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

NCT ID: NCT00065871

Last Updated: 2007-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-02-28

Brief Summary

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.

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.

Conditions

Contraception

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Contraceptive Screening by Pharmacist

Intervention Type: BEHAVIORAL

Contraceptive Prescribing by Pharmacist

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: lead

Principal Investigators

Jacqueline Gardner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Fred Meyer Pharmacy

Kent, Washington, United States

Fred Meyer Pharmacy

Kirkland, Washington, United States

Fred Meyer Pharmacy

Puyallup-South Hill, Washington, United States

Bartell Drugs, University Village

Seattle, Washington, United States

Fred Meyer Pharmacy

Seattle-Broadway, Washington, United States

Countries

United States

References

Stewart FH, Harper CC, Ellertson CE, Grimes DA, Sawaya GF, Trussell J. Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence. JAMA. 2001 May 2;285(17):2232-9. doi: 10.1001/jama.285.17.2232.

Reference Type: BACKGROUND

PMID: 11325325 (View on PubMed)

Gardner JS, Hutchings J, Fuller TS, Downing D. Increasing access to emergency contraception through community pharmacies: lessons from Washington State. Fam Plann Perspect. 2001 Jul-Aug;33(4):172-5. No abstract available.

Reference Type: BACKGROUND

PMID: 11496935 (View on PubMed)

Faculty of Family Planning and Reproductive Health Care. Royal College of Obstetricians and Gynaecologists. First prescription of combined oral contraception: recommendations for clinical practice. Br J Fam Plann. 2000 Jan;26(1):27-38. No abstract available.

Reference Type: BACKGROUND

PMID: 10819591 (View on PubMed)

Other Identifiers

HD42427

Identifier Type: -

Identifier Source: org_study_id