NCT05721183

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

January 31, 2023

Last Update Submit

February 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hand hygiene observations

    Self-reported proportion of correct compliance, in total and by occupation

    Day 1 to one year later

Secondary Outcomes (4)

  • Outbreaks of infectious diseases

    Day 1 to one year later

  • Surveillance of healthcare-associated infections

    Day 1 to one year later

  • Surveillance of postoperative site infections

    Day 1 to one year later

  • Length of stay

    Day 1 to one year later

Study Arms (2)

NOST

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in the no intervention arm arm are asked not to implement NOST.

Interventions

NOSTBEHAVIORAL

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.

NOST

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hospital wards with day- and night care.

You may not qualify if:

  • Intensivecare units.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Oslo, 0213, Norway

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Petter Elstrøm, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petter Elstrøm, PhD

CONTACT

Mette Fagernes, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The reserachers who evaluates the outcome of interest will be masked for the group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

February 20, 2023

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

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).

Locations