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Modified Reporting From Indwelling Catheters

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ClinicalTrials.gov Identifier: NCT03488355
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Daley, Memorial University of Newfoundland

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE April 5, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE November 5, 2018
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Proportion of inappropriate antibiotic therapy prescribed by physicians (efficacy) [ Time Frame: 72 hours after urine collection ]
As assessed by investigator based on investigator's diagnosis of asymptomatic bacteriuria (should not be treated) or urinary tract infection (should be treated).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03488355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Adverse events (safety) [ Time Frame: 7 days ]
Untreated bacteremia or death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modified Reporting From Indwelling Catheters
Official Title  ICMJE Modified Reporting of Positive Urine Cultures Collected From Indwelling Catheters, a Randomized Controlled Trial
Brief Summary Positive urine cultures collected from indwelling catheters from inpatients will be randomized to standard reporting or modified reporting. Physician antibiotic treatment decisions will be prospectively observed and determined to be appropriate or inappropriate. The hypothesis is that modified reporting will lead to an increase in the percentage of appropriate therapy without an increase in pyelonephritis or sepsis.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Urinary Tract Infections
Intervention  ICMJE Other: 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."
Study Arms  ICMJE
  • Experimental: Modified Reporting
    Modified laboratory report
    Intervention: Other: Modified laboratory report
  • No Intervention: Standard Reporting
    Standard laboratory report
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03488355
Other Study ID Numbers  ICMJE MUN-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peter Daley, Memorial University of Newfoundland
Study Sponsor  ICMJE Memorial University of Newfoundland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brendan Barrett, MD Memorial University
PRS Account Memorial University of Newfoundland
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP