Patient Agreement Form and Medication Abortion Knowledge
Effect of the Patient Agreement Form (PAF) for Mifepristone on Medication Abortion Knowledge: A Randomized Controlled Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
-
San Francisco, California, Estados Unidos, 94110
- Planned Parenthood Northern California
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Colorado
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Denver, Colorado, Estados Unidos, 80207
- Planned Parenthood Rocky Mountain
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Illinois
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Carbondale, Illinois, Estados Unidos, 62901
- Choices
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Kansas
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Wichita, Kansas, Estados Unidos, 67208-3646
- Aria Medical Center
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Minnesota
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Saint Paul, Minnesota, Estados Unidos, 55114
- Planned Parenthood North Central States
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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.
|
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.
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|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Medication abortion knowledge
Prazo: 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).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Individual medication abortion knowledge items
Prazo: 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).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Daniel Grossman, MD, University of California, San Francisco
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 23-38724
Plano para dados de participantes individuais (IPD)
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