Engaging Families to Improve the Care of Patients With Hypospadias
Primary Purpose
Hypospadias
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid Website
Sponsored by
About this trial
This is an interventional other trial for Hypospadias focused on measuring hypospadias, shared decision making, decisional regret, decision aid
Eligibility Criteria
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.
Sites / Locations
- Indiana University
- UNC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parent Utilization of Decision Aid Website
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Percent of Eligible Parents Enrolled (Feasibility)
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)
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)
Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05056311
First Posted
August 31, 2021
Last Updated
August 2, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05056311
Brief Title
Engaging Families to Improve the Care of Patients With Hypospadias
Official Title
Engaging Families to Improve the Care of Patients With Hypospadias
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
October 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias
Keywords
hypospadias, shared decision making, decisional regret, decision aid
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent Utilization of Decision Aid Website
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Decision Aid Website
Intervention Description
The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery.
Primary Outcome Measure Information:
Title
Percent of Eligible Parents Screened (Feasibility)
Description
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)
Title
Percent of Eligible Parents Enrolled (Feasibility)
Description
The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100.
Time Frame
Baseline (T1)
Title
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability)
Description
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)
Title
Percentage of Parents Retained in the Study (Feasibility)
Description
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
Secondary Outcome Measure Information:
Title
Mean Decisional Conflict Scale (DCS) Score at T1 and T2
Description
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)
Title
Mean Decisional Conflict Scale (DCS) Score at T2 and T3
Description
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)
Title
Mean Decision-Specific Knowledge Scores
Description
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)
Title
Mean Decisional Regret Scale Score
Description
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)
Title
Hypospadias Treatment Preference by Category at T1 and T2
Description
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)
Title
Hypospadias Treatment Preference by Category at T2 and T3
Description
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)
Title
Awareness of Decision by Category at T1 and T2
Description
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)
Title
Awareness of Decision by Category at T2 and T3
Description
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)
Title
Mean Shared Decision Making Questionnaire Score
Description
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)
Title
Mean Preparation for Decision Making Score
Description
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Hubert Chan, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Engaging Families to Improve the Care of Patients With Hypospadias
We'll reach out to this number within 24 hrs