Decision Aid for Parents of Infants With UPJO

Not Applicable

Recruiting

• Conditions: Ureteropelvic Junction Obstruction; Ureteropelvic Junction; Obstruction, Congenital
• Interventions: Behavioral: Parent Decision Aid

• Registration Number: NCT05900375
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-21
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm - Receipt of PtDA	Parent Decision Aid	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.

Primary Outcome Measures

Name	Time	Method
Differences in the SDM-Q9 scores between arms	through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Assess differences in treatment decisions	through study completion, an average of 1 year	The surgical rates of each patient will be assessed in each arm. Demographic variables will be controlled for especially race, ethnicity, socioeconomic variables.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States