NCT04053257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

August 8, 2019

Last Update Submit

July 16, 2021

Conditions

Healthcare Associated InfectionHand HygieneNeonatal Infection

Outcome Measures

Primary Outcomes (2)

  • 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

  • Health care associated infection rate

    HAI number divided by the patient days in the unit

    12 weeks

Secondary Outcomes (2)

  • Number of HH opportunities per minute

    4 weeks

  • Hand hygiene compliance by indication

    4 weeks

Study Arms (2)

Before intervention

NO INTERVENTION

HH opportunities, compliant moments and HAIs recorded before the intervention

After intervention

ACTIVE COMPARATOR

HH opportunities, compliant moments and HAIs recorded after the intervention

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

Interventions

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.

After intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Hospital

Istanbul, 34896, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: Quasiexperimental, before and after study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 12, 2019

Study Start

July 29, 2019

Primary Completion

March 31, 2021

Study Completion

May 11, 2021

Last Updated

July 19, 2021

Record last verified: 2021-07

Locations

TU(1)