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Effect of a Diagnostic Algorithm for Urinary Tract Infection in General Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698332
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Anne Holm, University of Copenhagen

Brief Summary:

The aim of this study is to investigate the effect of diagnostic algorithm for urinary tract infection (UTI) on appropriate prescribing of antibiotics and use of diagnostics for patients with symptoms of urinary tract infection consulting their general practitioner.

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infection Device: Algorithm for UTI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of a Diagnostic Algorithm for Urinary Tract Infection on Appropriate Use of Antibiotics and Diagnostics in General Practice - a Cluster Randomized Trial
Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Algorithm for UTI
Practices in this groups receives a diagnostic algorithm for UTI by post
Device: Algorithm for UTI
The algorithm consists of one sheet of laminated paper with instruction in how to diagnose UTI

No Intervention: Control
Practices in this group does not receive anything in addition to instructions in the observational registration.



Primary Outcome Measures :
  1. Difference in appropriate primary choice of treatment in the two groups. [ Time Frame: 3 months ]
  2. Difference in price of point-of-care diagnostics used in the two groups [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Difference in appropriate final choice of treatment in the two groups. [ Time Frame: 3 months ]
  2. Difference in appropriate choice of treatment on the day of consultation (day 1) in the two groups [ Time Frame: 3 months ]
  3. Difference in appropriate choice of treatment on the day after consultation (day ) in the two groups [ Time Frame: 3 months ]
  4. Difference in correct decision to treat on the day of consultation (day 1) in the two groups [ Time Frame: 3 months ]
  5. Difference in correct decision to treat on the day after consultation (day 2) in the two groups [ Time Frame: 3 months ]
  6. Number of diagnostics used in the two groups [ Time Frame: 3 months ]
  7. Practice satisfaction with participation in the project in the two groups [ Time Frame: 4 months ]
    All participating practices received an online questionnaire after participation evaluating satisfaction with participation, the diagnostic algorithm and the smart-phone integrated web-page. Being "very satisfied" and being "very likely" to participate in a similar project or use the algorithm in the future was considered a positive response.

  8. Practice acceptance of the algorithm in the intervention group [ Time Frame: 4 months ]
    All participating practices received an online questionnaire after participation evaluating satisfaction with participation, the diagnostic algorithm and the smart-phone integrated web-page. Being "very satisfied" and being "very likely" to participate in a similar project or use the algorithm in the future was considered a positive response.


Other Outcome Measures:
  1. Association between use of microscopy and appropriate use of antibiotics on the day of consultation [ Time Frame: 3 months ]
    Outside randomization (embedded cohort study)

  2. Association between use of microscopy and appropriate use of antibiotics on the day after consultation [ Time Frame: 3 months ]
    Outside randomization (embedded cohort study)

  3. Association between use of point-of care culture and appropriate use of antibiotics on the day of consultation [ Time Frame: 3 months ]
    Outside randomization (embedded cohort study)

  4. Association between use of point-of care culture and appropriate use of antibiotics on the day after consultation [ Time Frame: 3 months ]
    Outside randomization (embedded cohort study)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients presenting in general practice with symptoms of UTI who has not formerly participated in the study.

Exclusion Criteria:

  • Acute admission to hospital.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698332


Locations
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Denmark
General Practice Copenhagen Region
Copenhagen, Denmark, 1014
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Anne Holm, MD University of Copenhagen
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Responsible Party: Anne Holm, MD PhD-fellow, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02698332    
Other Study ID Numbers: UCCAREALG
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases