An interventional study of Parent Decision Aid in Ureteropelvic Junction Obstruction and Ureteropelvic Junction; Obstruction, Congenital, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research
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.
26 studies on the registry are indexed under Multicystic renal dysplasia, bilateral; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 20 interventional studies indexed under Multicystic renal dysplasia, bilateral.
Browse Multicystic renal dysplasia, bilateral studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
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
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.
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.
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.
Time frame: through study completion, an average of 1 year
Assess differences in treatment decisions
The surgical rates of each patient will be assessed in each arm. Demographic variables will be controlled for especially race, ethnicity, socioeconomic variables.
Time frame: through study completion, an average of 1 year
Plan to share: No — Since the population affected is a small vulnerable population it is not ideal to share individual level data. Data sharing is possible if in aggregate form. Guides that are developed will be shared after publication.
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Multicystic renal dysplasia, bilateral →
University of Colorado, Denver →