Clinical trial NCT03962257: The Use of an Online Learning and Consent Platform in Infertility Treatment
Official title: Improving the Informed Consent Process for Infertile Patients Undergoing Assisted Reproductive Technology (ART) With EngagedMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: Patient education
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient understanding
timeFrame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
Other outcomes:
Locations:
city: Winter Park
country: United States
facility: Fertility CARE: The IVF Center
state: Florida
city: Madison
country: United States
facility: Positive Steps Fertility
state: Mississippi
city: Raleigh
country: United States
facility: UNC Fertility
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Linnea R Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernard AL, Barbour AK, Meernik C, Madeira JL, Lindheim SR, Goodman LR. The impact of an interactive multimedia educational platform on patient comprehension and anxiety during fertility treatment: a randomized controlled trial. F S Rep. 2022 May 22;3(3):214-222. doi: 10.1016/j.xfre.2022.05.006. eCollection 2022 Sep.