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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. Identifier: NCT03962257
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 27, 2019
Information provided by (Responsible Party):
Linnea Goodman, MD, University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient Satisfaction Other: EngagedMD online learning platform Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03962257

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Contact: Linnea R Goodman, MD 919-908-0000

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United States, Florida
Fertility CARE: The IVF Center Not yet recruiting
Winter Park, Florida, United States, 32792
Contact: Mark Trolice, MD    407-672-1106   
United States, Mississippi
Positive Steps Fertility Not yet recruiting
Madison, Mississippi, United States, 39110
Contact: Pres Parry, MD    601-559-5268   
United States, North Carolina
UNC Fertility Recruiting
Raleigh, North Carolina, United States, 27616
Contact: Linnea R Goodman, MD    919-908-0000   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Linnea R Goodman, MD UNC

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Responsible Party: Linnea Goodman, MD, Assistant Professor, University of North Carolina, Chapel Hill Identifier: NCT03962257     History of Changes
Other Study ID Numbers: 18-3258
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linnea Goodman, MD, University of North Carolina, Chapel Hill:
Patient education