Pilot-testing of a Decision Aid for Parents of Infants With Ureteropelvic Junction Obstruction (UPJO)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Alison Saville, MSPH, MSW
alison.saville@cuanschutz.edu
7202574406
Time Frame
Start Date: 2023-01-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Intervention Arm - Receipt of PtDA
Parents in the intervention arm will receive a paper decision aid prior to meeting with their health care professional about their child's treatment options for UPJO.
No_intervention: Control - Usual Care
Parents in the control arm will not receive a paper decision aid and instead will just receive usual care about their child's treatment options for UPJO.
Related Therapeutic Areas
Sponsors
Collaborators: Children's Hospital Colorado
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov