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| Name | Class |
|---|---|
| Purdue University | OTHER |
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The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are:
Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access.
Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAPPI Pharmacies | Other | This is a single-arm trial, so all pharmacies will serve as their own control. We will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control). Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI software in place of any paper or electronic processes that they were previously using. The results will then be compared between the control and the intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAPPI software | Other | We will enroll 15 community pharmacies. These 15 pharmacies will continue to provide birth control services as normal for several months (control). Then, we will introduce the intervention: the HAPPI software. The pharmacies will continue to provide birth control services while using the HAPPI software in place of any paper or electronic processes that they were previously using. The results will then be compared between the control and the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation - Service Characteristics Number of Pharmacists | Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure:
| up to 5 months |
| Implementation - Service Characteristics Number of Pharmacy Staff | Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure:
| up to 5 months |
| Implementation - Service Characteristics Cash Pay | Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure:
| up to 5 months |
| Implementation - Service Characteristics Insurance Billing | Implementation outcomes will focus on how the service (pharmacist-prescribed contraceptive services) is implemented. Name of the Measurement: Implementation - Service Characteristics Measurement Tool: Pharmacy Service Characteristics Questionnaire Unit of Measure:
| up to 5 months |
| Implementation - Proctor Implementation Outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Access to Care | Access to Care outcomes will be assessed using a previously developed scale of Access to Contraceptive Care (Newlon 2021) that assesses patients' access in terms of approachability, acceptability, availability and accommodation, affordability, appropriateness, and privacy. Unite of measure: 5-point Likert-type scale (1= strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree). This same scale is used for all implementation domains (approachability, acceptability, availability and accommodation, affordability, appropriateness, and privacy). |
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PHARMACIST Participants
Inclusion Criteria:
Exclusion Criteria:
PATIENT Participants
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny L Newlon, PharmD, PhD | Contact | 8584120984 | jenny@birthcontrolpharmacist.com | |
| Sally Rafie, PharmD | Contact | Sally@birthcontrolpharmacist.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EmpoweRx, Inc | Recruiting | Del Mar | California | 92014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39512515 | Background | Newlon JL, Campi JA, Rafie S, Meredith AH. Determining user implementation needs for pharmacist-prescribed contraception using concept mapping: A participatory, multiple stakeholder approach. Explor Res Clin Soc Pharm. 2024 Oct 11;16:100525. doi: 10.1016/j.rcsop.2024.100525. eCollection 2024 Dec. | |
| 39420991 | Background | Campi JA, Rafie S, Newlon JL, Meredith AH. Implementation of pharmacist-prescribed contraceptive services: A case series of early adopters. JAPhA Pract Innov. 2024 Jul;1(3):100011. doi: 10.1016/j.japhpi.2024.100011. Epub 2024 Apr 20. |
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Our clinical trial uses proprietary information related to the software that is the basis for our intervention. We will need to find a way to ensure we protect all intellectual property and proprietary information before we develop a plan to share IPD.
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Implementation outcomes will be measured using Proctor et al.'s (2011) implementation framework. The domains in this framework include appropriateness, acceptability, adoption, feasibility, and fidelity. Survey items will map to each of these domains.
Name of the measurement: Implementation - Proctor Implementation Outcomes Measurement tool: Implementation Outcomes Scale Unit of Measure: 5-point Likert-type scale (1= strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree). This same scale is used for all implementation domains (appropriateness, acceptability, adoption, feasibility, and fidelity).
| up to 5 months |
| up to 5 months |