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

NCT ID: NCT01797133

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

984 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-12-31

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

Conditions

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All Hospitalzied Patients No Specific Conditions Requires

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fellow arm

Patients in this arm will receive the ID fellow-based antibiotic pre-authorization intervention.

Group Type ACTIVE_COMPARATOR

ID fellow-based antibiotic pre-authorization

Intervention Type PROCEDURE

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.

Pharmacist arm

Patients in this arm will receive the pharmacist-based antibiotic pre-authorization intervention.

Group Type ACTIVE_COMPARATOR

Pharmacist-based antibiotic pre-authorization

Intervention Type PROCEDURE

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.

Interventions

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ID fellow-based antibiotic pre-authorization

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.

Intervention Type PROCEDURE

Pharmacist-based antibiotic pre-authorization

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pinyo Rattanaumpawan

Asssitant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pinyo Rattanaumpawan, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Rattanaumpawan P, Upapan P, Thamlikitkul V. A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows. Infect Control Hosp Epidemiol. 2018 Oct;39(10):1154-1162. doi: 10.1017/ice.2018.198. Epub 2018 Aug 29.

Reference Type DERIVED
PMID: 30156171 (View on PubMed)

Other Identifiers

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647/2555(EC1)

Identifier Type: -

Identifier Source: org_study_id

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