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

Primary Purpose

Infections, Respiratory, Healthcare Worker Patient Transmission

Status
Not yet recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
NOST
Sponsored by
Norwegian Institute of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Respiratory

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Hospital wards with day- and night care. Exclusion Criteria: Intensivecare units.

Sites / Locations

  • Norwegian Institute of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NOST

Control

Arm 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, 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Outbreaks of infectious diseases
Proportion of outbreaks per ward and secondary attack rate by inpatients and staff. Data collected from VESUV
Surveillance of healthcare-associated infections
Proportion of infected inpatients by type of infections. Data collected from NOIS
Surveillance of postoperative site infections
Proportion of infected patients by type of surgery and type of infections. Data collected from NOIS and POSI
Length of stay
Mean and median bed-days per stay. Data collected from NRP

Full Information

First Posted
January 31, 2023
Last Updated
February 17, 2023
Sponsor
Norwegian Institute of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT05721183
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 20, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Institute of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Respiratory, Healthcare Worker Patient Transmission

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The reserachers who evaluates the outcome of interest will be masked for the group allocation.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NOST
Arm Type
Experimental
Arm 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, 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the no intervention arm arm are asked not to implement NOST.
Intervention Type
Behavioral
Intervention Name(s)
NOST
Intervention 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, 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.
Primary Outcome Measure Information:
Title
Hand hygiene observations
Description
Self-reported proportion of correct compliance, in total and by occupation
Time Frame
Day 1 to one year later
Secondary Outcome Measure Information:
Title
Outbreaks of infectious diseases
Description
Proportion of outbreaks per ward and secondary attack rate by inpatients and staff. Data collected from VESUV
Time Frame
Day 1 to one year later
Title
Surveillance of healthcare-associated infections
Description
Proportion of infected inpatients by type of infections. Data collected from NOIS
Time Frame
Day 1 to one year later
Title
Surveillance of postoperative site infections
Description
Proportion of infected patients by type of surgery and type of infections. Data collected from NOIS and POSI
Time Frame
Day 1 to one year later
Title
Length of stay
Description
Mean and median bed-days per stay. Data collected from NRP
Time Frame
Day 1 to one year later

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hospital wards with day- and night care. Exclusion Criteria: Intensivecare units.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petter Elstrøm, PhD
Phone
+4721077000
Email
petter.elstrom@fhi.no
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Fagernes, PhD
Email
mette.fagernes@fhi.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter Elstrøm, PhD
Organizational Affiliation
Norwegian Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian Institute of Public Health
City
Oslo
ZIP/Postal Code
0213
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petter Elstrøm, PhD
Email
petter.elstrom@fhi.no
First Name & Middle Initial & Last Name & Degree
Mette Fagernes, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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).

Learn more about this trial

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

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