The Impact of De-implementing Urine Dipsticks for Diagnosis of UTIs in Hospitals

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJacob Bodilsen

About this trial

The goal of this interrupted time-series analysis is to evaluate the impact of the de-implementation of urine dipsticks as a diagnostic tool for urinary tract infections (UTIs) in hospitalized patients in the North Denmark Region. The main question it aims to answer is:

How does de-implementation of urine dipsticks affect the diagnosis and management of UTIs and related disorders?

Specifically, does it change the following parameters:

* Number and severity of UTI infections (lower and upper UTI, non-severe and severe) * Antibiotic prescription (overall, antibiotic classes, administration routes, duration, dosages) * Number of urine cultures and number of positive urine cultures * Risks of admission to intensive care units and 30-day mortality * Risk of drug toxicity * Length of hospital stay * Risk of admission to intensive care unit * 30-day risk of readmission after discharge * 6-month risks of Clostridioides difficile enterocolitis and de novo antimicrobial resistance in cultures obtained during routine clinical care.

Researchers hypothesize that de-implementing urine dipsticks will lead to a reduced frequency of diagnosed cystitis, reduced antibiotic use, and fewer urine cultures without negatively affecting patient mortality or readmission risk.

Researchers will compare the outcomes before and after the discontinuation of urine dipsticks across hospitals in the North Denmark Region. Furthermore, results will be compared to another Danish administrative healthcare region where dipsticks are still in use as well as urine culture data from the primary sector in the North Denmark Region.

Since this is a registry-based observational study utilizing data from the electronic patient record system in the North Denmark Region, no direct contact will be made with participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients admitted to emergency rooms (≥18 years) from 2019 and forward.

Disqualifiers

Patients directly admitted to an inpatient unit without first visiting an emergency room are excluded from the study.

For the primary analysis, only the first admission will be included; subsequent admissions will be excluded.

Trial population

A primary inclusion criterion is that adult patients (≥18 years of age) begin their admission in one of the four emergency rooms in the North Denmark Region. Three of these are part of Aalborg University Hospital, located in Hobro, Aalborg, and Thisted, while the fourth is at Hjørring, part of the North Denmark Regional Hospital. Patients arrive at the emergency rooms either through referrals from general practitioners or directly via emergency calls. Following admission, patients may be discharged or transferred to an inpatient unit, including internal medicine, abdominal surgery, or urological surgery departments. Other surgical departments (e.g., orthopedic surgery), emergency rooms for orthopedic injuries ("skadestuer"), and pediatric departments (\<18 years) are not included in this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • De-implementation of Urinary Dipsticks

    Diagnostic test

    In August 2023 / February 2024, urinary dipsticks were de-implemented in hospitals across the North Denmark Region. Using registry-based data, the investigators aim to evaluate the clinical impact of this decision.

  • Usual practice with no intervention

    Other intervention

    In hospitals within the Central Denmark Region and in the primary care sector, urinary dipsticks have not been de-implemented and remain in use. Registry-based data from these settings will serve as a control.

Treatment groups

480,000 Participants
are divided into 3 treatment groups
Group A: Emergency rooms in North Denmark Region1 intervention
Group B: Control hospital in Central Denmark Region1 intervention
Group C: Control urine cultures from general practice1 intervention

Trial outcomes

Primary outcomes

1

Monthly Incidence Rate of Urinary Tract Diagnoses (Composite Measure)

The monthly count of urinary tract infection diagnoses (ICD-10 codes: DN300, DN308C, DN309, DA419B) will be divided by the total person-time contributed by all admitted patients to the hospitals. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.

Time frame
The monthly incidence will be calculated between January 2019 to end of the study (September 2025)
2

Monthly Incidence Rate of Urine Cultures (Composite Measure)

The monthly count of urine cultures (including all cultures, both positive and negative) will be divided by the total person-time contributed by admitted patients. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.

Time frame
The monthly incidence will be calculated between January 2019 to end of the study period (September 2025)
3

Monthly Incidence Rate of Antibiotic Usage (Composite Measure)

The monthly count of urinary tract infection-specific antibiotic use (pivmecillinam, nitrofurantoin, sulfamethizole, and trimethoprim) will be divided by the total person-time contributed by all admitted patients to the hospitals. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.

Time frame
The monthly incidence rate will be calculated between January 2019 to end of the study period (September 2025)
4

Monthly Mortality Rate (Composite Measure)

The monthly count of deaths will be divided by the total person-time contributed by admitted patients. The resulting mortality rate will be expressed as the number of deaths per 1000 patient-days.

Time frame
The monthly mortality rate will be calculated between January 2019 to end of the study period (September 2025)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jacob Bodilsen

Lead sponsor

Aalborg University Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: