Clinical trial NCT02212808: Antimicrobial Stewardship in Community Hospitals
Official title: A Multicenter, 3-Stage Cluster Randomized Historically-Controlled Crossover Trial to Determine the Feasibility and Outcomes From Two Antimicrobial Stewardship Interventions in Community Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Stewardship in Community Hospitals
Keywords: Cluster-randomized crossover trial
Antimicrobial stewardship
Community hospitals
Feasibility
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2014-08-08
Enrollment: 3972
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Infectious Diseases Society of America (IDSA) guidelines recommend two "core" strategies for Antibiotic Stewardship (AS): 1) antimicrobial restriction and preauthorization and 2) prospective audit with intervention and feedback. Community hospitals have limited or no resources and staff dedicated to AS. Thus, understanding which of the core strategies is most feasible and effective in this practice setting would assist in appropriate allocation of limited resources. The purpose of this study is to evaluate the feasibility of implementing antimicrobial restriction and preauthorization vs. post antibiotic prescription review in resource-limited community hospitals.

Detailed description: This study is a three-stage cluster randomized historically controlled crossover trial designed to evaluate the feasibility of the implementation of two AS strategies. Four community hospitals in the Duke Infection Control Outreach Network (DICON) will be recruited for this study. Ideally, hospitals will have no teaching affiliation, bed size \<300, and no existing antimicrobial formulary restriction and preauthorization or post-antibiotic prescription review practices in place at study start.

Data will be obtained from the four community hospitals in three stages. In stage 1, historical data from each hospital will be collected for the year prior to study initiation from all participating hospitals. These data are used as a control representing current practice. In stage 2, the four hospitals will be divided into two pairs based upon bed size. One hospital from each pair will be randomly assigned to a six-month period of antimicrobial restriction and preauthorization (Strategy 1; stage 2) followed by a six-month period of post-antibiotic prescription review (Strategy 2; stage 3). The other two hospitals will undergo Strategy 2 in stage 2 followed by Strategy 1 in stage 3 to help alleviate the concern for seasonal/temporal effects when comparing the strategies to each other. A one-month wash out will be performed between each stage. Three antibiotics will be specifically targeted for intervention: anti-pseudomonal carbapenem of choice at the study hospital, vancomycin, and piperacillin-tazobactam. Utilization of alternative antimicrobials, including fluoroquinolones, cephalosporins, and anti-methicillin resistant Staphylococcus aureus (anti MRSA) systemic antimicrobials (e.g., nafcillin, daptomycin, linezolid, ceftaroline, clindamycin, and trimethoprim-sulfamethoxazole (TMP-SMX)) will also be collected. All study hospitals will have electronic systems that track antimicrobial prescriptions through orders, electronic medication administration records (eMAR), bar-coded medication administration (BCMA), or dispensing data.

Hospitals will have dedicated clinical pharmacist time for preauthorization or post-antibiotic review for the three targeted antibiotics in each arm of the study. Pharmacists (PharmDs) at each site will receive standardized training by study personnel in order to address common questions and anticipated arguments, and to establish a robust knowledge base regarding the targeted antimicrobials (anti-pseudomonal carbapenem of choice at the study hospital, vancomycin, and piperacillin-tazobactam). They will also be trained in conflict management.

Study personnel will provide suggested criteria for appropriate use of each targeted drug. Hospital P\&T committees will review, edit (if desired), and approve hospital-specific protocols for appropriate use criteria for each study drug. Pharmacists will be provided with specific clinical pathways for urinary tract infections (UTIs), community-acquired pneumonia (CAP), healthcare-associated pneumonia (HCAP), bacteremia, and "other" uses of targeted antimicrobial. Clinical pathways will be developed jointly by study personnel and based on Centers for Disease Control and Prevention pilot projects. Clinical pharmacists will determine appropriateness of therapy based on study clinical pathways, their baseline knowledge, and acquired knowledge derived by training from study personnel. Time spent performing the two stewardship strategies will be supported by grant funds. The designated pharmacist will be involved in two critical components of the protocol: a) completing the intervention and b) documenting the outcome of the intervention.

Eligibility criteria: Inclusion Criteria:

-All adult and pediatric patients admitted to the study hospital who are prescribed targeted or alternative antimicrobial agent(s) will have data collected from their medical records.

Exclusion Criteria:

* Any patient not meeting the criteria above will be excluded.
* Patients who receive \< 24 hours of surgical prophylaxis with a targeted or alternative antimicrobial will be excluded.
* Finally, any patient followed by an Infectious Disease consultant will be excluded.

Primary outcomes:
measure: Feasibility 1 - Intervention Approval
timeFrame: Prior to implementation, estimated length of 3 months up to 6 months
measure: Feasibility 2 - PharmD training
timeFrame: Prior to implementation, estimated length of 1 months up to 2 months
measure: Feasibility 3 - PharmD Time
timeFrame: Day of Intervention, expected length of 20 hours per week up to 52 weeks
measure: Feasibility 4 - Resource Utilization
timeFrame: During hospitalization, an expected length of 14 days, up to 30 days
Secondary outcomes:
measure: Antimicrobial utilization - Days of Therapy
timeFrame: During Hospitalization, an expected length of 14 days, up to 30 days
measure: Patient Outcomes
timeFrame: During Hospitalization, an expected length of 14 days, up to 30 days
measure: Pharmacist/Physician Perceptions
timeFrame: Within 1 month of completion of intervention arm
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Deverick J Anderson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson DJ, Watson S, Moehring RW, Komarow L, Finnemeyer M, Arias RM, Huvane J, Bova Hill C, Deckard N, Sexton DJ; Antibacterial Resistance Leadership Group (ARLG). Feasibility of Core Antimicrobial Stewardship Interventions in Community Hospitals. JAMA Netw Open. 2019 Aug 2;2(8):e199369. doi: 10.1001/jamanetworkopen.2019.9369.