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Patient Agreement Form and Medication Abortion Knowledge

19. maj 2026 opdateret af: University of California, San Francisco

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

637

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication abortion knowledge
Tidsramme: 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).
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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Individual medication abortion knowledge items
Tidsramme: 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.
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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Daniel Grossman, MD, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. januar 2025

Primær færdiggørelse (Faktiske)

17. oktober 2025

Studieafslutning (Faktiske)

17. oktober 2025

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 23-38724

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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