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

NCT06750666 | Not Yet Recruiting

• 1 other identifier: De-implementing Dipsticks
• Study Type: observational
• Target: 480,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Urinary Tract Infections; Diagnostic Techniques and Procedures; Point-of-Care Testing; Anti-Bacterial Agents; Registry; Clinical Decision-making; Urinalysis

Keywords

Urine Dipstick De-implementation; Urinary Tract Infections; Hospital; Registry-Based Study; Clinical Impact; urine dipsticks

Outcome Measures

Primary Outcomes (6)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Monthly Incidence Rate of Readmissions (Composite Measure)

  The monthly count of readmissions, defined as a return to an inpatient unit or emergency room within 30 days after the initial discharge, will be divided by the total person-time contributed by admitted patients. The resulting incidence rate will be expressed as the number of readmissions per 1000 patient-days.

  The monthly incidence rate of readmissions will be calculated between January 2019 and the end of the study period (September 2025)

• Median Length of Hospital Stay

  The length of hospital stay will be measured in days for each admitted patient. The monthly median and interquartile range will be calculated over the study period.

  The monthly median will be calculated from January 2019 to the end of the study period (September 2025).

Study Arms (3)

Emergency rooms in North Denmark Region

Data from all emergency rooms in North Denmark Region will be retrieved. This includes sites at Aalborg University Hospital and North Denmark Regional Hospital.

Diagnostic Test: De-implementation of Urinary Dipsticks

Control hospital in Central Denmark Region

The investigators aim to retrieve data from a hospital outside the North Denmark Region that continues to use urine dipsticks. Specifically, the investigators plan to collect data from Aarhus University Hospital, the largest hospital in the Central Denmark Region.

Other: Usual practice with no intervention

Control urine cultures from general practice

The count of urine cultures ordered in the primary sector outside hospitals in the North Denmark Region (general practice), where dipsticks remain in use, will serve as a control.

Other: Usual practice with no intervention

Interventions

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.

Emergency rooms in North Denmark Region

Usual practice with no intervention OTHER

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.

Control hospital in Central Denmark Region; Control urine cultures from general practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jacob Bodilsen: lead

Study Sites (2)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

North Denmark Regional Hospital

Hjørring, 9800, Denmark

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Peter Preben Eggertsen, MD, PhD

CONTACT

+45 97660566; p.eggertsen@rn.dk

Jacob Bodilsen, MD, PhD

CONTACT

+45 97660566; jacob.bodilsen@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)