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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Utah | OTHER |
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Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider. Over the past decade, pharmacists have gained the authority to prescribe contraceptives in many states, allowing patients to access these medications directly in pharmacies without first seeing another healthcare provider. The Pharmacist Resource to Implement Services as Modules (PRISM) is an Electronic Health Record platform designed to streamline workflows and provide clinical decision support, making it easier and safer to deliver clinical services in community pharmacies. This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community pharmacies across the United States over a 12-week period. The study will assess the quality of care, contraception continuation and failure rates, side effect rates, preventative healthcare utilization, and overall patient experience with pharmacy contraceptive services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist-Rendered Contraceptive Services | Experimental | Participants in this single-arm study are women seeking contraceptive services to prevent pregnancy in a community pharmacy setting. Pharmacists will deliver these services using an Electronic Health Record system that assists in evaluating each patient's eligibility based on the US Medical Eligibility Criteria (USMEC) guidelines. Pharmacists will be instructed to provide patient-centered contraceptive care. They retain full discretion to decide whether to issue a prescription, and if so, to select the most appropriate FDA-approved contraceptive option based on their clinical judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services | Other | An electronic health record (EHR) platform specifically designed to support community pharmacists in delivering contraceptive services. The platform streamlines clinical workflows, provides clinical decision support, and promotes adherence to the US Medical Eligibility Criteria (USMEC) guidelines and state regulatory requirements. |
| Measure | Description | Time Frame |
|---|---|---|
| Person-Centered Contraceptive Counseling (PCCC) Measure | The percentage of patients who report that the pharmacist provided overall patient-centered care, as defined by achieving the highest rating on all four items of the PCCC survey. | Within 7 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Three-month Contraceptive Continuation Rate | The percentage of patients who report continuous use of their selected contraceptive method three months after the pharmacist encounter. Continuous use is defined as using the method at the time of the survey with no gaps in use of one month or longer. | Within 97 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Failure Rate | The percentage of patients who have experienced unintended pregnancy while using the contraceptive method prescribed during the encounter. | Within 97 days post-intervention |
| Contraceptive Side Effect Rate |
Inclusion Criteria:
• Women presenting for hormonal contraceptives
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calabasas Pharmacy | Calabasas | California | 91302 | United States | ||
| Desert Pharmacy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2024 | Feb 5, 2025 |
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The percentage of patients who report one or more side effects from the contraceptive method prescribed during the encounter.
| Within 97 days post-intervention |
| Patient Contraceptive Satisfaction | 7-point Likert scale rating of patient satisfaction with the contraceptive method prescribed during the encounter. | Within 97 days post-intervention |
| Patient Perception, Attitudes, and Satisfaction Regarding Pharmacist Contraceptive Services | A series of Likert scale, Yes/No, and open-ended questions to discover patient perceptions, attitudes, and satisfaction regarding pharmacist contraceptive services. | Within 97 days post-intervention |
| Preventative Health Services Utilization | A series of Yes/No and multiple-choice questions to discover patient utilization of preventative health services including primary care and medical screening exams. | Within 97 post-intervention |
| El Centro |
| California |
| 92243 |
| United States |
| Local Health Pharmacy | Chicago | Illinois | 60647 | United States |
| Wolves Den Pharmacy | Stanford | Montana | 59479 | United States |
| Gaston Family Pharmacy | Gaston | South Carolina | 29053 | United States |
| ICF_000.pdf |