Infections, RespiratoryNCT05721183
Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST)
A study testing NOST in people with Infections, Respiratory and Healthcare Worker Patient Transmission, run by Norwegian Institute of Public Health at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infections, Respiratory, Healthcare Worker Patient Transmission
- What is being tested?
- NOST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNorway
- Study dates
- 20 Feb 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Hospital wards with day- and night care.
Who cannot join
- Intensivecare units.
Trial locations and contacts
1 site in 1 country.
Mette Fagernes, PhD contact
Norway1 site
Norwegian Institute of Public Health
Oslo, 0213
Petter Elstrøm, PhD, petter.elstrom@fhi.no
Mette Fagernes, PhD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- NOST
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOSTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: NOST |
| Control | No intervention | Participants in the no intervention arm arm are asked not to implement NOST. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand hygiene observations
Self-reported proportion of correct compliance, in total and by occupation
Measured: Day 1 to one year later
Secondary outcomes (4)
Outbreaks of infectious diseases
Proportion of outbreaks per ward and secondary attack rate by inpatients and staff. Data collected from VESUV
Measured: Day 1 to one year later
Surveillance of healthcare-associated infections
Proportion of infected inpatients by type of infections. Data collected from NOIS
Measured: 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
Measured: Day 1 to one year later
Length of stay
Mean and median bed-days per stay. Data collected from NRP
Measured: Day 1 to one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start20 Feb 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Petter Elstrøm, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721183
- Sponsor's protocol ID
- NOST
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST) - a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05721183
- Acronym / sponsor ID
- NOST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NOST | Experimental | Behavioral: NOSTThe 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. |
| Control | No intervention | –Participants in the no intervention arm arm are asked not to implement NOST. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hospital wards with day- and night care.
Key exclusion criteria (1 listed)
- Intensivecare units.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOSTThe 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. | Behavioural | NOST |
Primary outcome
Hand hygiene observations
Time frame: Day 1 to one year later
Self-reported proportion of correct compliance, in total and by occupation
4 secondary outcomes
Outbreaks of infectious diseases
Time frame: Day 1 to one year later
Surveillance of healthcare-associated infections
Time frame: Day 1 to one year later
Surveillance of postoperative site infections
Time frame: Day 1 to one year later
Length of stay
Time frame: Day 1 to one year later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Fagernes, PhD contact
Petter Elstrøm, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOST in people with Infections, Respiratory and Healthcare Worker Patient Transmission, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petter Elstrøm, PhD (+4721077000, petter.elstrom@fhi.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand hygiene observations (time frame: Day 1 to one year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.