Alternative Provision of Medication Abortion Via Pharmacy Dispensing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 6
- 主要终点
- Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex
研究概览
简要总结
This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.
详细描述
Improving access to and efficiency of abortion provision is important for patients and providers. The Risk Evaluation and Mitigation Strategy (REMS) requires that Mifeprex ® ( mifepristone) be dispensed only from a doctor's office, clinic or hospital (not from a pharmacy by prescription) by a certified health care provider and the health care provider must obtained a signed Patient Agreement Form before dispensing mifepristone. Data are needed to investigate the feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone. In order to address the study question, a mixed methods study design is appropriate. To assess feasibility, the study will collect data on pharmacists' satisfaction with dispensing mifepristone. To assess acceptability, qualitative data will be collected from pharmacists about their perspectives on dispensing Mifeprex before and after the study, as well as measure patient satisfaction through open-ended and close-ended survey questions. To assess effectiveness of the pharmacy dispensing model, the study will evaluate clinical outcomes from electronic health records. The proposed feasibility study would take place at sites in California and Washington states.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 70 days gestation
- •Eligible for Mifeprex® at a study clinical site
- •English or Spanish speaking
- •Willing and able to participate in the study, including willing to go to the study pharmacy to obtain mifepristone
排除标准
- •Not pregnant
- •Not seeking medication abortion
- •Under the age of 15
- •Contraindications for medication abortion
- •All pharmacists providing services at one of the study pharmacies during the study are eligible for the pharmacist survey and interview.
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) or vaginally (as soon as 6 hours following mifepristone)
干预措施: Mifepristone (Drug)
Pharmacists
Pharmacists providing services at one of the study pharmacies during the study
干预措施: Training on mifepristone dispensing (Other)
结局指标
主要结局
Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex
时间窗: End of the study, month 24
Number of pharmacists who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied are you with mifepristone dispensing at your pharmacy?" in endline survey
Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex
时间窗: End of the study, month 24
Number of pharmacists who objected to participate in dispensing Mifeprex at least once during the study period. This includes pharmacists who declined participation in the study training on medication abortion due to discomfort as well as pharmacists who participated in the training but declined to dispense Mifeprex.
次要结局
- Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy(Day 2 following initial medication abortion visit)
- Number of Participants With an Adverse Event(Up to 6 weeks after initial visit)
- Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion(Up to 6 weeks after initial visit)
- Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion(Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge)
研究者
Daniel Grossman
Professor in Dept ObGyn and Director of Advancing New Standards in Reproductive Health
University of California, San Francisco
