Decision Aid for Parents of Infants With UPJO

Ureteropelvic Junction Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05900375
• Other study ID #: 23-0037
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Alison Saville, MSPH, MSW
• Phone: 7202574406
• Email: alison.saville[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydronephrosis
• Multicystic Dysplastic Kidney
• Ureteral Obstruction
• Ureteropelvic Junction Obstruction

Intervention

Behavioral:
• Parent Decision Aid
A paper parent decision aid in color will be provided to all patients at the time of their appointment and will aid in discussion with health care professionals.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the SDM-Q9 scores between arms	The primary outcome will be differences in scores between the 9-item Shared Decision Making Questionnaire (SDM-Q9) survey scores between intervention and control arms. The SDM-Q9 is a validated survey instrument measuring patient understanding and engagement in the decision making process. The scale for each question is 1-5 and higher scores mean better parent involvment and understanding.	through study completion, an average of 1 year
Secondary	Assess differences in treatment decisions	The surgical rates of each patient will be assessed in each arm. Demographic variables will be controlled for especially race, ethnicity, socioeconomic variables.	through study completion, an average of 1 year