Clinical trial NCT03391960: Passive Disinfection Cap Compliance Study
Official title: A Compliance Improvement Project to Reduce Central Line Associated Blood Stream Infection (CLABSI) Using a Passive Disinfection Device in an Adult Oncological Hospital in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection, Hospital
Keywords: CLABSI
Septicemia
Bloodstream infection
Central line associated bloodstream infection
Catheter related bloodstream infection
Intravascular device
Catheter port
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: Eurotrials Brasil Consultores Cientificos Ltda
name: 3M
First posted: 2018-01-05
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.

The purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.

The compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.

Detailed description: Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.

The purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.

Compliance is defined as following the protocol for disinfection of the catheter port. In the pre-intervention period, the disinfection protocol will utilize existing institution scrub-the-hub method. Compliance in the pre-intervention period will be determined by survey.

After the pre-intervention period is complete, passive disinfecting devices (caps) will be implemented hospital-wide for any adult patient using CVC ports.

In the intervention period, the disinfection protocol consists of using the disinfecting barrier cap on every needless connector (catheter port) used for accessing CVC IV lines per protocol. Compliance will be measured using observations, according to a schedule to ensure the absence of a shift bias. Observations will contain the number of needless connectors on CVCs with, and the number of needleless connectors without, disinfecting barrier caps attached.

The compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.

Incidence of CLABSI will be noted from existing aggregate hospital surveillance system data. The incidence, in terms of catheter days, will be recorded for each assigned intervention ward and for intervention ward overall by month, in the six months before the intervention and in the six-month intervention recording period.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the participant oncologic hospital
* Adult patients in the assigned intervention units during the seven month intervention period who require needleless connectors for CVC IV tubing access.

Exclusion Criteria:

* Adult patients admitted to the participant oncologic hospital during the seven month intervention period that do not require needleless connectors for CVC IV access during their hospital stay.

Primary outcomes:
measure: Disinfecting Barrier Cap Compliance
timeFrame: 6-month prospective period
measure: Scrub the Hub Protocol Compliance
timeFrame: 6-month retrospective period
Secondary outcomes:
measure: CLABSI Rate
timeFrame: 6-month retrospective period and 6-month prospective period
measure: Catheter-associated Urinary Tract Infection (CAUTI) Rate
timeFrame: 6 months pre-intervention and 6 months post intervention
measure: Ventilator-associated Pneumonia (VAP) Rate
timeFrame: 6-month retrospective period and 6-month prospective period
measure: MBI-Related CLABSI Rate
timeFrame: 6-month retrospective period and 6-month prospective period
measure: Non MBI-related CLABSI Rate
timeFrame: 6-month retrospective period and 6-month prospective period
Other outcomes:
Locations:
city: Maplewood
country: United States
facility: 3M HealthCare
state: Minnesota
Study officials:
affiliation: Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
name: Ricardo A Zimerman, MD
role: PRINCIPAL_INVESTIGATOR
References: