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临床试验/NCT03320057
NCT03320057已完成4 期

Alternative Provision of Medication Abortion Via Pharmacy Dispensing

Daniel Grossman6 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Other

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

发起方
Daniel Grossman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Grossman

Professor in Dept ObGyn and Director of Advancing New Standards in Reproductive Health

University of California, San Francisco

研究点 (6)

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