Mail Order Mifepristone Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy

Conditions
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Abortion Early, Pregnancy Related

Intervention / Treatment
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* Drug: Mifepristone


Participation Criteria
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Eligibility Criteria
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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: Not pregnant Not seeking medication abortion under the age of 15 Over 63 days gestation Contraindicated for medication abortion

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Abortion Patients<br>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) | Drug: Mifepristone<br>* Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who report positive experience. | Proportion of patients reporting whether they would use the mail order service again if they needed another abortion. | Day 14 following initial medication abortion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who report timely delivery of medication. | Proportion of patients who receive medications by Day 2 and Day 3 and proportion of patients who indicate their confidentiality was maintained when receiving medications by mail. The investigators will also estimate the proportion of patients who report that medications were lost, stolen or damaged. | Day 3 following initial medication abortion visit | 
| Proportion of patients who have a complete abortion | Using electronic health record data related to abortion, the investigators will estimate the proportion of patients who experience a complete abortion and the proportion of patients who experience complications, including adverse or severe adverse events. | Up to 6 weeks after initial medication abortion visit. |