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

University of North Carolina (UNC)

Status: Completed

Conditions: Patient Satisfaction

Treatments: Other: EngagedMD online learning platform

Study type: Interventional

Funder types: Other

Identifiers

NCT03962257

18-3258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Conventional

No Intervention group

Description:

This group will have standard of care infertility counseling and consent processes.

Engaged MD

Experimental group

Description:

This group will have standard of care infertility counseling and access to online teaching modules and the ability to sign consents online.

Treatment:

Other: EngagedMD online learning platform