Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST)

Infections, Respiratory Clinical Trial

Official title:

Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST) - a Cluster Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05721183
• Other study ID #: NOST
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2023
• Source: Norwegian Institute of Public Health
• Contact: Petter Elstrøm, PhD
• Phone: +4721077000
• Email: petter.elstrom[@]fhi.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Norwegian Institute of Public Health (NIPH) is introducing a new electronic tool for direct observation of compliance with recommended infection prevention and control measures in healthcare. The solution is called the National Tool for Observation of Infection Prevention Measures (NOST). NOST is a quality improvement tool that includes a web-based solution for observing compliance with recommendations for hand hygiene and other IPC measures. Through NOST, healthcare personnel will be able to identify the local level of compliance, which in turn can reveal areas for improvement.

This protocol includes the evaluation of NOST in hospitals. The evaluation is designed as a cluster-randomized controlled trial with two arms where eligible wards in hospitals are randomly allocated into an intervention and a control arm. NOST is implemented in the intervention wards at the start of the evaluation period, and compliance with hand hygiene and other outcomes are measured in both the interventions and control wards one year later.

The objective of evaluating NOST is to:

• measure if implementation of NOST leads to improved infection prevention and control in the form of increased compliance with hand hygiene recommendations, and

• measure if changes in the quality of infection prevention and control as a result of implemented NOST affects the epidemiology of healthcare-associated infections in healthcare institutions and the length of hospital stays.

Description:

The evaluation og NOST is designed as a cluster-randomized controlled trial with two arms where eligible wards in hospitals are randomly allocated into an intervention and a control arm. NOST is implemented in the intervention wards at the start of the evaluation period, and compliance with hand hygiene and other outcomes are measured in both the interventions and control wards one year later.

Intervention

The intervention in the study is to implement NOST, which includes:

• observation and recording of compliance with hand hygiene recommendations

• identification of areas for improvement

• training or other actions taken to improve IPC in general or compliance with hand hygiene.

Thus, the intervention includes both observation of compliance and any additional improvement measures initiated as a result of the introduced NOST.

Observations of hand hygiene will be carried out in sessions of 20-30 minutes. During this period, all situations where hand hygiene is indicated (recommended) and whether hand hygiene is performed or not, are recorded. The number of hand hygiene indications during a session varies but will often be between 10 and 20.

When the intervention group has implemented and followed NOST for a year, the investigators will measure compliance with hand hygiene recommendations and reported HAIs, in wards that have had NOST and in wards that have not introduced NOST.

The intervention arm will be followed over time with repeated measurements of both compliance with hand hygiene and other outcome measures, to see if the effect increases in line with implemented observations and quality improvement measures, or if the effect decreases during the study period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospital wards with day- and night care.

Exclusion Criteria:

• Intensivecare units.

Related Conditions & MeSH terms

• Communicable Diseases
• Healthcare Worker Patient Transmission
• Infections
• Infections, Respiratory
• Respiratory Tract Infections

Intervention

Behavioral:
• NOST
The intervention is to implement NOST, which includes: observation and recording of compliance with hand hygiene recommendations identification of areas for improvement training or other actions taken to improve IPC in general or compliance with hand hygiene. Thus, the intervention includes both observation of compliance and any additional improvement measures initiated as a result of the introduced NOST. When the intervention group has implemented and followed NOST for a year, the investigators will measure compliance with hand hygiene recommendations and reported HAIs, in wards that have had NOST and in wards that have not introduced NOST. The intervention arm will be followed over time with repeated measurements of both compliance with hand hygiene and other outcome measures, to see if the effect increases in line with implemented observations and quality improvement measures, or if the effect decreases during the study period.

Locations

Country	Name	City	State
Norway	Norwegian Institute of Public Health	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand hygiene observations	Self-reported proportion of correct compliance, in total and by occupation	Day 1 to one year later
Secondary	Outbreaks of infectious diseases	Proportion of outbreaks per ward and secondary attack rate by inpatients and staff. Data collected from VESUV	Day 1 to one year later
Secondary	Surveillance of healthcare-associated infections	Proportion of infected inpatients by type of infections. Data collected from NOIS	Day 1 to one year later
Secondary	Surveillance of postoperative site infections	Proportion of infected patients by type of surgery and type of infections. Data collected from NOIS and POSI	Day 1 to one year later
Secondary	Length of stay	Mean and median bed-days per stay. Data collected from NRP	Day 1 to one year later