Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05056311
Other study ID # 21-0146
Secondary ID K23DK111987
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT02752308 - Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair Phase 2/Phase 3
Completed NCT04239066 - Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes N/A
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Completed NCT03677453 - Interactive Perioperative Teaching Platform (IPTP) N/A
Terminated NCT04826484 - Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel Phase 3
Completed NCT02103712 - Long Term Outcome of Hypospadias Repair
Suspended NCT05093166 - Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure Phase 1/Phase 2
Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
Not yet recruiting NCT05569863 - Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence
Completed NCT02495090 - Hypospadias and Exome: Identification of New Genes for Familial Hypospadias N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT01370798 - Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications Phase 3
Recruiting NCT06417060 - Caudal Anesthesia Versus Local Anesthesia in Hypospadias N/A
Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A