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

NCT ID: NCT05509322

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-04-10

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.

Conditions

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Fertility Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, interventional, multi-arm real-world study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Subsidy for fertility consult

Intervention Type OTHER

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

Invitation to purchase fertility consult

Intervention Type OTHER

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

Invitation to fertility consult without subsidy

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

Group Type ACTIVE_COMPARATOR

Invitation to purchase fertility consult

Intervention Type OTHER

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

Control (no invitation)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Subsidy for fertility consult

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

Intervention Type OTHER

Invitation to purchase fertility consult

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* Planning to move away from MN in the next year
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turtle Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35271530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27990627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12780419 (View on PubMed)

Other Identifiers

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016a

Identifier Type: -

Identifier Source: org_study_id

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