RECRUITING

Decision Aid for Parents of Infants With UPJO

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-21
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05900375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * does not meet age parameters
  2. * does not have a child with a UPJO

Contacts and Locations

Study Contact

Alison Saville, MSPH, MSW
CONTACT
7202574406
alison.saville@cuanschutz.edu

Principal Investigator

Vijaya Vemulakonda, MD, JD
PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Vijaya Vemulakonda, MD, JD, PRINCIPAL_INVESTIGATOR, Children's Hospital Colorado

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-21
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-01-21
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • shared decision making
  • pragmatic trial
  • congenital kidney anomaly

Additional Relevant MeSH Terms

  • Ureteropelvic Junction Obstruction
  • Ureteropelvic Junction; Obstruction, Congenital