MedDataX Logo

Patient Experiences With Contraceptive Care Provided by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform

NCT ID: NCT06819787

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-12

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Contraception Pregnancy Prevention Digital Health Pharmacist Community Pharmacy Services Patient-reported Outcomes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

OvaryIt, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Calabasas Pharmacy

Calabasas, California, United States

Site Status

Desert Pharmacy

El Centro, California, United States

Site Status

Local Health Pharmacy

Chicago, Illinois, United States

Site Status

Wolves Den Pharmacy

Stanford, Montana, United States

Site Status

Gaston Family Pharmacy

Gaston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2R44HD110346-02A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link