Medication Abortion Via Pharmacy Dispensing

Pregnancy Related Clinical Trial

Official title:

Alternative Provision of Medication Abortion Via Pharmacy Dispensing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320057
• Other study ID #: A128753
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: July 4, 2020

Study information

• Verified date: June 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: July 4, 2020
• Est. primary completion date: July 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abortion Early
• Pregnancy Related

Intervention

Drug:
• Mifepristone
Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit

Other:
• Training on mifepristone dispensing
Pharmacists were offered a training on medication abortion and mifepristone dispensing

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Daniel Grossman	Kaiser Permanente, Planned Parenthood of the Great Northwest and the Hawaiian Islands, University of California, Davis, University of California, San Diego, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex	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
Primary	Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex	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	Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy	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
Secondary	Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion	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
Secondary	Number of Participants With an Adverse Event	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
Secondary	Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion	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