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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Parent Decision Aid Tool, Patient Decision Aid (PtDA) Tool, Parent Decision Aid Tool for UPJO?

Research shows that Patient Decision Aids (PtDAs) help improve decision-making by providing real-world outcome information and facilitating shared decision-making between patients and clinicians. This approach has been effective in other conditions, such as kidney failure and juvenile idiopathic arthritis, suggesting it could also be beneficial for infant hydronephrosis. ^{1 2 3 4 5}

Is the Parent Decision Aid Tool safe for use in humans?

The research articles do not provide specific safety data for the Parent Decision Aid Tool or similar decision aids, but they generally support shared decision-making and have been used in various medical fields without reported safety concerns. ^{1 2 4 6 7}

How does the Decision Aid for Infant Hydronephrosis treatment differ from other treatments?

The Decision Aid for Infant Hydronephrosis is unique because it focuses on supporting shared decision-making between parents and clinicians, helping them understand real-world outcomes and make informed choices based on their values and expectations. Unlike traditional treatments, this approach emphasizes the use of decision aids to facilitate understanding and decision-making rather than directly treating the condition. ^{1 2 8 9 10}

Research Team

Vijaya Vemulakonda, MD, JD

Principal Investigator

Children's Hospital Colorado

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Development of an online patient decision aid for kidney failure treatment modality decisions. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Design and implementation of a decision aid for juvenile idiopathic arthritis medication choices. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Pilot Testing of a Mobile Based Patient Decision Aid for Childbirth Decision Making. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Patient decision aids for patients with differentiated thyroid carcinoma: development process and alpha and beta testing. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A decision aid for considering indomethacin prophylaxis vs. symptomatic treatment of PDA for extreme low birth weight infants. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A systematic development process for patient decision aids. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Ask the parents: Testing the acceptability and usability of a hypospadias decision aid. [2023]

9. United States 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Free Online Decision Tools to Support Parents Making Decisions About Their Children's Chronic Health Condition: An Environmental Scan. [2023]