Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900375
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-05-31
Brief Title:
Decision Aid for Parents of Infants With UPJO
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Pilot-testing of a Decision Aid for Parents of Infants With Ureteropelvic Junction Obstruction UPJO
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ureteropelvic junction obstruction UPJO is the most common etiology of high-grade hydronephrosis affecting approximately 4000-10000 infants annually in the US 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 hydronephrosis1-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 Childrens 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
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 Childrens 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None