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De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children (OPerAtiC)

Primary Purpose

Surgical Site Infection

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Order set review and modification with facilitation
Order set review and modification
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Site Infection focused on measuring children, antimicrobial stewardship, post-operative antibiotic prophylaxis, Deimplementation

Eligibility Criteria

0 Days - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Surgeries performed at the Children's Hospitals included in the study and are collected by NSQIP-P.
  2. Clean and clean-contaminated surgical procedures within the following specialties that are included in NSQIP-P:

General Surgery, Neurosurgery, Orthopedics, Otolaryngology, Plastic Surgery, Otolaryngology, and Urology

Exclusion Criteria:

1. Children undergoing clean or clean-contaminated procedures that are not collected by NSQIP-P data abstractors.

Sites / Locations

  • Johns Hopkins University School of Medicine / Johns Hopkins All Children's Hospital
  • Harvard Medical School / Boston Children's Hospital
  • University of Michigan / CS Mott Children's Hospital
  • University of Missouri - Kansas City / The Children's Mercy Hospital
  • Washington University in St. Louis / St. Louis Children's Hospital
  • The Ohio State University College of Medicine / Nationwide Children's Hospital
  • Vanderbilt University / Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Baylor College of Medicine / Texas Children's Hospital
  • University of Utah / Primary Children's Hospital
  • University of Washington / Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Order set review and modification

Order Set review and Modification plus facilitation

Arm Description

The antimicrobial stewardship program will review and change order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.

The antimicrobial stewardship program will receive facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.

Outcomes

Primary Outcome Measures

Percentage of clean and clean-contaminated cases in children receiving post-operative antibiotic prophylaxis.
Clean and clean-contaminated surgical cases in children will be assessed for whether they are receiving post operative prophylaxis utilizing the Pediatric National Surgical Quality Improvement Project (NSQIP) database. A percentage will be determined with the numerator being total number of clean and clean-contaminated cases receiving post operative surgical prophylaxis and the denominator will be total number of clean and clean-contaminated cases.

Secondary Outcome Measures

Rate of Surgical Site Infections (SSI) in clean and clean-contaminated cases
Among the captured clean and clean-contaminated cases utilized in the primary outcome, the SSI rate per 100 cases will be determined in patients both receiving and not receiving post-operative antibiotic prophylaxis
Rate of Clostridioides difficile infections (CDI) in clean and clean-contaminated cases
Among the captured clean and clean-contaminated cases utilized in the primary outcome, the CDI rate per 100 cases will be determined in patients both receiving and not receiving post-operative antibiotic prophylaxis

Full Information

First Posted
April 24, 2020
Last Updated
July 24, 2023
Sponsor
Washington University School of Medicine
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT04366440
Brief Title
De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
Acronym
OPerAtiC
Official Title
De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall objective of this study is to identify the best strategy to eliminate unnecessary antibiotic use after surgery in pediatric surgical procedures considered low-risk for an SSI. Based on literature and our preliminary data suggesting surgeons will not fully accept standardized order sets based on current guidelines, the investigators hypothesize that order set modification combined with ASP facilitation will outperform standard order set modification alone in de-implementing unnecessary postoperative antibiotic use.
Detailed Description
Antibiotics have revolutionized healthcare allowing clinicians the ability to treat life-threatening infections and to prevent infections following life-saving surgery. Unfortunately, antibiotic overuse results in antibiotic resistant bacteria and unnecessary adverse events including Clostridioides difficile infections (CDI). Data demonstrate that antibiotic resistant bacteria and CDI annually kill up to 150,000 and 29,000 Americans, respectively. Surgical antibiotic prophylaxis is a common area for unnecessary antibiotic use among children. Recent CDC surgical site infection (SSI) guidelines and the AAP Choosing Wisely Campaign recommend no postoperative antibiotic prophylaxis for procedures considered low risk for an SSI. In this study, our team will develop and test two theoretically informed strategies to eliminate ("de-implement") unnecessary postoperative antibiotic prophylaxis through the collaboration of surgeons and antimicrobial stewardship programs (ASPs). One promising strategy is the implementation of standard surgical order sets, which offer relative ease of implementation and a systematic approach across surgical subspecialties. While evidence suggests that order set standardization is a good approach, barriers to implementation are commonly noted, especially the lack of engagement with clinicians affected by change when initiating a new strategy. As such, complementary strategies are needed to extend the impact of order set standardization. This study will be guided by the i-PARIHS framework (Integrated Framework for Promoting Action on Research Implementation in Health Services), an implementation science framework designed to guide implementation of evidence-based practices. This framework posits that successful implementation of evidence into practice is a function of the quality and type of evidence to be implemented, the characteristics of the context where the evidence will be implemented, and the means by which it is integrated or facilitated into practice. Four primary constructs comprise the i-PARIHS framework: the innovation, recipients, context, and facilitation. Innovation describes the evidence and knowledge regarding a particular issue, as well as the qualities of the evidence that may influence how it is perceived by the potential user, recognizing that evidence may or may not be valuable to the end user based on local circumstances and priorities. Recipients are actors involved in implementation who may be affected by and influence the implementation of evidence. Context characterizes the circumstances in which knowledge and innovation uptake occurs, consisting of multiple factors at the micro, meso, and macro levels. Finally, integral to this framework is facilitation as the active mechanism by which uptake and implementation of evidence occurs, making it an ideal and appropriate fit for this study. All research activities for this study will be conducted in 9 children's hospitals that participate in both the SHARPS Collaborative and NSQIP-P. Our participating hospitals are geographically dispersed and (like most children's hospitals) are located in urban settings. SHARPS Collaborative hospitals feature active ASPs operated by dedicated pharmacists and physician leaders. Clinicians (MD/DO or PharmD) overseeing ASPs and surgical champions in participating hospitals will implement the proposed strategies and collect implementation outcomes that quantify the extent to which the test strategies are successfully deployed in the hospital. The daily work of these individuals to improve antibiotic use includes frequent interaction with surgical specialties that perform clean and clean-contaminated surgeries. Implementing our proposed strategies via established ASP clinicians and a surgical leader (rather than, for example, directly by a member of the research team) will leverage existing relationships between these clinicians and their associated surgical teams, creating a more realistic circumstance under which new ASP strategies are implemented. This approach will provide better insight into the feasibility of implementing these strategies in a sustainable way in the future. In addition to being SHARPS Collaborative hospitals, our participating hospitals will also be NSQIP-P hospitals, each with a full-time, trained dedicated data abstractor collecting data on surgeries and surgical outcomes. The investigators will compare the efficacy of the two strategies designed to reduce unnecessary postoperative antibiotic prophylaxis, using a cross-sectional stepped-wedge design. The investigators have identified 9 Children's Hospitals from across the US to participate in the study. Each of the 9 hospitals will be randomized into one of 3 clusters (cluster size = 3). All hospitals will begin with the control intervention-implementation of order set review and modification-at time 0. Each Step will last 6 months. Prior to the beginning of Step 1, Cluster 1 hospitals will receive the experimental intervention -order set review and modification plus facilitation. Just prior to steps 1, 2 and 3, the ASP teams will receive a 2-day in-person workshop led by the implementation scientist (Co-I Dr. McKay) and PI Dr. Newland, covering the specific facilitation strategies to be utilized. Every 6 months, an additional cluster will initiate the experimental condition (Steps 2 and 3). The amount of time each cluster will receive the experimental condition will be 30 months (Cluster 1), 24 months (Cluster 2), and 18 months (Cluster 3). Monthly study webinars will occur with all sites in step 0. During steps 1 and 2, sites in the experimental arm will have a monthly webinar separate from the group still in the control arm. By step 3 all sites will be a part of the same monthly webinar.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
children, antimicrobial stewardship, post-operative antibiotic prophylaxis, Deimplementation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A stepped-wedge study design will be utilized. All sites will begin in the control intervention, order set review and modification. Sequentially, clusters of 3 hospitals will begin in the experimental intervention, order set review and modification plus facilitation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Order set review and modification
Arm Type
Other
Arm Description
The antimicrobial stewardship program will review and change order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Arm Title
Order Set review and Modification plus facilitation
Arm Type
Other
Arm Description
The antimicrobial stewardship program will receive facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Intervention Type
Behavioral
Intervention Name(s)
Order set review and modification with facilitation
Intervention Description
The antimicrobial stewardship program will receive facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Intervention Type
Other
Intervention Name(s)
Order set review and modification
Intervention Description
The antimicrobial stewardship program will work to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
Primary Outcome Measure Information:
Title
Percentage of clean and clean-contaminated cases in children receiving post-operative antibiotic prophylaxis.
Description
Clean and clean-contaminated surgical cases in children will be assessed for whether they are receiving post operative prophylaxis utilizing the Pediatric National Surgical Quality Improvement Project (NSQIP) database. A percentage will be determined with the numerator being total number of clean and clean-contaminated cases receiving post operative surgical prophylaxis and the denominator will be total number of clean and clean-contaminated cases.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rate of Surgical Site Infections (SSI) in clean and clean-contaminated cases
Description
Among the captured clean and clean-contaminated cases utilized in the primary outcome, the SSI rate per 100 cases will be determined in patients both receiving and not receiving post-operative antibiotic prophylaxis
Time Frame
3 years
Title
Rate of Clostridioides difficile infections (CDI) in clean and clean-contaminated cases
Description
Among the captured clean and clean-contaminated cases utilized in the primary outcome, the CDI rate per 100 cases will be determined in patients both receiving and not receiving post-operative antibiotic prophylaxis
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Implementation Outcome: Acceptability of the Interventions
Description
A validated 4 question survey will be used to assess the acceptability of each intervention.
Time Frame
3 years
Title
Implementation Outcome: Feasibility of the Interventions
Description
A validated 4 question survey will be used to assess the feasibility of each intervention.
Time Frame
3 years
Title
Implementation Outcome: Appropriateness of the Interventions
Description
A validated 4 question survey will be used to assess the appropriateness of each intervention.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Surgeries performed at the Children's Hospitals included in the study and are collected by NSQIP-P. Clean and clean-contaminated surgical procedures within the following specialties that are included in NSQIP-P: General Surgery, Neurosurgery, Orthopedics, Otolaryngology, Plastic Surgery, Otolaryngology, and Urology Exclusion Criteria: 1. Children undergoing clean or clean-contaminated procedures that are not collected by NSQIP-P data abstractors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason G Newland, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine / Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Harvard Medical School / Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan / CS Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Missouri - Kansas City / The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University in St. Louis / St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Ohio State University College of Medicine / Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Vanderbilt University / Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine / Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah / Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Washington / Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Links:
URL
http://pediatrics.wustl.edu/sharps
Description
SHARPS Collaborative Website
URL
https://www.facs.org/quality-programs/childrens-surgery/pediatric
Description
NSQIP-P Website
URL
https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf
Description
CDC Threat Report 2019
URL
https://www.choosingwisely.org/societies/american-academy-of-pediatrics-committee-on-infectious-diseases-and-the-pediatric-infectious-diseases-society/
Description
American Academy of Pediatrics Choosing Wisely- Infectious Diseases

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De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children

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