NCT05509322

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

August 10, 2022

Last Update Submit

April 10, 2023

Conditions

Fertility Risk

Outcome Measures

Primary Outcomes (1)

  • Image quality

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

    6 weeks

Secondary Outcomes (22)

  • False positives

    6 weeks

  • Recalled Net Promoter Score

    6 weeks

  • Number of patients opening box at correct time

    6 weeks

  • Number of correct patients identified

    6 weeks

  • Number of patients who used probe cover

    6 weeks

  • +17 more secondary outcomes

Study Arms (3)

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.

Other: Subsidy for fertility consultOther: Invitation to purchase fertility consult

Invitation to fertility consult without subsidy

ACTIVE COMPARATOR

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

Other: Invitation to purchase fertility consult

Control (no invitation)

NO INTERVENTION

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

Interventions

Subsidy for fertility consultOTHER

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

Invitation to fertility consult with subsidy
Invitation to purchase fertility consultOTHER

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

Invitation to fertility consult with subsidyInvitation to fertility consult without subsidy

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Planning to move away from MN in the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (3)

  • 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.

    PMID: 35271530BACKGROUND

  • 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.

    PMID: 27990627BACKGROUND

  • 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.

    PMID: 12780419BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Prospective, interventional, multi-arm real-world study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 22, 2022

Study Start

January 1, 2023

Primary Completion

April 10, 2023

Study Completion

April 10, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

US(1)