Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02351258
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2015-01-27
Brief Title:
Community Central Line Infection Prevention Trial
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Community Central Line Infection Prevention Trial
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCLIP
Brief Summary:
The overall goal of this Community Central Line Infection Prevention CCLIP trial supported by grant R01 HS022870 from the Agency for Healthcare Research and Quality is to determine whether use of a promising new intervention namely 70 isopropyl alcohol embedded protective caps on central lines in the home setting is associated with a reduction in ambulatory central line-associated bloodstream infections CLABSI in a high-risk population of pediatric hematologyoncology patients Despite successes in CLABSI reduction efforts for inpatients it remains unknown what generalizable best practices should be with chronic central lines in the home setting and how effective involving patients and caregivers across multiple institutions in CLABSI reduction efforts will be This research will involve a cluster-randomized cross-over design clinical trial This proposal will focus on the caregivers integral to ambulatory pediatric central line care patients and families The specific aims of the proposed research program are
Specific Aim 1 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the ambulatory CLABSI rate for pediatric hematologyoncology patients
Specific Aim 2 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the positive blood culture rate at home for pediatric hematologyoncology patients
Specific Aim 3 Evaluate whether the use of 70 isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will reduce Gram-positive CLABSI secondary blood steam infections and single positive blood cultures at home for pediatric hematologyoncology patients
Specific Aim 1 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the ambulatory CLABSI rate for pediatric hematologyoncology patients
Specific Aim 2 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the positive blood culture rate at home for pediatric hematologyoncology patients
Specific Aim 3 Evaluate whether the use of 70 isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will reduce Gram-positive CLABSI secondary blood steam infections and single positive blood cultures at home for pediatric hematologyoncology patients
Detailed Description:
Study Design and Population The proposed study will use a cluster-randomized 2 period crossover design clinical trial to evaluate a promising new intervention namely 70 isopropyl alcohol embedded protective caps to reduce CLABSIs 2ndry BSI and SPBC at home for chronic central lines in pediatric hematologyoncology patients The Control Arm will involve usual care for ambulatory central lines per institutional policy and the Intervention Arm will add use of 70 isopropyl alcohol embedded protective caps to usual care Each participating institution will be randomly assigned to either the intervention or control phase of the design for the first 12 months of the study There will then be a 3 month wash out period followed by each institution then implementing either the control or intervention phase for another 12 months such that each institution will complete 12 months each in the intervention arm and the control arms of the study
Sixteen pediatric hematologyoncology institutions will serve as the core population for this proposal and unit of randomization All ambulatory patients taken care of by these pediatric hematologyoncology clinics at these institutions will be eligible for this study The only inclusion criteria will be presence of an external central line Given the intervention is a protective cap for central line access ports patients who only have a totally implanted port as their central venous access will not be eligible for this study as the intervention is not physically applicable to such central lines
The intervention the investigators will deploy is the CUROS brand of 70 isopropyl alcohol embedded protective caps for central lines These caps are manufactured by Ivera Medical Corporation As in kind contribution to this proposed study Ivera Medical Corporation has agreed to donate and distribute all needed CUROS caps to the participating institutions for the duration of this study If any of the participating teams wishes to instead use a comparable brand of 70 isopropyl alcohol embedded protective caps for central lines that will be permitted
Distribution of the CUROS caps will be accomplished within the clinics of each participating institution and compliance with the intervention at homes will be monitored by clinic staff via tracking counts of CUROS caps dispensed to families Children with chronic hematologiconcologic conditions are seen frequently in clinic often up to every week Clinic staff can distribute and track volume of CUROS caps dispensed to each familypatient with the familypatient can report back each visit on the volume of CUROS caps utilized This will ensure reliable distribution to the familiespatients provide a face to face educational opportunity to ensure proper application of the CUROS cap and provide compliance opportunities via counts of CUROS caps utilized
This proposal will involve a cluster-randomized 2 period crossover design clinical trial Given this proposals focus on reducing central line infections at home the main facilitators of best practice use of these caps at home will be the families and patients themselves The research team will spread the needed additional education tools data analyses and support for this proposal
Study Organization and Timeline The work will build on the partnership between the pediatric quality improvement research group at Johns Hopkins University and the vendor Ivera Medical Corporation maker of the CUROS brand 70 isopropyl alcohol embedded protective caps for central lines Dr Miller is Principal Investigator and serves as Vice Chair of Quality and Safety Director of Division of Quality and Safety at the Johns Hopkins Childrens Center Dr Miller had led and continues to lead efforts to transform the quality and safety of the delivery system at Johns Hopkins University and is a formally trained in Lean Six Sigma quality improvement as well as having her Masters of Science degree in clinical research In addition Dr Aaron Milstone at Johns Hopkins University director of pediatric hospital epidemiology and infection control and an accomplished researcher in pediatric infection prevention will be a Co-Investigator on this proposal Dr Milstone led the recently published clinical trial work in Lancet describing the impact of chlorhexidine bathing on CLABSI and positive blood cultures in children in 10 PICUs Dr Elizabeth Colantuoni is a Biostatistician and Assistant Scientist in the Johns Hopkins Bloomberg School of Public Health
The work will span four years Year 1 Preparatory work will include establishing Institutional Review Board approval at each of the participating institutions setting up data collection and submission processes setting up distribution mechanisms for the intervention both to the clinics and then within each clinic to the homes and educating providers patients and families on how to apply the CUROS cap across all the participating institutions Years 2 3 and 4 will include two 12 month trial periods with a 3 month wash out period in between The last 9 months of Year 4 will be used for data analysis and manuscript preparation
Methods SPECIFIC AIM 1 and SPECIFIC AIM 2
Specific Aim 1 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the ambulatory CLABSI rate for pediatric hematologyoncology patients
Specific Aim 2 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the positive blood culture rate at home for pediatric hematologyoncology patients
Independent variables The primary independent variable will be ambulatory CLABSI rates for Specific Aim 1 and all positive blood culture rates defined as CLABSI rate MBI-CLABSI rates Secondary BSI rates single positive blood culture SPBC rates for Specific Aim 2 All of the participating units already devote Hospital Infection Control staff to identify and track all 3 of these types of ambulatory central line infections
Dependent variable The dependent variable for these Specific Aims will be the dichotomous assignment to either control or intervention arms where unit will receive both arms
Data collection method All HematologyOncology units will submit monthly aggregate clinic data on CLABSI MBI-CLABSI Secondary BSI and SPBC numerators and denominators via a web-based data entry tool
Exploratory analyses Events and line-days at the unit level will be calculated to summarize rates of infections CLABSI and all infections by treatment and period as well as by month to assess for any important trends These trends will be evaluated using scatterplots and line plots overall and separately by treatment arm and period Summary statistics such as mean median interquartile range and variance for the monthly number of infection events and rates will be calculated for the overall sample and by treatment and period In case missing data occurs in our analysis we will explore the relationship between missing data and the units observed data in months prior and our analysis methods will be valid under the assumptions that the missing data are generated completely at random or depend on the prior observed rates missing at random Our data integrity efforts and frequent contacts with this team will work to minimize any instances of missing data
Multivariate analyses Random effects Poisson regression models will be used to test for a treatment effect Specifically the monthly number of CLABSI Specific Aim 1 or the monthly number of all infections Specific Aim 2 will be modeled as a function of the dichotomous treatment assignment and an indicator for when the treatment arm was received first or second 12 month period with inclusion of an offset representing the monthly number of central line days and a random intercept for unit to account for the correlation of monthly rates of infections over time within the same unit The models rely on two key assumptions i the infection rates follow a Poisson distribution where the mean rate is the same as the variance in the rate and ii the correlation of the rates within a unit over time is exchangeable These assumptions will be assessed via descriptive analyses and by adding a robust variance estimate clustering on the unit
Methods Specific Aim 3 To evaluate whether the use of 70 isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with altered microbial epidemiology for CLABSI secondary blood steam infections and single positive blood cultures at home for pediatric hematologyoncology patients
Independent variables Organisms isolated for all blood cultures CLABSI MBI-CLABSI Secondary BSI SPBC in patients involved in this study will be collected from participating teams during both the Control and Intervention arms of the clinical trial and sorted into Gram Positive versus Gram Negative organisms
Dependent variable The dependent variable for this Specific Aim will be the dichotomous assignment to either control or intervention arms
Data collection method All HematologyOncology ambulatory care teams will submit the microbial pattern data for all positive blood cultures
Analyses The analysis would be a comparison of proportions of Gram positive organisms causing CLABSI SPBC and all positive blood cultures between the control and intervention study arms Given that Gram positive organisms are the most common organisms causing CLABSI and SPBC in children achieving a reduction in Gram positive organisms would be an important additional finding of this clinical trial
Sixteen pediatric hematologyoncology institutions will serve as the core population for this proposal and unit of randomization All ambulatory patients taken care of by these pediatric hematologyoncology clinics at these institutions will be eligible for this study The only inclusion criteria will be presence of an external central line Given the intervention is a protective cap for central line access ports patients who only have a totally implanted port as their central venous access will not be eligible for this study as the intervention is not physically applicable to such central lines
The intervention the investigators will deploy is the CUROS brand of 70 isopropyl alcohol embedded protective caps for central lines These caps are manufactured by Ivera Medical Corporation As in kind contribution to this proposed study Ivera Medical Corporation has agreed to donate and distribute all needed CUROS caps to the participating institutions for the duration of this study If any of the participating teams wishes to instead use a comparable brand of 70 isopropyl alcohol embedded protective caps for central lines that will be permitted
Distribution of the CUROS caps will be accomplished within the clinics of each participating institution and compliance with the intervention at homes will be monitored by clinic staff via tracking counts of CUROS caps dispensed to families Children with chronic hematologiconcologic conditions are seen frequently in clinic often up to every week Clinic staff can distribute and track volume of CUROS caps dispensed to each familypatient with the familypatient can report back each visit on the volume of CUROS caps utilized This will ensure reliable distribution to the familiespatients provide a face to face educational opportunity to ensure proper application of the CUROS cap and provide compliance opportunities via counts of CUROS caps utilized
This proposal will involve a cluster-randomized 2 period crossover design clinical trial Given this proposals focus on reducing central line infections at home the main facilitators of best practice use of these caps at home will be the families and patients themselves The research team will spread the needed additional education tools data analyses and support for this proposal
Study Organization and Timeline The work will build on the partnership between the pediatric quality improvement research group at Johns Hopkins University and the vendor Ivera Medical Corporation maker of the CUROS brand 70 isopropyl alcohol embedded protective caps for central lines Dr Miller is Principal Investigator and serves as Vice Chair of Quality and Safety Director of Division of Quality and Safety at the Johns Hopkins Childrens Center Dr Miller had led and continues to lead efforts to transform the quality and safety of the delivery system at Johns Hopkins University and is a formally trained in Lean Six Sigma quality improvement as well as having her Masters of Science degree in clinical research In addition Dr Aaron Milstone at Johns Hopkins University director of pediatric hospital epidemiology and infection control and an accomplished researcher in pediatric infection prevention will be a Co-Investigator on this proposal Dr Milstone led the recently published clinical trial work in Lancet describing the impact of chlorhexidine bathing on CLABSI and positive blood cultures in children in 10 PICUs Dr Elizabeth Colantuoni is a Biostatistician and Assistant Scientist in the Johns Hopkins Bloomberg School of Public Health
The work will span four years Year 1 Preparatory work will include establishing Institutional Review Board approval at each of the participating institutions setting up data collection and submission processes setting up distribution mechanisms for the intervention both to the clinics and then within each clinic to the homes and educating providers patients and families on how to apply the CUROS cap across all the participating institutions Years 2 3 and 4 will include two 12 month trial periods with a 3 month wash out period in between The last 9 months of Year 4 will be used for data analysis and manuscript preparation
Methods SPECIFIC AIM 1 and SPECIFIC AIM 2
Specific Aim 1 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the ambulatory CLABSI rate for pediatric hematologyoncology patients
Specific Aim 2 Evaluate whether use of 70 isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25 reduction in the positive blood culture rate at home for pediatric hematologyoncology patients
Independent variables The primary independent variable will be ambulatory CLABSI rates for Specific Aim 1 and all positive blood culture rates defined as CLABSI rate MBI-CLABSI rates Secondary BSI rates single positive blood culture SPBC rates for Specific Aim 2 All of the participating units already devote Hospital Infection Control staff to identify and track all 3 of these types of ambulatory central line infections
Dependent variable The dependent variable for these Specific Aims will be the dichotomous assignment to either control or intervention arms where unit will receive both arms
Data collection method All HematologyOncology units will submit monthly aggregate clinic data on CLABSI MBI-CLABSI Secondary BSI and SPBC numerators and denominators via a web-based data entry tool
Exploratory analyses Events and line-days at the unit level will be calculated to summarize rates of infections CLABSI and all infections by treatment and period as well as by month to assess for any important trends These trends will be evaluated using scatterplots and line plots overall and separately by treatment arm and period Summary statistics such as mean median interquartile range and variance for the monthly number of infection events and rates will be calculated for the overall sample and by treatment and period In case missing data occurs in our analysis we will explore the relationship between missing data and the units observed data in months prior and our analysis methods will be valid under the assumptions that the missing data are generated completely at random or depend on the prior observed rates missing at random Our data integrity efforts and frequent contacts with this team will work to minimize any instances of missing data
Multivariate analyses Random effects Poisson regression models will be used to test for a treatment effect Specifically the monthly number of CLABSI Specific Aim 1 or the monthly number of all infections Specific Aim 2 will be modeled as a function of the dichotomous treatment assignment and an indicator for when the treatment arm was received first or second 12 month period with inclusion of an offset representing the monthly number of central line days and a random intercept for unit to account for the correlation of monthly rates of infections over time within the same unit The models rely on two key assumptions i the infection rates follow a Poisson distribution where the mean rate is the same as the variance in the rate and ii the correlation of the rates within a unit over time is exchangeable These assumptions will be assessed via descriptive analyses and by adding a robust variance estimate clustering on the unit
Methods Specific Aim 3 To evaluate whether the use of 70 isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of ambulatory pediatric hematologyoncology patients
Hypothesis Use of 70 isopropyl alcohol embedded protective caps on central lines will be associated with altered microbial epidemiology for CLABSI secondary blood steam infections and single positive blood cultures at home for pediatric hematologyoncology patients
Independent variables Organisms isolated for all blood cultures CLABSI MBI-CLABSI Secondary BSI SPBC in patients involved in this study will be collected from participating teams during both the Control and Intervention arms of the clinical trial and sorted into Gram Positive versus Gram Negative organisms
Dependent variable The dependent variable for this Specific Aim will be the dichotomous assignment to either control or intervention arms
Data collection method All HematologyOncology ambulatory care teams will submit the microbial pattern data for all positive blood cultures
Analyses The analysis would be a comparison of proportions of Gram positive organisms causing CLABSI SPBC and all positive blood cultures between the control and intervention study arms Given that Gram positive organisms are the most common organisms causing CLABSI and SPBC in children achieving a reduction in Gram positive organisms would be an important additional finding of this clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HS022870 | AHRQ | None | httpsreporternihgovquickSearchR01HS022870 |