Decision Aid for Parents of Infants With UPJO

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ureteropelvic Junction Obstruction; Ureteropelvic Junction; Obstruction, Congenital
• Intervention / Treatment: Behavioral: Parent Decision Aid

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison Saville, MSPH, MSW; Phone Number: 7202574406; Email: alison.saville@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Vijaya Vemulakonda, MD, JD; Phone Number: 720-777-4052; Email: vijaya.vemulakonda@childrenscolorado.org
      • Contact: Amelia Corl; Email: amelia.corl@cuanschutz.edu
      • Principal Investigator: Vijaya Vemulakonda, MD, JD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado
• Investigators: Principal Investigator: Vijaya Vemulakonda, MD, JD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: shared decision making; pragmatic trial; congenital kidney anomaly
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urogenital Abnormalities; Congenital Abnormalities; Ureteral Diseases; Kidney Diseases, Cystic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Ureteral Obstruction; Multicystic Dysplastic Kidney; Hydronephrosis
• Other Study ID Numbers: 23-0037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since the population affected is a small vulnerable population it is not ideal to share individual level data. Data sharing is possible if in aggregate form. Guides that are developed will be shared after publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No