A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization

Study Overview
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Brief Summary
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We will conduct a cluster randomized controlled trial to compare two antibiotic pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and duration of antibiotic consumption would be lower in the pharmacist group while the clinical outcome would be equivalent between two groups.

Detailed Description
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Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand

Official Title
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A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures

Conditions
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All Hospitalzied Patients, No Specific Conditions Requires

Intervention / Treatment
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* Procedure: ID fellow-based antibiotic pre-authorization
* Procedure: Pharmacist-based antibiotic pre-authorization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients Received at least one dose of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem or Doripenem) Each patient may be enrolled more than once, if he/she receives the controlled antibiotic for a new episode of infection (at least 48 hour apart) Exclusion Criteria: Died prior to receive the controlled antibiotic

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fellow arm<br>Patients in this arm will receive the ID fellow-based antibiotic pre-authorization intervention. | Procedure: ID fellow-based antibiotic pre-authorization<br>* All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by ID-fellows, under the supervision of ID staffs.<br>|
| Active Comparator: Pharmacist arm<br>Patients in this arm will receive the pharmacist-based antibiotic pre-authorization intervention. | Procedure: Pharmacist-based antibiotic pre-authorization<br>* All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by general pharmacists, under the supervision of ID staffs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defined Daily Dose (DDD) of antibiotics | DDD of antibiotic use for that given infection (all antibiotics and controlled antibiotics) | Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of antibiotic use | Total duration of antibiotic use for that given infection (all antibiotics and controlled antibiotics) | Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks |