Infection Control Link Nurses Program to Improve Compliance With Standard Precautions, Hand Hygiene, and Prevent Healthcare-Associated Infections
NCT ID: NCT06857825
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-03-20
2026-08-31
Brief Summary
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* 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).
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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
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
Control group
In the Control group, 4 hospital medical-surgical wards and intensive care units will continue their normal practice, following usual IPC measures
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Centro Cardiologico Monzino
OTHER
Responsible Party
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Principal Investigators
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Miriana D'Andrea, Master of Science in Nursing
Role: PRINCIPAL_INVESTIGATOR
Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
Locations
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Centro Cardiologico Monzino, IRCCS
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Dekker 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.
Ghorbanmovahhed 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.
Sopirala 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.
Donati 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.
Dekker 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.
Cusumaro 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.
Dekker 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.
Peter 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.
Dawson 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.
Dekker 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.
Dekker 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.
Brusaferro 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.
Related Links
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Royal College of Nursing. The Role of the Link Nurse in Infection Prevention and Control (IPC): developing a link nurse framework. RCN
European Centre for Disease Prevention and Control. Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals, 2022-2023.
Other Identifiers
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CCM L2-284
Identifier Type: -
Identifier Source: org_study_id
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