NCT03245879

Antibiotic Stewardship in Small Hospitals

Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Trial Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30,000 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Core elements of effective antibiotic stewardship programs (ASPs) have been identified and evidence-based guidelines have been developed for implementation. The majority of the evidence used for these guidelines are from published studies on the effectiveness of ASPs in large academic or large community hospitals. A significant portion of healthcare in the United States, however, takes place in small hospitals. In 2015, 73% of US hospitals had \< 200 beds (4,057 hospitals) and accounted for 29% of all US inpatient bed days. Limited studies on the effectiveness of antibiotic stewardship implementation have been performed in hospitals with \< 200 beds. Antibiotic use rates and selection patterns in these small hospitals are similar to that of large hospitals and the majority of small hospitals lack formal ASP that meet the CDC's core elements. The objective of this real-world implementation study was to assess the effectiveness of three ASP strategies of escalating intensity designed specifically for small hospitals within a vertically integrated healthcare delivery system.

Detailed description

The investigators designed a clustered randomized controlled intervention to evaluate 3 antibiotic stewardship strategies designed for small hospitals. Each hospital was randomized to one of three ASP interventions with increasing levels of intensity and intervention (Programs 1, 2, 3). The investigators felt that clinical equipoise about the effect of ASPs did not exist and randomizing to a no-intervention group was unacceptable. Antibiotic use was compared within each group before and after the intervention. In keeping with other real-world implementation studies, secondary analyses were planned to include an interrupted time series design to evaluate the impact of each strategy. Randomization of hospitals was stratified based on patient volume. Hospital administration and clinical leadership were not blinded to which ASP program they were randomly assigned to, but there were no public announcements. The intervention started March 2014 and ended June 2015.

Conditions

• Inappropriate Prescribing
• Antibiotic Stewardship
• Anti-Bacterial Agents

Interventions

Type	Name	Description
BEHAVIORAL	Program 1	Program 1 hospitals received a basic curriculum and tools for implementation of basic antibiotic stewardship interventions. Hospitals required an indication for every antibiotic order. A daily email was sent to a designated email account when a patient had been on an antibiotic for \>48 hours. Curriculum included implementing antibiotic time-outs, IV to PO conversion, indications, evaluating for bug-drug mismatches, and recommendations on when to call the Infectious Diseases (ID) hotline. A daily antibiotic stewardship check list was created. All materials were provided to all pharmacists and remained on-site. Clinicians had access to an ID telephone hotline to answer clinical questions. Pharmacy directors and hospital leadership were provided a monthly, hospital-specific, antibiotic use dashboard. All pharmacy directors and staff received a monthly newsletter.
BEHAVIORAL	Program 2	Program 2 hospitals received all the interventions of Program 1. In addition, Program 2 hospitals received more intense antibiotic stewardship education. Educational topics included audit and feedback, antibiotic de-escalation, the need for antibiotics targeting anaerobic bacteria, antibiotic allergy verification, and antibiotic restrictions. Pharmacists in Program 2 hospitals reviewed patients on vancomycin, piperacillin/tazobactam, imipenem, meropenem, and cefepime. For patients receiving one of these antibiotics, pharmacists reviewed the patients' microbiology data to identify opportunities for antibiotic de-escalation, IV to PO conversion, bug-drug mismatches, and/or indications for calling the ID hotline. Program 2 hospitals also restricted daptomycin, linezolid, imipenem, meropenem, ceftaroline, tigecycline, and all mold active antifungals. In Program 2 hospitals, the local pharmacy staff pre-authorized restricted antibiotics based on defined criteria.
BEHAVIORAL	Program 3	Program 3 hospitals received all the interventions of Program 1 and Program 2. In addition, pharmacists in program 3 hospitals reviewed an expanded list of antibiotics for audit and feedback. These antibiotics included: Vancomycin, piperacillin/tazobactam, imipenem, meropenem, cefepime, ertapenem, aminoglycosides, ceftriaxone, and fluoroquinolones. Program 3 hospitals implemented the same antibiotic restrictions as Program 2 but ID pharmacists controlled pre-authorization of restricted antibiotics. In addition, an ID physician reviewed pre-specified positive cultures (e.g. all positive blood cultures, cultures with highly resistant Enterobacteraciae) and contacted providers with recommendations as needed. ID physician review occurred Monday through Friday and alerts were batched daily at 6am.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2017-08-10
• Last updated: 2017-08-10