Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04432792 |
Other study ID # |
20-32951 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.