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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| University of California, Davis | OTHER |
| University of Washington | OTHER |
| Kaiser Permanente |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication abortion patients | Experimental | 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) |
|
| Pharmacists | Other | Pharmacists providing services at one of the study pharmacies during the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Not pregnant
Not seeking medication abortion
Under the age of 15
Contraindications for medication abortion
Females seeking medication abortion
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Grossman, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Family Planning Clinic at University of California Davis | Sacramento | California | 95817 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34281806 | Derived | 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. | |
| 33706339 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Pharmacist Providing Services at One of the Study Pharmacies During the Study | All pharmacists providing services at one of the study pharmacies during the study were invited to participate in the training on dispensing mifepristone and surveys. Only trained pharmacists were eligible to participate in the endline survey. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population includes patient study participants having medication abortion and receiving mifepristone at a study pharmacy. Pharmacist participants are not reported here as baseline demographics were not collected from them.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Pharmacists invited to participate in mifepristone dispensing | Posted | Count of Participants | Participants | End of the study, month 24 |
|
Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)
Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill.
Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | General disorders | Systematic Assessment |
We aimed to recruit 300-350 patients for this study. We had to stop recruitment early because of the COVID-19 pandemic, reaching 89% of our planned minimum sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelly Kaller | University of California San Francisco | 510-986-8945 | shelly.kaller@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2020 | Feb 10, 2020 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2021 | May 21, 2021 | SAP_007.pdf |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| OTHER |
| Planned Parenthood of the Great Northwest and Hawaiian Islands | OTHER |
Prospective cohort
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| Training on mifepristone dispensing | Other | Pharmacists were offered a training on medication abortion and mifepristone dispensing |
|
| 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 |
| 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 |
| 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 |
| Women's Health Services at University of California San Diego |
| San Diego |
| California |
| 92103 |
| United States |
| Kaiser Permanente Northern California | San Francisco | California | 94115 | United States |
| Mt. Zion Women's Options Clinic, University | San Francisco | California | 94115 | United States |
| University of Washington | Seattle | Washington | 98105 | United States |
| Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky | Tacoma | Washington | 98405 | United States |
| 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. |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Sex/Gender Not Collected | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education, Categorical | Count of Participants | Participants |
|
| Relationship status, Categorical | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| History of abortion, Categorical | Count of Participants | Participants |
|
| Gestational age at initial visit, Continuous | Median | Full Range | days |
|
| Gestational age at initial visit, Categorical | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| 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 | Pharmacists at study pharmacist who were trained to dispense mifepristone and completed an endline survey | Posted | Count of Participants | Participants | 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?" | Patient participants who completed Day 2 survey following initial medication abortion visit | Posted | Count of Participants | Participants | 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" | Patient participants with abortion outcome information | Posted | Count of Participants | Participants | 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 | Patients with follow-up data from clinical data or survey responses | Posted | Count of Participants | Participants | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge |
|
|
|
|
| 0 |
| 260 |
| 0 |
| 260 |
| 4 |
| 260 |
| EG001 | Pharmacists | Pharmacists providing services at one of the study pharmacies during the study and consenting to training | 0 | 60 | 0 | 60 | 0 | 60 |
| Heavy uterine bleeding | Reproductive system and breast disorders | Systematic Assessment | Uterine bleeding is a normal part of the medication abortion process, however, bleeding is reported here as an adverse event because it caused the participant to go to the emergency department |
|
| Pelvic Inflammatory Disease | Reproductive system and breast disorders | Systematic Assessment | Diagnosis of pelvic inflammatory disease after aspiration for incomplete medication abortion |
|
| Swelling in cheeks | Skin and subcutaneous tissue disorders | Systematic Assessment | Swelling in cheeks and transient pain in cheeks after taking misoprostol buccally, thought to be a possible allergic reaction |
|
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| D011083 |
| Polycyclic Compounds |
|