Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 536
- 试验地点
- 11
- 主要终点
- Acceptability: Would Use Mail-Order Dispensing Again
研究概览
简要总结
This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.
详细描述
This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women seeking medication abortion through 63 days gestation
- •Eligible for MifeprexⓇ at a study site
- •English or Spanish speaking
- •Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit
排除标准
- •Not pregnant
- •Not seeking medication abortion
- •under the age of 15
- •Over 63 days gestation
- •Contraindicated for medication abortion
研究组 & 干预措施
Medication Abortion Patients
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
干预措施: Mifepristone (Drug)
结局指标
主要结局
Acceptability: Would Use Mail-Order Dispensing Again
时间窗: Day 14 following initial medication abortion visit
Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
时间窗: Day 14 following initial medication abortion visit
Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.
次要结局
- Provider Acceptability of Mail-Order Dispensing of Medication Abortion(Up to 3 months after data collection completed.)
- Feasibility: Confidentiality Maintained When Receiving Medications by Mail(Day 3 following initial medication abortion visit)
- Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3(Day 3 following initial medication abortion visit)
- Clinical Effectiveness of Mail-Order Medication Abortion(Up to 6 weeks after initial medication abortion visit.)
- Clinical Safety of Mail-Order Medication Abortion(Up to 6 weeks after initial medication abortion visit.)
研究者
Daniel Grossman, MD
Professor and Director of ANSIRH
University of California, San Francisco