Decision Aid for Parents of Infants With UPJO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-21

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ureteropelvic Junction Obstruction Ureteropelvic Junction; Obstruction, Congenital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Parent Decision Aid

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.