Clinical trial NCT05721183: Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST)
Official title: Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST) - a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infections, Respiratory
Healthcare Worker Patient Transmission
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2023-02-09
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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, 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.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Hospital wards with day- and night care.

Exclusion Criteria:

* Intensivecare units.

Primary outcomes:
measure: Hand hygiene observations
timeFrame: Day 1 to one year later
Secondary outcomes:
measure: Outbreaks of infectious diseases
timeFrame: Day 1 to one year later
measure: Surveillance of healthcare-associated infections
timeFrame: Day 1 to one year later
measure: Surveillance of postoperative site infections
timeFrame: Day 1 to one year later
measure: Length of stay
timeFrame: Day 1 to one year later
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
affiliation: Norwegian Institute of Public Health
name: Petter Elstrøm, PhD
role: PRINCIPAL_INVESTIGATOR
References: