Engaging Families to Improve the Care of Patients With Hypospadias

Hypospadias Clinical Trial

Official title:

Engaging Families to Improve the Care of Patients With Hypospadias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056311
• Other study ID #: 21-0146
• Secondary ID: K23DK111987
• Status: Completed
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: October 6, 2022

Study information

• Verified date: July 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 0 Years to 5 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• As target enrollment groups are filled, parents may be excluded in order to achieve a balanced sample, e.g. exclusion of mothers/female caregivers.

Related Conditions & MeSH terms

• Hypospadias

Intervention

Other:
• Decision Aid Website
The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery.

Locations

Country	Name	City	State
United States	UNC	Chapel Hill	North Carolina
United States	Indiana University	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (T1)
Primary	Percent of Eligible Parents Enrolled (Feasibility)	The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100.	Baseline (T1)
Primary	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.	Pre-consultation, 1 week after baseline (T2)
Primary	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.	T1 to T4, a total of approximately 6 months
Secondary	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.	Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Secondary	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.	Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Secondary	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.	Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Secondary	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.	3-month post-consultation (T4)
Secondary	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.	Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Secondary	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.	Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Secondary	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.	Baseline (T1), Pre-consultation, 1 week after baseline (T2)
Secondary	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.	Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
Secondary	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.	Initial post-consultation, within 48 hours of urology visit (T3)
Secondary	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.	Pre-consultation, 1 week after baseline (T2)