Recurrent Urinary Tract Infection
Conditions
Keywords
unnecessary antibiotics, self-management, digital platform, texting, implementation science, recurrent UTI, healthcare utilization, patient education
Brief summary
The goal of this clinical trial is to compare a texting platform to usual care for managing recurrent urinary tract infections (UTI). The main question it aims to answer is: • can a texting platform that integrates symptom triage and prevention education reduce the rate of unnecessary antibiotics for recurrent UTIs as compared to usual care? Participants enrolled onto the texting platform will: • receive evidence-based clinical guidance for the management of symptoms of UTI and receive educational videos on how to prevent UTIs. An important secondary outcome is to determine if the texting platform improves self-efficacy for the management of recurrent UTI.
Interventions
DEVICEEHR-integrated texting platform (Urotrust)
* An evidence-based algorithm that provides symptom triage and clinical guidance during an episode of acute UTI * Evidence-based prevention education material on recurrent UTIs * 5 standing orders for urinalysis and urine culture in the EHR upon enrollment * Standard-of-care management for recurrent UTI
OTHERUsual care
• Standard-of-care management of recurrent UTI (phone calls and/or secure EHR messages for acute symptoms) and follow up visits as determined by patients and their providers.
Sponsors
University of Pennsylvania
Independence Blue Cross
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistant extracting data on primary and secondary outcomes will be masked to randomization
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Females who currently meet the criteria for recurrent UTIs 4. Age 18 years or older 5. Owns a mobile device with text messaging capability 6. Ability to read and write English 7. Currently receiving care from a provider in Penn Urogynecology or Penn Urology
Exclusion criteria
1. History of known multidrug resistant UTIs 2. History of interstitial cystitis/bladder pain syndrome or current diagnosis of chronic pelvic pain 3. On continuous suppressive antibiotics currently 4. Currently pregnant or within 6 weeks of pregnancy 5. Transplant patient on immunosuppressive medication currently 6. Practice of chronic self-catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Unnecessary Antibiotics | 3 months | Antibiotics prescribed for patients when 1) urine culture is negative and/or urine microscopy has pyuria \< 10 WBC/HPF, 2) asymptomatic bacteriuria is present, or 3) there is no urine testing and no urinary symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Self-efficacy | 3 months | Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy) |
| Patient Satisfaction: Patient Global Impression of Improvement Score | 3 months | Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better). |
| Healthcare-related Quality of Life: EQ-5D-5L Score | 3 months | EuroQol 5-Dimension 5-Level (EQ-5D-5L) score which assesses how good or bad their health is on a scale from 0 to 100 with a higher score indicating better health status. |
| Healthcare-related Quality of Life: Recurrent UTI Impact Questionnaire Score | 3 months | Recurrent Urinary Tract Infection Impact Questionnaire score. Scores range from 0 to 100, with greater scores indicating greater overall UTI symptom and pain severity. |
| Healthcare Utilization | 3 months | Combined number of phone calls, secure messages per UTI episode |
| Antibiotic Prescriptions | 3 months | Number of antibiotic prescriptions given for UTI episodes |
| Patient Medication Compliance | 3 months | Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage) |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66 years |
| Body Mass Index | 26.8 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 72 Participants |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 0 Participants |
| Social Vulnerability Index | .23 index score |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
None listed