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| ID | Type | Description | Link |
|---|---|---|---|
| U54CK000610-02-00 | Other Grant/Funding Number | Centers for Disease Control | |
| U54CK000610 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
| St. Louis Children's Hospital | OTHER |
| Johns Hopkins University | OTHER |
| University of Pennsylvania |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICU Clinicians and Sepsis stakeholders | Other | Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention:
|
|
| PICU Patients with suspected sepsis | No Intervention | Research procedures involving patients will be limited to medical record review. This medical record review will help inform the intervention directed at PICU clinicians/stakeholders and the assessment of study outcomes. Approximately 50,000 patients will participate in the study. Data elements will be collected at each site and stored as password-protected Comma-separated values (CSV) files. These files will not contain any direct Protected Health Information (PHI) but will contain elements of date (e.g., date of admission, date of suspected sepsis episode). The study Identification (ID) number will be used to identify each unique patient. Each site will collect and store data in compliance with the Children's Hospital of Philadelphia (CHOP) and local Institutional Review Board (IRB) policies. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifaceted de-implementation strategy to reduce vancomycin overuse | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vancomycin use | 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. | Baseline to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days. | 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. | Baseline to 5 years |
| PICU all-cause mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Adoption of intervention | 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. | Onset of intervention to 2 years |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Clinician Inclusion Criteria:
Clinician Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Chiotos, MD, MSCE | Contact | 215-590-5505 | chiotosk@chop.edu | |
| Kai Inoki, MPH | Contact | 215-590-5505 | meyahnwid@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Chiotos, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28914721 | Background | Kissoon N, Reinhart K, Daniels R, Machado MFR, Schachter RD, Finfer S. Sepsis in Children: Global Implications of the World Health Assembly Resolution on Sepsis. Pediatr Crit Care Med. 2017 Dec;18(12):e625-e627. doi: 10.1097/PCC.0000000000001340. | |
| 32032273 | Background | Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198. |
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This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.
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| OTHER |
| Centers for Disease Control and Prevention | FED |
Multicenter, mixed methods, implementation science study with a quasi-experimental design.
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|
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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. |
| Up to 3 years |
| PICU length of stay | Time elapsed between a patient's admission into the PICU and discharge from the PICU. | Up to 3 years |
| Hospital length of stay | Time elapsed between a patient's hospital admittance and discharge. | Up to 3 years |
| 30-day PICU readmission | 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. | Within 30 days of discharge from a PICU admission |
| 30-day hospital readmission | 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. | Within 30 days of discharge from a hospital admission |
| Use of other broad-spectrum antibiotics | Cefepime, ceftriaxone, and piperacillin-tazobactam DOT/1000 PICU days, measured monthly (as a non-equivalent dependent variable). | Up to 5 years |
| Use of other anti-MRSA antibiotics | 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). | Up to 5 years |
| Prevalence of infections due to organisms requiring vancomycin | 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. | Up to 5 years |
| Appropriateness of intervention | 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. | Onset of intervention to 2 years |
| Acceptability of intervention | 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. | Onset of intervention to 2 years |
| Measure of feasibility of intervention | 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. | Onset of intervention to 2 years |
| Johns Hopkins Children's Center | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| St. Louis Children's Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19146 | United States |
|
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| 28178770 | Background | Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4. |
| 30020464 | Background | Lorencatto F, Charani E, Sevdalis N, Tarrant C, Davey P. Driving sustainable change in antimicrobial prescribing practice: how can social and behavioural sciences help? J Antimicrob Chemother. 2018 Oct 1;73(10):2613-2624. doi: 10.1093/jac/dky222. |
| 34099497 | Background | Pandolfo AM, Horne R, Jani Y, Reader TW, Bidad N, Brealey D, Enne VI, Livermore DM, Gant V, Brett SJ; INHALE WP2 Study Group. Understanding decisions about antibiotic prescribing in ICU: an application of the Necessity Concerns Framework. BMJ Qual Saf. 2022 Mar;31(3):199-210. doi: 10.1136/bmjqs-2020-012479. Epub 2021 Jun 7. |
| 32356696 | Background | Wunderink RG, Srinivasan A, Barie PS, Chastre J, Dela Cruz CS, Douglas IS, Ecklund M, Evans SE, Evans SR, Gerlach AT, Hicks LA, Howell M, Hutchinson ML, Hyzy RC, Kane-Gill SL, Lease ED, Metersky ML, Munro N, Niederman MS, Restrepo MI, Sessler CN, Simpson SQ, Swoboda SM, Guillamet CV, Waterer GW, Weiss CH. Antibiotic Stewardship in the Intensive Care Unit. An Official American Thoracic Society Workshop Report in Collaboration with the AACN, CHEST, CDC, and SCCM. Ann Am Thorac Soc. 2020 May;17(5):531-540. doi: 10.1513/AnnalsATS.202003-188ST. |
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| 20957426 | Background | Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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