Care Expansion Across Remote Environments - Substudy of the SELF-GYN [Sonograms Enable Looking Forward - Get Your iNformation] Extension - I Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Image quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •All exclusion criteria from the SELF-GYN1 trial apply
- •Planning to move away from MN in the next year
结局指标
主要结局
Image quality
时间窗: 6 weeks
Percent of women whose stills are clinical quality, in each of 3 populations of interest.
次要结局
- Number of patients who used probe cover(6 weeks)
- Number of patients placing probe in correct cavity(6 weeks)
- Rate of return packages sent(6 weeks)
- Rate of working probes(6 weeks)
- Clinically significant findings(6 weeks)
- Number of couples who participate(6 months)
- Number of IVF cycles(6 months)
- Number of gynecological surgeries(6 months)
- Percentage of minimally invasive gynecological surgeries(6 months)
- False positives(6 weeks)
- Number of correct patients identified(6 weeks)
- Rate of probes being reprocessed(6 weeks)
- Number of other follow-up care(6 months)
- Rate of probes that crack(6 weeks)
- Adverse events(6 weeks)
- Number of participants per subsidy(6 months)
- Percentage of IVF cycles(6 months)
- Percentage of gynecological surgeries(12 months)
- Number of additional TVUS(6 months)
- Percentage of follow up care per arm(6 months)
- Recalled Net Promoter Score(6 weeks)
- Number of patients opening box at correct time(6 weeks)