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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fertility Risk
• Intervention / Treatment: Other: Subsidy for fertility consult; Other: Invitation to purchase fertility consult

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Invitation to fertility consult with subsidy; 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; Some participants will receive a subsidy when they purchase the fertility consult.; Other: Invitation to purchase fertility consult; Some participants will receive an invitation from their health center to purchase an at-home fertility consult.
Active Comparator: Invitation to fertility consult without subsidy; This group will be invited to purchase a fertility consult at full price.	Other: Invitation to purchase fertility consult; Some participants will receive an invitation from their health center to purchase an at-home fertility consult.
No Intervention: Control (no invitation); This group will not receive invitations to purchase a fertility consult.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Turtle Health, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 016a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No