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

Turtle Health

Status: Withdrawn

Conditions: Fertility Risk

Treatments: Other: Subsidy for fertility consult; Other: Invitation to purchase fertility consult

Study type: Interventional

Funder types: Industry

Identifiers

NCT05509322

016a

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Invitation to fertility consult with subsidy

Experimental group

Description:

This group will be invited to purchase a fertility consult, and will be offered a subsidy if they choose to purchase the consult.

Treatment:

Other: Invitation to purchase fertility consult

Other: Subsidy for fertility consult

Invitation to fertility consult without subsidy

Active Comparator group

Description:

This group will be invited to purchase a fertility consult at full price.

Treatment:

Other: Invitation to purchase fertility consult

Control (no invitation)

No Intervention group

Description:

This group will not receive invitations to purchase a fertility consult.