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Appropriateness of Intravenous Antibiotics Prescriptions at Hospital Discharge

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ClinicalTrials.gov Identifier: NCT03173768
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Romanee Chaiwarith, Chiang Mai University

Brief Summary:
A quasi-experimental study was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital to determine the appropriateness of intravenous antibiotics at hospital discharge with and without ID consultation.

Condition or disease Intervention/treatment Phase
Anti-Infectives Adverse Reaction Procedure: ID specialist approval Not Applicable

Detailed Description:

The pre-intervention period was started from November 1, 2015 to April 30, 2016 (6-month period), in which the intravenous antibiotics at hospital discharge were prescribed by the primary care team. The post-intervention period was started from May 1, 2016 to February 28, 2017 (10-month period), in which the intravenous antibiotics at hospital discharge were reviewed and intervened by ID team.

The appropriateness of intravenous antibiotics was assessed separately by the ID fellow and ID specialist. If disagreement occurred, the feedback to the ID fellow was performed and the decision by ID specialist was used in the final analysis of appropriateness.

In post-intervention period, ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics

Finally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Quasi-experimental Study Comparing Intravenous Antibiotics Prescriptions at Hospital Discharge With and Without ID Consultation
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: pre-intervention period
The charts of patients who were prescribed intravenous antibiotics at hospital discharge were reviewed. Appropriateness of intravenous antibiotics was assessed by ID specialists.
Experimental: post-intervention period
The intervention is the charts of patients who were prescribed intravenous antibiotics at hospital discharge by the primary team were prospectively reviewed and intervened by ID team (ID specialist approval)
Procedure: ID specialist approval
Appropriateness of intravenous antibiotics ordered by the primary team was assessed by ID specialist. ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics. Finally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.




Primary Outcome Measures :
  1. The proportion of appropriateness of intravenous antibiotics prescriptions at hospital discharge between groups [ Time Frame: 16 months ]
    To calculate the number of antibiotic prescriptions at hospital discharge over the total number of prescriptions, comparing between pre-and post-intervention period.


Secondary Outcome Measures :
  1. The costs of antibiotics for the course of treatment [ Time Frame: 16 months ]
    To compare the cost of antibiotics for the course of treatment between the 2 periods

  2. Clinical improvement at 1 week [ Time Frame: 1 week ]
    To calculate the number of patients who had clinical improvement at 1 week over the total number of patients in each period, comparing between the 2 periods

  3. Readmission within 30 days, length of hospital stay [ Time Frame: 30 days ]
    To calculate the number of patients who were readmitted within 30 days over the total number of patients in each period, comparing between the 2 periods

  4. Length of hospital stay [ Time Frame: 60 days ]
    To calculate the length of hospital stays in days between 2 periods



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All adult patients who met the following criteria were consecutively enrolled;

  1. age≥ 15 years old and
  2. had infections at any sites and received intravenous antibiotics.

Exclusion Criteria:

- They were evaluated by infectious diseases specialist for appropriate antibiotics during admission


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173768


Locations
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Thailand
Department of Medicine
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Romanee Chaiwarith, MD Maharaj Nakorn Chiang Mai Hospital

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Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03173768     History of Changes
Other Study ID Numbers: 3631
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romanee Chaiwarith, Chiang Mai University:
intravenous antibiotics
appropriateness
outpatient antimicrobial therapy
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents