Infection, Hospital
Conditions
Keywords
CLABSI, Septicemia, Bloodstream infection, Central line associated bloodstream infection, Catheter related bloodstream infection, Intravascular device, Catheter port
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.
Interventions
DEVICEPassive disinfection device
Add use of passive disinfection cap to existing central line needleless connector infection control procedure
Sponsors
Eurotrials Brasil Consultores Cientificos Ltda
3M
Solventum US LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disinfecting Barrier Cap Compliance | 6-month prospective period | 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. |
| Scrub the Hub Protocol Compliance | 6-month retrospective period | Compliance with Scrub the hub protocol Data collected retrospectively by survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-associated Pneumonia (VAP) Rate | 6-month retrospective period and 6-month prospective period | 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. |
| CLABSI Rate | 6-month retrospective period and 6-month prospective period | 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 |
| Non MBI-related CLABSI Rate | 6-month retrospective period and 6-month prospective period | 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. |
| MBI-Related CLABSI Rate | 6-month retrospective period and 6-month prospective period | 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. |
| Catheter-associated Urinary Tract Infection (CAUTI) Rate | 6 months pre-intervention and 6 months post intervention | 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. |
Countries
United States
Participant flow
Recruitment details
No individual patient was recruited into the study.
Participants by arm
| Arm | Count |
|---|---|
| Not Applicable During the study, Baseline data were not collected for the health care workers. No individual patient was consented in the study. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 6-month prospective period
Population: No patients assessed for disinfecting barrier cap compliance. Compliance with disinfecting barrier cap was measured by observation of numbers of applicable capped, uncapped ports and misused caps. A total of 156 audits were performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disinfecting Barrier Cap Compliance | Disinfecting Barrier Cap Compliance | 98.43 percentage of connector with compliance | Standard Deviation 4.18 |
Primary
Scrub the Hub Protocol Compliance
Compliance with Scrub the hub protocol Data collected retrospectively by survey
Time frame: 6-month retrospective period
Population: Compliance with scrub the hub was retrospectively obtained by a survey from 165 healthcare workers who were using needlessness connectors for patient IV access. One was excluded from the compliance analysis due to an inconsistency in the survey data. No patients assessed for disinfecting barrier cap compliance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Disinfecting Barrier Cap Compliance | Scrub the Hub Protocol Compliance | 5.95 percentage of protocol compliance | Standard Deviation 21.36 |
Secondary
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.
Time frame: 6 months pre-intervention and 6 months post intervention
Population: Infections from patients with indwelling urinary catheters in one ICU ward. Total 6 units. No individual patients were enrolled in this study. No patients assessed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disinfecting Barrier Cap Compliance | Catheter-associated Urinary Tract Infection (CAUTI) Rate | 0.78 CAUTI rate per 1000 catheter days |
| CLABSI Rate for Post-intervention Period | Catheter-associated Urinary Tract Infection (CAUTI) Rate | 2.26 CAUTI rate per 1000 catheter days |
Secondary
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
Time frame: 6-month retrospective period and 6-month prospective period
Population: Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disinfecting Barrier Cap Compliance | CLABSI Rate | 2.9 CLABSI rate per 1000 catheter days |
| CLABSI Rate for Post-intervention Period | CLABSI Rate | 3.2 CLABSI rate per 1000 catheter days |
Secondary
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.
Time frame: 6-month retrospective period and 6-month prospective period
Population: Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disinfecting Barrier Cap Compliance | MBI-Related CLABSI Rate | 1 MBI CLABSI rate per 1000 catheter days |
| CLABSI Rate for Post-intervention Period | MBI-Related CLABSI Rate | 1.28 MBI CLABSI rate per 1000 catheter days |
Secondary
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.
Time frame: 6-month retrospective period and 6-month prospective period
Population: Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disinfecting Barrier Cap Compliance | Non MBI-related CLABSI Rate | 1.93 CLABSI rate per 1000 catheter days |
| CLABSI Rate for Post-intervention Period | Non MBI-related CLABSI Rate | 1.92 CLABSI rate per 1000 catheter days |
Secondary
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.
Time frame: 6-month retrospective period and 6-month prospective period
Population: Infections from patients who have been intubated and received mechanical ventilation in one ICU ward (6 units). No Patients assessed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disinfecting Barrier Cap Compliance | Ventilator-associated Pneumonia (VAP) Rate | 6.2 VAP rate per 1000 ventilator days |
| CLABSI Rate for Post-intervention Period | Ventilator-associated Pneumonia (VAP) Rate | 5.35 VAP rate per 1000 ventilator days |