Clinical trial NCT04432792: The California Home Abortion by Telehealth (CHAT) Study
Official title: The California Home Abortion by Telehealth (CHAT) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion Early
Keywords: Telemedicine
Telehealth
Telephone
Remote
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: California Latinas for Reproductive Justice
name: UCGHI Center for Gender and Health Justice Center of Expertise
First posted: 2020-06-16
Enrollment: 6020
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will aim to reach a diverse sample of medication abortion patients across the country in states where care is provided including California, New York, and Washington, thus far. In California alone, an estimated 50% of all abortions are medication abortions resulting in \>66,000 medication abortions per year. California accounts for 20% of the nation's medication abortions.

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.

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

Primary outcomes:
measure: The proportion of participants with a successful abortion
timeFrame: Documented resolution of pregnancy, for most patients assessed at 7 days
measure: The proportion of participants reporting satisfaction with telehealth for abortion
timeFrame: Documented satisfaction measured at approximately 4 weeks follow up
measure: The proportion of participants reporting they would use the telehealth option again if needed
timeFrame: Documented at approximately 4 weeks follow up
measure: The total percentage of participants who carried out the study tasks as directed.
timeFrame: Documented at the 7 day follow up survey
Secondary outcomes:
measure: The total percentage of participants who experienced a major adverse event
timeFrame: Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Advancing New Standards in Reproductive Health (ANSIRH)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ushma Upadhyay, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: