HypospadiasNCT05056311
Engaging Families to Improve the Care of Patients With Hypospadias
A study testing Decision Aid Website in people with Hypospadias, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Read more about this study
- Who is it for?
- Ages 0 to 5 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Decision Aid Website
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jun 2021to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- parents 18 years of age and older of sons with hypospadias, or a tentative hypospadias diagnosis, and/or referral to a urologist for hypospadias
- patient newborn up to age 5 years
- parent able to consent and do interview in English
- parent access to a reliable internet and smart phone, tablet, or computer to view the website
- child/patient scheduled to see a urologist, but must not have yet seen the urologist at the time of enrollment
- parent aware that there is an issue with child's pee hole
- parent planning to attend urology appointment
Who cannot join
- As target enrollment groups are filled, parents may be excluded in order to achieve a balanced sample, e.g. exclusion of mothers/female caregivers.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC
Chapel Hill, North Carolina, 27599
Indiana University
Indianapolis, Indiana, 46202
About this study
Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach.
A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.
- Conditions
- Hypospadias
- Being tested
- Decision Aid Website
- Keywords
- hypospadias, shared decision making, decisional regret, decision aid
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid WebsiteOther
The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery.
| Study group | Role | What they receive |
|---|---|---|
| Parent Utilization of Decision Aid Website | Experimental | All enrolled parents will view the decision aid website for as long and as frequently as they wish before the initial visit to the urologist. Receives: Other: Decision Aid Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Eligible Parents Screened (Feasibility)
Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100.
Measured: Baseline (T1)
Percent of Eligible Parents Enrolled (Feasibility)
The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100.
Measured: Baseline (T1)
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability)
Acceptability of a decision aid refers to ratings regarding the comprehensibility of components of a decision aid, its length, clarity, amount of information, and balance in presentation of information about options. The tool has 4 questions with answers on a Likert scale ranging from 1-5 (length, amount of information, and balance) and 1-4 (clarity). A response of 3 is ideal for information, length, and balance and a response of 1 is ideal for clarity.
Measured: Pre-consultation, 1 week after baseline (T2)
Percentage of Parents Retained in the Study (Feasibility)
Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100.
Measured: T1 to T4, a total of approximately 6 months
Secondary outcomes (10)
Mean Decisional Conflict Scale (DCS) Score at T1 and T2
The Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. This study utilizes the full version, a Likert-type scale consisting of 16 questions and answer options of strongly agree to strongly disagree. Total scores range from 0-100, a higher score means more decisional conflict.
Measured: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Mean Decisional Conflict Scale (DCS) Score at T2 and T3
The Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. This study utilizes the full version, a Likert-type scale consisting of 16 questions and answer options of strongly agree to strongly disagree. Total scores range from 0-100, a higher score means more decisional conflict. Time frame revised to address original entry error.
Measured: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Mean Decision-Specific Knowledge Scores
Decision-Specific Knowledge is a six-question tool with multiple choice question and answer options created by the investigator to measure pre/post knowledge of hypospadias and repair surgery. Total scores range from 0-100% with a higher score indicating more correct answers.
Measured: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Mean Decisional Regret Scale Score
The Decision Regret Scale measures distress or remorse after a decision. Brehaut's (2003) 5-item scale has scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret.
Measured: 3-month post-consultation (T4)
Hypospadias Treatment Preference by Category at T1 and T2
This is a single question created by the investigator asking "Do you intend for your son to have hypospadias surgery?" with yes/no/unsure answer options to measure a change in response, or not, after viewing the decision aid website.
Measured: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Hypospadias Treatment Preference by Category at T2 and T3
This is a single question created by the investigator asking "Do you intend for your son to have hypospadias surgery?" with yes/no/unsure answer options to measure a change in response, or not, after viewing the decision aid website.
Measured: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Awareness of Decision by Category at T1 and T2
This is a single question created by the investigator asking "Is there a decision to make about whether your son should have surgery for his hypospadias?" with yes/no/unsure answer options to measure a change in awareness of decision, or not, after viewing the decision aid website.
Measured: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Awareness of Decision by Category at T2 and T3
This is a single question created by the investigator asking "Is there a decision to make about whether your son should have surgery for his hypospadias?" with yes/no/unsure answer options to measure a change in awareness of decision, or not, after viewing the decision aid website.
Measured: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Mean Shared Decision Making Questionnaire Score
The Shared Decision Making Questionnaire measures the decisional process in medical encounters from both the patient and the physician perspectives. The questionnaire contains 9 questions with answers on a 6-point Likert scale. Scores range from 0-100 with higher scores indicating a higher perceived level of shared decision making.
Measured: Initial post-consultation, within 48 hours of urology visit (T3)
Mean Preparation for Decision Making Score
The Preparation for Decision Making scale (Prep-DM) scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. The scale contains 10 questions with answers on a Likert Scale Scores range from 0-100 with higher scores indicating a higher perceived level of preparation for decision making.
Measured: Pre-consultation, 1 week after baseline (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start9 Jun 2021
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Katherine Hubert Chan, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056311
- Sponsor's protocol ID
- 21-0146
- Other IDs
- K23DK111987
- Status last verified
- Jul 2023
- First submitted
- 31 Aug 2021
- Last updated
- 30 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Families to Improve the Care of Patients With Hypospadias
- ClinicalTrials.gov ID
- NCT05056311
- Acronym / sponsor ID
- 21-0146
- Conditions
- Hypospadias
- Keywords
- hypospadias, shared decision making, decisional regret, decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Posted 30 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach.
A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent Utilization of Decision Aid Website | Experimental | Other: Decision Aid WebsiteAll enrolled parents will view the decision aid website for as long and as frequently as they wish before the initial visit to the urologist. |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- parents 18 years of age and older of sons with hypospadias, or a tentative hypospadias diagnosis, and/or referral to a urologist for hypospadias
- patient newborn up to age 5 years
- parent able to consent and do interview in English
- parent access to a reliable internet and smart phone, tablet, or computer to view the website
- child/patient scheduled to see a urologist, but must not have yet seen the urologist at the time of enrollment
Key exclusion criteria (1 listed)
- As target enrollment groups are filled, parents may be excluded in order to achieve a balanced sample, e.g. exclusion of mothers/female caregivers.
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 |
|---|---|---|
| Decision Aid WebsiteThe (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery. | Other | Parent Utilization of Decision Aid Website |
Primary outcome
Percent of Eligible Parents Screened (Feasibility)
Time frame: Baseline (T1)
Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100.
Percent of Eligible Parents Enrolled (Feasibility)
Time frame: Baseline (T1)
The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100.
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability)
Time frame: Pre-consultation, 1 week after baseline (T2)
Acceptability of a decision aid refers to ratings regarding the comprehensibility of components of a decision aid, its length, clarity, amount of information, and balance in presentation of information about options. The tool has 4 questions with answers on a Likert scale ranging from 1-5 (length, amount of information, and balance) and 1-4 (clarity). A response of 3 is ideal for information, length, and balance and a response of 1 is ideal for clarity.
Percentage of Parents Retained in the Study (Feasibility)
Time frame: T1 to T4, a total of approximately 6 months
Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100.
10 secondary outcomes
Mean Decisional Conflict Scale (DCS) Score at T1 and T2
Time frame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Mean Decisional Conflict Scale (DCS) Score at T2 and T3
Time frame: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Mean Decision-Specific Knowledge Scores
Time frame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Mean Decisional Regret Scale Score
Time frame: 3-month post-consultation (T4)
Hypospadias Treatment Preference by Category at T1 and T2
Time frame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Hypospadias Treatment Preference by Category at T2 and T3
Time frame: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Awareness of Decision by Category at T1 and T2
Time frame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Awareness of Decision by Category at T2 and T3
Time frame: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Mean Shared Decision Making Questionnaire Score
Time frame: Initial post-consultation, within 48 hours of urology visit (T3)
Mean Preparation for Decision Making Score
Time frame: Pre-consultation, 1 week after baseline (T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Katherine Hubert Chan, MD, MPH principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid Website in people with Hypospadias, run by University of North Carolina, Chapel Hill at 2 sites 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Eligible Parents Screened (Feasibility) (time frame: Baseline (T1)). The study lists 4 primary outcomes in all. 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 30 Aug 2023.