Bone Marrow Transplant, Central Line Associated Bloodstream Infections (CLABSI)
Conditions
Brief summary
The purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess the ease of use of parafilm.
Detailed description
Central line associated bloodstream infections (CLABSI) result in significant morbidity and mortality, particularly in patients undergoing hematopoietic cell transplantation (HCT). HCT patients are at high risk for CLABSI due to multiple factors, including prolonged immune suppression and the need for long-term central venous access. The investigators want to assess the feasibility of the use of a parafilm central line barrier (parafilm) as standard of care in pediatric HCT patients. The investigators will also assess the effectiveness of the parafilm to reduce the incidence of CLABSI in these patients.
Interventions
DEVICEParafilm
Single-use, pre-cut sections of parafilm over the central venous catheter (CVC) hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC until it is removed.
Sponsors
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Arm 1 is comprised of study participants receiving parafilm applied over the CVC hub or around the CVC hub connection. Arm 2 is a retrospective historical cohort of pediatric patients receiving HCT for the purpose of comparing CLABSI rates.
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Must be between the age of 0 and 21 years at the time of enrollment * Must be undergoing allogeneic or autologous HCT for a malignant or non-malignant disorder * Must have or be scheduled to have a tunneled CVC
Exclusion criteria
* Patients undergoing other interventions to prevent CLABSI (e.g. Children's Oncology Group (COG) study ACCL1034 with Chlorhexidine Gluconate (CHG); antimicrobial lock therapy, etc.) * Patients who only have a port
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm | Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months) | For observed compliance, the outpatient nurse recorded whether the patient's parafilm was correctly applied/intact (yes), not applied (no), or incorrectly applied/not intact (yes-inc) at the beginning of the visit. The percentage of outpatient observed catheter-days where parafilm was correctly in use/intact was calculated. |
| Rate of Central Line Associated Bloodstream Infections (CLABSI) | Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months) | Central line associated bloodstream infections (CLABSI) is the identification of a bacterial infection from a blood culture drawn from a central venous catheter (CVC) in the absence of a primary source of infection from another body site. The CLABSI rate (total number of CLABSI/1000 catheter-days) in parafilm study participants will be calculated and compared to the CLABSI rate in a historical cohort of pediatric patients who are serving as a control group. |
| Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm | At discharge (an expected average of 6 weeks from admission) | In the inpatient setting, compliance was measured by once daily recording of parafilm change by nursing in the electronic medical record. These data were significantly limited by electronic medical record charting on parafilm change being required only once per day. Thus, once daily data collection failed to capture daily parafilm change, given multiple nursing shifts on a single calendar day. Nonetheless, the percentage of catheter-days with intact correctly applied parafilm, as reported by nursing staff, was calculated. |
| Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm | Time between initial bone marrow transplant (BMT) discharge and either central venous line (CVL) removal or transfer back to primary MD (an expected average of 2-3 months) | Observed compliance occurred during weekly line rounds. Rounding providers indicated whether a patient's parafilm is intact and correctly applied, not applied, or incorrectly applied or not intact. The percentage of observed catheter-days where patients had correct use of intact parafilm were to be calculated. To track observed inpatient compliance with applying parafilm, data fields were added to the entered to the nursing charts of the participant's electronic medical record (EMR). The primary field added was a no/question about parafilm applied. Per study protocol, the intent was to document nursing changing of the parafilm, at the time it was changed. However, on reviewing the data, it appears that nursing just charted once per day whether they had changed parafilm or not, while the parafilm may have been changed earlier by a different nurse. |
| Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm | Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months) | For outpatient reported compliance, parents of study participants provided their logs to outpatient staff who documented the number of days parafilm was correctly in use/intact vs not in use or incorrectly in use/not intact. The cumulative percentage of catheter-days where parafilm was intact was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Antibiotic Treatment Courses Per Participant | Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months) | The number of antibiotic treatment courses per participant in the parafilm study will be recorded. |
| Duration of Antibiotic Treatment Exposure | Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months) | Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported. |
| Number of ICU Admissions Secondary to Sepsis | Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months) | The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported. |
| Death | Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months) | Deaths from infection and death from any cause among participants in the parafilm study are reported. |
| Perception of Parafilm | Month 3 (average time till removal of CVC) | The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled in the parafilm study between March 2015 and June 2017. All study procedures and follow up was completed on March 29, 2018.
Pre-assignment details
Fifty-one individuals consented to participate in the study. Prior to beginning any study interventions one was lost to follow up, one withdrew, and one did not begin the prep regimen, resulting in 48 participants who began the study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Parafilm Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected). | 48 |
| Historical Cohort Pediatric patients receiving hematopoietic cell transplantation in the 16 months preceding the study intervention. Data were obtained retrospectively through medical records for the purpose of comparing CLABSI rates among recipients of parafilm to a control group. | 71 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Parafilm | Total | Historical Cohort |
|---|---|---|---|
| Age, Customized Age in years Between 10 and 21 years | 16 Participants | 44 Participants | 28 Participants |
| Age, Customized Age in years Between 3 and 9 years | 25 Participants | 47 Participants | 22 Participants |
| Age, Customized Age in years Less than or equal to 2 years | 7 Participants | 28 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 105 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Black or African American | 21 Participants | 53 Participants | 32 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White | 25 Participants | 59 Participants | 34 Participants |
| Region of Enrollment United States | 48 participants | 119 participants | 71 participants |
| Sex: Female, Male Female | 17 Participants | 42 Participants | 25 Participants |
| Sex: Female, Male Male | 31 Participants | 77 Participants | 46 Participants |
| Type of HCT Allogeneic | 35 Participants | 84 Participants | 49 Participants |
| Type of HCT Autologous | 13 Participants | 35 Participants | 22 Participants |
| Underlying disease Malignant, hematologic | 17 Participants | 41 Participants | 24 Participants |
| Underlying disease Malignant, solid tumor | 12 Participants | 33 Participants | 21 Participants |
| Underlying disease Non-malignant | 19 Participants | 45 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 48 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 3 / 48 |
Outcome results
Primary
Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm
Observed compliance occurred during weekly line rounds. Rounding providers indicated whether a patient's parafilm is intact and correctly applied, not applied, or incorrectly applied or not intact. The percentage of observed catheter-days where patients had correct use of intact parafilm were to be calculated. To track observed inpatient compliance with applying parafilm, data fields were added to the entered to the nursing charts of the participant's electronic medical record (EMR). The primary field added was a no/question about parafilm applied. Per study protocol, the intent was to document nursing changing of the parafilm, at the time it was changed. However, on reviewing the data, it appears that nursing just charted once per day whether they had changed parafilm or not, while the parafilm may have been changed earlier by a different nurse.
Time frame: Time between initial bone marrow transplant (BMT) discharge and either central venous line (CVL) removal or transfer back to primary MD (an expected average of 2-3 months)
Population: The data collected indicated that nursing staff did not understand how the parafilm monitoring needed to be charted for the purposes of data analysis. Although a data field was created in the EMR, in practice, the data collected was not an accurate assessment of parafilm use, thus no data are available for analysis of this outcome measure.
Primary
Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
For observed compliance, the outpatient nurse recorded whether the patient's parafilm was correctly applied/intact (yes), not applied (no), or incorrectly applied/not intact (yes-inc) at the beginning of the visit. The percentage of outpatient observed catheter-days where parafilm was correctly in use/intact was calculated.
Time frame: Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)
Population: Observed outpatient compliance was not performed as it was difficult to implement this in a busy clinic setting.
Primary
Rate of Central Line Associated Bloodstream Infections (CLABSI)
Central line associated bloodstream infections (CLABSI) is the identification of a bacterial infection from a blood culture drawn from a central venous catheter (CVC) in the absence of a primary source of infection from another body site. The CLABSI rate (total number of CLABSI/1000 catheter-days) in parafilm study participants will be calculated and compared to the CLABSI rate in a historical cohort of pediatric patients who are serving as a control group.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parafilm | Rate of Central Line Associated Bloodstream Infections (CLABSI) | 3.69 CLABSI/1000 catheter-days |
| Historical Cohort | Rate of Central Line Associated Bloodstream Infections (CLABSI) | 4.37 CLABSI/1000 catheter-days |
Primary
Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm
In the inpatient setting, compliance was measured by once daily recording of parafilm change by nursing in the electronic medical record. These data were significantly limited by electronic medical record charting on parafilm change being required only once per day. Thus, once daily data collection failed to capture daily parafilm change, given multiple nursing shifts on a single calendar day. Nonetheless, the percentage of catheter-days with intact correctly applied parafilm, as reported by nursing staff, was calculated.
Time frame: At discharge (an expected average of 6 weeks from admission)
Population: Participants in the parafilm study are included in this analysis. Percentage of inpatient days where nursing charted parafilm change in the electronic medical record is reported for the entire parafilm cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parafilm | Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm | 65.2 percentage of central-line days |
Primary
Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
For outpatient reported compliance, parents of study participants provided their logs to outpatient staff who documented the number of days parafilm was correctly in use/intact vs not in use or incorrectly in use/not intact. The cumulative percentage of catheter-days where parafilm was intact was calculated.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Population: The population used for this analysis consists of caretakers who returned outpatient logs of parafilm use at the end of the study. Forty-one participants used parafilm in the outpatient setting and of these 34 returned the outpatient logs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parafilm | Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm | 64.7 percent of catheter-days |
Secondary
Death
Deaths from infection and death from any cause among participants in the parafilm study are reported.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Population: Participants in the parafilm study are included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parafilm | Death | Death from infection | 0 Participants |
| Parafilm | Death | Death from any cause | 3 Participants |
Secondary
Duration of Antibiotic Treatment Exposure
Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Population: Data on duration of antibiotic treatments were not collected.
Secondary
Number of Antibiotic Treatment Courses Per Participant
The number of antibiotic treatment courses per participant in the parafilm study will be recorded.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Population: Data on antibiotic treatment courses were not collected.
Secondary
Number of ICU Admissions Secondary to Sepsis
The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Population: Participants in the parafilm study are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parafilm | Number of ICU Admissions Secondary to Sepsis | 8 ICU admissions |
Secondary
Perception of Parafilm
The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported
Time frame: Month 3 (average time till removal of CVC)
Population: A survey was initially planned for in the protocol but was removed from the study procedures prior to any participants completing the survey.