Electronic Health Record Platform for Birth Control

(PRISM-CS Trial)

Not currently recruiting at 4 trial locations

Overseen By Devin Bustin

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: OvaryIt, LLC

Must be taking: Hormonal contraceptives

Disqualifiers: Age < 18, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an electronic health record platform that enables pharmacists to provide birth control prescriptions directly, eliminating the need for a prior doctor's visit. It aims to determine if obtaining contraceptives from pharmacists is as safe and effective as traditional methods, with a focus on patient satisfaction and quality of care. Women seeking hormonal birth control who can become pregnant are suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative healthcare solutions that could simplify access to birth control.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on providing contraceptive services through pharmacists.

What prior data suggests that this Electronic Health Record platform is safe for contraceptive services?

Research has shown that the PRISM platform helps pharmacists offer contraceptive services safely and efficiently. Studies have found that this electronic health record system boosts patient safety by 40%. It allows pharmacists to quickly access important information, enabling informed decisions about prescribing contraceptives.

The PRISM platform assists pharmacists in checking each patient's eligibility for different contraceptive options. It uses guidelines to determine which methods are safe for each individual, helping pharmacists select the best FDA-approved contraceptive. Overall, the platform ensures pharmacists can provide high-quality, patient-focused contraceptive care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pharmacist Resource to Implement Services as Modules (PRISM) because it represents a new approach to delivering contraceptive care. Unlike traditional methods where patients often visit a doctor's office for prescriptions, this system empowers pharmacists in community settings to provide personalized contraceptive services. By using an Electronic Health Record platform, pharmacists can quickly evaluate a woman's eligibility for various birth control options based on established guidelines, streamlining the process and potentially increasing access to contraception. This innovative model not only makes contraceptive care more accessible but also leverages pharmacists' expertise to deliver patient-centered care.

What evidence suggests that the PRISM platform is effective for providing contraceptive services?

Research has shown that pharmacists can safely and effectively provide contraceptive services. By prescribing birth control directly, they make it easier and more convenient for many women to access these services. In this trial, the PRISM platform helps pharmacists deliver contraceptive services more efficiently by offering guidance and simplifying tasks. While specific data on PRISM's impact on outcomes is limited, it builds on proven methods demonstrating that pharmacists can successfully manage contraceptive care. Overall, this approach aims to maintain high-quality care while improving accessibility. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for women seeking hormonal contraceptives. It's designed to evaluate their experience when getting these services directly from pharmacists using a special electronic platform called PRISM.

Inclusion Criteria

I am seeking hormonal contraceptives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive contraceptive services from pharmacists using the PRISM platform

12 weeks

Visits as needed for contraceptive services

Follow-up

Participants are monitored for patient-reported outcomes, including satisfaction and side effects

14 weeks

Follow-up surveys conducted

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist Resource to Implement Services as Modules (PRISM)

Trial Overview The study tests the PRISM platform, which helps pharmacists prescribe and manage contraceptive care. Over 12 weeks at five pharmacies in the U.S., it will look into how this system affects service quality and patient outcomes.

How Is the Trial Designed?

Group I: Pharmacist-Rendered Contraceptive Services Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

OvaryIt, LLC

Lead Sponsor

Trials

1

Recruited

130+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06819787

Patient Experiences With Contraceptive Care Provided by ... This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community ...

2. trialx.com trialx.com/clinical-trials/listings/300354/patient-experiences-with-contraceptive-care-provided-by-community-pharmacists-using-the-pharmacist-resource-to-implement-services-as-modules-platform/

Patient Experiences With Contraceptive Care Provided by ... This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at ...

3. drugtopics.com drugtopics.com/view/the-platform-aiding-pharmacists-in-safe-efficient-contraceptive-services

The Platform Aiding Pharmacists in Safe, Efficient ... One of the more recent platforms that has emerged within the pharmacy industry is PRISM, or the Pharmacist Resource to Implement Services as ...

4. trial.medpath.com trial.medpath.com/clinical-trial/8bbdf85c84e4a5da/nct06819787-contraceptive-services-community-pharmacists-prism

Patient Experiences With Contraceptive Care Provided by ... This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT06819787/ICF_000.pdf

Patient-Reported Outcomes of Contraceptive Services ... This research will utilize a multi-phase approach to obtain surveys, feedback, and concerns of patients wishing to obtain contraception ...

6. drugtopics.com drugtopics.com/shorts/prism-automates-safe-contraceptive-services-access

PRISM Automates Safe Contraceptive Services, Access The PRISM platform, also known as the pharmacist resource to implement services as modules, is an electronic health record designed by pharmacists, ...