Decision Aid for Infant Hydronephrosis

Overseen By Alison Saville, MSPH, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Age, No UPJO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new tool designed to help parents choose the best treatment for infants with severe hydronephrosis, a kidney condition. Doctors seek to determine whether early surgery or waiting is better for these children, and the Parent Decision Aid Tool may help parents understand their options. The trial includes two groups: one will use the decision aid, and the other will receive standard care information. Parents of children aged 30 days to 2 years with severe hydronephrosis attending appointments at Children's Hospital Colorado may be eligible to participate. As an unphased trial, this study offers parents a unique opportunity to contribute to research that could enhance decision-making tools for future families.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this decision aid tool is safe for use in parental decision-making?

Research has not specifically tested the Parent Decision Aid Tool for safety in people. Available information does not mention any risks or side effects from using this tool. It is important to note that this tool is not a drug or a surgery. Instead, it serves as a guide to help parents make informed choices about their child's treatment for ureteropelvic junction obstruction (UPJO). Since it does not involve taking medicine or undergoing surgery, it is generally considered safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Infant Hydronephrosis because it empowers parents with crucial information before they meet with healthcare professionals. Unlike the usual care, which may leave parents feeling overwhelmed with complex medical choices, this paper decision aid offers a clear, concise summary of treatment options for ureteropelvic junction obstruction (UPJO). This tool helps parents make more informed decisions, potentially improving outcomes for their children by navigating treatment choices with greater confidence and understanding.

What evidence suggests that this decision aid tool is effective for improving parental understanding and engagement in UPJO treatment decisions?

This trial will compare the use of the Parent Decision Aid Tool with usual care for parents of infants with ureteropelvic junction obstruction (UPJO). Research has shown that the Parent Decision Aid Tool helps parents understand and participate in decisions about treating UPJO in infants. The tool explains the choices and possible outcomes of either early surgery or a watch-and-wait approach. Studies have found that tools like this can boost parents' involvement and confidence in making health decisions. Although specific data on this tool's effectiveness for UPJO is not yet available, similar tools have proven helpful in other situations. This approach could assist parents in making more informed decisions about their child's treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Vijaya Vemulakonda, MD, JD

Principal Investigator

Children's Hospital Colorado

Are You a Good Fit for This Trial?

This trial is for parents aged 18-89 with infants (30 days to 2 years old) diagnosed with severe hydronephrosis due to UPJO, who are consulting at Children's Hospital Colorado. The child must have undergone or be scheduled for a MAG 3 test.

Inclusion Criteria

I am a parent aged 18-89 with a child aged 30 days to 2 years.

My child has severe kidney swelling and is seeing a doctor at Children's Hospital Colorado.

A parent or child who has had a MAG 3 test at a urology appointment or recently.

Exclusion Criteria

I do not meet the age requirements for the trial.

You do not have a child with a condition called UPJO.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents in the intervention arm receive a paper decision aid prior to meeting with their health care professional about their child's treatment options for UPJO

4-8 weeks

1 visit (in-person)

Control

Parents in the control arm receive usual care about their child's treatment options for UPJO

4-8 weeks

1 visit (in-person)

Follow-up

Participants are monitored for differences in SDM-Q9 scores and treatment decisions

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Parent Decision Aid Tool

Trial Overview The study is testing a Parent Decision Aid tool designed to help parents understand and engage in decision-making about early surgery versus observation for their infant's kidney obstruction.

How Is the Trial Designed?

Group I: Intervention Arm - Receipt of PtDA Experimental Treatment 1 Intervention

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.

Group II: Control - Usual Care Active Control 1 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 Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Published Research Related to This Trial

The Patient Decision Aid (PtDA) mobile application significantly improved knowledge and reduced decisional conflict among pregnant women regarding their childbirth options, as shown in a study involving 60 pregnant women and 9 clinical professionals.

The intervention led to a notable shift in preferences from cesarean section to vaginal delivery among women using the PtDA, indicating its effectiveness in empowering informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot Testing of a Mobile Based Patient Decision Aid for Childbirth Decision Making. Madhani, Z., Aslani, A., Kasraeian, M.[2019]

A new computer-based Decision Aid (DA) was developed to help parents of extreme low birth weight infants make informed choices about indomethacin therapy, involving input from parents, neonatologists, and decision-making experts.

Pilot testing showed that the DA significantly improved parents' knowledge about the treatment and reduced their decisional conflict, indicating its potential effectiveness in guiding parental preferences in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decision aid for considering indomethacin prophylaxis vs. symptomatic treatment of PDA for extreme low birth weight infants. Alfaleh, KM., Al Luwaimi, E., Alkharfi, TM., et al.[2021]

A new evidence-based decision aid was developed to help patients with localized renal masses make informed choices between partial and radical nephrectomy, meeting high standards for quality and certification.

The decision aid was well-received by users, with 91% of respondents finding the language acceptable and 82% appreciating its length, indicating it is a useful tool for facilitating shared decision-making in urology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and acceptability testing of a patient decision aid for individuals with localized renal masses considering surgical removal with partial or radical nephrectomy. McAlpine, K., Breau, RH., Stacey, D., et al.[2020]

The 'Kidney Failure Decision Aid' was developed to support shared decision-making in kidney failure treatment by providing real-world outcome information, including survival probabilities and treatment event rates, through a paper hand-out, an interactive website, and a personal summary sheet.

Initial testing showed that while some patients found survival probabilities confronting, both patients and clinicians believed the PtDA would enhance informed decision-making and align treatment choices with patient values and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online patient decision aid for kidney failure treatment modality decisions. Engels, N., van der Nat, PB., Ankersmid, JW., et al.[2022]

A decision aid for treating children with juvenile idiopathic arthritis was developed with input from patients, parents, and clinicians, and was positively received after 18 rounds of testing.

Despite high user acceptability, the decision aid was only used in 35% of relevant clinical visits, and no significant differences in shared decision making or uncertainty were found between visits with and without the aid, indicating challenges in reliable implementation in routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a decision aid for juvenile idiopathic arthritis medication choices. Brinkman, WB., Lipstein, EA., Taylor, J., et al.[2022]

A web-based decision aid (DA) prototype for parents of sons with hypospadias was developed and received positive feedback for its usability and acceptability, with participants rating their preparation for decision-making at an average of 86.8 out of 100.

The DA was revised based on participant feedback to improve clarity and organization, including enhancements to the values clarification methods and the addition of visual aids, indicating its potential effectiveness in aiding parents' understanding and decision-making regarding surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ask the parents: Testing the acceptability and usability of a hypospadias decision aid. Binion, K., Miller, A., Misseri, R., et al.[2023]

Out of 21 free online decision support tools for parents of children with chronic health conditions, only 14 (67%) provided enough detail for specific decision-making, but none met the necessary certification criteria to ensure safety and reduce potential harm.

Most tools were difficult to read, with only 3 (14%) rated as fairly easy or easy to understand, and there was limited evidence that using these tools improved parents' knowledge or alignment with their decision-making preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free Online Decision Tools to Support Parents Making Decisions About Their Children's Chronic Health Condition: An Environmental Scan. Wilkin, T., Stott, A., Lin, JL., et al.[2023]

The review of patient decision aids (PtDAs) revealed that only about half of the published reports had been field tested with patients, indicating a gap in practical evaluation before widespread use.

A new model development process for PtDAs was proposed, emphasizing the need for thorough documentation and testing at each stage, including prototype development and distribution strategies, to enhance the quality and effectiveness of these tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic development process for patient decision aids. Coulter, A., Stilwell, D., Kryworuchko, J., et al.[2022]

Patient decision aids (PtDAs) have been shown to significantly improve both the decision-making process and the quality of decisions made by patients, based on a review of 86 trials.

Despite the strong evidence supporting the effectiveness of PtDAs, there is a lack of consensus on how to measure decision-making processes and decision quality, indicating a need for standardized measurement tools in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. Sepucha, KR., Borkhoff, CM., Lally, J., et al.[2022]

Patient decision aids (PtDAs) were developed for patients with differentiated thyroid cancer to assist in making informed decisions about surgery and the use of tyrosine kinase inhibitors, based on a structured process involving patient and physician feedback.

Testing showed that the PtDAs were well-received, with 90% of patients finding them readable and helpful for decision-making, indicating their potential effectiveness in enhancing patient engagement and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aids for patients with differentiated thyroid carcinoma: development process and alpha and beta testing. Koot, A., Hermens, R., Ottevanger, P., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05900375

Decision Aid for Parents of Infants With UPJO ... tool and pilot test its ... The SDM-Q9 is a validated survey instrument measuring patient understanding and engagement in the decision making process.

2. withpower.com withpower.com/trial/phase-hydronephrosis-5-2023-47afe

Decision Aid for Infant Hydronephrosis Trial Overview The study is testing a Parent Decision Aid tool designed to help parents understand and engage in decision-making about early surgery versus ...

3. ctv.veeva.com ctv.veeva.com/study/decision-aid-for-parents-of-infants-with-upjo

Decision Aid for Parents of Infants With UPJO To address this gap, the purpose of this pilot test is to develop a patient decision aid (PtDA) tool ... patient groups. Intervention Arm - ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10426279/

Parental experience and understanding of parent-provider ... This focus on patient/parent decision-making and development of tools to support parental engagement in decision-making is relatively novel ...

5. researchgate.net researchgate.net/publication/333483628_Surgical_decision-making_in_infants_with_suspected_UPJ_obstruction_stakeholder_perspectives

Surgical decision-making in infants with suspected UPJ obstruction Objective: The purpose of this study was to understand parents' and surgeons' perceived roles in the surgical DM process for infants with high-grade ...

6. nature.com nature.com/articles/s41598-024-72271-9

The Hydronephrosis Severity Index guides paediatric ... To create an automated HN Severity Index (HSI) that helps guide clinical decision-making directly from renal ultrasound images. We applied a ...