The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies

April 5, 2007 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Improving Contraceptive Practice and Delivery Through Community Pharmacists: The Direct Access Study

Hormonal birth control methods include birth control pills, patches, and vaginal rings; they are normally available only with a doctor's prescription. This study will evaluate a program designed to increase the availability of birth control by allowing pharmacists to give women hormonal birth control without a doctor's prescription. Under this program, pharmacists will evaluate women who want to use birth control according to specific guidelines created by doctors. If a woman meets the criteria in the guidelines, a pharmacist could then give her the appropriate form of hormonal birth control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Institute of Medicine's Committee on Unintended Pregnancy urges increasing access to contraception through broadening the range of health professionals that provide birth control. Evidence-based family planning practice no longer requires a physical examination before prescribing hormonal contraceptives to women. Community pharmacists efficiently provide emergency contraceptive pills (ECP) and women report satisfaction with the direct access. These women, as well as many women purchasing less effective over-the-counter (OTC) contraceptive methods, could benefit from more pharmacist-dispensed birth control choices, such as hormonal methods. The Direct Access Study will assess the feasibility of pharmacists, under Collaborative Drug Therapy Agreements with independent prescribers, providing hormonal contraceptives in community pharmacies. Specifically, the study will evaluate the impact upon hormonal contraception initiation and continuation rates when women's care is managed by pharmacists.

Using Collaborative Drug Therapy Agreements jointly developed with licensed prescribers (physicians and nurse practitioners), pharmacists in four Fred Meyer pharmacies will identify women who are at risk of unintended pregnancy and will offer to evaluate them for their suitability to safely use oral contraceptives, contraceptive patches, or the contraceptive vaginal ring. Through self-administered medical and contraceptive history questionnaires, interested women will select the most suitable contraceptive methods. Pharmacists will then complete the screening process and prescribe hormonal contraceptives according to the protocol guidelines.

Pharmacists will encourage women to follow up with a primary care practitioner or family planning clinic for cervical exams and reproductive tract infection screening as indicated. Pharmacists will have authority to provide an initial 3-month prescription and an additional 9-month prescription if blood pressure is normal at a three-month revisit. Effectiveness of pharmacists' interventions will be measured by initiation and continuation of hormonal methods by women to whom pharmacists have offered them. Feasibility will be determined by measurement of both acceptability and sustainability. Acceptability will be measured by surveys of women, pharmacists, and prescribers. Sustainability will be measured by economic and work-flow outcomes for the pharmacies, including evidence that women, private third-party payers, and public payers are willing to pay for the services. If safety is documented after preliminary analysis, injectable contraceptive methods will be added to the study.

Study Type

Interventional

Enrollment

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Kent, Washington, United States
        • Fred Meyer Pharmacy
      • Kirkland, Washington, United States
        • Fred Meyer Pharmacy
      • Puyallup-South Hill, Washington, United States
        • Fred Meyer Pharmacy
      • Seattle, Washington, United States
        • Bartell Drugs, University Village
      • Seattle-Broadway, Washington, United States
        • Fred Meyer Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • At risk for unintended pregnancy
  • Access to participating Fred Meyer Pharmacy
  • English-speaking
  • Health insurance or ability to pay for contraceptive care

Exclusion Criteria

  • Age less than 18 years
  • Age greater than 45 years
  • Unable to become pregnant
  • Not English speaking
  • Not planning to remain in area
  • Not planning to use the same pharmacy
  • Unable to pay for services

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The number and characteristics of women who seek hormonal contraceptives from pharmacists as evidenced by study consent or enrollment.
The number and characteristics of women not able to obtain hormonal contraceptives due to contraindications, costs, etc.
The proportion and characteristics of those women who continue to use the initial method after 3, 6, and 12-months compared with national literature and with women who do not obtain the method by direct pharmacist access.
Safety evaluation to include prescribing protocol adherence (no women with absolute contraindication given estrogen; blood pressure monitoring done prior to more than three cycles of estrogen methods; no woman given a hormonal method while pregnant.

Secondary Outcome Measures

Outcome Measure
The number and characteristics of women who choose hormonal contraceptives for the first time compared to national literature.
The amount of time required for pharmacists to be trained and to conduct the defined interventions in the course of their ongoing pharmach practice.
The number and characteristics of eligible Medicaid waiver applicants enrolled by pharmacists compared with state figures for other providers.
The proportion of billed insurance claims that are paid.
The number and types of referrals to clinicians made by pharmacists and the proportion of counseled clients who follow through on the referrals that were made.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Jacqueline Gardner, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion

December 6, 2022

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

August 1, 2003

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

April 6, 2007

Last Update Submitted That Met QC Criteria

April 5, 2007

Last Verified

November 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD42427

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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