REVAMP: Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05975671

Collaborator

Children's Healthcare of Atlanta (Other), St. Louis Children's Hospital (Other), Johns Hopkins University (Other), University of Pennsylvania (Other), Centers for Disease Control and Prevention (U.S. Fed)

52,500

Enrollment

Locations

Arms

Anticipated Duration (Months)

13125

Patients Per Site

451.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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)

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: 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.

Arm

Intervention/Treatment

Other: 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 Names:

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

Primary Outcome Measures

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 Outcome Measures

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.
PICU length of stay [Up to 3 years]
Time elapsed between a patient's admission into the PICU and discharge from the PICU.
Hospital length of stay [Up to 3 years]
Time elapsed between a patient's hospital admittance and discharge.
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 broad-spectrum antibiotics [Up to 5 years]
Cefepime, ceftriaxone, and piperacillin-tazobactam DOT/1000 PICU days, measured monthly (as a non-equivalent dependent variable).
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.

Other Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patient Inclusion Criteria:

Admitted to one of the participating PICUs during the study period

Patient Exclusion Criteria:

None

Clinician Inclusion Criteria:

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
Age ≥ 18 years old
Employed by one of the participating sites

Clinician Exclusion Criteria:

Volunteers or other non-employee hospital staff
Limited English proficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30322
2	Johns Hopkins Children's Center	Baltimore	Maryland	United States	21287
3	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
4	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19146