Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
NCT05900375

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

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here