Effect of a Diagnostic Algorithm for Urinary Tract Infection in General Practice
NCT ID: NCT02698332
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1550 participants
INTERVENTIONAL
2016-03-31
2016-06-30
Brief Summary
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70 general practices participating in an observational study regarding UTI are randomized to either receiving a diagnostic algorithm or not receiving anything additional.
The study is observational on the patient level and interventional on the practice level.
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Detailed Description
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RANDOMIZATION AND BLINDING Randomization was performed using an online random number generator and an employee not part of the investigation team sent out the diagnostic algorithm to the intervention group. The practices were asked not to reveal their allocation to the investigators in case of contact. Allocation was concealed to the investigators until after analysis of the primary outcomes.
INTERVENTION AND CONTROLS The practices in the intervention group received a laminated diagnostic algorithm by post and got access to a smart-phone integrated web-page, which could calculate post-test probabilities based on pre-test probabilities and accuracy of diagnostic tests .The diagnostic algorithm consists of three parts, one about urine dipstick, one about point-of-care microscopy and one about urine culture . The practices were instructed, use of the algorithm was voluntary. Control practices did not receive a diagnostic algorithm and did not have access to the smart-phone integrated web-page.
RECRUITMENT OF PATIENTS The practices were told to register diagnostics and treatment on the first 20-40 patients presenting in general practice with symptoms of UTI regardless of age, sex and comorbidity. For each patient, the practice sent a urine sample to the microbiological department as reference.
INCLUSION AND EXCLUSION CRITERIA Inclusion criteria were all patients with symptoms of UTI who had not formerly participated in the study and where urinalysis was performed. The only exclusion criterion was acute admission to hospital.
DATA COLLECTION AND MANAGEMENT On the patient-level, the study was observational and anonymous. The practices registered clinical history, diagnostics and treatment using a case-report form where data on all patients fit into one sheet of paper. On day one (the day of consultation), clinical history, diagnostics, diagnosis and treatment were registered. On day two (the day after the consultation), result of the point-of-care urine culture, if such was performed, and the subsequent diagnosis and treatment were registered. The result of the reference urine culture was registered when the result was reported back to the practice on day 4-6. The intervention group could use the algorithm as they saw fit.
REFERENCE CULTURE Urine for the microbiological department was incubated in a standardized boric-acid container (Urine-Monovette®, Sarstedt) and collected by a transport service from the microbiological departments. At the microbiological laboratories (Herlev and Hvidovre), urine sample were analyzed on Inoqul A™ Bi-plate (CHROMagar and blood agar) with 10 μL on each half of the agar. The susceptibility pattern was determined on Mueller Hinton agars with disks containing mecillinam, trimethoprim, nitrofurantoin and sulfamethizol. Significant growth was defined as growth of ≥103 cfu/mL for E. coli and S. saprophyticus, ≥104 cfu/mL for other typical uropathogens and ≥105 cfu/ml for possible uropathogens in accordance with European consensus\[21\]. Plates with significant growth of more than two uropathogens were labeled as mixed cultures (inconclusive). The result was sent to practices within 4-5 workdays electronically and practices registered the result of the culture and susceptibility against mecillinam, trimethoprim, nitrofurantoin and sulfamethizol on the case-report.
ETHICS AND PATIENT SAFETY The study was presented to the ethical committee of Copenhagen and did not require ethical approval since the study was purely observational on the patient level and did not interfere with patient-treatment. Registration of patient data was done anonymously and did not require approval from the Danish data protection agency.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Algorithm for UTI
Practices in this groups receives a diagnostic algorithm for UTI by post
Algorithm for UTI
The algorithm consists of one sheet of laminated paper with instruction in how to diagnose UTI
Control
Practices in this group does not receive anything in addition to instructions in the observational registration.
No interventions assigned to this group
Interventions
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Algorithm for UTI
The algorithm consists of one sheet of laminated paper with instruction in how to diagnose UTI
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Anne Holm
MD PhD-fellow
Principal Investigators
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Anne Holm, MD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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General Practice Copenhagen Region
Copenhagen, , Denmark
Countries
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References
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Holm A, Siersma V, Cordoba GC. Diagnosis of urinary tract infection based on symptoms: how are likelihood ratios affected by age? a diagnostic accuracy study. BMJ Open. 2021 Jan 8;11(1):e039871. doi: 10.1136/bmjopen-2020-039871.
Holm A, Siersma V, Bjerrum L, Cordoba G. Availability of point-of-care culture and microscopy in general practice - does it lead to more appropriate use of antibiotics in patients with suspected urinary tract infection? Eur J Gen Pract. 2020 Dec;26(1):175-181. doi: 10.1080/13814788.2020.1853697.
Other Identifiers
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UCCAREALG
Identifier Type: -
Identifier Source: org_study_id
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