Passive Disinfection Cap Compliance Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-10-31

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.

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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.

Conditions

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Infection, Hospital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Disinfecting barrier cap

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.

Group Type OTHER

Passive disinfection device

Intervention Type DEVICE

Add use of passive disinfection cap to existing central line needleless connector infection control procedure

Interventions

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Passive disinfection device

Add use of passive disinfection cap to existing central line needleless connector infection control procedure

Intervention Type DEVICE

Other Intervention Names

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Passive disinfecting cap Disinfecting cap Curos disinfecting cap Curos cap

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No