- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173768
Appropriateness of Intravenous Antibiotics Prescriptions at Hospital Discharge
Quasi-experimental Study Comparing Intravenous Antibiotics Prescriptions at Hospital Discharge With and Without ID Consultation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Chiang Mai, Thailand, 50200
- Department of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- They were evaluated by infectious diseases specialist for appropriate antibiotics during admission
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
16 months
|
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
|
1 week
|
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
|
30 days
|
Length of hospital stay
Time Frame: 60 days
|
To calculate the length of hospital stays in days between 2 periods
|
60 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Romanee Chaiwarith, MD, Maharaj Nakorn Chiang Mai Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3631
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anti-Infectives Adverse Reaction
-
Chiayi Christian HospitalCompletedInfections | Breast Cancer | Perforator Flap | Anti-Infectives Adverse Reaction
-
Assistance Publique - Hôpitaux de ParisRecruitingPatient Receiving Anti-infectives Whatever DiseaseFrance
-
Sun Yat-sen UniversityUnknownNon-steroidal Anti-inflammatory Drug Adverse ReactionChina
-
Galeno Desenvolvimento de Pesquisas ClínicasBiolab Sanus FarmaceuticaCompletedLidocaine Adverse Reaction | Prilocaine Adverse ReactionBrazil
-
The Leeds Teaching Hospitals NHS TrustLeeds Clinical Commissioning GroupRecruitingAdherence, Medication | Statin Adverse Reaction | Anticoagulant Adverse ReactionUnited Kingdom
-
Rigshospitalet, DenmarkUnknownAnalgesic Adverse Reaction | Gonad Regulating Hormone Adverse ReactionDenmark
-
University of Texas Southwestern Medical CenterRecruitingAnesthesia | Anesthesia; Reaction | Anesthesia Complication | Anesthesia; Adverse Effect | Propofol Adverse Reaction | Etomidate Adverse ReactionUnited States
-
Clinical Hospital Center ZemunWithdrawnBisoprolol Adverse Reaction | Nebivolol Adverse ReactionSerbia
-
PT Bio FarmaCenter for Child Health Universitas Gadjah Mada (CCH-PRO UGM; Cipto Mangunkusumo... and other collaboratorsRecruitingVaccine Adverse Reaction | Vaccine ReactionIndonesia
-
Izmir Ataturk Training and Research HospitalNot yet recruitingPsychotropic Agents Causing Adverse Effects in Therapeutic Use | Anticholinergic Adverse Reaction | Anticholinergic Syndrome | Antiarrhythmic Drug Adverse Reaction | Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use | Antispasmodic Adverse Reaction
Clinical Trials on ID specialist approval
-
PATHSID TechnologiesCompletedInjections, IntradermalUnited States
-
PulseMedicaRecruiting
-
Idorsia Pharmaceuticals Ltd.CompletedRenal ImpairmentGermany
-
University College, LondonLund University; University Hospital, Bordeaux; Ludwig-Maximilians - University... and other collaboratorsCompletedParkinson's Disease | Late Stage Parkinson's DiseaseNetherlands, United Kingdom, Germany, France, Portugal, Sweden
-
Aga Khan UniversityWorld Health OrganizationCompleted
-
Indiana UniversityNational Institute on Aging (NIA); Regenstrief Institute, Inc.; Hebrew SeniorLifeCompletedDementia | Alzheimer DiseaseUnited States
-
Seoul National University HospitalUnknownAbnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal PainKorea, Republic of
-
PATHCompletedInjections, IntradermalUnited States
-
Queen's University, BelfastUniversity of Sheffield; University of Glasgow; University of South Wales; Baily...Recruiting
-
Portsmouth Hospitals NHS TrustBritish Lung Foundation; University of OxfordCompletedMesothelioma, MalignantUnited Kingdom, Australia