The Use of an Online Learning and Consent Platform in Infertility Treatment

• ClinicalTrials.gov Identifier: NCT03962257
• Recruitment Status: Completed
• First Posted: May 24, 2019
• Last Update Posted: July 22, 2021
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 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
• Actual Primary Completion Date: December 10, 2020
• Actual Study Completion Date: December 10, 2020

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Florida

Fertility CARE: The IVF Center

Winter Park, Florida, United States, 32792

United States, Mississippi

Positive Steps Fertility

Madison, Mississippi, United States, 39110

United States, North Carolina

UNC Fertility

Raleigh, North Carolina, United States, 27616

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Linnea R Goodman, MD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03962257
• Other Study ID Numbers: 18-3258
• First Posted: May 24, 2019
• Last Update Posted: July 22, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:

Patient education