Abortion Early, Pregnancy Related
Conditions
Keywords
medication abortion, mifepristone
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.
Interventions
DRUGMifepristone
Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
OTHERTraining on mifepristone dispensing
Pharmacists were offered a training on medication abortion and mifepristone dispensing
Sponsors
University of California, San Diego
University of California, Davis
University of Washington
Kaiser Permanente
Planned Parenthood of the Great Northwest and Hawaiian Islands
Daniel Grossman
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Prospective cohort
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex | 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. |
| Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy | 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? |
| Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion | 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 |
| Number of Participants With an Adverse Event | 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 |
| Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion | 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. |
Countries
United States
Participant flow
Recruitment details
Patient Recruitment: Study recruitment began in July 2018 and was halted before reaching our desired sample size in March 2020 owing to the coronavirus disease 2019 (COVID-19) pandemic, which limited the ability to have research staff in clinical facilities and lengthen patient visits for the purposes of research consent. Pharmacist Recruitment: We invited all pharmacists providing services at the study pharmacies to participate in the study and dispense mifepristone to study patients.
Pre-assignment details
Research staff assessed 499 patients for eligibility, of whom 233 were ineligible (n=163) or declined to participate (n=70). We enrolled 266 patient participants, all of whom received the study medications from the pharmacy. We invited 72 pharmacists working at six study pharmacy sites to participate in the study, including training to dispense mifepristone and completion of the baseline survey.
Participants by arm
| Arm | Count |
|---|---|
| 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)
Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit | 260 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not take mifepristone or misoprostol | 2 | 0 |
| Overall Study | Lost to Follow-up | 4 | 17 |
Baseline characteristics
| Characteristic | Medication Abortion Patients |
|---|---|
| Age, Continuous | 28 years |
| Age, Customized Age, Categorical 16-20 years | 22 Participants |
| Age, Customized Age, Categorical 21-24 years | 45 Participants |
| Age, Customized Age, Categorical 25-29 years | 78 Participants |
| Age, Customized Age, Categorical 30-34 years | 69 Participants |
| Age, Customized Age, Categorical 35-44 years | 46 Participants |
| Education, Categorical Advanced degree | 28 Participants |
| Education, Categorical College degree | 90 Participants |
| Education, Categorical High school or less | 39 Participants |
| Education, Categorical Missing | 10 Participants |
| Education, Categorical Some college or professional school | 93 Participants |
| Gestational age at initial visit, Categorical 49 days or less | 176 Participants |
| Gestational age at initial visit, Categorical 50-56 days | 43 Participants |
| Gestational age at initial visit, Categorical 57-63 days | 32 Participants |
| Gestational age at initial visit, Categorical 64-70 days | 9 Participants |
| Gestational age at initial visit, Continuous | 46 days |
| History of abortion, Categorical Missing | 7 Participants |
| History of abortion, Categorical None | 165 Participants |
| History of abortion, Categorical Previous medication abortion | 48 Participants |
| History of abortion, Categorical Previous procedural abortion only | 40 Participants |
| Parity Nulliparous | 171 Participants |
| Parity Parous | 89 Participants |
| Race/Ethnicity, Customized Race and ethnicity, Categorical Alaska Native or Native American | 2 Participants |
| Race/Ethnicity, Customized Race and ethnicity, Categorical Asian or Pacific Islander | 45 Participants |
| Race/Ethnicity, Customized Race and ethnicity, Categorical Hispanic | 65 Participants |
| Race/Ethnicity, Customized Race and ethnicity, Categorical Missing | 1 Participants |
| Race/Ethnicity, Customized Race and ethnicity, Categorical Non-Hispanic Black | 29 Participants |
| Race/Ethnicity, Customized Race and ethnicity, Categorical Non-Hispanic White | 99 Participants |
| Race/Ethnicity, Customized Race and ethnicity, Categorical Other and mixed race and ethnicity | 19 Participants |
| Region of Enrollment United States | 260 participants |
| Relationship status, Categorical Committed relationship | 110 Participants |
| Relationship status, Categorical Married | 54 Participants |
| Relationship status, Categorical Missing | 12 Participants |
| Relationship status, Categorical Neither married nor in a relationship | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 260 | 0 / 60 |
| other Total, other adverse events | 4 / 260 | 0 / 60 |
| serious Total, serious adverse events | 0 / 260 | 0 / 60 |
Outcome results
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.
Time frame: End of the study, month 24
Population: Pharmacists invited to participate in mifepristone dispensing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists | Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex | 4 Participants |
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
Time frame: End of the study, month 24
Population: Pharmacists at study pharmacist who were trained to dispense mifepristone and completed an endline survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists | Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex | 36 Participants |
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.
Time frame: Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge
Population: We compared knowledge scores for pharmacists at baseline and endline. We excluded from the baseline knowledge analyses four respondents who participated in the study training on medication abortion prior to taking the baseline survey and one person from the overall knowledge analyses because they only completed four items.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacists | Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion | Baseline knowledge score | 0.51 score on a scale | Standard Deviation 0.21 |
| Pharmacists | Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion | Endline knowledge score | 0.64 score on a scale | Standard Deviation 0.24 |
Comparison: Medication abortion knowledge scores were based on a set of 15 items. We first assessed the internal consistency reliability of the 15 knowledge items and considered a Cronbach's alpha coefficient above .70 to be acceptable to examine the items as a combined score.p-value: <0.0595% CI: [0.11, 0.17]Regression, Linear
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?
Time frame: Day 2 following initial medication abortion visit
Population: Patient participants who completed Day 2 survey following initial medication abortion visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists | Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy | 230 Participants |
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
Time frame: Up to 6 weeks after initial visit
Population: Patient participants with abortion outcome information
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists | Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion | 243 Participants |
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
Time frame: Up to 6 weeks after initial visit
Population: Patients with follow-up data from clinical data or survey responses
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists | Number of Participants With an Adverse Event | 4 Participants |