Care Expansion Across Remote Environments - Sub-Study of the SELF-GYN1 Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Care Expansion Across Remote Environments - Substudy of the SELF-GYN [Sonograms Enable Looking Forward - Get Your iNformation] Extension - I Trial

Conditions
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Fertility Risk

Intervention / Treatment
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* Other: Subsidy for fertility consult
* Other: Invitation to purchase fertility consult


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria from the SELF-GYN1 trial apply Planning to move away from MN in the next year

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, interventional, multi-arm real-world study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Invitation to fertility consult with subsidy<br>This group will be invited to purchase a fertility consult, and will be offered a subsidy if they choose to purchase the consult. | Other: Subsidy for fertility consult<br>* Some participants will receive a subsidy when they purchase the fertility consult.<br>Other: Invitation to purchase fertility consult<br>* Some participants will receive an invitation from their health center to purchase an at-home fertility consult.<br>|
| Active Comparator: Invitation to fertility consult without subsidy<br>This group will be invited to purchase a fertility consult at full price. | Other: Invitation to purchase fertility consult<br>* Some participants will receive an invitation from their health center to purchase an at-home fertility consult.<br>|
| No Intervention: Control (no invitation)<br>This group will not receive invitations to purchase a fertility consult. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality | Percent of women whose stills are clinical quality, in each of 3 populations of interest. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False positives | Rate of false positives of 'significant findings' | 6 weeks | 
| Recalled Net Promoter Score | 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. | 6 weeks | 
| Number of patients opening box at correct time | Confirming patient opens box at correct time (not early) | 6 weeks | 
| Number of correct patients identified | Correct patient is identified by tech and tests (not wrong patient) | 6 weeks | 
| Number of patients who used probe cover | 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 | 6 weeks | 
| Number of patients placing probe in correct cavity | Patient places probe in correct cavity (vaginal vs. anal) | 6 weeks | 
| Rate of return packages sent | Patient ships product back in a timely fashion | 6 weeks | 
| Rate of probes that crack | Probe does not crack on out-return trip | 6 weeks | 
| Rate of working probes | Probe remains in working condition | 6 weeks | 
| Rate of probes being reprocessed | Probe is reprocessed properly per internal SOPs | 6 weeks | 
| Adverse events | Number and type of adverse events that occur | 6 weeks | 
| Number of participants per subsidy | Level of participation (purchase and completion of consult) per subsidy level within each cohort of interest | 6 months | 
| Number of couples who participate | 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 | 6 months | 
| Clinically significant findings | Percentage of patients in which clinically significant findings are identified | 6 weeks | 
| Number of IVF cycles | Number of IVF cycles conducted | 6 months | 
| Percentage of IVF cycles | Percentage of IVF cycles considered clinically necessary based on treating physician survey | 6 months | 
| Number of gynecological surgeries | Number of gynecological surgeries conducted | 6 months | 
| Percentage of minimally invasive gynecological surgeries | Percentage of those surgeries that are considered minimally invasive based on treating physician survey | 6 months | 
| Percentage of gynecological surgeries | Percentage of those surgeries that are considered clinically necessary within next 12 months based on treating physician survey | 12 months | 
| Number of additional TVUS | Number of additional transvaginal ultrasounds conducted to monitor findings identified during at-home consult | 6 months | 
| Number of other follow-up care | Number of other follow-up care sought based on findings identified during at-home consult | 6 months | 
| Percentage of follow up care per arm | Percentage of patients in each arm seeking follow up care of any kind; fertility care in particular after consult | 6 months |