Decision Aid for Parents of Infants With UPJO

NCT05900375 | Recruiting

• 1 other identifier: 23-0037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteropelvic Junction Obstruction; Ureteropelvic Junction; Obstruction, Congenital

Keywords

shared decision making; pragmatic trial; congenital kidney anomaly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess differences in treatment decisions

  through study completion, an average of 1 year

Study Arms (2)

Intervention Arm - Receipt of PtDA

EXPERIMENTAL

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

Control - Usual Care

NO INTERVENTION

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.

Interventions

Parent Decision Aid 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.

Intervention Arm - Receipt of PtDA

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral; Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Vijaya Vemulakonda, MD, JD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Saville, MSPH, MSW

CONTACT

7202574406; alison.saville@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 12, 2023
• Study Start: January 21, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)