Health Knowledge Attitudes and Practice, Medication Abortion, Pregnant People
Conditions
Keywords
medication abortion, health knowledge
Brief summary
This study evaluates whether exposure to the U.S. Food and Drug Administration (FDA)-required Patient Agreement Form (PAF) for mifepristone improves patient knowledge about medication abortion. Participants seeking medication abortion at clinical sites in the United States were randomized to complete a knowledge assessment either before or after reviewing and signing the PAF. The primary objective was to assess whether exposure to the PAF improves knowledge related to medication abortion, including medication use, effectiveness, risks, and when to seek medical care.
Detailed description
This multi-site randomized controlled trial was conducted among individuals seeking medication abortion or receiving mifepristone for miscarriage management at five abortion facilities in the United States, including three Planned Parenthood health centers and two independent abortion clinics located in California, Colorado, Illinois, Kansas, and Minnesota. Participating sites varied in their duration of providing medication abortion services, with some sites offering services since the early to mid-2000s and others more recently initiating services in 2022-2023. All participants received standard counseling and the mifepristone medication guide before being randomized into a study group. After consenting in the study, participants were then randomized to complete a knowledge assessment on an electronic survey either before (control group) or after (exposed group) receiving and signing the Patient Agreement Form (PAF) and any associated PAF-related counseling. The primary outcome was overall medication abortion knowledge (range 0-12), measured using a 12-item index assessing understanding of medication abortion, which included: administration (2 items), effectiveness (3 items), potential serious risks (2 items), side effects (1 item), and when to seek medical care (4 items). Secondary outcomes included each individual knowledge item. Statistical analyses compared medication abortion knowledge between study groups using binomial regression with a log-link and robust standard errors, adjusting for recruitment site and baseline participant characteristics that differed by study group. Secondary analyses included logistic regression for individual knowledge items. Sensitivity analyses were conducted using multiple imputation for missing covariate data. This study was registered retrospectively following completion. The study protocol and statistical analysis plan were finalized and approved by the University of California, San Francisco Institutional Review Board prior to participant enrollment, and no substantive changes were made after study initiation.
Interventions
BEHAVIORALPatient Agreement Form (PAF)
The Patient Agreement Form is a document required under the FDA Risk Evaluation and Mitigation Strategy (REMS) program for mifepristone. It includes information about medication abortion, including risks, side effects, and instructions for use, and must be reviewed and signed by patients prior to receiving the medication.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Participants and clinic staff were unaware of study group assignment prior to randomization. Following group assignment, masking was not maintained because the study design required participants in one group to be exposed to the intervention (receive, review, and sign the PAF) prior to completing the knowledge assessment. Outcome assessment was based on a self-administered electronic knowledge survey which was administered after group assignment either before or after exposure to the intervention. No additional parties were masked.
Intervention model description
Participants were randomized into one of two parallel groups (exposed vs control) that differed in the timing of exposure to the Patient Agreement Form (PAF) relative to outcome assessment (knowledge survey). All participants first received standard counseling and the mifepristone medication guide. Participants in the control group completed the knowledge survey prior to receiving and signing the PAF and any PAF-related counseling. Participants in the exposed group completed the knowledge survey after receiving and signing the PAF and any PAF-related counseling. All study procedures occurred during a single clinical visit.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 15 years or older * Able to read and speak English or Spanish * Seeking medication abortion or receiving mifepristone for miscarriage management
Exclusion criteria
* Does not meet inclusion criteria * Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication abortion knowledge | Knowledge will be assessed only once, during the same clinicial visit on the day of recruitment (Day 1), following standard counseling (before or after exposure to the PAF depending on assigned study group). | Number of correct responses to 12 knowledge items related to medication abortion as presented in the Patient Agreement Form. Topics included when to seek medical care (4 items), effectiveness (3 items), medication administration (2 items), potential serious risks (2 items), and side effects (1 item). We created binary items by coding responses as correct if they matched the information presented in the PAF. We estimated mean scores be examining participants' performance on all 12 items, with scores ranging from 0 (none correct) to 12 (all correct). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual medication abortion knowledge items | Knowledge will be assessed only once, during the same clinicial visit on the day of recruitment (Day 1), following standard counseling (before or after exposure to the PAF depending on assigned study group). | Correct vs incorrect responses to on each individual knowledge item (12 items). We created binary items by coding responses as correct if they matched the information presented in the PAF. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Grossman, MD
University of California, San Francisco
Outcome results
None listed