Prevention of Urinary Stones With Hydration (PUSH)
|Urinary Stones||Behavioral: Fluid prescription Behavioral: Financial incentive Behavioral: Structured Problem Solving|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.Primary Purpose: Prevention
|Official Title:||Prevention of Urinary Stones With Hydration|
- Stone passage observed and/or captured by the study participant. [ Time Frame: From Baseline through 24 months. ]Will be measured by the time from Baseline to the passage of 1 or more stones by a participant.
- Procedural intervention for symptomatic stone [ Time Frame: From Baseline through 24 months. ]From Baseline through 24 months; will be measured by the time from Baseline to a procedure to remove a symptomatic stone by a participant.
- Any procedural intervention for removal of asymptomatic renal or ureteral stone [ Time Frame: From Baseline through 24 months. ]Will be measured by the time from Baseline to a procedure to remove an asymptomatic stone by a participant.
- Asymptomatic formation of new stone detected by imaging [ Time Frame: From Baseline through 24 months. ]Will be measured by the time from Baseline to the formation of an asymptomatic stone by a participant.
- Change in size of existing stone by ≥ 2 mm in any dimension detected by imaging [ Time Frame: From Baseline through 24 months. ]Comparison of the size of any stone on first observation versus later observations or at passage. Will be measured primarily through imaging (CT scan or ultrasound).
- Composite outcome: symptomatic stone recurrence, asymptomatic stone formation, increase of existing stone by ≥2 mm in any dimension detected by imaging [ Time Frame: From Baseline through 24 months. ]
- 24 hour urine total volume [ Time Frame: From Baseline through 24 months. ]Will measure and compare 24 hour urine volumes from screening through 24 months.
- Costs of study interventions and treatments for USD during the follow‐up period [ Time Frame: Compared total between Baseline and the Month 24 visit. ]
- Presence of lower urinary tract symptoms (Comprehensive Assessment of Self‐reported Urinary Symptoms) [ Time Frame: From Baseline through the Month 24 visit. ]Will compare the results of the CASUS questionnaires completed throughout the study
|Actual Study Start Date:||September 13, 2017|
|Estimated Study Completion Date:||September 1, 2021|
|Estimated Primary Completion Date:||September 1, 2021 (Final data collection date for primary outcome measure)|
Participants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake.
Behavioral: Fluid prescription
The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.Behavioral: Financial incentive
Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.Behavioral: Structured Problem Solving
Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.
No Intervention: Control
Participants in the control arm will receive standard care instructions according to American Urological Association (AUA) guidelines to increase overall fluid consumption to achieve study-specified urine output. They will also receive a "smart" water bottle with capability to self-monitor their fluid intake.
This is a two arm randomized controlled trial that incorporates pragmatic features, an adaptable intervention, patient choice, and remote monitoring of fluid intake through a "smart" water bottle. The study period is 24 months and will enroll approximately 1642 participants. Randomization will be stratified within a study site by age (adult vs. adolescent) and first time vs. recurrent stone former.
Intervention and control arm study participants will receive a smart water bottle that records daily fluid consumption, usual care including guideline-based recommendations of adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03244189
|Contact: Laura Johnsonfirstname.lastname@example.org|
|Contact: Sharon Settlesemail@example.com|
|United States, Missouri|
|Washington University, St. Louis||Not yet recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Aleksandra Klim 314-747-9781 firstname.lastname@example.org|
|Principal Investigator: Henry Lai, MD|
|Principal Investigator: Alana Desai, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Neda Khan 215-746-4177 Neda.Khan@uphs.upenn.edu|
|Principal Investigator: Peter Reese, MD, MSCE|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19146|
|Contact: Brittney Henderson 267-426-1337 email@example.com|
|Principal Investigator: Gregory Tasian, MD, MSc, MSCE|
|United States, Texas|
|University of Texas Southwestern||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Martinez Hill 214-456-0279 MARTINEZ.HILL@childrens.com|
|Principal Investigator: Naim Maalouf, MD|
|Sub-Investigator: Linda Baker, MD|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Kati Wilkins 415-810-4590 firstname.lastname@example.org|
|Principal Investigator: Jonathan Harper, MD|
|Principal Investigator: Hunter Wessells, MD, FACS|
|Principal Investigator:||Charles Scales, MD, MSHS||Duke University|