Patient Experiences With Contraceptive Care Provided by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform (PRISM-CS)

Patient-Reported Outcomes of Contraceptive Services Rendered by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform: The PRISM-CS Study

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Other: Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Calabasas, California, United States, 91302
      • Calabasas Pharmacy
    • El Centro, California, United States, 92243
      • Desert Pharmacy
  • Illinois
    • Chicago, Illinois, United States, 60647
      • Local Health Pharmacy
  • Montana
    • Stanford, Montana, United States, 59479
      • Wolves Den Pharmacy
  • South Carolina
    • Gaston, South Carolina, United States, 29053
      • Gaston Family Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women presenting for hormonal contraceptives

Exclusion Criteria:

• Age less than 18 years
• Pregnancy
• Unable to become pregnant
• Not English speaking
• Suspected coercion
• Unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pharmacist-Rendered Contraceptive Services; 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.

Other: Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: OvaryIt, LLC
• Collaborators: National Institutes of Health (NIH); University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Contraception; Digital Health; Pharmacist; Patient-reported Outcomes; Pregnancy Prevention; Community Pharmacy Services
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: 2R44HD110346-02A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No