Clinical trial NCT04108910: Morbidity Rate for UTI Through Use of PCR-Based Diagnosis and Management
Official title: Reduction in Morbidity Rate for Urinary Tract Infections Through Use of PCR-Based Diagnosis and Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Keywords: UTI
Home Care
Lead sponsor: Pathnostics
Sponsor class: INDUSTRY
First posted: 2019-09-30
Enrollment: 66381
Sex: ALL
Minimum age (years): 18
Maximum age (years): 111
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are visited by a House Call Physician and attend to elderly and other adults patients who are suffering from illness or chronic conditions in the safety, privacy, and comfort of their home or assisted living location.

Brief summary: This retrospective study is to determine if the use of PCR for detection and identification of pathogens in UTI along with antimicrobial susceptibility information, affords more efficacious treatment of UTI, as compared to traditional urine culture for patients served by House Call Physicians.

Detailed description: The objective of this study is to determine if retrospective data will show that use of PCR for detection and identification of pathogens in UTI, and antimicrobial susceptibility information, affords more efficacious treatment of UTI, thereby reducing UTI-related morbidity and costs in a patient population that is served by House Call Physicians. House call physicians attend elderly and other adults patients who are suffering from illness or chronic conditions in the safety, privacy, and comfort of their home or assisted living location. In making house calls, physicians ease the burden and difficulty of these chronic patients from traveling to the doctor's office.

Eligibility criteria: Inclusion Criteria:

* All patients that the House Call Physician suspects the patient has a UTI and are tagged with the following codes within the medical record

Exclusion Criteria:

* Records where the NPI does not match a known provider or the office listed is not a Specific Population
* Hospice patients
* Records for which DX codes of "X" and "NoDx" where there isn't a diagnostic description.

Primary outcomes:
measure: ER Visits and or Hospital Admission Rate within 30 days of initial visit related to UTI
timeFrame: 18 Months
Secondary outcomes:
measure: Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity.
timeFrame: 18 Months
Other outcomes:
measure: Identify the frequency of observed polymicrobial infections
timeFrame: 18 Months
Locations:
Study officials:
affiliation: Visiting Physicians Association
name: Kirk Wojno, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suskind AM, Saigal CS, Hanley JM, Lai J, Setodji CM, Clemens JQ; Urologic Diseases of America Project. Incidence and Management of Uncomplicated Recurrent Urinary Tract Infections in a National Sample of Women in the United States. Urology. 2016 Apr;90:50-5. doi: 10.1016/j.urology.2015.11.051. Epub 2016 Jan 26.
citation: Simmering JE, Tang F, Cavanaugh JE, Polgreen LA, Polgreen PM. The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998-2011. Open Forum Infect Dis. 2017 Feb 24;4(1):ofw281. doi: 10.1093/ofid/ofw281. eCollection 2017 Winter.
citation: Qiang XH, Yu TO, Li YN, Zhou LX. Prognosis Risk of Urosepsis in Critical Care Medicine: A Prospective Observational Study. Biomed Res Int. 2016;2016:9028924. doi: 10.1155/2016/9028924. Epub 2016 Feb 3.
citation: Gharbi M, Drysdale JH, Lishman H, Goudie R, Molokhia M, Johnson AP, Holmes AH, Aylin P. Antibiotic management of urinary tract infection in elderly patients in primary care and its association with bloodstream infections and all cause mortality: population based cohort study. BMJ. 2019 Feb 27;364:l525. doi: 10.1136/bmj.l525.
citation: Hsiao CY, Yang HY, Chang CH, Lin HL, Wu CY, Hsiao MC, Hung PH, Liu SH, Weng CH, Lee CC, Yen TH, Chen YC, Wu TC. Risk Factors for Development of Septic Shock in Patients with Urinary Tract Infection. Biomed Res Int. 2015;2015:717094. doi: 10.1155/2015/717094. Epub 2015 Aug 25.
citation: Simmering JE, Cavanaugh JE, Polgreen LA, Polgreen PM. Warmer weather as a risk factor for hospitalisations due to urinary tract infections. Epidemiol Infect. 2018 Feb;146(3):386-393. doi: 10.1017/S0950268817002965. Epub 2018 Jan 8.
citation: Anderson JE. Seasonality of symptomatic bacterial urinary infections in women. J Epidemiol Community Health. 1983 Dec;37(4):286-90. doi: 10.1136/jech.37.4.286.
citation: Kolman KB. Cystitis and Pyelonephritis: Diagnosis, Treatment, and Prevention. Prim Care. 2019 Jun;46(2):191-202. doi: 10.1016/j.pop.2019.01.001.