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Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP)

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ClinicalTrials.gov Identifier: NCT05975671
Recruitment Status : Recruiting
First Posted : August 4, 2023
Last Update Posted : September 13, 2023
Sponsor:
Collaborators:
Children's Healthcare of Atlanta
St. Louis Children's Hospital
Johns Hopkins University
University of Pennsylvania
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sepsis Sepsis Mrsa Sepsis Bacteremia Antimicrobial - Induced Nephropathy Sepsis, Severe Septic Shock Septic Syndrome Behavioral: Multifaceted de-implementation strategy to reduce vancomycin overuse Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, mixed methods, implementation science study with a quasi-experimental design.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP-Sepsis)
Actual Study Start Date : August 21, 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Arm Intervention/treatment
PICU Clinicians and Sepsis stakeholders

Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention:

  • All the PICU (Pediatric Intensive Care Unit) prescribing clinicians and sepsis stakeholders in the participating sites will receive clinical guidelines, unit-level feedback reports, and education on Vancomycin use during the intervention.
  • Investigators will perform semi-structured interviews with 90 PICU clinicians and sepsis stakeholders.
  • Surveys will be sent to all eligible clinicians, estimated to be up to 2500 individuals across the 4 sites. These structured surveys will be done at baseline and at 9 months post-implementation.
 Behavioral: Multifaceted 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.
Other Name: Mixed methods intervention
No Intervention: PICU Patients with suspected sepsis
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in vancomycin use [ Time Frame: 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 Outcome Measures :
  1. Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days. [ Time Frame: 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.

  2. PICU all-cause mortality [ Time Frame: 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.

  3. PICU length of stay [ Time Frame: Up to 3 years ]
    Time elapsed between a patient's admission into the PICU and discharge from the PICU.

  4. Hospital length of stay [ Time Frame: Up to 3 years ]
    Time elapsed between a patient's hospital admittance and discharge.

  5. 30-day PICU readmission [ Time Frame: 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.

  6. 30-day hospital readmission [ Time Frame: 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.

  7. Use of other broad-spectrum antibiotics [ Time Frame: Up to 5 years ]
    Cefepime, ceftriaxone, and piperacillin-tazobactam DOT/1000 PICU days, measured monthly (as a non-equivalent dependent variable).

  8. Use of other anti-MRSA antibiotics [ Time Frame: 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).

  9. Prevalence of infections due to organisms requiring vancomycin [ Time Frame: 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.


Other Outcome Measures:
  1. Adoption of intervention [ Time Frame: 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.

  2. Appropriateness of intervention [ Time Frame: 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.

  3. Acceptability of intervention [ Time Frame: 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.

  4. Measure of feasibility of intervention [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Exclusion Criteria:

  1. Volunteers or other non-employee hospital staff
  2. Limited English proficiency
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975671


Contacts
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Contact: Kathleen Chiotos, MD, MSCE 215-590-5505 chiotosk@chop.edu
Contact: Didien Meyahnwi, MD 215-590-5505 meyahnwid@chop.edu

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Preeti Jaggi, MD    404-727-4807    preeti.jaggi@emory.edu   
United States, Maryland
Johns Hopkins Children's Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Pranita Tamma, MD, MPH       ptamma1@jhmi.edu   
United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jason Newland, MD, MEd    314-747-5128    jgnewland@wustl.edu   
Contact: Luke Starnes, PhD    314-286-2092    garys@wustl.edu   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Kathleen Chiotos, MD, MSCE    215-590-5505    chiotosk@chop.edu   
Principal Investigator: Kathleen Chiotos         
Sub-Investigator: Rebecca Same         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Healthcare of Atlanta
St. Louis Children's Hospital
Johns Hopkins University
University of Pennsylvania
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Kathleen Chiotos, MD, MSCE Children's Hospital of Philadelphia
More Information
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Publications:
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT05975671    
Other Study ID Numbers: 21-019410
U54CK000610-02-00 ( Other Grant/Funding Number: Centers for Disease Control )
U54CK000610 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Sepsis
Vancomycin use
methicillin-resistant Staphylococcus aureus (MRSA)
Antibiotic Stewardship
Implementation science
Additional relevant MeSH terms:
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Sepsis
Toxemia
Bacteremia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents