Trial Outcomes & Findings for Engaging Families to Improve the Care of Patients With Hypospadias (NCT NCT05056311)

Last Updated: 2023-08-30

Results Overview

Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Baseline (T1)

Results posted on

2023-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	Parent Utilization of Decision Aid Website 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. 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.
Overall Study STARTED	65
Overall Study Received Intervention	64
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Parent Utilization of Decision Aid Website 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. 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.
Overall Study Lost to Follow-up	14
Overall Study Withdrawal by Subject	1
Overall Study Dropped from study due to no Hypospadias	23

Baseline Characteristics

Only 30 children were diagnosed with hypospadias at the consultation with the urologist.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parent Utilization of Decision Aid Website n=64 Participants 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. 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.
Education Some High School	4 Participants n=64 Participants
Education Graduated High School	13 Participants n=64 Participants
Education Some College	19 Participants n=64 Participants
Education College Degree	22 Participants n=64 Participants
Education Post-Graduate Degree	6 Participants n=64 Participants
Health Insurance Public (Medicaid/Children's Special Services/TBC)	28 Participants n=64 Participants
Health Insurance Private (Anthem/Aetna/TBC)	19 Participants n=64 Participants
Health Insurance Other insurance type/unknown	9 Participants n=64 Participants
Health Insurance Self-pay	8 Participants n=64 Participants
Health Literacy Never	39 Participants n=64 Participants
Health Literacy Rarely	13 Participants n=64 Participants
Health Literacy Sometimes	8 Participants n=64 Participants
Health Literacy Often	2 Participants n=64 Participants
Health Literacy Always	2 Participants n=64 Participants
Mean Income by Zip Code	55900 dollars annually STANDARD_DEVIATION 18000 • n=64 Participants
Age, Continuous	29.2 years STANDARD_DEVIATION 5.37 • n=64 Participants
Sex: Female, Male Female	62 Participants n=64 Participants
Sex: Female, Male Male	2 Participants n=64 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=64 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=64 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=64 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=64 Participants
Race (NIH/OMB) Asian	1 Participants n=64 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=64 Participants
Race (NIH/OMB) Black or African American	7 Participants n=64 Participants
Race (NIH/OMB) White	49 Participants n=64 Participants
Race (NIH/OMB) More than one race	2 Participants n=64 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=64 Participants
Region of Enrollment United States	64 Participants n=64 Participants
Child's Age at Consent	149 days STANDARD_DEVIATION 197 • n=64 Participants
Child's Meatal Location (Confirmed hypospadias) Glanular (includes megameatus)	15 Participants n=30 Participants • Only 30 children were diagnosed with hypospadias at the consultation with the urologist.
Child's Meatal Location (Confirmed hypospadias) Distal Shaft	10 Participants n=30 Participants • Only 30 children were diagnosed with hypospadias at the consultation with the urologist.
Child's Meatal Location (Confirmed hypospadias) Mid Shaft	3 Participants n=30 Participants • Only 30 children were diagnosed with hypospadias at the consultation with the urologist.
Child's Meatal Location (Confirmed hypospadias) Penoscrotal	2 Participants n=30 Participants • Only 30 children were diagnosed with hypospadias at the consultation with the urologist.
Child's Meatal Location (Confirmed hypospadias) Perineal	0 Participants n=30 Participants • Only 30 children were diagnosed with hypospadias at the consultation with the urologist.
Marital Status Single	26 Participants n=64 Participants
Marital Status Married	33 Participants n=64 Participants
Marital Status Separated	1 Participants n=64 Participants
Marital Status Divorced	3 Participants n=64 Participants
Marital Status Widowed	0 Participants n=64 Participants
Marital Status Other	1 Participants n=64 Participants

PRIMARY outcome

Timeframe: Baseline (T1)

Population: All available data are reported. Data reported for parents who were screened for eligibility.

Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=148 Participants 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. 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.
Percent of Eligible Parents Screened (Feasibility)	90.5 percentage of parents recruited

PRIMARY outcome

Timeframe: Baseline (T1)

Population: All available data are reported. Data reported for eligible parents.

The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=134 Participants 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. 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.
Percent of Eligible Parents Enrolled (Feasibility)	48.5 percentage of parents enrolled

PRIMARY outcome

Timeframe: Pre-consultation, 1 week after baseline (T2)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=54 Participants 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. 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.
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Information : Much less than wanted	0 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Information : A little less than wanted	4 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Information : About right	38 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Information : A little more than wanted	7 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Information : Much more than wanted	5 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Length: Much too long	1 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Length: A little too long	2 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Length: About right	45 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Length: A little too short	5 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Length: Much too short	1 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Clarity: Everything was clear	16 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Clarity: Most things were clear	34 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Clarity: Some things were clear	3 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Clarity: Many things were unclear	1 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Balance: Clearly slanted to surgery	3 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Balance: Slightly slanted to surgery	10 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Balance: Completely balanced	38 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Balance: Slightly slanted to no surgery	3 Participants
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) Balance: Clearly slanted to no surgery	0 Participants

PRIMARY outcome

Timeframe: T1 to T4, a total of approximately 6 months

Population: All available data are reported. Of the 64 parents who completed T1, 9 were lost to follow up and 1 withdrew. Of the 54 who completed T2, 1 parent was lost to follow up before the consultation. Of the 53 completing the consultation, 23 were found to not to have hypospadias. Of the 30 patients diagnosed with hypospadias, 1 parent was lost to follow up prior to T3. Of the 29 parents who completed T3, 2 parents were lost to follow up prior to T4 resulting in a total of 27 parents who completed T4.

Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=64 Participants 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. 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.
Percentage of Parents Retained in the Study (Feasibility)	42.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1), Pre-consultation, 1 week after baseline (T2)

Population: All available data are reported. Data reported includes participants who completed the Decisional Conflict Scale for T1, T2, and T3. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=54 Participants 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. 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.
Mean Decisional Conflict Scale (DCS) Score at T1 and T2 T1	35.97 score on a scale Standard Deviation 18.81
Mean Decisional Conflict Scale (DCS) Score at T1 and T2 T2	21.93 score on a scale Standard Deviation 11.84

SECONDARY outcome

Timeframe: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. Of the 53 who completed the consultation, 23 were found to not to have hypospadias and were discontinued. One parent was lost to follow up during T3, resulting in 29.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=29 Participants 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. 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.
Mean Decisional Conflict Scale (DCS) Score at T2 and T3 T2	21.93 score on a scale Standard Deviation 11.84
Mean Decisional Conflict Scale (DCS) Score at T2 and T3 T3	8.78 score on a scale Standard Deviation 9.61

SECONDARY outcome

Timeframe: Baseline (T1), Pre-consultation, 1 week after baseline (T2)

Population: All available data are reported. 64 participants completed the baseline decision-specific knowledge quiz but 10 did not complete the pre-clinic decision-specific knowledge quiz. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study. Scores are reported for 54 participants who completed the baseline and pre-clinic decision-specific knowledge quiz.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=54 Participants 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. 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.
Mean Decision-Specific Knowledge Scores T1	54.32 score on a scale Standard Deviation 22.24
Mean Decision-Specific Knowledge Scores T2	75.62 score on a scale Standard Deviation 16.42

SECONDARY outcome

Timeframe: 3-month post-consultation (T4)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up during T3. Two parents were lost to follow up between T3 and T4 totaling 27.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=27 Participants 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. 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.
Mean Decisional Regret Scale Score	25.0 score on a scale Standard Deviation 47.03

SECONDARY outcome

Timeframe: Baseline (T1), Pre-consultation, 1 week after baseline (T2)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=64 Participants 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. 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.
Hypospadias Treatment Preference by Category at T1 and T2 T1 · Yes	31 Participants
Hypospadias Treatment Preference by Category at T1 and T2 T1 · No	2 Participants
Hypospadias Treatment Preference by Category at T1 and T2 T1 · Unsure	31 Participants
Hypospadias Treatment Preference by Category at T1 and T2 T2 · Yes	27 Participants
Hypospadias Treatment Preference by Category at T1 and T2 T2 · No	2 Participants
Hypospadias Treatment Preference by Category at T1 and T2 T2 · Unsure	25 Participants

SECONDARY outcome

Timeframe: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up during T3.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=54 Participants 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. 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.
Hypospadias Treatment Preference by Category at T2 and T3 T2 · Yes	27 Participants
Hypospadias Treatment Preference by Category at T2 and T3 T2 · No	25 Participants
Hypospadias Treatment Preference by Category at T2 and T3 T2 · Unsure	2 Participants
Hypospadias Treatment Preference by Category at T2 and T3 T3 · Yes	18 Participants
Hypospadias Treatment Preference by Category at T2 and T3 T3 · No	1 Participants
Hypospadias Treatment Preference by Category at T2 and T3 T3 · Unsure	10 Participants

SECONDARY outcome

Timeframe: Baseline (T1), Pre-consultation, 1 week after baseline (T2)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=64 Participants 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. 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.
Awareness of Decision by Category at T1 and T2 T1 · Yes	37 Participants
Awareness of Decision by Category at T1 and T2 T1 · No	6 Participants
Awareness of Decision by Category at T1 and T2 T1 · Unsure	21 Participants
Awareness of Decision by Category at T1 and T2 T2 · Yes	34 Participants
Awareness of Decision by Category at T1 and T2 T2 · No	0 Participants
Awareness of Decision by Category at T1 and T2 T2 · Unsure	20 Participants

SECONDARY outcome

Timeframe: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up during T3.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=54 Participants 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. 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.
Awareness of Decision by Category at T2 and T3 T2 · Yes	34 Participants
Awareness of Decision by Category at T2 and T3 T2 · No	20 Participants
Awareness of Decision by Category at T2 and T3 T2 · Unsure	0 Participants
Awareness of Decision by Category at T2 and T3 T3 · Yes	20 Participants
Awareness of Decision by Category at T2 and T3 T3 · No	1 Participants
Awareness of Decision by Category at T2 and T3 T3 · Unsure	8 Participants

SECONDARY outcome

Timeframe: Initial post-consultation, within 48 hours of urology visit (T3)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54. Of the 54, 1 parent was lost to follow up prior to provider consultation. After completing the consultation, 23 were diagnosed without hypospadias and were discontinued. One parent was lost to follow up before T3, resulting in 29 parents.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=29 Participants 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. 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.
Mean Shared Decision Making Questionnaire Score	82.5 score on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: Pre-consultation, 1 week after baseline (T2)

Population: All available data are reported. Between T1 and T2, 9 parents were lost to follow up and 1 parent withdrew from the study for a total of 54.

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.

Outcome measures

Outcome measures
Measure	Parent Utilization of Decision Aid Website n=54 Participants 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. 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.
Mean Preparation for Decision Making Score	82.6 score on a scale Standard Deviation 14.1

Adverse Events

Parent Utilization of Decision Aid Website

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elaine Cuevas

Indiana University

Phone: 317-278-7495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place