Engaging Families to Improve the Care of Patients With Hypospadias
Phase: NA
Conditions: Hypospadias
Sponsor: University of North Carolina, Chapel Hill

 
 
Engaging Families to Improve Care of Patients with Hypospadias: 
Decision Aid Pilot Testing 
 
 
NCT number NCT05056311 
Document Date 07/24/2023 
 

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Engaging Families to Improve Care of Patients with Hypospadias: 
Decision Aid Pilot Testing 
 
Katherine Hubert Chan, MD, MPH 
khchan@med.unc.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
Martin Kaefer, MD, Professor 
Department of Urology 
Indiana University School of Medicine 
 
 
 
 
Support Provided by: 
NIDDK 
 
 
 
 
 

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Table of Contents: 
 
Study Schema 
1.0 
Background & Rationale 
2.0 
Research Aims 
3.0 
Pilot Testing Objectives 
4.0 
Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
5.0 
Study Design 
6.0 
Enrollment 
6.1 
Parents/Patients 
6.2 
Providers 
7.0 
Study Procedures 
7.1 
Parent Pilot Testing of Decision Aid 
7.2 
Post-Pilot Testing and Debriefing with Providers 
8.0 
Study Calendar 
9.0 
Reportable Events 
10.0 
Data Safety Monitoring 
11.0 
Study Withdrawal/Discontinuation 
12.0 
Statistical Considerations 
13.0 
Statistical Data Management 
14.0 
Privacy/Confidentiality Issues 
15.0 
Follow-up and Record Retention 
16.0 
References 
17.0 
Appendix 
 

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1.0 Background & Rationale 
 
Parents faced with surgical decisions for their children encounter irreversible choices with 
potentially lifelong consequences. They must balance tradeoffs between disease outcomes, 
surgical treatment success, and side effects given that no single management strategy will 
achieve all of a patient’s or parent’s goals. Therefore, decisional conflict may arise, manifesting 
itself through patients’ or parents’ verbalizing uncertainty, expressing concerns about 
outcomes, wavering between choices, delaying decisions, questioning their personal values, 
being preoccupied with the decision, or expressing emotional distress.1 To date, few studies 
have examined parental decision-making for pediatric surgery or decisional conflict/regret 
regarding these decisions.2-6 The objective of this 5-year project is to use a multi-modal 
approach to develop a decision aid that will deliver clear, accurate parent-informed material 
about hypospadias. The goals of this research are to empower parents to make informed 
decisions about surgery for their children and improve their level of satisfaction with the 
decision afterwards. The central hypothesis is that decision aids developed using parent-
centered research strategies can successfully reduce decisional conflict by better informing the 
surgical decision-making process.  
 
2.0 Research Aims 
 
AIM 1 (Year 1): Utilize patient-centered design research methods to explore: a) the parental 
decision making process regarding hypospadias repair, including identifying parental attitudes, 
perceptions, and informational needs, and b) outcomes of importance to parents of children 
with hypospadias.  
 
AIM 2 (Year 2): Assess qualitatively providers’ attitudes about shared decision-making and use 
of a decision aid (DA) for hypospadias, including feasibility and utilization in the context of a 
clinic visit.  
 
AIM 3 (Years 3 and 4): Create a decision aid and postoperative outcome measurement tool for 
use by parents facing decisions regarding hypospadias repair and by those who have elected 
repair, respectively, based on the factors identified in Aims 1 and 2 of the study.  
 
AIM 4 (Years 4 and 5): Conduct a pilot field test (pre-test/post-test) of the decision aid in the 
clinical setting and conduct a preliminary psychometric assessment of the patient-centered 
outcome measurement tool.  
 
3.0 Pilot Testing Objectives 
 
The primary purpose of the pilot field test is to determine the feasibility and acceptability of 
implementing the decision aid (DA) in the clinical setting and to measure its efficacy for our key 
outcomes. To determine feasibility, our primary outcomes are: (1) percent of eligible parents 
screened; (2) percent of eligible parents enrolled, and (3) percent of parents retained in the 
study. To determine acceptability, our primary outcome is to assess the DA’s content, length, 

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clarity, and balance of information. Our secondary outcomes include knowledge of treatment 
options, knowledge of hypospadias, choice predisposition, decisional conflict, decisional regret, 
shared decision making, and preparation for decision making. We will also qualitatively 
examine urologists’ views about the DA’s applicability in their practice context, DA’s perceived 
efficacy in assisting parents to arrive at a treatment-related decision, and perceived barriers 
and facilitators to DA implementation.  
 
4.0  Criteria 
 
4.1 Inclusion Criteria 
 
Parents: 18 years of age and older of sons (ages up to 5 years) with hypospadias, or a tentative 
hypospadias diagnosis and/or referral to urology for hypospadias and are planning to attend 
the urology appointment; able to consent and do interview in English; aware that there is an 
issue with the child’s pee hole; and, have access to a reliable internet and smart phone, tablet, 
or computer to view the website (DA). The child/patient will be scheduled to see a urologist but 
must not have seen the urologist at the time of enrollment. (Parents ideally have not yet made 
a final decision about surgery at the time of enrollment.)  
 
To assure representation in our parent sample, we will attempt to recruit samples that include 
mothers, fathers, diversity in patient/parent race and ethnicity, education/socioeconomic 
status, health literacy and possibly device used to access the website (e.g. computer, phone). 
 
Providers: general pediatrician or general pediatric nurse practitioner; pediatric urologist or 
pediatric urology nurse practitioner. 
 
4.2 Exclusion Criteria 
 
Parent Pilot Testing: If, during the recruitment call the parent states they are not aware of any 
issue with the child’s pee hole, not simply unaware of the term hypospadias, then the parent 
would be excluded. If, at the clinic visit, the urologist decides that the patient does not have 
hypospadias, then the parent will be notified that she/he will be withdrawn from the remaining 
data collection points as they are no longer in a decision-making process about surgery. If we fill 
target groups (to balance parents’ gender, race, or ethnicity), we may exclude some parents in 
order to have a balanced sample.  
 
For all potential participants (except providers), the PI may use discretion if a medical (or other) 
condition makes a patient or parent inappropriate to enroll in a study activity.  
 
All participants: Non-English speaking or illiterate. All activities will require a discussion and/or 
completion of written activities that require English competency. 
 
 
 

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5.0 Study Design 
 
We will use a multi-modal, parent-centered approach to develop a decision aid that will deliver 
clear, accurate parent-informed material about distal hypospadias surgery. The decision aid will 
undergo three sets of testing and iterative re-designs. The study’s current phase, pilot testing, 
involves field testing of the website by parents of boys with hypospadias and by providers (e.g. 
pediatric urologists).   
 
6.0 Enrollment  
 
6.1 Parents/Patients 
 
We will identify new patients via urology clinic schedules (patients diagnosed with hypospadias 
and/or received a referral for hypospadias). Providers may also refer patients and parents to 
the research team. Recruitment of parents for pilot testing will take place via a phone with 
caller ID, in person/in the clinic, U.S. mail, email, and/or text message. First, a well-trained 
research assistant will introduce him/herself. For example, “I am a research assistant working 
with Dr. Katherine Chan who is a pediatric urologist at UNC Chapel Hill. I am located at IU 
School of Medicine and we are partnering with her team at UNC on this research. I’m calling to 
invite you to review a tool to help parents and physicians make decisions about surgery.” If the 
parent expresses interest, the RA will then review the study procedures and goals with parents 
verbally in person, over the phone and/or by text. Over the phone, the research assistant will 
offer to send a copy of the consent documents via email. Parents will have the opportunity to 
ask questions and further consider participation. Those who choose to enroll will provide verbal 
consent, which will be documented by the research assistant in the REDCap database (on a 
secure departmental server).   
 
6.2 Providers 
 
Medical providers (including pediatric urologists, general pediatricians or general pediatric 
nurse practitioners, pediatric urologists or pediatric urology nurse practitioners) will be invited 
to participate via email, in person, or over the phone. A research assistant will present and 
explain the Study Information Sheet to the provider. Then, the provider will have the 
opportunity to ask questions and further consider participation. Those who choose to enroll will 
provide verbal consent, which will be documented by the research assistant in the REDCap 
database.   
 
7.0 Study Procedures 
 
7.1 Parent Pilot Testing of Decision Aid 
 
Research assistants will collect data from parents at four time points, twice before and twice 
after their son’s first visit with a pediatric urologist/pediatric urology nurse practitioner for a 
potential or actual diagnosis of hypospadias. The questions will address website usability, 

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feedback on content, usefulness in decision-making, and basic demographic questions. Data 
will be collected via phone interview with a research assistant. Interviews may be recorded and 
professionally transcribed for analysis. Reminders will be sent to parents between the four time 
points regarding looking at the website and the upcoming data collection calls. We anticipate 
that each data collection point will require 10-30 minutes for parents to complete. We will also 
use a website plug-in to track any analyze how parents move through the website. We plan to 
interview 10-25, but no more than 40 parents (n=40) who complete all timepoints of the study. 
 
7.2 Post-Pilot Testing and Debriefing with Providers  
 
Urology providers permission to approach their individual patients will be requested on a 
rolling basis during the enrollment portion of the study. If the provider allows approach, and 
consent is given, the provider will be notified their patient’s parent has consented and will be 
reminded of the upcoming consented patient appointment. Research assistants and/or the PI 
will conduct interviews with urology providers. Interviews will occur after a provider has 
interacted with parent participants at their child’s clinic visit for hypospadias. We will assess the 
providers’ views of the applicability of the decision aid in the practice context, perceived 
efficacy of the tool in assisting parents to arrive at a treatment-related decision, and perceived 
facilitators to decision aid implementation. We will also collect any feedback on the content 
and layout of the decision aid website. We anticipate that interviews will be 10-30 minutes long 
and may be recorded and professionally transcribed for analysis. We will also use a website 
plug-in to track and analyze how providers move through the website. We plan to interview 5-
10 providers. 
 
8.0 Study Calendar 
 
 
Parent Pilot Test Data Collection Schedule 
Baseline (T1) 
• Demographics/Health Literacy (8 questions) 
• Decisional Conflict Scale (DCS) (16 questions) 
• Decision-Specific Knowledge Test (6 questions) 
• Treatment Preference/Awareness of Decision (2 questions) 
Recommendation: Have any of your child’s healthcare 
providers already made a recommendation about your son’s 
hypospadias?  If so, what was the recommendation? (1 
question) 
Pre-consultation, 1 
week after baseline 
(T2) 
• Website Viewed (3 questions) 
o Did you have time to look at the website 
o Did you view the website with anyone else? 
o Did you view the website on a smart phone, tablet, or 
computer? 
• Treatment Preference/Awareness of Decision (2 questions) 
• Decisional Conflict Scale (DCS) (16 questions) 
• Decision-Specific Knowledge (6 questions) 

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9.0 Reportable Events 
 
We will assess for adverse events (AE) and actively monitor for a security breech or protocol 
deviations that might affect the confidentiality or privacy of the sensitive data we store, manage 
and analyze.  If there are any AEs identified, we will report these to the Institutional Review Board 
(IRB) within the required timeframe. 
 
10.0 Data Safety Monitoring 
 
There will be regular review meetings that will occur, at a minimum, quarterly throughout the 
year. The study team will review current accrual, data management concerns, and data 
analysis/interpretation. 
 
11.0 Study Withdrawal/Discontinuation 
 
If a parent or provider wishes to withdraw from the study, s/he may inform the research 
assistant or PI at any point and s/he will be withdrawn from the study immediately. If the 
consented parent did not attend the urology visit or if the study team is unable to reach the 
parent or unable to collect Timepoint 2 before the urology visit occurs, then the parent will be 
withdrawn. Additionally, if the urologists recommends no surgery, in typically mild cases, then 
the parent may be withdrawn. Parents may be notified of withdrawal by email, text, or phone 
call.  
• Decision Aid Acceptability Questionnaire (4 questions) 
• Preparation for Decision Making Scale (10 questions) 
Initial post-
consultation, within 48 
hours of urology visit 
(T3) 
• Treatment Preference/Awareness of Decision (2 questions) 
• Decisional Conflict Scale (DCS) (16 questions) 
• Shared Decision Making Questionnaire (SDM-Q-9) (9 questions) 
• Preparation for Decision Making Scale (PrepDM) (10 questions) 
• Open-ended questions (3 questions) 
o What most impacted your decision during/after your 
visit with the urologist? 
o How did you use the decision aid during your visit with 
the urologist? 
o Is there anything we didn’t cover that you would like to 
share? 
3-month post-
consultation (T4) 
• Decision Regret Scale (5 questions) 
• Open-ended questions (2 questions) 
o What do you wish you would’ve known when you were 
making the decision? 
o Is there anything that we didn’t cover that you would 
like to share? 

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12.0 Statistical Considerations 
 
To inform sample size calculations and feasibility for a larger trial, we will analyze data as in a 
larger study and generate estimates of variance and correlation.9 We will check all quantitative 
data for departures from normality and analyze it with descriptive statistics. We will compute 
measures of central tendency and dispersion for continuous variables, and frequencies and 
proportions for categorical variables.  
 
To examine the effect of the DA on decisional conflict and knowledge, we will examine 
differences between pre- and post-intervention measures (i.e. the decisional conflict scale and 
the decision-specific knowledge test) using paired t-tests or Wilcoxon signed-rank tests for all 
continuous measures.  
 
As this protocol focuses on appropriateness, acceptability and pilot testing of the DA, no sub-
analyses are planned. We will plan to undertake examination of the influence of participant 
characteristics in future studies. 
  
We will analyze all transcribed qualitative data, including parent participant and provider 
follow-up interviews, using inductive thematic qualitative content analysis.7,8 The frequency, 
extensiveness, and specificity of comments will guide data categorization into recurrent 
themes.7,8 We will alter and refine these themes through a recursive process from the data to 
analyst-generated categorical and conceptual definitions. The qualitative results are considered 
to be tertiary/exploratory as the findings provide additional context to the quantitative scores. 
The qualitative results are not primary or secondary outcomes of this study.  
 
13.0 Statistical Data Management 
 
Primary data for surveys and interviews will be collected, managed, and stored electronically in 
REDCap and/or the secure department server. During data collection, any questions or 
concerns will be flagged in the REDCap database for PI review. Additional quality assurance 
steps will include: testing of database by study team prior to moving to production mode and 
extraction and cleaning of data that will be used for analysis every two months. 
14.0 Privacy/Confidentiality Issues 
 
This study presents a minimal risk of loss of confidentiality. Efforts will be made to keep 
personal information confidential. We cannot guarantee absolute confidentiality. Personal 
information may be disclosed if required by law. Participant identity will be held in confidence 
in reports in which the study may be published and databases in which results may be stored. 
Participants will have the option to pass/skip any questions or activities that they do not want 
to answer or participate in. Any study data used for dissemination, publications, or the decision 
aid will be de-identified with the exception of the parent testimonial videos. 
 
 

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15.0 Follow-up and Record Retention 
 
The study will continue through December 2023. After that, records will be retained for the 
minimum time allowed by law and then de-identified or destroyed. 
 
16.0 References 
 
1. O'Connor AM, Jacobsen MJ, Stacey D. An evidence-based approach to managing women's 
decisional conflict. Journal of obstetric, gynecologic, and neonatal nursing : JOGNN / 
NAACOG. Sep-Oct 2002;31(5):570-581. https://doi.org/ 10.1111/j.1552-
6909.2002.tb00083.x 
 
2. Lorenzo AJ, Pippi Salle JL, Zlateska B, Koyle MA, Bagli DJ, Braga LH. Decisional regret after 
distal hypospadias repair: single institution prospective analysis of factors associated 
with subsequent parental remorse or distress. Urol J. May 2014;191(5 Suppl):1558-
1563. https://doi.org/10.1016/j.juro.2013.10.036 
 
3. Bradbury ET, Kay SP, Tighe C, Hewison J. Decision-making by parents and children in 
paediatric hand surgery. Br J Plast Surg. Jul 1994;47(5):324-330. 
https://doi.org/10.1016/0007-1226(94)90091-4 
 
4. Hyde M, Punch R, Komesaroff L. Coming to a decision about cochlear implantation: parents 
making choices for their deaf children. JDSDE. Spring 2010;15(2):162-178. 
https://doi.org/10.1093/deafed/enq004 
 
5. Hsieh MH, Madden-Fuentes RJ, Bayne A, et al. Cross-sectional evaluation of parental decision 
making factors for vesicoureteral reflux management in children. Urol J. Oct 2010;184(4 
Suppl):1589-1593. https://doi.org/ 10.1016/j.juro.2010.03.083 
 
6. Mahant S, Jovcevska V, Cohen E. Decision-making around gastrostomy-feeding in children 
with neurologic disabilities. Pediatr. Jun 2011;127(6):e1471-1481. https://doi.org/ 
10.1542/peds.2010-3007 
 
7. Morgan, D. L. (1993). Qualitative content analysis: a guide to paths not taken. Qual Health 
Res. Feb 1993;3(1): 112-121. https://doi.org/10.1177/104973239300300107 
 
8. Sandelowski, M. Whatever happened to qualitative description? Res Nurs Health. Aug 2000; 
23(4):334-340. https://doi.org/10.1002/1098-240x(200008)23:4<334::aid-
nur9>3.0.co;2-g 
 

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9. Stange, K. C., Miller, W. L., Crabtree, B. F., O'Connor, P. J., & Zyzanski, S. J. (1994). 
Multimethod research: approaches for integrating qualitative and quantitative methods. 
J Gen Intern Med. May 1994;9(5):278-282. https://doi.org/10.1007/BF02599656 
 
10. Streiner, D., & Norman, G. (2008). Health Measurement Scales: a practical guide to their 
development and use (Fourth ed.). Oxford University Press. 
 
11. Weber, D. M., Schonbucher, V. B., Landolt, M. A., & Gobet, R. The Pediatric Penile 
Perception Score: an instrument for patient self-assessment and surgeon evaluation 
after hypospadias repair. J Urol. 2008;180(3): 1080-1084; discussion 1084. 
https://doi.org/10.1016/j.juro.2008.05.060 
 
17.0 Appendix 
 
To assess the quality of the decision-making process and the impact of the decision aid, we will 
utilize these scales:   
 
• Decisional Conflict Scale (DCS). DCS is a validated scale that has been extensively studied 
and consists of 10 statements and 5 response categories ranging between 0 (no decisional 
conflict) and 100 (extremely high decisional conflict).   
• Decision-SpecificKnowledge. We used data from Aims 1 and 2 to inform the development 
of a questionnaire to determine decision-specific knowledge of hypospadias treatment 
options/outcomes. We decided a priori that a score of 80% must be attained on this 
questionnaire as an indicator of being “informed.” 
• Hypospadias Treatment Preference/Awareness of Decision. Parents will be asked whether 
they intend to have their child undergo hypospadias surgical repair and whether they are 
aware that there is a decision to be made.  
• Decision Aid Acceptability Questionnaire. We will also assess the acceptability of the DA 
using a tool similar to the Decision Aid Acceptability Questionnaire. Questions will elicit 
feedback on amount of content, clarity, and helpfulness of the DA, acceptability of format 
and whether the information was presented in a balanced and fair manner.  
• Preparation for Decision Making Scale (PrepDM). This 10-item scale assesses a patient's 
perception of how useful a decision aid is in preparing the respondent to communicate with 
their practitioner at a consultation focused on making a health decision. 
• Shared Decision Making Questionnaire (SDM-Q-9): This is a 9-item self-report instrument 
developed to measure the process of SDM as perceived by the patient. The scale has high 
internal consistency, high item discriminations, and showed high face and factorial validity.  
• Decision Regret Scale: The Decision Regret Scale measures distress or remorse after a 
health care decision. We will perform an early assessment of DR in this study with plans to 
re-assess the long-term level of regret in a future randomized controlled trial.