Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-07 @ 1:22 AM
Study NCT ID:
NCT03320057
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2017-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Medication Abortion Via Pharmacy Dispensing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shelly.kaller@ucsf.edu', 'phone': '510-986-8945', 'title': 'Shelly Kaller', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months)', 'description': "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.\n\nPharmacists: 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.", 'eventGroups': [{'id': 'EG000', 'title': 'Medication Abortion Patients', 'description': '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)\n\nMifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 4, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pharmacists', 'description': 'Pharmacists providing services at one of the study pharmacies during the study and consenting to training', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heavy uterine bleeding', 'notes': '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', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic Inflammatory Disease', 'notes': 'Diagnosis of pelvic inflammatory disease after aspiration for incomplete medication abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling in cheeks', 'notes': 'Swelling in cheeks and transient pain in cheeks after taking misoprostol buccally, thought to be a possible allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacists', 'description': 'Pharmacists providing services at one of the study pharmacies during the study'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of the study, month 24', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacists invited to participate in mifepristone dispensing'}, {'type': 'PRIMARY', 'title': 'Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacists', 'description': 'Pharmacists providing services at one of the study pharmacies during the study'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of the study, month 24', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacists at study pharmacist who were trained to dispense mifepristone and completed an endline survey'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': '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)\n\nMifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit'}], 'classes': [{'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2 following initial medication abortion visit', 'description': '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?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient participants who completed Day 2 survey following initial medication abortion visit'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': '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)\n\nMifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit'}], 'classes': [{'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 weeks after initial visit', 'description': '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"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient participants with abortion outcome information'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': '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)\n\nMifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 weeks after initial visit', 'description': "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", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with follow-up data from clinical data or survey responses'}, {'type': 'SECONDARY', 'title': "Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacists', 'description': 'Pharmacists providing services at one of the study pharmacies during the study'}], 'classes': [{'title': 'Baseline knowledge score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Endline knowledge score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'Beta Coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.17', 'estimateComment': 'Coefficients in adjusted analyses examining overall medication abortion knowledge represent the difference in mean knowledge scores between baseline and endline.', 'groupDescription': "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.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "We conducted multivariable logistic regression analyses using Generalized Estimating Equation (GEE) models to assess whether study implementation was associated with pharmacists' overall medication abortion knowledge. Multivariable GEE analyses included time period (baseline and endline) as the primary independent variable, adjusted for gender and years of experience, and accounted for clustering by pharmacy site and individual pharmacist."}], 'paramType': 'MEAN', 'timeFrame': 'Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medication Abortion Patients', 'description': '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)\n\nMifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit'}, {'id': 'FG001', 'title': 'Pharmacist Providing Services at One of the Study Pharmacies During the Study', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}, {'comment': 'Includes pharmacists at study pharmacies that consented to training on mifepristone dispensing.', 'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': "Patient's Clinical Outcome Information Obtained", 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}, {'comment': 'Clinical outcome data were not collected for pharmacists - this milestone does not apply', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Pharmacist Training', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Pharmacists Completed Baseline Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'comment': 'This includes pharmacists who completed the endline survey. Only trained pharmacists (n=56) were eligible.', 'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Did not take mifepristone or misoprostol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.\n\nPharmacist Recruitment: We invited all pharmacists providing services at the study pharmacies to participate in the study and dispense mifepristone to study patients.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Medication Abortion Patients', 'description': '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)\n\nMifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '44'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'title': '16-20 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '21-24 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': '25-29 years', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': '30-34 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': '35-44 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex/Gender Not Collected'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and ethnicity, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Asian or Pacific Islander', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Alaska Native or Native American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other and mixed race and ethnicity', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '260', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'title': 'High school or less', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Some college or professional school', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'College degree', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Advanced degree', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relationship status, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Neither married nor in a relationship', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Married', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Committed relationship', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Nulliparous', 'measurements': [{'value': '171', 'groupId': 'BG000'}]}, {'title': 'Parous', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of abortion, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '165', 'groupId': 'BG000'}]}, {'title': 'Previous medication abortion', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Previous procedural abortion only', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at initial visit, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gestational age at initial visit, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}]}], 'categories': [{'title': '49 days or less', 'measurements': [{'value': '176', 'groupId': 'BG000'}]}, {'title': '50-56 days', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': '57-63 days', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '64-70 days', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '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.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-09', 'size': 604142, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-10T16:58', 'hasProtocol': True}, {'date': '2021-05-01', 'size': 214969, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_007.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-21T01:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective cohort'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2017-09-26', 'resultsFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-18', 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex', 'timeFrame': 'End of the study, month 24', 'description': '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.'}, {'measure': 'Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex', 'timeFrame': 'End of the study, month 24', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy', 'timeFrame': 'Day 2 following initial medication abortion visit', 'description': '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?"'}, {'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', 'description': '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"'}, {'measure': 'Number of Participants With an Adverse Event', 'timeFrame': 'Up to 6 weeks after initial visit', 'description': "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"}, {'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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medication abortion', 'mifepristone'], 'conditions': ['Pregnancy Related', 'Abortion Early']}, 'referencesModule': {'references': [{'pmid': '34281806', 'type': 'DERIVED', '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."}, {'pmid': '33706339', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Females seeking medication abortion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Women seeking medication abortion through 70 days gestation\n* Eligible for Mifeprex® at a study clinical site\n* English or Spanish speaking\n* Willing and able to participate in the study, including willing to go to the study pharmacy to obtain mifepristone\n\nPatient Exclusion Criteria:\n\n* Not pregnant\n* Not seeking medication abortion\n* Under the age of 15\n* Contraindications for medication abortion\n\n * All pharmacists providing services at one of the study pharmacies during the study are eligible for the pharmacist survey and interview.'}, 'identificationModule': {'nctId': 'NCT03320057', 'briefTitle': 'Medication Abortion Via Pharmacy Dispensing', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Alternative Provision of Medication Abortion Via Pharmacy Dispensing', 'orgStudyIdInfo': {'id': 'A128753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medication abortion patients', 'description': '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)', 'interventionNames': ['Drug: Mifepristone']}, {'type': 'OTHER', 'label': 'Pharmacists', 'description': 'Pharmacists providing services at one of the study pharmacies during the study', 'interventionNames': ['Other: Training on mifepristone dispensing']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit', 'armGroupLabels': ['Medication abortion patients']}, {'name': 'Training on mifepristone dispensing', 'type': 'OTHER', 'description': 'Pharmacists were offered a training on medication abortion and mifepristone dispensing', 'armGroupLabels': ['Pharmacists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Obstetrics and Gynecology Family Planning Clinic at University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Services at University of California San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "Mt. Zion Women's Options Clinic, University", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': "Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky", 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Daniel Grossman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daniel Grossman', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'Planned Parenthood of the Great Northwest and Hawaiian Islands', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor in Dept ObGyn and Director of Advancing New Standards in Reproductive Health', 'investigatorFullName': 'Daniel Grossman', 'investigatorAffiliation': 'University of California, San Francisco'}}}}