The California Home Abortion by Telehealth (CHAT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,020
- 试验地点
- 1
- 主要终点
- The proportion of participants reporting satisfaction with telehealth for abortion
研究概览
简要总结
This study aims to assess efficacy and safety outcomes of a telehealth model of abortion care. The study will compare efficacy of this model to usual in-clinic care based on published rates. It will also investigate participant acceptability and feasibility of this model of care.
详细描述
There are 2 components to the study:
- A clinical records review on all patients
- A survey study on a subset of patients who agree to participate.
Clinical Records Review: We will examine medical chart data on all patients from partnered telehealth providers to analyze efficacy and safety outcomes for medication abortion. These medical chart data will include medical/pregnancy history and abortion outcome and de-identified apart from date of birth, zip code, and dates of service.
Survey Study: Following completion of the telehealth provider's standard medical screening, all patients eligible to receive care through the telehealth provider will be directed to a page providing detailed information about the CHAT Evaluation Study and given the option to participate. Participation in the study involves completing our online questionnaires only. Being in the research study will not affect their care or treatment plan. Declining to participate in our research study will not affect their care.
If interested, the patient will provide electronic consent and complete a baseline survey to report socio-demographic characteristics, pregnancy history, and reasons for interest in telehealth medication abortion services. An online follow-up survey will be administered 3-7 days after receiving mifepristone and then once again 4 weeks after taking mifepristone; assessments will include self-report of medication administration, adverse events, and satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Current patient of a participating telehealth platform for medication abortion (includes ages 13-64 years)
- •Able to read and write in English or Spanish
- •Willing to participate in enrollment survey and two follow-up surveys
排除标准
- •Not a current patient of a participating telehealth platform for medication abortion
- •Unable to read or write in English or Spanish
- •Unwilling to participate in study surveys
结局指标
主要结局
The proportion of participants reporting satisfaction with telehealth for abortion
时间窗: Documented satisfaction measured at approximately 4 weeks follow up
The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.
The total percentage of participants who carried out the study tasks as directed.
时间窗: Documented at the 7 day follow up survey
The total percentage of participants who carried out the study tasks as directed.
The proportion of participants with a successful abortion
时间窗: Documented resolution of pregnancy, for most patients assessed at 7 days
The proportion of participants who have a successful abortion defined as complete abortion without continuing pregnancy, need for manual vacuum aspiration or an additional round of treatment to complete the abortion.
The proportion of participants reporting they would use the telehealth option again if needed
时间窗: Documented at approximately 4 weeks follow up
The proportion of participants reporting they would use the telehealth option again if needed
次要结局
- The total percentage of participants who experienced a major adverse event(Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants)