Clinical trial NCT06106204: Reducing Overuse of Antibiotics at Discharge Home
Official title: A Parallel Cluster Randomized Trial of a Participatory Approach to Reduce Overuse of Antibiotics at Hospital Discharge: The ROAD Home Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pneumonia
Urinary Tract Infection
Antibiotic Stewardship
Care Transition
Keywords: Antibiotic Stewardship
Hospital Discharge
Urinary Tract Infection
Pneumonia
Facilitation
Adaptation
i-PARIHS Framework
Implementation Research Logic Model
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2023-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel, cluster-randomized trial of 40 hospitals randomized to an implementation intervention designed to support antibiotic stewardship interventions vs. usual care control.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this two-arm parallel cluster-randomized trial of 40 hospitals is to test the effectiveness of the ROAD Home Intervention on days of antibiotic overuse at discharge in patients hospitalized with community-acquired pneumonia (CAP) or urinary tract infection (UTI). The main question it aims to answer is: Does an antibiotic stewardship approach that is customized to the needs, goals, and resources of a hospital (i.e., the ROAD Home Intervention) compared to standard stewardship approaches reduce antibiotic overuse at discharge in hospitalized patients with CAP and UTI? The investigators will randomize 20 hospitals in the Michigan Hospital Medicine Safety Consortium (HMS) to the intervention group and 20 HMS hospitals to the "usual care" control group. During the study the investigators will: (a) assess baseline performance, existing stewardship strategies, hospital priorities, and resources; (b) develop a customized discharge stewardship "suite" for each intervention hospital based on the findings of the baseline assessment and informed by the ROAD Home Framework; and (c) support hospitals in selecting strategies and creating an implementation blueprint to be implemented over 12 to 15 months. After the intervention period, the investigators will compare days of antibiotic overuse at discharge and patient outcomes between intervention and "usual care" hospitals. It is hypothesized that hospitals randomized to the ROAD Home Intervention will have fewer days of antibiotic overuse at discharge compared to "stewardship as usual" control hospitals.

Detailed description: The Reducing Overuse of Antibiotics at Discharge (ROAD) Home study is designed to test the hypothesis that hospitals randomized to an implementation intervention that includes external facilitation to support participants while allowing for free choice in selecting and implementing evidence-based antibiotic stewardship strategies based on local context will have fewer days of antibiotic overuse at discharge than "stewardship as usual" control hospitals. The first aim of this study is to evaluate the effectiveness of the ROAD Home Intervention on days of antibiotic overuse at discharge for hospitalized patients treated for CAP and UTI. The second aim of this study is to identify contextual factors influencing the implementation of the ROAD Home Intervention and to assess implementation outcomes (acceptability, feasibility, fidelity, and sustainment) to inform future broad dissemination.

A two-arm, parallel, cluster-randomized trial will assess the effect of the ROAD Home Intervention on days of antibiotic overuse at discharge. Forty hospitals will be recruited from the Michigan Hospital Medicine Safety Consortium (HMS; https://mi-hms.org/), a statewide 69-hospital collaborative consisting of diverse hospitals and focused on improving the care of hospitalized patients. HMS hospitals that agree to participate will undergo covariate-constrained randomization to improve balancing of critical hospital characteristics between groups with 1:1 allocation to the ROAD Home intervention vs. a "stewardship as usual" control. In the 12- to 15-month intervention period, hospitals will implement the intervention while investigators assess days of antibiotic overuse at discharge and patient outcomes. During the intervention period and in the 9-month post-intervention period, investigators will conduct a theory-informed mixed-methods process evaluation to evaluate barriers, facilitators, and implementation outcomes across hospitals.

Eligibility criteria: Inclusion Criteria:

All Patients:

* Adult patient admitted and discharged from the participating hospital and included in HMS registry
* Admitted to a general care medicine service
* Received any eligible antibiotic during the symptom collection window (-1 to +2 days for UTI; day 1 or 2 for pneumonia)
* Immunocompetent (allowing for mild immune suppression)
* Do not have a concomitant infection (e.g., antibiotic treatment for unrelated infection or prophylaxis)

Specific inclusion criteria for patients with UTI:

* Positive urine culture
* Have normal urinary anatomy

Specific inclusion criteria for patients with pneumonia:

- Discharge diagnosis of pneumonia

Exclusion Criteria:

All Patients:

* Left against medical advice or refused medical care
* Admitted on hospice
* Pregnant
* Unable to determine actual or expected antibiotic duration

Specific exclusions for patients with UTI:

- spinal cord injury

Specific exclusions for patients with pneumonia:

* Cystic fibrosis
* Pneumonia-related complication (e.g., empyema)

Primary outcomes:
measure: Days of antibiotic overuse at hospital discharge
timeFrame: 12 months; from discharge prescription
Secondary outcomes:
measure: Number of cases with antibiotic-associated adverse events
timeFrame: 12 months; 30-days post hospital discharge
Other outcomes:
measure: Number of cases with composite 30-day outcome event
timeFrame: 12 months; 30-days post hospital discharge
measure: Number of cases with 30-day mortality
timeFrame: 12 months; 30-days post hospital discharge
measure: Number of cases with 30-day readmission
timeFrame: 12 months; 30-days post hospital discharge
measure: Number of cases with 30-day C Difficile infection
timeFrame: 12 months; 30-days post hospital discharge
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Valerie M Vaughn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaughn VM, Ratz D, Greene MT, Flanders SA, Gandhi TN, Petty LA, Huls S, Feng X, White AT, Hersh AL. Antibiotic Stewardship Strategies and Their Association With Antibiotic Overuse After Hospital Discharge: An Analysis of the Reducing Overuse of Antibiotics at Discharge (Road) Home Framework. Clin Infect Dis. 2022 Sep 29;75(6):1063-1072. doi: 10.1093/cid/ciac104.
citation: Vaughn VM, Gandhi TN, Chopra V, Petty LA, Giesler DL, Malani AN, Bernstein SJ, Hsaiky LM, Pogue JM, Dumkow L, Ratz D, McLaughlin ES, Flanders SA. Antibiotic Overuse After Hospital Discharge: A Multi-hospital Cohort Study. Clin Infect Dis. 2021 Dec 6;73(11):e4499-e4506. doi: 10.1093/cid/ciaa1372.
citation: Vaughn VM, Hersh AL, Spivak ES. Antibiotic Overuse and Stewardship at Hospital Discharge: The Reducing Overuse of Antibiotics at Discharge Home Framework. Clin Infect Dis. 2022 May 3;74(9):1696-1702. doi: 10.1093/cid/ciab842.