Modified Reporting of Positive Urine Cultures Collected From Long Term Care

NCT ID: NCT03554603

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2019-07-31

Brief Summary

Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

Detailed Description

Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.

Conditions

Urinary Tract Infections; Asymptomatic Bacteriuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Modified Reporting

Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results"

Group Type: EXPERIMENTAL

Modified Report

Intervention Type: BEHAVIORAL

An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.

Standard Reporting

Microbiology laboratory will report identification and susceptibility results

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Modified Report

An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.

Intervention Type: BEHAVIORAL

Other Intervention Names

Restricted Report

Eligibility Criteria

Inclusion Criteria

1. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).

Exclusion Criteria

1. Positive urine cultures not collected from Long term care facility patients

2. Pregnancy

3. Antibiotic treatment at the time of collection

4. Patients known to have blood neutrophils <1.0 within 7 days of urine collection

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial University of Newfoundland

OTHER

Sponsor Role: lead

Responsible Party

Peter Daley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Sciences Center

St. John's, Newfoundland and Labrador, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MUN-04

Identifier Type: -

Identifier Source: org_study_id