The California Home Abortion by Telehealth (CHAT) Study

NCT04432792 | Completed DMC

• 1 other identifier: 20-32951
• Study Type: observational
• Target: 6,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion Early

Keywords

Telemedicine; Telehealth; Telephone; Remote

Outcome Measures

Primary Outcomes (4)

• The proportion of participants with a successful abortion

  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.

  Documented resolution of pregnancy, for most patients assessed at 7 days

• The proportion of participants reporting satisfaction with telehealth for abortion

  The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.

  Documented satisfaction measured at approximately 4 weeks follow up

• The proportion of participants reporting they would use the telehealth option again if needed

  The proportion of participants reporting they would use the telehealth option again if needed

  Documented at approximately 4 weeks follow up

• The total percentage of participants who carried out the study tasks as directed.

  The total percentage of participants who carried out the study tasks as directed.

  Documented at the 7 day follow up survey

Secondary Outcomes (1)

• 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

Study Arms (2)

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.

Study Survey Participants

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

Other: Questionnaire

Interventions

Questionnaire OTHER

Study survey participants will be administered 3 online surveys.

Study Survey Participants

Eligibility Criteria

• Age: 13 Years+
• Gender Eligibility Details: Any pregnant person seeking medication abortion regardless of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• California Latinas for Reproductive Justice: collaborator
• UCGHI Center for Gender and Health Justice Center of Expertise: collaborator

Study Sites (1)

Advancing New Standards in Reproductive Health (ANSIRH)

San Francisco, California, 94612, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ushma Upadhyay, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: May 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)