Pneumonia Clinical Trial
Official title:
A Parallel Cluster Randomized Trial of a Participatory Approach to Reduce Overuse of Antibiotics at Hospital Discharge: The ROAD Home Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
| Completed |
NCT05815264 -
Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above
|
Phase 1 | |
| Recruiting |
NCT04589936 -
Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care
|
N/A | |
| Completed |
NCT02905383 -
The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital
|
N/A | |
| Completed |
NCT06210737 -
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
|
Phase 4 | |
| Terminated |
NCT03944551 -
Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa
|
N/A | |
| Terminated |
NCT04660084 -
Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP
|
N/A | |
| Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
| Withdrawn |
NCT05702788 -
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)
|
Phase 2 | |
| Not yet recruiting |
NCT04171674 -
Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.
|
N/A | |
| Active, not recruiting |
NCT03140163 -
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
|
N/A | |
| Completed |
NCT02638649 -
Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
|
||
| Completed |
NCT02864420 -
Hospitalization at Home: The Acute Care Home Hospital Program for Adults
|
N/A | |
| Recruiting |
NCT02515565 -
Physiotherapy in Patients Hospitalized Due to Pneumonia.
|
N/A | |
| Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
| Completed |
NCT01446926 -
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
|
Phase 1 | |
| Completed |
NCT01416519 -
Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
|
N/A | |
| Completed |
NCT01399723 -
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
|
Phase 3 | |
| Terminated |
NCT02358642 -
Drug to Prevent Pneumonia in the Tube Fed
|
Phase 4 | |
| Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A |