NCT06106204

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
28mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Nov 2023Aug 2028

First Submitted

Initial submission to the registry

October 7, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

October 7, 2023

Last Update Submit

January 12, 2026

Conditions

PneumoniaUrinary Tract InfectionAntibiotic StewardshipCare Transition

Keywords

Antibiotic StewardshipHospital DischargeUrinary Tract InfectionPneumoniaFacilitationAdaptationi-PARIHS FrameworkImplementation Research Logic Model

Outcome Measures

Primary Outcomes (1)

  • Days of antibiotic overuse at hospital discharge

    Antibiotic overuse at discharge is a composite score of unnecessary antibiotic use, excessive antibiotic duration, and avoidable fluoroquinolones. The score is number of days of antibiotic overuse at hospital discharge.

    12 months; from discharge prescription

Secondary Outcomes (1)

  • Number of cases with antibiotic-associated adverse events

    12 months; 30-days post hospital discharge

Other Outcomes (4)

  • Number of cases with composite 30-day outcome event

    12 months; 30-days post hospital discharge

  • Number of cases with 30-day mortality

    12 months; 30-days post hospital discharge

  • Number of cases with 30-day readmission

    12 months; 30-days post hospital discharge

  • +1 more other outcomes

Study Arms (2)

ROAD Home Intervention

EXPERIMENTAL

Hospitals randomized to receive the ROAD Home Intervention will receive an implementation intervention that includes external facilitation to support them in selecting and implementing evidence-based antibiotic stewardship strategies based on local context and the ROAD Home framework (https://academic.oup.com/cid/article/74/9/1696/6374407).

Other: ROAD Home Intervention

Stewardship as Usual

NO INTERVENTION

Hospitals randomized to the control group will continue usual antibiotic stewardship activities. Although control hospitals are part of the HMS collaborative, during the intervention period they will not receive any of the ROAD Home Intervention components including analysis of their baseline data or needs assessment, customized suite of stewardship strategies, supported decision-making in selecting ROAD Home strategies to implement, an implementation blueprint, adaptable stewardship tools, or external facilitation from study investigators.

Interventions

ROAD Home InterventionOTHER

Hospitals randomized to receive the ROAD Home Intervention will undergo (1) a baseline needs assessment to create a customized suite of stewardship strategies, (2) supported decision-making in selecting ROAD Home strategies to implement, and (3) external facilitation following an implementation blueprint.

ROAD Home Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Positive urine culture
  • Have normal urinary anatomy
  • \- Discharge diagnosis of pneumonia

You may not qualify if:

  • All Patients:
  • Left against medical advice or refused medical care
  • Admitted on hospice
  • Pregnant
  • Unable to determine actual or expected antibiotic duration
  • \- spinal cord injury
  • Cystic fibrosis
  • Pneumonia-related complication (e.g., empyema)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (5)

  • 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.

    PMID: 35143638BACKGROUND

  • 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.

    PMID: 32918077BACKGROUND

  • 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.

    PMID: 34554249BACKGROUND

  • Vaughn VM, Horowitz J, Gandhi T, Neetz RA, Petty L, Hersh A, Lindenauer P, Bernstein SJ, Flanders SA, Harrison JD, Smith JD, White AT, Szymczak JE. Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers. BMJ Open. 2025 Sep 16;15(9):e094925. doi: 10.1136/bmjopen-2024-094925.

    PMID: 40962335DERIVED

  • Szymczak JE, Petty LA, Gandhi TN, Neetz RA, Hersh A, Presson AP, Lindenauer PK, Bernstein SJ, Muller BM, White AT, Horowitz JK, Flanders SA, Smith JD, Vaughn VM. Protocol for a parallel cluster randomized trial of a participatory tailored approach to reduce overuse of antibiotics at hospital discharge: the ROAD home trial. Implement Sci. 2024 Mar 4;19(1):23. doi: 10.1186/s13012-024-01348-w.

    PMID: 38439076DERIVED

Related Links

MeSH Terms

Conditions

PneumoniaUrinary Tract Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Valerie M Vaughn, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two-arm, parallel, cluster-randomized trial of 40 hospitals randomized to an implementation intervention designed to support antibiotic stewardship interventions vs. usual care control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor; Director of Hospital Medicine Research

Study Record Dates

First Submitted

October 7, 2023

First Posted

October 30, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Hospitals enrolled in the study will report aggregate patient data. No IPD will be shared.

Locations

US(1)