About this trial
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:
1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy? 2. Does the HAPPI software make it easier for patients to access birth control?
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Provide birth control services in a participating pharmacy
Use the HAPPI software to provide birth control services
Disqualifiers
None
18 years of age or older
Seek birth control services at a participating pharmacy
Use the HAPPI software to receive birth control services at a participating pharmacy
Trial design
Single group
Treatments tested in this trial
HAPPI software
Other interventionWe 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.
Treatment groups
Trial outcomes
Primary outcomes
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: * Number of pharmacists involved in providing birth control services
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: * Number of pharmacy staff (non-pharmacists) involved in providing birth control services
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: * Total amount of money coming in (revenue) from the service via cash pay
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: * Total amount of money coming in (revenue) from the service via insurance billing
Secondary outcomes
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).
Sponsors and contacts
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EMPOWERX INC
Lead sponsor
Purdue University
Collaborator