Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06106204
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-06
First Post:
2023-10-07
Brief Title:
Reducing Overuse of Antibiotics at Discharge Home
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
A Parallel Cluster Randomized Trial of a Participatory Approach to Reduce Overuse of Antibiotics at Hospital Discharge The ROAD Home Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROAD Home
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 ie 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 httpsmi-hmsorg 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 11 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
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 httpsmi-hmsorg 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None