- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03172039
Antimicrobial Use and Stewardship in an Outpatient Hemodialysis Unit
Study Overview
Status
Detailed Description
Description of Study:
Patients who make up the ambulatory hemodialysis (HD) population at Toronto General Hospital (TGH) are interviewed on a weekly basis about their antimicrobial use during the nursing-led bedside huddle as part of the standard of care. These huddles take place daily during each of the four HD shifts: morning, afternoon, evening and nocturnal. During the huddle the nurse or patient care coordinator asks the patient if they have been prescribed an oral or intravenous antimicrobial by a hospital or community prescriber in the past 7 days. A Best Possible Medication History (BPMH) is completed by a HD Pharmacy team member for all patients who stated they have started a new antimicrobial. A BPMH is a patient's medication history which is defined as "a systematic process of interviewing the patient/family", and "a review of at least one other reliable source of information" (e.g., dispensing pharmacy records, hospital discharge records etc.) to confirm medication use. The BPMH is part of routine care in the HD unit and obtained at regular intervals (e.g., when a medication is started, changed or discontinued) to ensure the most accurate medication history is available. The BPMH containing information about the antimicrobial treatment is documented in the patient's medical chart, as well as in the electronic pharmacy patient profile. There will be no disruption to the current pharmacy practice and workflow in the HD unit by this study.
At the end of the data collection period, a panel compromising of a pharmacy resident, antimicrobial stewardship pharmacist, nephrology pharmacist, nurse practitioner and nephrologist will adjudicate each antimicrobial prescription with a presumed indication for congruence with available clinical guidelines and antimicrobial principles described by CDC. Each antimicrobial regimen will be categorized as congruent or non-congruent; any regimen for which there is inadequate or unavailable documentation in support of congruence will be classified as unknown congruence. The primary tool for assessing antimicrobial therapy will be against antimicrobial stewardship best practices guiding principles established by CDC, supplemented by applicable guidelines for each site of suspected infection published by major infectious disease and nephrology societies. Evidence-based resources for drug dosing in renal failure will be used to determine whether the prescribed antimicrobial regimen is consistent with literature-based dosing recommendations. The prescription will be assessed for types of stewardship-discordant prescribing that will be defined based on general stewardship principles a priori such as the following:
i) antimicrobial regimen has incorrect dose/route/frequency for intended infectious syndrome, pathogens and/or patient factors ii) length of treatment too short (discontinuation before adequate source control or clinical stability) or too long (prolonged therapy despite documented microbiologic clearance or resolution of symptoms) iii) empiric therapy spectrum too broad or narrow considering possible causative pathogens iv) antimicrobial therapy not tailored/streamlined/de-escalated for microbiology results v) non-infectious syndrome
Number of subjects:
The outpatient HD unit at TGH has a typical census of 300 patients. It is estimated that approximately 300 patient charts will be identified for inclusion as this study will be a non-comparative analysis of all patients admitted to the HD unit.
Statistics:
Data will be tabulated and analyzed using Microsoft Excel software. Descriptive statistics will be used to analyze the data. Means and standard deviations, as well as counts and proportions will be calculated for baseline parameters and relevant endpoints as appropriate. No interim analyses of the data are anticipated.
Procedure for accounting for missing, unused, and spurious data:
A patient's medical chart and pharmacy patient profile are comprehensive for obtaining a patient's medication history and therefore missing data should not be a concern. If this issue arises all available data sources will be exhausted (e.g., electronic patient record, pharmacy patient profiles).
Quality Assurance:
All data will be collected by the designated study team member using a data collection sheet and following a systematic approach approved by the project team. Raw data will be validated and reviewed by the project team following the completion of data collection and prior to data analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 18 years of age
- Receiving outpatient hemodialysis (HD) for at least 3 months
- Prescribed at least one oral or intravenous antimicrobial (antibacterial or antifungal or antiviral) by a hospital or community prescriber between September 2016 to April 30 2017 inclusive
Exclusion Criteria:
- In-patients admitted to hospital
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of antimicrobial prescriptions in an ambulatory hemodialysis population
Time Frame: September 1 2016 - April 30 2017
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Prevalence will be determined by the total number of antimicrobial prescriptions in the study population over the period of study.
An antimicrobial prescription will be defined as any oral or intravenous antibacterial or antifungal or antiviral agent prescribed by a community or hospital prescriber to a patient receiving hemodialysis (HD) from Toronto General Hospital's outpatient HD unit.
An antimicrobial prescription will follow the 21-day rule.The 21-day rule is that there must be 21 or more days from the end of one antimicrobial course to the beginning of a second antimicrobial course for two courses to be reported as separate prescriptions.
If antimicrobials are stopped for fewer than 21 days and then restarted, the second start is not considered a new prescription, and therefore will not be reported.
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September 1 2016 - April 30 2017
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Congruence of prescribed antimicrobial regimens
Time Frame: September 1 2016 - April 30 2017
|
Proportion of antimicrobial prescriptions congruent with available clinical guidelines and antimicrobial stewardship principles based on: i) indication ii) antimicrobial agent iii) spectrum of activity against most likely causative pathogen iv) dose v) route of administration vi) dosing frequency vii) length of treatment |
September 1 2016 - April 30 2017
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Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-6388
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
product manufactured in and exported from the U.S.
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.
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