Patient SatisfactionNCT03962257
The Use of an Online Learning and Consent Platform in Infertility Treatment
A study testing EngagedMD online learning platform in people with Patient Satisfaction, run by University of North Carolina, Chapel Hill at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- EngagedMD online learning platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Mar 2019to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects must be 18-49 years of age undergoing fertility treatment
- Able to give Informed Consent
Who cannot join
- Patients who do not have adequate command of the English language to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Positive Steps Fertility
Madison, Mississippi, 39110
UNC Fertility
Raleigh, North Carolina, 27616
Fertility CARE: The IVF Center
Winter Park, Florida, 32792
About this study
Official title: Improving the Informed Consent Process for Infertile Patients Undergoing Assisted Reproductive Technology (ART) With EngagedMD
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.
Read the 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.
- Conditions
- Patient Satisfaction
- Being tested
- EngagedMD online learning platform
- Keywords
- Patient education
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EngagedMD online learning platformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | This group will have standard of care infertility counseling and consent processes. |
| Engaged MD | Experimental | This group will have standard of care infertility counseling and access to online teaching modules and the ability to sign consents online. Receives: Other: EngagedMD online learning platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient understanding
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.
Measured: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
Secondary outcomes (1)
Patient satisfaction
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.
Measured: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start30 Mar 2019
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linnea R Goodman, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962257
- Sponsor's protocol ID
- 18-3258
- Status last verified
- Jul 2021
- First submitted
- 20 May 2019
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36212557
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Informed Consent Process for Infertile Patients Undergoing Assisted Reproductive Technology (ART) With EngagedMD
- ClinicalTrials.gov ID
- NCT03962257
- Acronym / sponsor ID
- 18-3258
- Conditions
- Patient Satisfaction
- Keywords
- Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –This group will have standard of care infertility counseling and consent processes. |
| Engaged MD | Experimental | Other: EngagedMD online learning platformThis group will have standard of care infertility counseling and access to online teaching modules and the ability to sign consents online. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female subjects must be 18-49 years of age undergoing fertility treatment
- Able to give Informed Consent
Key exclusion criteria (1 listed)
- Patients who do not have adequate command of the English language to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EngagedMD online learning platformThe 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. | Other | Engaged MD |
Primary outcome
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.
1 secondary outcome
Patient satisfaction
Time frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 36212557Bernard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linnea R Goodman, MD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EngagedMD online learning platform in people with Patient Satisfaction, run by University of North Carolina, Chapel Hill at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient understanding (time frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.