Patient Agreement Form and Medication Abortion Knowledge

Effect of the Patient Agreement Form (PAF) for Mifepristone on Medication Abortion Knowledge: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge Attitudes and Practice; Medication Abortion; Pregnant People
• Intervention / Treatment: Behavioral: Patient Agreement Form (PAF)

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.

• Study Type: Interventional
• Enrollment (Actual): 637
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Planned Parenthood Northern California
  • Colorado
    • Denver, Colorado, United States, 80207
      • Planned Parenthood Rocky Mountain
  • Illinois
    • Carbondale, Illinois, United States, 62901
      • Choices
  • Kansas
    • Wichita, Kansas, United States, 67208-3646
      • Aria Medical Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Planned Parenthood North Central States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1: Control group (No PAF Exposure at Time of Assessment); 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.	Behavioral: Patient 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.
Experimental: Arm 2: Exposed group (Exposed to PAF prior to assessment); Participants received and signed the Patient Agreement Form (PAF) and any site-standard PAF-related counseling prior to completing the knowledge survey.	Behavioral: Patient 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Daniel Grossman, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Actual): October 17, 2025
• Study Completion (Actual): October 17, 2025

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: medication abortion; health knowledge
• Other Study ID Numbers: 23-38724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No