Mail Order Mifepristone Study

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Medication Abortion Patients	Mifepristone	Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)

Primary Outcome Measures

Name	Time	Method
Acceptability: Would Use Mail-Order Dispensing Again	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	Day 14 following initial medication abortion visit	Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.

Secondary Outcome Measures

Name	Time	Method
Provider Acceptability of Mail-Order Dispensing of Medication Abortion	Up to 3 months after data collection completed.	Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.
Feasibility: Confidentiality Maintained When Receiving Medications by Mail	Day 3 following initial medication abortion visit	Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.
Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3	Day 3 following initial medication abortion visit	Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.
Clinical Effectiveness of Mail-Order Medication Abortion	Up to 6 weeks after initial medication abortion visit.	Percentage of participants who experienced a complete medication abortion, by abortion instance.
Clinical Safety of Mail-Order Medication Abortion	Up to 6 weeks after initial medication abortion visit.	Percentage of participants who experience adverse events related to the abortion, by abortion instance.

Locations (11): Delaware County Women's Center
🇺🇸
Chester, Pennsylvania, United States
Christiana Care Health System
🇺🇸
Wilmington, Delaware, United States
Highland Hospital
🇺🇸
Oakland, California, United States
Southern Tier Women's Health Services
🇺🇸
Vestal, New York, United States
Children's Hospital Oakland
🇺🇸
Oakland, California, United States
Lifespan
🇺🇸
Providence, Rhode Island, United States
Brown Family Medicine
🇺🇸
Pawtucket, Rhode Island, United States
Planned Parenthood Rocky Mountains
🇺🇸
Denver, Colorado, United States
Allegheny Reproductive Health Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Atlanta Comprehensive Wellness Clinic
🇺🇸
Atlanta, Georgia, United States
Albert Einstein College of Medicine
🇺🇸
New York, New York, United States