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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Control group (No PAF Exposure at Time of Assessment) | Other | Participants completed the knowledge survey before receiving and signing the Patient Agreement Form (PAF) and before receiving any PAF-related counseling. All participants were subsequently exposed to the intervention (PAF) as part of routine clinical care. |
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| Arm 2: Exposed group (Exposed to PAF prior to assessment) | Experimental | Participants received and signed the Patient Agreement Form (PAF) and any site-standard PAF-related counseling prior to completing the knowledge survey. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Agreement Form (PAF) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication abortion knowledge | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Individual medication abortion knowledge items | 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Grossman, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Northern California | San Francisco | California | 94110 | United States | ||
| Planned Parenthood Rocky Mountain |
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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.
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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.
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| Denver |
| Colorado |
| 80207 |
| United States |
| Choices | Carbondale | Illinois | 62901 | United States |
| Aria Medical Center | Wichita | Kansas | 67208-3646 | United States |
| Planned Parenthood North Central States | Saint Paul | Minnesota | 55114 | United States |