Clinical trial NCT04366440: De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
Official title: De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: children
antimicrobial stewardship
post-operative antibiotic prophylaxis
Deimplementation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-04-28
Enrollment: 39363
Sex: ALL
Minimum age (years): 0
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of clean and clean-contaminated cases in children receiving post-operative antibiotic prophylaxis.
timeFrame: 3 years
Secondary outcomes:
measure: Rate of Surgical Site Infections (SSI) in clean and clean-contaminated cases
timeFrame: 3 years
measure: Rate of Clostridioides difficile infections (CDI) in clean and clean-contaminated cases
timeFrame: 3 years
Other outcomes:
measure: Implementation Outcome: Acceptability of the Interventions
timeFrame: 3 years
measure: Implementation Outcome: Feasibility of the Interventions
timeFrame: 3 years
measure: Implementation Outcome: Appropriateness of the Interventions
timeFrame: 3 years
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins University School of Medicine / Johns Hopkins All Children's Hospital
state: Florida
city: Boston
country: United States
facility: Harvard Medical School / Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan / CS Mott Children's Hospital
state: Michigan
city: Kansas City
country: United States
facility: University of Missouri - Kansas City / The Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis / St. Louis Children's Hospital
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University College of Medicine / Nationwide Children's Hospital
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University / Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine / Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah / Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: University of Washington / Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Jason G Newland, MD
role: PRINCIPAL_INVESTIGATOR
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