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

O

OvaryIt, LLC

Status

Completed

Conditions

Contraception

Treatments

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

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT06819787
2R44HD110346-02A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

Female

Ages

18 to 51 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

75 participants in 1 patient group

Pharmacist-Rendered Contraceptive Services
Experimental group
Description:
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.
Treatment:
Other: Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services

Trial documents
1

Trial contacts and locations

5

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Central trial contact

Mary Kucek; Devin Bustin

Data sourced from clinicaltrials.gov

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