Ureteropelvic Junction ObstructionNCT05900375
Decision Aid for Parents of Infants With UPJO
A study testing Parent Decision Aid in people with Ureteropelvic Junction Obstruction and Ureteropelvic Junction; Obstruction, Congenital, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Ureteropelvic Junction Obstruction, Ureteropelvic Junction; Obstruction, Congenital
- What is being tested?
- Parent Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- does not meet age parameters
- does not have a child with a UPJO
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Vijaya Vemulakonda, MD, JD, 720-777-4052, vijaya.vemulakonda@childrenscolorado.org
Amelia Corl, amelia.corl@cuanschutz.edu
About this study
Official title: Pilot-testing of a Decision Aid for Parents of Infants With Ureteropelvic Junction Obstruction (UPJO)
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.
- Being tested
- Parent Decision Aid
- Keywords
- shared decision making, pragmatic trial, congenital kidney anomaly
- Medical subject headings
- Multicystic renal dysplasia, bilateral, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Decision AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start21 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteropelvic Junction ObstructionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Vijaya Vemulakonda, MD, JD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900375
- Sponsor's protocol ID
- 23-0037
- Status last verified
- May 2024
- First submitted
- 31 May 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-testing of a Decision Aid for Parents of Infants With Ureteropelvic Junction Obstruction (UPJO)
- ClinicalTrials.gov ID
- NCT05900375
- Acronym / sponsor ID
- 23-0037
- Keywords
- shared decision making, pragmatic trial, congenital kidney anomaly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Receipt of PtDA | Experimental | Behavioral: Parent Decision AidParents 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. |
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- does not meet age parameters
- does not have a child with a UPJO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Decision AidA 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. | Behavioural | Intervention Arm - Receipt of PtDA |
Primary outcome
Differences in the SDM-Q9 scores between arms
Time frame: through study completion, an average of 1 year
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.
1 secondary outcome
Assess differences in treatment decisions
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijaya Vemulakonda, MD, JD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Decision Aid in people with Ureteropelvic Junction Obstruction and Ureteropelvic Junction; Obstruction, Congenital, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alison Saville, MSPH, MSW (7202574406, alison.saville@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the SDM-Q9 scores between arms (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.