Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Infections in NICU (CaM-HAI)

July 16, 2021 updated by: Marmara University

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.

Study Overview

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)

Study Type

Interventional

Enrollment (Actual)

8335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34896
        • Marmara University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Before intervention
HH opportunities, compliant moments and HAIs recorded before the intervention
ACTIVE_COMPARATOR: After intervention
HH opportunities, compliant moments and HAIs recorded after the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total hand hygiene compliance of health care workers
Time Frame: 4 weeks
By dividing the total HH opportunities for each subject by the number of HH compliance × 100
4 weeks
Health care associated infection rate
Time Frame: 12 weeks
HAI number divided by the patient days in the unit
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of HH opportunities per minute
Time Frame: 4 weeks
Total number of HH opportunities divided by total HH observation minutes
4 weeks
Hand hygiene compliance by indication
Time Frame: 4 weeks
Dividing HH opportunities for each indication by HH compliance for each indication.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 29, 2019

Primary Completion (ACTUAL)

March 31, 2021

Study Completion (ACTUAL)

May 11, 2021

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (ACTUAL)

August 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 09.2019.710

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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