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Healthcare Associated InfectionCaM-HAINCT04053257

Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Infections in NICU

A study testing Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs in people with Healthcare Associated Infection and Hand Hygiene, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if use of the video camera surveillance system for HH observation and performance feedback about HH compliance rates can improve the HH compliance of HCWs and reduce healthcare-associated infections in the NICU. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,335 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Jul 2019to 11 May 2021
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

  • All HCWs working in the NICU during the study period.

Who cannot join

  • Visiting patient relatives in the NICU during the study period.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University Hospital

    Istanbul, 34896

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Healthcare Associated Infections in Neonatal Intensive Care Unit, an Interventional Study

The purpose of this study is to determine if use of the video camera surveillance system for HH observation and performance feedback about HH compliance rates can improve the HH compliance of HCWs and reduce healthcare-associated infections in the NICU.

Read the detailed description

Hypothesis:

H1: Hand hygiene (HH) compliance monitoring using video camera surveillance and giving feedback of HH compliance rates to HCWs would effect the hand hygiene behavior of health care workers (HCW) and healthcare-associated infections (HAI).

Study design:

A video camera surveillance system is in place in all NICU rooms since 2018. The investigators designed a quasiexperimental (before-after) study.

Study site and participants:

The research will take place in NICU from July 2019 to March 2020. All nurses, attending physicians, resident physicians, environmental services staff, medical assistants work in NICU.

Control period (Before intervention):

We will observe HH behavior of HCWs using the video camera surveillance for four weeks. This will give us the baseline HH compliance rates of NICU.

The baseline HAI rates will be calculated of the 3 months before intervention.

Intervention:

We will report baseline HH compliance rates and HAI rates to HCWs during a meeting where all HCWs are present. During this meeting we will remind major infection control measures, give examples of common mistakes they made without violating personal privacy rights of HCWs and patients.

Experimental period (After intervention):

The investigators will perform HH observation for four weeks after the intervention. At the end of the observation period, feedback about the HH compliance rates, change and detailed analysis of HH compliance rates by indication, day of week, hour of the day and NICU rooms will be given during a second meeting with HCWs.

HAI rates will be calculated for period of 3 months after intervention.

Sustainability of the intervention:

We will measure HH compliance rates 12 weeks after the intervention to investigate the sustainability of our intervention.

A third meeting will be done with HCWs in the unit which the investigator give feedback about the HH compliance, HAI rates before and after the intervention periods.

Data collection:

Seven, trained HH observers will participate in the study. These observers will achieve at least 80% concordance before the study. HH compliance data will be collected using a mobile app. HH monitoring will be performed Monday through Sunday making observations from randomly selected 20 minutes lapses of morning (08:00 am - 04:59 pm), afternoon (05:00 pm - 11:59 pm) and night (00:00 am - 07:59 am) shifts of the day. All HCWs in the room during the 20 minutes observation period are monitored for HH opportunities. Each HH opportunity was stratified as compliant or noncompliant and was classified according to the three of WHO's My 5 Moments for HH as follows: (1) before touching a patient, (4) after touching a patient, and (5) after contact with the patient's environment. HH moments before an aseptic task (2) and after body fluid exposure risk (3) was not included due to low resolution of video camera surveillance system.

Compliance was calculated by dividing the total HH opportunities for each subject by the number of HH compliance × 100. Adequate materials for HH are defined using either the soap and water or alcohol-based handrub solution.

HAIs are identified and recorded by active surveillance method in NICU. HAIs are identified using CDC criteria.

Sample Size:

We used G-power program for sample size calculation. With a power of 90%, 0.05 type I error rate and anticipated HH compliance increase before and after intervention period as 10% we planned to record 538 HH opportunities for each period (1076 HH opportunities total)

Being tested
Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
Medical subject headings
Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWsOther

    Intervention:

    We will report baseline HH compliance rates and HAI rates to HCWs during a meeting where all HCWs are present. During this meeting we will remind major infection control measures, give examples of common mistakes they made without violating personal privacy rights of HCWs and patients.

Study groups in NCT04053257
Study groupRoleWhat they receive
Before interventionNo interventionHH opportunities, compliant moments and HAIs recorded before the intervention
After interventionActive comparatorHH opportunities, compliant moments and HAIs recorded after the intervention
Receives: Other: Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total hand hygiene compliance of health care workers

    By dividing the total HH opportunities for each subject by the number of HH compliance × 100

    Measured: 4 weeks

  2. Health care associated infection rate

    HAI number divided by the patient days in the unit

    Measured: 12 weeks

Secondary outcomes (2)
  1. Number of HH opportunities per minute

    Total number of HH opportunities divided by total HH observation minutes

    Measured: 4 weeks

  2. Hand hygiene compliance by indication

    Dividing HH opportunities for each indication by HH compliance for each indication.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2019
  2. Study start29 Jul 2019
  3. Primary completion31 Mar 2021
  4. Study completion11 May 2021

Resources

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
Screening
Allocation
Non-randomised
Intervention model
Sequential
Model description
Quasiexperimental, before and after study
Masking
None (open label)
Enrolment
8,335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04053257
Sponsor's protocol ID
09.2019.710
Acronym
CaM-HAI
Status last verified
Jul 2021
First submitted
8 Aug 2019
Last updated
19 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs in people with Healthcare Associated Infection and Hand Hygiene, run by Marmara University at 1 site in Turkey (Türkiye).

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: finished, as of the sponsor's last update on 19 Jul 2021. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total hand hygiene compliance of health care workers (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 19 Jul 2021.

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