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

Primary Purpose

Healthcare Associated Infection, Hand Hygiene, Neonatal Infection

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Healthcare Associated Infection

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Marmara University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Before intervention

After intervention

Arm Description

HH opportunities, compliant moments and HAIs recorded before the intervention

HH opportunities, compliant moments and HAIs recorded after the intervention

Outcomes

Primary Outcome Measures

Total hand hygiene compliance of health care workers
By dividing the total HH opportunities for each subject by the number of HH compliance × 100
Health care associated infection rate
HAI number divided by the patient days in the unit

Secondary Outcome Measures

Number of HH opportunities per minute
Total number of HH opportunities divided by total HH observation minutes
Hand hygiene compliance by indication
Dividing HH opportunities for each indication by HH compliance for each indication.

Full Information

First Posted
August 8, 2019
Last Updated
July 16, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04053257
Brief Title
Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Infections in NICU
Acronym
CaM-HAI
Official Title
Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Healthcare Associated Infections in Neonatal Intensive Care Unit, an Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

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 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Associated Infection, Hand Hygiene, Neonatal Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Quasiexperimental, before and after study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Before intervention
Arm Type
No Intervention
Arm Description
HH opportunities, compliant moments and HAIs recorded before the intervention
Arm Title
After intervention
Arm Type
Active Comparator
Arm Description
HH opportunities, compliant moments and HAIs recorded after the intervention
Intervention Type
Other
Intervention Name(s)
Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total hand hygiene compliance of health care workers
Description
By dividing the total HH opportunities for each subject by the number of HH compliance × 100
Time Frame
4 weeks
Title
Health care associated infection rate
Description
HAI number divided by the patient days in the unit
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of HH opportunities per minute
Description
Total number of HH opportunities divided by total HH observation minutes
Time Frame
4 weeks
Title
Hand hygiene compliance by indication
Description
Dividing HH opportunities for each indication by HH compliance for each indication.
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - All HCWs working in the NICU during the study period. Exclusion Criteria: - Visiting patient relatives in the NICU during the study period.
Facility Information:
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
34896
Country
Turkey

12. IPD Sharing Statement

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

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