Actively Recruiting
Decision Aid for Parents of Infants With UPJO
Led by University of Colorado, Denver · Updated on 2024-05-23
100
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
C
Children's Hospital Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
Ureteropelvic junction obstruction (UPJO) is the most common etiology of high-grade hydronephrosis, affecting approximately 4,000-10,000 infants annually in the U.S. The goal of surgical treatment of UPJO is to minimize the risk of kidney damage associated with obstruction, which may occur in 30-60% of infants with high-grade hydronephrosis.1-However, the benefit of early surgery compared to observation and potential later surgery to preserve kidney function has not been well-defined. Consequently, surgeons differ on whether to initially treat with surgery or observation, with surgical rates in the first year of life varying from 15-50% across surgical practices. These variations are important to understand, as the decision for early surgery is not without risk. Prior studies suggest that infants treated surgically are at higher risk for readmission and reoperation. Early surgery also raises concerns about neurodevelopmental effects of anesthetic exposure. To address this gap, the purpose of this pilot test is to develop a patient decision aid (PtDA) tool and pilot test its effect on parental understanding and engagement in the decision-making process at Children's Hospital Colorado. The proposed pilot is a necessary first step in preparation for a future multicenter hybrid effectiveness-implementation trial. This work will also be used to support future studies evaluating the impact of a PtDA on surgical variations and treatment outcomes in patients with UPJO and other complex congenital urologic anomalies.
CONDITIONS
Official Title
Decision Aid for Parents of Infants With UPJO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents aged 18 to 89 years
- Child aged 30 days to 2 years
- Child presenting for consultation for SFU grade 3-4 Hydronephrosis at Children's Hospital Colorado
- Parents/child attending urology appointment where a MAG 3 scan is performed or has recently been performed
You will not qualify if you...
- Not within the specified age range
- Does not have a child with ureteropelvic junction obstruction (UPJO)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Alison Saville, MSPH, MSW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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