection Control Link Nurses Program to Improve Compliance With Standard Precautions, Hand Hygiene, and Prevent Healthcare-Associated Infections
A study of Standard Precautions and Hand Hygiene Behavior, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Standard Precautions, Hand Hygiene Behavior, Healthcare Associated Infections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nursing staff working full time in the hospital wards and intensive care units partecipating in the study
Who cannot join
- Nurses unavailable to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Miriana D'Andrea, Master of Science in Nursing contact
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino, IRCCS
Milan, Italy, 20138
Miriana D'Andrea, Master of Science in Nursing, +39 0258002997, miriana.dandrea@cardiologicomonzino.it
Claudio Bassi, Master of Science in Nursing, +39 0258002518, claudio.bassi@cardiologicomonzino.it
About this study
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
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.
Read more
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).
Read the 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).
- Being tested
- Implementation of Infection Control Link Nurses (ICLNs)
- Keywords
- Infection Control Link Nurse, Nursing, Hand Hygiene, Standard Precautions, Healthcare-associated infections
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Infection Control Link Nurses (ICLNs)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Infection Control Link Nurses | Experimental | 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 Receives: Behavioral: Implementation of Infection Control Link Nurses (ICLNs) |
| Control group | No intervention | In the Control group, 4 hospital medical-surgical wards and intensive care units will continue their normal practice, following usual IPC measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurses' compliance with standard precautions
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
Measured: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Secondary outcomes (3)
Healthcare professionals' compliance with hand hygiene
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.
Measured: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Alchol-Based Hand Rub (ABHR) consumption
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.
Measured: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Incidence of Healthcare-Associated Infections (HAIs)
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
Measured: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start20 Mar 2025
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Standard PrecautionsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miriana D'Andrea, Master of Science in Nursing, Principal investigator, Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857825
- Sponsor's protocol ID
- CCM L2-284
- Acronym
- INFECTION
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ojanpera H, Kanste OI, Syrjala H. Hand-hygiene compliance by hospital staff and incidence of health-care-associated infections, Finland. Bull World Health Organ. 2020 Jul 1;98(7):475-483. doi: 10.2471/BLT.19.247494. Epub 2020 May 26.
PubMed 32742033Dekker M, Jongerden IP, Caris MG, de Bruijne MC, Vandenbroucke-Grauls CMJE, van Mansfeld R. Evaluation of an infection control link nurse program: an analysis using the RE-AIM framework. BMC Health Serv Res. 2023 Feb 9;23(1):140. doi: 10.1186/s12913-023-09111-5.
PubMed 36759832Ghorbanmovahhed S, Shahbazi S, Gilani N, Ostadi A, Shabanloei R, Gholizadeh L. Effectiveness of implementing of an infection control link nurse program to improve compliance with standard precautions and hand hygiene among nurses: a quasi-experimental study. BMC Med Educ. 2023 Apr 19;23(1):265. doi: 10.1186/s12909-023-04208-1.
PubMed 37076871Sopirala MM, Yahle-Dunbar L, Smyer J, Wellington L, Dickman J, Zikri N, Martin J, Kulich P, Taylor D, Mekhjian H, Nash M, Mansfield J, Pancholi P, Howard M, Chase L, Brown S, Kipp K, Lefeld K, Myers A, Pan X, Mangino JE. Infection control link nurse program: an interdisciplinary approach in targeting health care-acquired infection. Am J Infect Control. 2014 Apr;42(4):353-9. doi: 10.1016/j.ajic.2013.10.007. Epub 2014 Feb 16.
PubMed 24548456Donati D, Miccoli GA, Cianfrocca C, Di Stasio E, De Marinis MG, Tartaglini D. Effectiveness of implementing link nurses and audits and feedback to improve nurses' compliance with standard precautions: A cluster randomized controlled trial. Am J Infect Control. 2020 Oct;48(10):1204-1210. doi: 10.1016/j.ajic.2020.01.017. Epub 2020 Mar 13.
PubMed 32178856Dekker M, van Mansfeld R, Vandenbroucke-Grauls C, de Bruijne M, Jongerden I. Infection control link nurse programs in Dutch acute care hospitals; a mixed-methods study. Antimicrob Resist Infect Control. 2020 Feb 27;9(1):42. doi: 10.1186/s13756-020-0704-2.
PubMed 32106884Cusumaro C, Ocagli H. [The Healthcare-associated infections (HAIs) and infection Control link nurse as a strategy to face them: review of literature]. Prof Inferm. 2021 Jul-Sep;74(3):153-160. doi: 10.7429/pi.2021.742153. Italian.
PubMed 35084158Dekker M, van Mansfeld R, Vandenbroucke-Grauls CM, Lauret TE, Schutijser BC, de Bruijne MC, Jongerden IP. Role perception of infection control link nurses; a multi-centre qualitative study. J Infect Prev. 2022 May;23(3):93-100. doi: 10.1177/17571774211066786. Epub 2022 Feb 18.
PubMed 35495104Peter D, Meng M, Kugler C, Mattner F. Strategies to promote infection prevention and control in acute care hospitals with the help of infection control link nurses: A systematic literature review. Am J Infect Control. 2018 Feb;46(2):207-216. doi: 10.1016/j.ajic.2017.07.031.
PubMed 29413157Dawson SJ. The role of the infection control link nurse. J Hosp Infect. 2003 Aug;54(4):251-7; quiz 320. doi: 10.1016/s0195-6701(03)00131-2.
PubMed 12919754Dekker M, Jongerden IP, van Mansfeld R, Ket JCF, van der Werff SD, Vandenbroucke-Grauls CMJE, de Bruijne MC. Infection control link nurses in acute care hospitals: a scoping review. Antimicrob Resist Infect Control. 2019 Jan 28;8:20. doi: 10.1186/s13756-019-0476-8. eCollection 2019.
PubMed 30705754Dekker M, Jongerden IP, van Mansfeld R. Implementation of infection prevention in intensive and critical care: What an infection control link nurse can contribute. Intensive Crit Care Nurs. 2024 Aug;83:103705. doi: 10.1016/j.iccn.2024.103705. Epub 2024 Apr 16. No abstract available.
PubMed 38631276Brusaferro S, Arnoldo L, Cattani G, Fabbro E, Cookson B, Gallagher R, Hartemann P, Holt J, Kalenic S, Popp W, Privitera G, Prikazsky V, Velasco C, Suetens C, Varela Santos C. Harmonizing and supporting infection control training in Europe. J Hosp Infect. 2015 Apr;89(4):351-6. doi: 10.1016/j.jhin.2014.12.005. Epub 2015 Jan 7.
PubMed 25777079
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06857825
- Acronym / sponsor ID
- INFECTION / CCM L2-284
- Keywords
- Infection Control Link Nurse, Nursing, Hand Hygiene, Standard Precautions, Healthcare-associated infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 4 Mar 2025 (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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Infection Control Link Nurses | Experimental | Behavioral: Implementation of Infection Control Link Nurses (ICLNs)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 |
| Control group | No intervention | –In the Control group, 4 hospital medical-surgical wards and intensive care units will continue their normal practice, following usual IPC measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nursing staff working full time in the hospital wards and intensive care units partecipating in the study
Key exclusion criteria (1 listed)
- Nurses unavailable to sign informed consent
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 |
|---|---|---|
| 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 | Behavioural | Infection Control Link Nurses |
Primary outcome
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
3 secondary outcomes
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 32742033Ojanpera H, Kanste OI, Syrjala H. Hand-hygiene compliance by hospital staff and incidence of health-care-associated infections, Finland. Bull World Health Organ. 2020 Jul 1;98(7):475-483. doi: 10.2471/BLT.19.247494. Epub 2020 May 26.
- Background: PubMed 36759832Dekker M, Jongerden IP, Caris MG, de Bruijne MC, Vandenbroucke-Grauls CMJE, van Mansfeld R. Evaluation of an infection control link nurse program: an analysis using the RE-AIM framework. BMC Health Serv Res. 2023 Feb 9;23(1):140. doi: 10.1186/s12913-023-09111-5.
- Background: PubMed 37076871Ghorbanmovahhed S, Shahbazi S, Gilani N, Ostadi A, Shabanloei R, Gholizadeh L. Effectiveness of implementing of an infection control link nurse program to improve compliance with standard precautions and hand hygiene among nurses: a quasi-experimental study. BMC Med Educ. 2023 Apr 19;23(1):265. doi: 10.1186/s12909-023-04208-1.
- Background: PubMed 24548456Sopirala MM, Yahle-Dunbar L, Smyer J, Wellington L, Dickman J, Zikri N, Martin J, Kulich P, Taylor D, Mekhjian H, Nash M, Mansfield J, Pancholi P, Howard M, Chase L, Brown S, Kipp K, Lefeld K, Myers A, Pan X, Mangino JE. Infection control link nurse program: an interdisciplinary approach in targeting health care-acquired infection. Am J Infect Control. 2014 Apr;42(4):353-9. doi: 10.1016/j.ajic.2013.10.007. Epub 2014 Feb 16.
- Background: PubMed 32178856Donati D, Miccoli GA, Cianfrocca C, Di Stasio E, De Marinis MG, Tartaglini D. Effectiveness of implementing link nurses and audits and feedback to improve nurses' compliance with standard precautions: A cluster randomized controlled trial. Am J Infect Control. 2020 Oct;48(10):1204-1210. doi: 10.1016/j.ajic.2020.01.017. Epub 2020 Mar 13.
- Background: PubMed 32106884Dekker M, van Mansfeld R, Vandenbroucke-Grauls C, de Bruijne M, Jongerden I. Infection control link nurse programs in Dutch acute care hospitals; a mixed-methods study. Antimicrob Resist Infect Control. 2020 Feb 27;9(1):42. doi: 10.1186/s13756-020-0704-2.
- Background: PubMed 35084158Cusumaro C, Ocagli H. [The Healthcare-associated infections (HAIs) and infection Control link nurse as a strategy to face them: review of literature]. Prof Inferm. 2021 Jul-Sep;74(3):153-160. doi: 10.7429/pi.2021.742153. Italian.
- Background: PubMed 35495104Dekker M, van Mansfeld R, Vandenbroucke-Grauls CM, Lauret TE, Schutijser BC, de Bruijne MC, Jongerden IP. Role perception of infection control link nurses; a multi-centre qualitative study. J Infect Prev. 2022 May;23(3):93-100. doi: 10.1177/17571774211066786. Epub 2022 Feb 18.
- Background: PubMed 29413157Peter D, Meng M, Kugler C, Mattner F. Strategies to promote infection prevention and control in acute care hospitals with the help of infection control link nurses: A systematic literature review. Am J Infect Control. 2018 Feb;46(2):207-216. doi: 10.1016/j.ajic.2017.07.031.
- Background: PubMed 12919754Dawson SJ. The role of the infection control link nurse. J Hosp Infect. 2003 Aug;54(4):251-7; quiz 320. doi: 10.1016/s0195-6701(03)00131-2.
- Background: PubMed 30705754Dekker M, Jongerden IP, van Mansfeld R, Ket JCF, van der Werff SD, Vandenbroucke-Grauls CMJE, de Bruijne MC. Infection control link nurses in acute care hospitals: a scoping review. Antimicrob Resist Infect Control. 2019 Jan 28;8:20. doi: 10.1186/s13756-019-0476-8. eCollection 2019.
- Background: PubMed 38631276Dekker M, Jongerden IP, van Mansfeld R. Implementation of infection prevention in intensive and critical care: What an infection control link nurse can contribute. Intensive Crit Care Nurs. 2024 Aug;83:103705. doi: 10.1016/j.iccn.2024.103705. Epub 2024 Apr 16. No abstract available.
- European Centre for Disease Prevention and Control. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals, 2022-2023.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Miriana D'Andrea, Master of Science in Nursing contact
Miriana D'Andrea, Master of Science in Nursing principal investigator
Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Standard Precautions and Hand Hygiene Behavior, run by Centro Cardiologico Monzino at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriana D'Andrea, Master of Science in Nursing (+39 0258002997, miriana.dandrea@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses' compliance with standard precautions (time frame: Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857825, which also lists 13 linked publications.
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 4 Apr 2025.