The California Home Abortion by Telehealth (CHAT) Study

NCT ID: NCT04432792

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6020 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-06-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Clinical Records Review

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.

No interventions assigned to this group

Study Survey Participants

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

Questionnaire

Intervention Type: OTHER

Study survey participants will be administered 3 online surveys.

Interventions

Questionnaire

Study survey participants will be administered 3 online surveys.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

California Latinas for Reproductive Justice

UNKNOWN

Sponsor Role: collaborator

UCGHI Center for Gender and Health Justice Center of Expertise

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ushma Upadhyay, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Advancing New Standards in Reproductive Health (ANSIRH)

San Francisco, California, United States

Countries

United States

Other Identifiers

20-32951

Identifier Type: -

Identifier Source: org_study_id