Clinical trial NCT05900375: Decision Aid for Parents of Infants With UPJO
Official title: Pilot-testing of a Decision Aid for Parents of Infants With Ureteropelvic Junction Obstruction (UPJO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ureteropelvic Junction Obstruction
Ureteropelvic Junction; Obstruction, Congenital
Keywords: shared decision making
pragmatic trial
congenital kidney anomaly
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2023-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria (all of following are needed):

* parents (age 18-89 years) of children age 30 days - 2 years
* child is presenting for consultation for SFU grade 3-4 Hydronephrosis at Children's Hospital Colorado
* parents/child presenting at Urology appointment where a MAG 3 is performed or has recently been performed.

Exclusion Criteria:

* does not meet age parameters
* does not have a child with a UPJO

Primary outcomes:
measure: Differences in the SDM-Q9 scores between arms
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Assess differences in treatment decisions
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Vijaya Vemulakonda, MD, JD
role: PRINCIPAL_INVESTIGATOR
References: