Patient Agreement Form and Medication Abortion Knowledge
Effect of the Patient Agreement Form (PAF) for Mifepristone on Medication Abortion Knowledge: A Randomized Controlled Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
-
San Francisco, California, 미국, 94110
- Planned Parenthood Northern California
-
-
Colorado
-
Denver, Colorado, 미국, 80207
- Planned Parenthood Rocky Mountain
-
-
Illinois
-
Carbondale, Illinois, 미국, 62901
- Choices
-
-
Kansas
-
Wichita, Kansas, 미국, 67208-3646
- Aria Medical Center
-
-
Minnesota
-
Saint Paul, Minnesota, 미국, 55114
- Planned Parenthood North Central States
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Medication abortion knowledge
기간: 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).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Individual medication abortion knowledge items
기간: 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).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Daniel Grossman, MD, University of California, San Francisco
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .