Hormonal Contraception Access Through Pharmacist Prescribing Implementation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMPOWERX INC

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • HAPPI software

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: HAPPI PharmaciesOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 5 months
2

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

Time frame
up to 5 months
3

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

Time frame
up to 5 months
4

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

Time frame
up to 5 months

Secondary outcomes

1

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).

Time frame
up to 5 months

Other outcomes

Sponsors and contacts

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EMPOWERX INC

Lead sponsor

Purdue University

Collaborator