Medication Abortion Via Pharmacy Dispensing

June 18, 2021 updated by: Daniel Grossman

Alternative Provision of Medication Abortion Via Pharmacy Dispensing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Obstetrics and Gynecology Family Planning Clinic at University of California Davis
      • San Diego, California, United States, 92103
        • Women's Health Services at University of California San Diego
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Northern California
      • San Francisco, California, United States, 94115
        • Mt. Zion Women's Options Clinic, University
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington
      • Tacoma, Washington, United States, 98405
        • Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Patient Inclusion Criteria:

  • 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

Patient Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Drug: Mifepristone
Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
OTHER: Pharmacists
Pharmacists providing services at one of the study pharmacies during the study
Other: Training on mifepristone dispensing
Pharmacists were offered a training on medication abortion and mifepristone dispensing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex
Time Frame: 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.
End of the study, month 24
Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex
Time Frame: 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
End of the study, month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy
Time Frame: Day 2 following initial medication abortion visit
Number of participants who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied were you with your experience at the pharmacy when you got the abortion pill?"
Day 2 following initial medication abortion visit
Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion
Time Frame: Up to 6 weeks after initial visit
Number of participants who report that their "abortion is now complete and they are no longer pregnant" and who did not "end up having a suction procedure (or vacuum aspiration or dilation and curettage procedure) to complete the abortion"
Up to 6 weeks after initial visit
Number of Participants With an Adverse Event
Time Frame: Up to 6 weeks after initial visit
Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill
Up to 6 weeks after initial visit
Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion
Time Frame: Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge
Difference in pharmacists' mean knowledge score related to medication abortion. Knowledge scores were based on a set of 15 statements or questions related to medication abortion for which respondents selected answer(s) from multiple choice response options. Topics included medication abortion dosing regimen, biological processes during medication abortion, clinical outcomes, and federal and state policies relating to medication abortion. For pharmacists who had completed at least 50% of the items, we calculated their average number of correct responses among completed items, as a proportion of correct answers, ranging from 0-1, with 1 meaning 100% correct. All questions or statements included an "I don't know" response option, which we coded as incorrect. Higher scores mean a higher level of knowledge.
Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Grossman

Collaborators

University of California, San Diego
University of California, Davis
University of Washington
Kaiser Permanente
Planned Parenthood of the Great Northwest and the Hawaiian Islands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

July 4, 2020

Study Completion (ACTUAL)

July 4, 2020

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (ACTUAL)

October 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A128753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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