- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432792
The California Home Abortion by Telehealth (CHAT) Study (CHAT)
Study Overview
Detailed Description
There are 2 components to the study:
- A clinical records review on all patients
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94612
- Advancing New Standards in Reproductive Health (ANSIRH)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Study survey participants will be administered 3 online surveys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of participants with a successful abortion
Time Frame: Documented resolution of pregnancy, for most patients assessed at 7 days
|
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
Time Frame: Documented satisfaction measured at approximately 4 weeks follow up
|
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
Time Frame: Documented at approximately 4 weeks follow up
|
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.
Time Frame: Documented at the 7 day follow up survey
|
The total percentage of participants who carried out the study tasks as directed.
|
Documented at the 7 day follow up survey
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total percentage of participants who experienced a major adverse event
Time Frame: Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ushma Upadhyay, PhD, MPH, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-32951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abortion Early
-
Columbia UniversityCompletedAbortion EarlyUnited States
-
University of California, San FranciscoWithdrawnEarly Abortion
-
Ain Shams Maternity HospitalRecruiting
-
University of UtahGrand Challenges CanadaActive, not recruitingAbortion EarlyUnited States
-
Gynuity Health ProjectsAll Families HealthcareRecruiting
-
NHS LothianKarolinska Institutet; University of EdinburghCompleted
-
Gynuity Health ProjectsStanford University; Planned Parenthood of the Rocky Mountains; Planned Parenthood...Active, not recruiting
-
Maternal and Child Health Hospital of Hubei ProvinceThe Hong Kong Polytechnic UniversityCompleted
-
Center for Information and Counseling on Reproductive...Grand Challenges Canada; Gynuity Health Projects; Healthy LifeUnknown
-
Daniel GrossmanUniversity of California, San Diego; University of California, Davis; University... and other collaboratorsCompleted
Clinical Trials on Questionnaire
-
H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaCompletedAnxiety | Psychological StressUnited States
-
Centre Hospitalier Universitaire de NiceCompletedGeneral Population | TDAH | Children Aged 5 to 18 YearsFrance
-
Imperial College LondonRoyal Marsden NHS Foundation Trust; University College London Hospitals; The... and other collaboratorsCompleted
-
Minneapolis Veterans Affairs Medical CenterUnited States Department of DefenseCompletedLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury)United States
-
NSABP Foundation IncNational Cancer Institute (NCI)Completed
-
Rabin Medical CenterCompleted
-
Stanford UniversityRecruitingAstigmatism | Nearsightedness | FarsightednessUnited States
-
University of LiegeCompletedCritical Illness | Covid19 | Psychological Stress | FamilyBelgium
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
National Taiwan University HospitalNational Taiwan UniversityUnknownComputerized Physician Order EntryTaiwan