The California Home Abortion by Telehealth (CHAT) Study

Abortion Early Clinical Trial

— CHAT  

Official title:

The California Home Abortion by Telehealth (CHAT) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432792
• Other study ID #: 20-32951
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6020
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion Early

Intervention

Other:
• Questionnaire
Study survey participants will be administered 3 online surveys.

Locations

Country	Name	City	State
United States	Advancing New Standards in Reproductive Health (ANSIRH)	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	California Latinas for Reproductive Justice, UCGHI Center for Gender and Health Justice Center of Expertise

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	The total percentage of participants who experienced a major adverse event	Major adverse events, either reported by the patient or documented through clinical records. Major adverse events will be defined as any abortion requiring blood transfusion, surgery, or hospitalization	Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants