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

NCT06857825 | Recruiting DMC

• 1 other identifier: CCM L2-284
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Standard Precautions; Hand Hygiene Behavior; Healthcare Associated Infections

Keywords

Infection Control Link Nurse; Nursing; Hand Hygiene; Standard Precautions; Healthcare-associated infections

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)

• Alchol-Based Hand Rub (ABHR) consumption

  Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)

• Incidence of Healthcare-Associated Infections (HAIs)

  Data will be collected at enrollment (baseline), and at the end of study (12 months after baseline)

Study Arms (2)

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

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

Interventions

Implementation of Infection Control Link Nurses (ICLNs) BEHAVIORAL

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

Infection Control Link Nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Nurses unavailable to sign informed consent

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead

Study Sites (1)

Centro Cardiologico Monzino, IRCCS

Milan, Italy, 20138, Italy

RECRUITING

Related Publications (13)

• 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.

  PMID: 32742033 BACKGROUND

• 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.

  PMID: 36759832 BACKGROUND

• 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.

  PMID: 37076871 BACKGROUND

• 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.

  PMID: 24548456 BACKGROUND

• 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.

  PMID: 32178856 BACKGROUND

• 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.

  PMID: 32106884 BACKGROUND

• 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.

  PMID: 35084158 BACKGROUND

• 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.

  PMID: 35495104 BACKGROUND

• 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.

  PMID: 29413157 BACKGROUND

• 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.

  PMID: 12919754 BACKGROUND

• 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.

  PMID: 30705754 BACKGROUND

• 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.

  PMID: 38631276 BACKGROUND

• 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.

  PMID: 25777079 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miriana D'Andrea, Master of Science in Nursing

  Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriana D'Andrea, Master of Science in Nursing

CONTACT

+39 0258002997; miriana.dandrea@cardiologicomonzino.it

Claudio Bassi, Nursing manager (Director)

CONTACT

+39 0258002518; claudio.bassi@cardiologicomonzino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 20, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)