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This will be a pilot study among two pharmacists providing start to finish medication abortions to 10 patients utilizing a previously created toolkit. Following completion of the pilot, we will perform in-depth semi-structured interviews with the participating patients and pharmacists to understand their experiences with pharmacist provision of medication abortion. In addition, we will elicit feedback about ways to refine the toolkit to support the scale-up of pharmacist provision of medication abortion in the future.
We will conduct a 'proof of concept' pilot study. Participating patients will be counseled by a trained pharmacist who will provide Mifepristone 200 mg and two doses of 800 mcg of Misoprostol. Patients will be instructed to take the 800 mcg of misoprostol buccally 24-48 hours after their Mifepristone. Patients whose estimated gestational age is between 64 and 70 days will be instructed to take the additional dose of 800 mcg of misoprostol 4 hours after the first dose. Patients who estimated gestational age is 63 days or less will be instructed to take the additional dose of 800 mcg of misoprostol if they do not experience at least moderate bleeding within the first 24 hours following their first misoprostol dose.
The standard Mifepristone consent form will be signed at this time and the patient will then be instructed to take the Mifepristone orally.
Participants will be contacted one week after receiving treatment by the providing pharmacist. If the participant history suggests concern for a continuing pregnancy, ectopic pregnancy or worrisome bleeding, they will be scheduled for in person evaluation. If the participant does not indicate any concern, they will be instructed to use the high sensitivity urine pregnancy test four weeks after taking their misoprostol. If the participant's first high sensitivity urine pregnancy test is positive but they have no symptoms concerning for ongoing pregnancy, they will be instructed to perform a second, high sensitivity urine pregnancy test in one week. If the second, high sensitivity urine pregnancy test is also positive, the patient will be evaluated in person.
We will continue our study by performing in-depth semi-structured interviews with the participating patients and pharmacists to understand their experiences and elicit feedback about ways to refine the toolkit. We will follow a prepared interview guide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist provision of medication abortion | Experimental | This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist Provision of Medication Abortion | Other | Pharmacists providing start to finish medication abortions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Medication Abortion | Negative Pregnancy Test | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction, # of Patients Reporting "Very Satisfied" | qualitative analysis of post abortion in depth interviews | 2 weeks following completion of medication abortion |
| Pharmacist Experience |
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Inclusion Criteria:
Exclusion Criteria:
Any contraindications to medication abortion, as reported on their medical history. These contraindicated include:
d) Allergy to misoprostol or mifepristone
Any patient with complex medical conditions will also be excluded from this initial pilot. These medical conditions include:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Averbach, MD, MAS | UC San Diego Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38065286 | Background | Sandoval S, Rafie S, Kully G, Mody S, Averbach S. Pharmacist provision of medication abortion: A pilot study. Contraception. 2024 Mar;131:110346. doi: 10.1016/j.contraception.2023.110346. Epub 2023 Dec 7. |
| Label | URL |
|---|---|
| Pharmacist provision of medication abortion: A pilot study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacist Provision of Medication Abortion | This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist. Pharmacist Provision of Medication Abortion: Pharmacists providing start to finish medication abortions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacist Provision of Medication Abortion | This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist. Pharmacist Provision of Medication Abortion: Pharmacists providing start to finish medication abortions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Completion of Medication Abortion | Negative Pregnancy Test | Posted | Count of Participants | Participants | 6 weeks |
|
|
6 weeks
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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 | Pharmacist Provision of Medication Abortion | This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist. Pharmacist Provision of Medication Abortion: Pharmacists providing start to finish medication abortions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Office of Clinical Trials Administration | University of California, San Diego | 858-822-2940 | octa@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2021 | Apr 26, 2024 | Prot_SAP_000.pdf |
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qualitative analysis of post pilot in depth interviews
| 2 weeks following completion of all 10 medication abortion visits |
| Toolkit Changes | per recommendation by participating pharmacists at post pilot in depth interviews | 2 weeks following completion of all 10 medication abortion visits |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | not recorded | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Patient Satisfaction, # of Patients Reporting "Very Satisfied" | qualitative analysis of post abortion in depth interviews | only 9 of the 10 participants completed post-abortion interview | Posted | Count of Participants | Participants | 2 weeks following completion of medication abortion |
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|
|
| Secondary | Pharmacist Experience | qualitative analysis of post pilot in depth interviews | Not Posted | 2 weeks following completion of all 10 medication abortion visits | Participants |
| Secondary | Toolkit Changes | per recommendation by participating pharmacists at post pilot in depth interviews | Not Posted | 2 weeks following completion of all 10 medication abortion visits | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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