NCT04432792

The California Home Abortion by Telehealth (CHAT) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,020 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 13 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

There are 2 components to the study: 1. A clinical records review on all patients 2. 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. Among those who complete the study surveys, we will investigate the feasibility, time to abortion, efficacy, safety, and acceptability of telehealth provision of mifepristone, measured using a 4-week follow-up though open-ended and closed-ended survey questions. Individuals who opted not to take the medications will be asked a separate set of follow-up questions to collect data related to diversion, to better understand potential risks.

Conditions

• Abortion Early

Interventions

Type	Name	Description
OTHER	Questionnaire	Study survey participants will be administered 3 online surveys.

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-06-16
• Last updated: 2023-02-03

Locations

1 site across 1 country: United States