Clinical trial NCT03320057: Medication Abortion Via Pharmacy Dispensing
Official title: Alternative Provision of Medication Abortion Via Pharmacy Dispensing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy Related
Abortion Early
Keywords: medication abortion
mifepristone
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: University of California, Davis
name: University of Washington
name: Kaiser Permanente
name: Planned Parenthood of the Great Northwest and Hawaiian Islands
First posted: 2017-10-25
Enrollment: 326
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex
timeFrame: End of the study, month 24
measure: Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex
timeFrame: End of the study, month 24
Secondary outcomes:
measure: Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy
timeFrame: Day 2 following initial medication abortion visit
measure: Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion
timeFrame: Up to 6 weeks after initial visit
measure: Number of Participants With an Adverse Event
timeFrame: Up to 6 weeks after initial visit
measure: Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion
timeFrame: Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Obstetrics and Gynecology Family Planning Clinic at University of California Davis
state: California
city: San Diego
country: United States
facility: Women's Health Services at University of California San Diego
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: San Francisco
country: United States
facility: Mt. Zion Women's Options Clinic, University
state: California
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Tacoma
country: United States
facility: Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
state: Washington
Study officials:
affiliation: University of California, San Francisco
name: Daniel Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaller S, Morris N, Biggs MA, Baba CF, Rafie S, Raine-Bennett TR, Creinin MD, Berry E, Micks EA, Meckstroth KR, Averbach S, Grossman D. Pharmacists' knowledge, perspectives, and experiences with mifepristone dispensing for medication abortion. J Am Pharm Assoc (2003). 2021 Nov-Dec;61(6):785-794.e1. doi: 10.1016/j.japh.2021.06.017. Epub 2021 Jun 18.
citation: Grossman D, Baba CF, Kaller S, Biggs MA, Raifman S, Gurazada T, Rafie S, Averbach S, Meckstroth KR, Micks EA, Berry E, Raine-Bennett TR, Creinin MD. Medication Abortion With Pharmacist Dispensing of Mifepristone. Obstet Gynecol. 2021 Apr 1;137(4):613-622. doi: 10.1097/AOG.0000000000004312.