Fertility Risk
Conditions
Brief summary
This real-world, interventional sub-study will evaluate the impact of potential payer subsidies for Turtle Health at-home consults on subsequent interactions with the healthcare system within select sub-populations of interest.
Detailed description
The present study is a sub-study of the SELF-GYN1 study. The SELF-GYN1 study is a multicenter study designed to evaluate the efficacy and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist. In addition to the main questions of the SELF-GYN1 study, additional questions related to patient decision-making and pricing dynamics for patients who purchase patient's decisions to purchase a fertility consult alongside enrolling in the SELF-GYN1 trial, will be studied at Mayo Clinic, through providing subsidies for the purchasing of the fertility consult.
Interventions
OTHERSubsidy for fertility consult
Some participants will receive a subsidy when they purchase the fertility consult.
OTHERInvitation to purchase fertility consult
Some participants will receive an invitation from their health center to purchase an at-home fertility consult.
Sponsors
Turtle Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will be blinded in the sense that they will be offered the consult at a particular price, and may be informed of the expected list price of the consult (i.e. what the price would be without the subsidy offered to the patient), but patients will not be aware that others are being offered different levels of subsidy. Independent raters will be blinded as to the level of subsidy the patient has received; reasonable effort will be made to maintain investigator blinding; however, nothing will prevent the patient from proactively mentioning to the investigator the price they are paying or considering paying for the consult.
Intervention model description
Prospective, interventional, multi-arm real-world study
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* All inclusion criteria from the SELF-GYN1 trial apply * Participant in Mayo Clinic health system * Lives in MN * Belongs to a sub-population targeted for enrollment that has not yet met its enrollment target * Consent to participate in electronic health record monitoring and outreach
Exclusion criteria
* All
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality | 6 weeks | Percent of women whose stills are clinical quality, in each of 3 populations of interest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recalled Net Promoter Score | 6 weeks | Difference between recalled in-clinic Net Promoter Score and at-home Net Promoter Score. The Net Promoter Score has a range of 0-10 with higher scores indicating more favorable responses. |
| Number of patients opening box at correct time | 6 weeks | Confirming patient opens box at correct time (not early) |
| Number of correct patients identified | 6 weeks | Correct patient is identified by tech and tests (not wrong patient) |
| Number of patients who used probe cover | 6 weeks | Patient correctly applies probe cover without either a) failing to apply it or b) ripping it, including in low light or other sub-optimal conditions |
| Number of patients placing probe in correct cavity | 6 weeks | Patient places probe in correct cavity (vaginal vs. anal) |
| Rate of return packages sent | 6 weeks | Patient ships product back in a timely fashion |
| Rate of probes that crack | 6 weeks | Probe does not crack on out-return trip |
| Rate of working probes | 6 weeks | Probe remains in working condition |
| Rate of probes being reprocessed | 6 weeks | Probe is reprocessed properly per internal SOPs |
| Adverse events | 6 weeks | Number and type of adverse events that occur |
| False positives | 6 weeks | Rate of false positives of 'significant findings' |
| Number of couples who participate | 6 months | Level of participation in couple consults where offered - i.e., purchase of both male and female consult, per subsidy level within each cohort of interest |
| Clinically significant findings | 6 weeks | Percentage of patients in which clinically significant findings are identified |
| Number of IVF cycles | 6 months | Number of IVF cycles conducted |
| Percentage of IVF cycles | 6 months | Percentage of IVF cycles considered clinically necessary based on treating physician survey |
| Number of gynecological surgeries | 6 months | Number of gynecological surgeries conducted |
| Percentage of minimally invasive gynecological surgeries | 6 months | Percentage of those surgeries that are considered minimally invasive based on treating physician survey |
| Percentage of gynecological surgeries | 12 months | Percentage of those surgeries that are considered clinically necessary within next 12 months based on treating physician survey |
| Number of additional TVUS | 6 months | Number of additional transvaginal ultrasounds conducted to monitor findings identified during at-home consult |
| Number of other follow-up care | 6 months | Number of other follow-up care sought based on findings identified during at-home consult |
| Percentage of follow up care per arm | 6 months | Percentage of patients in each arm seeking follow up care of any kind; fertility care in particular after consult |
| Number of participants per subsidy | 6 months | Level of participation (purchase and completion of consult) per subsidy level within each cohort of interest |
Countries
United States
Outcome results
None listed