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

Turtle Health, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Conditions

Fertility Risk

Interventions

Subsidy for fertility consultOTHER

Some participants will receive a subsidy when they purchase the fertility consult.

Invitation to purchase fertility consultOTHER

Some participants will receive an invitation from their health center to purchase an at-home fertility consult.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Image quality

Percent of women whose stills are clinical quality, in each of 3 populations of interest.

Time frame: 6 weeks

Secondary Outcomes

False positives

Rate of false positives of 'significant findings'

Time frame: 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.

Time frame: 6 weeks

Number of patients opening box at correct time

Confirming patient opens box at correct time (not early)

Time frame: 6 weeks

Number of correct patients identified

Correct patient is identified by tech and tests (not wrong patient)

Time frame: 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

Time frame: 6 weeks

Number of patients placing probe in correct cavity

Patient places probe in correct cavity (vaginal vs. anal)

Time frame: 6 weeks

Rate of return packages sent

Patient ships product back in a timely fashion

Data from ClinicalTrials.gov

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