Antibiotic Stewardship in Small Hospitals (SCORE)

Intermountain Health Care, Inc.

Status: Completed

Conditions: Inappropriate Prescribing; Antibiotic Stewardship; Anti-Bacterial Agents

Treatments: Behavioral: Program 1; Behavioral: Program 3; Behavioral: Program 2

Study type: Interventional

Funder types: Other

Identifiers

NCT03245879

1024823

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intermountain Healthcare acute care hospital with < 200 licensed beds
• No formal antibiotic stewardship program in place

Exclusion criteria

-All Intermountain Healthcare specialty hospitals, regardless of bed size

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30,000 participants in 3 patient groups

Program 1

Active Comparator group

Description:

Implementation of a basic antibiotic stewardship program focusing on education, access to Infectious Diseases physicians, and availability of antibiotic use data.

Treatment:

Behavioral: Program 1

Program 2

Active Comparator group

Description:

This arm increases antibiotic stewardship education and interventions. Program 2 hospitals performed audit and feedback of pre-specified antibiotics and implemented locally controlled restrictions.

Treatment:

Behavioral: Program 2

Program 3

Active Comparator group

Description:

This arm was the most intensive antibiotic stewardship intervention. It included signficant audit and feedback, ID controlled restrictions, and ID review of designated culture/lab results.

Treatment:

Behavioral: Program 3