- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03488355
Modified Reporting From Indwelling Catheters
Modified Reporting of Positive Urine Cultures Collected From Indwelling Catheters, a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study is a randomized trial of two methods of laboratory reporting in which physicians are the main research participants. At the time of positive urine culture results, the patient will be randomized by computer generated random number placed into serially numbered sealed, opaque envelopes into two equal groups. One group will receive modified reporting, with a report that states "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results." The other group will receive conventional reporting of identification and susceptibility. Physicians will then have the option of calling the laboratory to receive the results or not. Complete results will be released by telephone and laboratory information system to physicians who call to request them. Physicians will be informed about the study prior to initiation, and debriefed about the study after the results have been collected.
Inclusion criteria will include consecutive positive urine cultures collected from indwelling catheters among patients admitted to acute care, that are greater than or equal to 18 years of age. Inpatients must be admitted to Health Sciences Center or St. Clare's Mercy hospitals only, in order to facilitate access to inpatient records.
Exclusion criteria will include pregnancy, antibiotic treatment at the time of collection, patients in the Intensive Care Unit and patients with blood neutrophils <1.0 within 7 days, which will help protect immunocompromised individuals.
Investigators will review patient charts at 24 and 72 hours and 7 days after collection. After randomization and reporting, a physician investigator will assess inpatients for the true diagnosis of asymptomatic bacteriuria (AB) or urinary tract infection (UTI). Health records will be accessed including demographics, treatment decisions and outcomes (untreated UTI or pyelonephritis). Frequency of physician calls requesting complete reporting will be recorded.
The research hypothesis is that restricted reporting will reduce the rate of inappropriate treatment prescribed by physicians. Among inpatients, the expected rate of inappropriate treatment in the control group will be 50 percent, and 20 percent in the intervention group. Accepting a risk of type 1 error of five percent, and a risk of type 2 error of twenty percent, the study will recruit 72 patients. In order to account for missing data, recruitment will be increased to 100 patients. The statistical test to be used is a comparison of proportions between two groups (T test, two sided analysis). An intention to treat analysis including all patients randomized will be performed.
Physicians must remain unaware of the research project so that their treatment decisions are unbiased. However, a general notice will be sent to all physicians regarding the study design, and a debrief will be provided in which study results are presented and the option to withdraw data will be provided. This will cause physicians to feel less deceived while still not informing them of the study and thus will not change their behavior.
Physicians of discharged inpatients will be contacted at 7 days to assess for adverse events. Because recruitment will be brief, it is unlikely that physicians will have a second patient in the study.
Ethics permission will be sought from the local ethics board. Consent of patients or physicians will not be requested. In compliance with ethics requirements, participants will experience no more than minimal risk. If an adverse event occurs, the patient will be removed from the study immediately and given standard treatment. Physician consent will not be requested, as awareness of the study would bias treatment decisions.
The benefit of this study to patients includes a reduction in adverse events caused by inappropriate treatment. The risk to patients includes possible untreated UTI. The benefit to physicians includes education toward appropriate treatment of AB. The risk to physicians includes additional effort to access laboratory results for UTI.
Data collection will use a paper case report form, and entry into a password protected online database. Analysis will be performed using SPSS 20.0 (IBM). The only expense of the project will be the graduate student to collect the data, perform the analysis and write the manuscript. The manuscript will be published in a peer-reviewed journal and presented at a national conference.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Newfoundland and Labrador
-
Saint John's, Newfoundland and Labrador, Canada, A1B3V6
- Health Sciences Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- consecutive positive urine cultures collected from indwelling catheters in inpatients that are greater than or equal to 18 years of age.
- admitted to Health Sciences Center or St. Clare's Mercy hospitals only
Exclusion Criteria:
- pregnancy
- antibiotic treatment at the time of collection
- patients in the Intensive Care Unit
- blood neutrophils count <1.0 x 10E9/l, within 7 days of urine collection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Modified Reporting
Modified laboratory report
|
Report from microbiology laboratory: "This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection.
If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
|
No Intervention: Standard Reporting
Standard laboratory report
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Appropriate Treatment
Time Frame: 7 days after positive urine culture
|
Untreated catheter-associated asymptomatic bacteriurias, plus treated catheter-associated urinary tract infections, divided by total patients.
|
7 days after positive urine culture
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 7 days
|
All-cause mortality
|
7 days
|
Adverse Events
Time Frame: 7 days after positive urine culture
|
Number of participants with adverse events.
|
7 days after positive urine culture
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brendan Barrett, MD, Memorial University
Publications and helpful links
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 (Estimate)
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
- MUN-3
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.
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