NCT03173768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

April 3, 2017

Last Update Submit

June 1, 2017

Conditions

Keywords

intravenous antibioticsappropriatenessoutpatient antimicrobial therapy

Outcome Measures

Primary Outcomes (1)

  • The proportion of appropriateness of intravenous antibiotics prescriptions at hospital discharge between groups

    To calculate the number of antibiotic prescriptions at hospital discharge over the total number of prescriptions, comparing between pre-and post-intervention period.

    16 months

Secondary Outcomes (4)

  • The costs of antibiotics for the course of treatment

    16 months

  • Clinical improvement at 1 week

    1 week

  • Readmission within 30 days, length of hospital stay

    30 days

  • Length of hospital stay

    60 days

Study Arms (2)

pre-intervention period

NO INTERVENTION

The charts of patients who were prescribed intravenous antibiotics at hospital discharge were reviewed. Appropriateness of intravenous antibiotics was assessed by ID specialists.

post-intervention period

EXPERIMENTAL

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

Interventions

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.

post-intervention period

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients who met the following criteria were consecutively enrolled;
  • age≥ 15 years old and
  • had infections at any sites and received intravenous antibiotics.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine

Chiang Mai, 50200, Thailand

Location

Study Officials

  • Romanee Chaiwarith, MD

    Maharaj Nakorn Chiang Mai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 3, 2017

First Posted

June 2, 2017

Study Start

November 1, 2015

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

June 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations