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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04053257
Other study ID # 09.2019.710
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 29, 2019
Est. completion date May 11, 2021

Study information

Verified date July 2021
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 8335
Est. completion date May 11, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
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.

Locations

Country Name City State
Turkey Marmara University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total hand hygiene compliance of health care workers By dividing the total HH opportunities for each subject by the number of HH compliance × 100 4 weeks
Primary Health care associated infection rate HAI number divided by the patient days in the unit 12 weeks
Secondary Number of HH opportunities per minute Total number of HH opportunities divided by total HH observation minutes 4 weeks
Secondary Hand hygiene compliance by indication Dividing HH opportunities for each indication by HH compliance for each indication. 4 weeks
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