The California Home Abortion by Telehealth (CHAT) Study

University of California San Francisco (UCSF)

Status: Completed

Conditions: Abortion Early

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04432792

20-32951

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,020 patients

Sex: Female

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Current patient of a participating telehealth platform for medication abortion (includes ages 13-64 years)
2. Able to read and write in English or Spanish
3. Willing to participate in enrollment survey and two follow-up surveys

Exclusion criteria

1. Not a current patient of a participating telehealth platform for medication abortion
2. Unable to read or write in English or Spanish
3. Unwilling to participate in study surveys

Trial design

6,020 participants in 2 patient groups

Clinical Records Review

Description:

We will receive clinical chart data from the telehealth providers on 3,000 patients (which could include the survey study participants, but we will not know their identities) which will include date of birth, zip code, and dates of service - but will otherwise be de-identified.

Study Survey Participants

Description:

We aim to enroll at least 3,000 participants to complete the study surveys.

Treatment:

Other: Questionnaire