Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
研究概览
简要总结
The primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in/urgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Thus, the research team will compare Unplanned Healthcare Utilization, i.e. the frequency of triage calls, MyChart messages, Urgent Care visits, and Emergency Department visits related to urinary symptoms, between participants in the self-start intervention group and those in the triage control group. The team hypothesizes that patients in the "self-start" intervention group will demonstrate a lower frequency of healthcare utilization events when compared to those in the standard of care control.
详细描述
Study Procedure and Intervention
Following enrollment and consent, participants will be randomized into two groups allocated 1:1 as follows:
- Intervention Group: Standing Prescription (Self-Start) + Sterile Urine Cup
- Control Group: Standard Triage Line.
Provider stratified block randomization (block size 4) will be implemented by REDCap randomization module on the day of participants scheduled procedure. At this point, each participant will be given a unique Study ID number to allow study coordinators to commence data abstraction from the EMR (EPIC) into REDCap.
All participants, regardless of randomization, will follow the current practice with provider specific antibiotic prophylaxis protocol as prescribed. Electronic medical record review will be performed by the study investigators to obtain relevant medical history, treatment plan and demographic information for each participant and transcribed into REDCap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients of all races and ethnicities aged 18 years and older.
- •Diagnosis of Overactive Bladder (OAB) and/or Urge Urinary Incontinence (UUI).
- •Scheduled to receive intradetrusor onabotulinumtoxinA (Botox®) for symptom management.
- •Has decision making capacity to provide informed consent and comply with and follow study protocols.
- •Ability to navigate a computer system independently
- •Access to MyChart and email account
排除标准
- •Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter.
- •History of Severe Renal Impairment Cr/Cl - <60 ml/min 1.73m2
- •History of recurrent UTIs (defined as >3x symptomatic UTIs in 12 months).
- •Post-Void Residual (PVR) volume >150 mL.
- •Active UTI at the time of procedure (procedure cancellation criteria).
- •Patients currently on prophylactic antibiotics.
- •Inability to provide informed consent.
研究组 & 干预措施
Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine Culture
Following the procedure, subjects will receive a standing prescription for oral Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture and discharge instructions.
Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.
干预措施: Macrobid® Capsules 100 mg (Drug)
Standard Triage Line; Standard Medical Care (SMC)
Subjects will receive standard post-procedure discharge instructions which typically instruct participants to follow routine practice if a UTI is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic.
干预措施: Standard Medical Care (SMC) (Other)