The Use of an Online Learning and Consent Platform in Infertility Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03962257|
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Patient Satisfaction||Other: EngagedMD online learning platform||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial comparing one group receiving standard care and the other with standard care with the addition of the online learning platform|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving the Informed Consent Process for Infertile Patients Undergoing Assisted Reproductive Technology (ART) With EngagedMD|
|Actual Study Start Date :||March 30, 2019|
|Estimated Primary Completion Date :||March 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
No Intervention: Conventional
This group will have standard of care infertility counseling and consent processes.
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.
Other: EngagedMD online learning platform
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962257
|Contact: Linnea R Goodman, MDemail@example.com|
|United States, Florida|
|Fertility CARE: The IVF Center||Not yet recruiting|
|Winter Park, Florida, United States, 32792|
|Contact: Mark Trolice, MD 407-672-1106 firstname.lastname@example.org|
|United States, Mississippi|
|Positive Steps Fertility||Not yet recruiting|
|Madison, Mississippi, United States, 39110|
|Contact: Pres Parry, MD 601-559-5268 email@example.com|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27616|
|Contact: Linnea R Goodman, MD 919-908-0000 firstname.lastname@example.org|
|Principal Investigator:||Linnea R Goodman, MD||UNC|