Patient Agreement Form and Medication Abortion Knowledge

NCT07604675 | Completed

• 1 other identifier: 23-38724
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 5

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.

Conditions

Medication Abortion; Health Knowledge Attitudes and Practice; Pregnant People

Keywords

medication abortion; health knowledge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (2)

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.

Behavioral: Patient Agreement Form (PAF)

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.

Behavioral: Patient Agreement Form (PAF)

Interventions

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.

Arm 1: Control group (No PAF Exposure at Time of Assessment); Arm 2: Exposed group (Exposed to PAF prior to assessment)

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 15 years or older
• Able to read and speak English or Spanish
• Seeking medication abortion or receiving mifepristone for miscarriage management

You may not qualify if:

• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (5)

Planned Parenthood Northern California

San Francisco, California, 94110, United States

Location

Planned Parenthood Rocky Mountain

Denver, Colorado, 80207, United States

Location

Choices

Carbondale, Illinois, 62901, United States

Location

Aria Medical Center

Wichita, Kansas, 67208-3646, United States

Location

Planned Parenthood North Central States

Saint Paul, Minnesota, 55114, United States

Location

Study Officials

• Daniel Grossman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 22, 2026
• Study Start: January 15, 2025
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)