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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infections, Respiratory; Healthcare Worker Patient Transmission
• Intervention / Treatment: Behavioral: NOST

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0213
    • Norwegian Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospital wards with day- and night care.

Exclusion Criteria:

• Intensivecare units.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; Participants in the no intervention arm arm are asked not to implement NOST.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand hygiene observations	Self-reported proportion of correct compliance, in total and by occupation	Day 1 to one year later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Surveillance of healthcare-associated infections	Proportion of infected inpatients by type of infections. Data collected from NOIS	Day 1 to one year later
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
Length of stay	Mean and median bed-days per stay. Data collected from NRP	Day 1 to one year later

Collaborators and Investigators

• Sponsor: Norwegian Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: NOST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In this project, the investigators will not register or collect direct identifiable personal data. In the hand hygiene observations, only the events and occupation are recorded, but not personal data on the people observed. Furthermore, the investigators will only ask for statistics from VESUV and NOIS/NOIS-POSI. This data will include the number of people infected in outbreaks per ward distributed by employees and inpatients, as well as the number of inpatients with relevant types of infection in the surveillance of HAI. These data are regularly published at the hospital level. The investigators will apply for data from NPR that includes information on each patient admitted to the relevant wards in the period from 1 January 2022 to mid-2024. However, the investigators will ask for data without directly personally identifiable information (data without name and social security number).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No