Decision Aid for Parents of Infants With UPJO

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Ureteropelvic Junction; Obstruction, Congenital; Ureteropelvic Junction Obstruction

Treatments: Behavioral: Parent Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT05900375

23-0037

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Intervention Arm - Receipt of PtDA

Experimental group

Description:

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.

Treatment:

Behavioral: Parent Decision Aid

Control - Usual Care

No Intervention group

Description:

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.