Engaging Families to Improve the Care of Patients With Hypospadias

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.

Time frame: 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.

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

Time frame: 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.

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

Time frame: Baseline (T1)

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

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

Time frame: Baseline (T1)

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

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.

Time frame: 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.

Time frame: 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.

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.

Time frame: 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.

Time frame: 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.

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: 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. Time frame revised to address original entry error.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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 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.

Time frame: 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.