The Use of an Online Learning and Consent Platform in Infertility Treatment
July 21, 2021 updated by: University of North Carolina, Chapel Hill
Improving the Informed Consent Process for Infertile Patients Undergoing Assisted Reproductive Technology (ART) With EngagedMD
The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online library of interactive videos, compared to the traditional process of consent and one-on-one teaching using a 15 question evaluation.
The secondary outcome will be to qualitatively assess patients' overall experience of the teaching process comparing the addition of the EngagedMD content to solely traditional teaching for infertility treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants: This will be a multi-center trial with each center planning on recruiting 100 couples. Half of the couples will be planning on undergoing ovulation induction with insemination (OI/IUI) and the other half in-vitro fertilization (IVF).
Procedures (methods): This is a multi-center prospective randomized controlled trial where couples undergoing OI/IUI or IVF will be randomized to receiving the current traditional standard of in-person treatment teaching by their physician and nursing team with standard paper consents or to the identical process of in-person teaching with the addition of unrestricted access to the EngagedMD online video resource platform with online consents.
Patient demographics, knowledge base, psychological impact of with the treatment, teaching and the consent process and overall satisfaction with the process as a whole will be assessed using surveys administered at three time points throughout the treatment process. A subset of patients that agree will be contacted after the completion of the treatment cycle for a live phone interview.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Winter Park, Florida, United States, 32792
- Fertility CARE: The IVF Center
-
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Mississippi
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Madison, Mississippi, United States, 39110
- Positive Steps Fertility
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North Carolina
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Raleigh, North Carolina, United States, 27616
- UNC Fertility
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female subjects must be 18-49 years of age undergoing fertility treatment
- Able to give Informed Consent
Exclusion Criteria:
- Patients who do not have adequate command of the English language to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Conventional
This group will have standard of care infertility counseling and consent processes.
|
|
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Experimental: Engaged MD
This group will have standard of care infertility counseling and access to online teaching modules and the ability to sign consents online.
|
The EngagedMD online learning platform is a compilation of learning modules and questions designed to give patients at-home access to visual and audio aids in infertility treatment.
It also gives patients the ability to read and sign consents from home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient understanding
Time Frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
|
Patient understanding of infertility diagnoses and treatment by use of a pre and post test.
The test comprises of 15 multiple choice questions and the patients will receive a score of 0-15 and this will be compared as a paired continuous variable from the pre-test score to their post-test score as well as an un-paired continuous variable between the conventional group and the EngagedMD group for pre- and post-test scores as well as delta scores between the two.
|
Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
|
Patient satisfaction with their infertility treatment and consent processes will be assessed using questionnaires using a 5 point Likert scale progressing from very unsatisfied to very satisfied across a number of questions.
The 5 point Likert questions will be assigned a value of 1-5 (with 1 being very unsatisfied and 5 being very satisfied) and will be assessed as a sum of points from the individual questions and compared as continuous variables between the conventional arm and the EngagedMD arm.
There is an additional question asking patients to rank their satisfaction on a scale of 1-10 (with 1 being not satisfied at all and 10 being extremely satisfied) which will be used independently as a measure of patient satisfaction overall.
|
Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Linnea R Goodman, MD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2019
Primary Completion (Actual)
December 10, 2020
Study Completion (Actual)
December 10, 2020
Study Registration Dates
First Submitted
May 20, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 24, 2019
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 21, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-3258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.