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Study is no longer going to be occurring- no subjects were enrolled at any point.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invitation to fertility consult with subsidy | Experimental | 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 | Active Comparator | This group will be invited to purchase a fertility consult at full price. |
|
| Control (no invitation) | No Intervention | This group will not receive invitations to purchase a fertility consult. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subsidy for fertility consult | Other | Some participants will receive a subsidy when they purchase the fertility consult. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Image quality | Percent of women whose stills are clinical quality, in each of 3 populations of interest. | 6 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35271530 | Background | Chung EH, Petishnok LC, Conyers JM, Schimer DA, Vitek WS, Harris AL, Brown MA, Jolin JA, Karmon A, Styer AK. Virtual Compared With In-Clinic Transvaginal Ultrasonography for Ovarian Reserve Assessment. Obstet Gynecol. 2022 Apr 1;139(4):561-570. doi: 10.1097/AOG.0000000000004698. Epub 2022 Mar 10. | |
| 27990627 | Background |
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Prospective, interventional, multi-arm real-world study
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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.
| Invitation to purchase fertility consult | Other | Some participants will receive an invitation from their health center to purchase an at-home fertility consult. |
|
| 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 |
| Birch Petersen K, Maltesen T, Forman JL, Sylvest R, Pinborg A, Larsen EC, Macklon KT, Nielsen HS, Hvidman HW, Nyboe Andersen A. The Fertility Assessment and Counseling Clinic - does the concept work? A prospective 2-year follow-up study of 519 women. Acta Obstet Gynecol Scand. 2017 Mar;96(3):313-325. doi: 10.1111/aogs.13081. Epub 2017 Feb 3. |
| 12780419 | Background | Farquhar C, Ekeroma A, Furness S, Arroll B. A systematic review of transvaginal ultrasonography, sonohysterography and hysteroscopy for the investigation of abnormal uterine bleeding in premenopausal women. Acta Obstet Gynecol Scand. 2003 Jun;82(6):493-504. doi: 10.1034/j.1600-0412.2003.00191.x. |