NCT06819787

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 12, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 5, 2025

Last Update Submit

February 2, 2026

Conditions

Contraception

Keywords

ContraceptionPregnancy PreventionDigital HealthPharmacistCommunity Pharmacy ServicesPatient-reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Three-month Contraceptive Continuation Rate

    Within 97 days post-intervention

Other Outcomes (5)

  • Contraceptive Failure Rate

    Within 97 days post-intervention

  • Contraceptive Side Effect Rate

    Within 97 days post-intervention

  • Patient Contraceptive Satisfaction

    Within 97 days post-intervention

  • +2 more other outcomes

Study Arms (1)

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.

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

Interventions

Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive ServicesOTHER

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.

Pharmacist-Rendered Contraceptive Services

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women presenting for hormonal contraceptives

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Calabasas Pharmacy

Calabasas, California, 91302, United States

Location

Desert Pharmacy

El Centro, California, 92243, United States

Location

Local Health Pharmacy

Chicago, Illinois, 60647, United States

Location

Wolves Den Pharmacy

Stanford, Montana, 59479, United States

Location

Gaston Family Pharmacy

Gaston, South Carolina, 29053, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 11, 2025

Study Start

July 12, 2025

Primary Completion

November 1, 2025

Study Completion

January 31, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)