EHR-integrated rUTI Texting Platform

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare a texting platform to usual care for recurrent urinary tract infection (UTI) disease management. The main question it aims to answer is: • can a texting platform that integrates symptom triage and prevention education improve patients' sense of self-efficacy in managing recurrent UTIs as compared to usual care? Participants enrolled onto the texting platform will: receive evidence-based clinical guidance for the management of acute symptoms of UTI and receive regular prevention education. Researchers will compare the texting platform to usual care to see if there is any difference in patients' self-efficacy scores post-intervention.

Official Title
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An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections

Conditions
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Recurrent Urinary Tract Infection

Intervention / Treatment
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* Device: EHR-integrated texting platform
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Females who currently meet the criteria for recurrent UTIs Age 18 years or older Owns a mobile device with text messaging capability Ability to read and write English Exclusion Criteria: Known congenital or acquired anatomical anomaly of the urinary tract system or neurogenic bladder History of interstitial cystitis/bladder pain syndrome History of chronic pelvic pain History of urinary tract malignancy with or without radiation On continuous suppressive antibiotics currently Currently pregnant or within 6 weeks of pregnancy Inadequately controlled diabetes (HbA1c > 9) On immunosuppressive or steroid medication currently Practice of chronic self-catheterization (> 1 year)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic health record (EHR)-integrated texting platform<br> | Device: EHR-integrated texting platform<br>* 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<br>|
| Active Comparator: Usual care<br> | Other: Usual care<br>* • Standard-of-care management of recurrent UTI (phone calls and/or secure EHR messages for acute symptoms, and 3 to 6 month in-person visits for check-ins and prevention treatment discussion)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-efficacy | Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction: Patient Global Impression of Improvement score | Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better) | 3 months | 
| Healthcare-related quality of life: EQ-5D-5L score | EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems) | 3 months | 
| Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score | Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree) | 3 months | 
| Healthcare utilization | Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode | 3 months | 
| Antibiotic prescriptions | Number of antibiotic prescriptions given for UTI episodes | 3 months | 
| Patient medication compliance | Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage) | 3 months | 
| Patient anxiety level | Generalized Anxiety Disorder - 7 score (score range 0-21 with 0-4 indicating minimal anxiety) | 3 months |