Reducing Overuse of Antibiotics at Discharge Home

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06106204
Status
Enrolling By Invitation

Conditions

  • Antibiotic Stewardship
  • Care Transition
  • Pneumonia
  • Urinary Tract Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ROAD Home Intervention — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: ROAD Home Intervention
    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).
  • No Intervention: Stewardship as Usual
    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.

Primary Outcome Measure

Days of antibiotic overuse at hospital discharge [ Time Frame: 12 months; from discharge prescription ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84132-

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By research site
University of Utah· Salt Lake City, UT

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