Care Expansion Across Remote Environments - Sub-Study of the SELF-GYN1 Trial
- Conditions
- Fertility Risk
- Interventions
- Other: Subsidy for fertility consultOther: Invitation to purchase fertility consult
- Registration Number
- NCT05509322
- Lead Sponsor
- Turtle Health, Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- All exclusion criteria from the SELF-GYN1 trial apply
- Planning to move away from MN in the next year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Invitation to fertility consult with subsidy Subsidy for fertility consult This group will be invited to purchase a fertility consult, and will be offered a subsidy if they choose to purchase the consult. Invitation to fertility consult with subsidy Invitation to purchase fertility consult This group will be invited to purchase a fertility consult, and will be offered a subsidy if they choose to purchase the consult. Invitation to fertility consult without subsidy Invitation to purchase fertility consult This group will be invited to purchase a fertility consult at full price.
- Primary Outcome Measures
Name Time Method Image quality 6 weeks Percent of women whose stills are clinical quality, in each of 3 populations of interest.
- Secondary Outcome Measures
Name Time Method Number of correct patients identified 6 weeks Correct patient is identified by tech and tests (not wrong patient)
Rate of probes being reprocessed 6 weeks Probe is reprocessed properly per internal SOPs
Number of IVF cycles 6 months Number of IVF cycles conducted
Number of gynecological surgeries 6 months Number of gynecological surgeries conducted
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 working probes 6 weeks Probe remains in working condition
Clinically significant findings 6 weeks Percentage of patients in which clinically significant findings are identified
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
Percentage of minimally invasive gynecological surgeries 6 months Percentage of those surgeries that are considered minimally invasive based on treating physician survey
False positives 6 weeks Rate of false positives of 'significant findings'
Number of other follow-up care 6 months Number of other follow-up care sought based on findings identified during at-home consult
Rate of probes that crack 6 weeks Probe does not crack on out-return trip
Adverse events 6 weeks Number and type of adverse events that occur
Number of participants per subsidy 6 months Level of participation (purchase and completion of consult) per subsidy level within each cohort of interest
Percentage of IVF cycles 6 months Percentage of IVF cycles considered clinically necessary 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
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
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)
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States