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)
