Antimicrobial - Induced Nephropathy, Sepsis, Sepsis Bacteremia, Sepsis Mrsa, Sepsis, Severe, Septic Shock, Septic Syndrome
Conditions
Keywords
Sepsis, Vancomycin use, methicillin-resistant Staphylococcus aureus (MRSA), Antibiotic Stewardship, Implementation science
Brief summary
The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU). There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include: * Implementation of a clinical guideline indicating when vancomycin should and should not be used * Unit-level feedback on overall vancomycin use within and across centers * Clinician education.
Detailed description
Vancomycin is among the most commonly prescribed antibiotics in United States children's hospitals, and inappropriate use of vancomycin is common. Given the high prevalence of acute kidney injury associated with vancomycin of up to 25%, reducing vancomycin overuse is a key opportunity to reduce preventable patient harm. The primary objective of this study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care PICUs. This intervention will be informed by baseline data surrounding vancomycin use and infections due to organisms requiring vancomycin therapy which will allow selective use of vancomycin, as well as a concurrent mixed methods process and formative evaluation to inform implementation of the intervention. During the baseline period, Electronic Health Record (EHR) data will be used to retrospectively quantify unit-level vancomycin use over 24 months (measured as vancomycin days of therapy \[DOT\]/1000 patient days), as well as the frequency of vancomycin use and prevalence of infections due to organisms requiring vancomycin therapy among patients with suspected and confirmed sepsis. During the post-intervention period, which will last approximately 24 months, a multifaceted stewardship intervention to reduce vancomycin use informed by these baseline data, including: * The creation of a consensus guideline for vancomycin use; * Ad hoc education related to vancomycin overuse, and; * Unit-level feedback on vancomycin prescribing. The feedback on vancomycin use will be provided to clinicians at each site, both within their site (to compare to past performance) and across sites (to compare local performance to the performance of other sites). This intervention will be locally adapted by the investigative team and sepsis stakeholders at each site. Data from the EHR will be used to assess vancomycin use (DOT/1000 patient days), as well as the secondary outcomes. Investigators will perform semi-structured interviews and repeat surveys 9 months after the implementation of the intervention. This mixed-methods process and formative evaluation will help investigators understand which elements of implementation were successful and which were not.
Interventions
BEHAVIORALMultifaceted de-implementation strategy to reduce vancomycin overuse
* Clinical guidelines and group-level feedback on vancomycin use will be provided to clinicians/sepsis stakeholders at each site. * The semi-structured interviews will be performed by a trained member of the research team, under the supervision of a medical sociologist who is one of the co-investigators. A semi-structured interview guide will be used during the interviews. Interviews will be recorded and transcribed, then uploaded to a qualitative analysis software for management and coding. Names will not be recorded, and pseudonyms will be used in notes, communications about the study, and any presentations. Verbal consent will be obtained before conducting and recording the interviews. * The surveys will be performed using REDCap survey software, and participation will be voluntary. No identifiers will be collected.
Sponsors
Children's Healthcare of Atlanta
St. Louis Children's Hospital
Johns Hopkins University
University of Pennsylvania
Centers for Disease Control and Prevention
Children's Hospital of Philadelphia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Multicenter, mixed methods, implementation science study with a quasi-experimental design.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Admitted to one of the participating PICUs during the study period Patient
Exclusion criteria
* None Clinician Inclusion Criteria: 1. PICU prescribing clinician (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) OR sepsis stakeholder (leader of sepsis quality improvement work, medical director) at one of the participating sites at the time the survey is deployed 2. Age ≥ 18 years old 3. Employed by one of the participating sites Clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vancomycin use | Baseline to 5 years | Vancomycin use will be measured as DOT per 1000 PICU patient days, measured monthly. Every day in which one or more doses of parenteral vancomycin is administered is classified as one vancomycin DOT. Every day or portion of a day a patient is admitted to the PICU is classified as one PICU patient day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PICU length of stay | Up to 3 years | Time elapsed between a patient's admission into the PICU and discharge from the PICU. |
| 30-day PICU readmission | Within 30 days of discharge from a PICU admission | Readmission to the PICU is defined as an admission to the PICU occurring within 30 days following discharge from an admission in which there was one or more episodes of suspected or confirmed sepsis. Only one episode of suspected or confirmed sepsis will be counted in this measure. Patients without a readmission to the index hospital or health system will be counted as no readmission, due to the inability to assess readmissions to outside institutions. |
| 30-day hospital readmission | Within 30 days of discharge from a hospital admission | The percentage of patients that are readmitted to the hospital within 30 days following discharge from an admission in which there was one or more episodes of suspected or confirmed sepsis. Only one episode of suspected or confirmed sepsis will be counted in this measure. |
| Use of other anti-MRSA antibiotics | Up to 5 years | Linezolid, Ceftaroline, clindamycin, and trimethoprim-sulfamethoxazole in DOT/1000 patient days, measured monthly (as a balancing measure to evaluate any increase in other anti-MRSA antibiotics that may occur as an unintended consequence of reducing vancomycin use). |
| Prevalence of infections due to organisms requiring vancomycin | Up to 5 years | Microbiologic outcome measures will focus on the prevalence of vancomycin-requiring organisms in the suspected and confirmed sepsis cohorts, and will also be measured relative to the frequency of empiric vancomycin administration and compliance with the guideline. |
| Use of other broad-spectrum antibiotics | Up to 5 years | Cefepime, ceftriaxone, and piperacillin-tazobactam DOT/1000 PICU days, measured monthly (as a non-equivalent dependent variable). |
| Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days. | Baseline to 5 years | Change in the rate of suspected and confirmed sepsis episodes in which new or persistent respiratory, renal, cardiovascular, or hematologic organ dysfunction occur at day 3 and at day 7. |
| PICU all-cause mortality | Up to 3 years | All-cause mortality will be measured at 30 days following sepsis onset as a proportion of suspected and confirmed sepsis episodes. Only one episode of suspected or confirmed sepsis will be counted in this measure. |
| Hospital length of stay | Up to 3 years | Time elapsed between a patient's hospital admittance and discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of intervention | Onset of intervention to 2 years | Acceptability, how well the intervention was received by the PICU clinicians will be measured during surveys and semi-structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree. |
| Measure of feasibility of intervention | Onset of intervention to 2 years | Feasibility, the extent to which the intervention can be carried out in the setting, will be determined in collaboration with our local stakeholders but may include the proportion of PICU clinicians who attend educational sessions and/or unit-based meetings during which vancomycin use data is reviewed. |
| Appropriateness of intervention | Onset of intervention to 2 years | Appropriateness, the perceived compatibility of the intervention to the PICU practice setting, will be measured during surveys and semi-structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree. |
| Adoption of intervention | Onset of intervention to 2 years | Adoption, the decision to adhere to the guideline for vancomycin use, will be measured as the proportion of sepsis episodes in which the clinician adhered to the guideline based on medical record review. Adoption will be evaluated in a 10% random sample of sepsis episodes each month by chart review. |
Countries
United States
Contacts
Primary ContactKathleen Chiotos, MD, MSCE
Backup ContactKai Inoki, MPH
Outcome results
None listed