Passive Disinfection Cap Compliance Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infection, Hospital

Intervention / Treatment
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* Device: Passive disinfection device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Disinfecting barrier cap<br>In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly. | Device: Passive disinfection device<br>* Add use of passive disinfection cap to existing central line needleless connector infection control procedure<br>* Other names: Curos cap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disinfecting Barrier Cap Compliance | Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage. | 6-month prospective period | 
| Scrub the Hub Protocol Compliance | Compliance with Scrub the hub protocol Data collected retrospectively by survey | 6-month retrospective period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments to determine the CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access | 6-month retrospective period and 6-month prospective period | 
| Catheter-associated Urinary Tract Infection (CAUTI) Rate | Rate of CAUTI per 1000 indwelling urinary catheter days. CAUTI data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of CAUTI is only mandatory in the intensive care setting in Brazil. | 6 months pre-intervention and 6 months post intervention | 
| Ventilator-associated Pneumonia (VAP) Rate | Rate of VAP per 1000 ventilator days. VAP data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of VAP is only mandatory in the intensive care setting in Brazil. | 6-month retrospective period and 6-month prospective period | 
| MBI-Related CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. MBI-related CLABSIs and CVC/day were used to determine MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access. | 6-month retrospective period and 6-month prospective period | 
| Non MBI-related CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. Non MBI-related CLABSIs and CVC/day were used to determine Non-MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access. | 6-month retrospective period and 6-month prospective period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLABSI, Septicemia, Bloodstream infection, Central line associated bloodstream infection, Catheter related bloodstream infection, Intravascular device, Catheter port