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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00065871
• Other study ID #: HD42427
• Status: Active, not recruiting
• Phase: N/A
• First received: August 1, 2003
• Last updated: April 5, 2007
• Start date: June 2003
• Est. completion date: February 2006

Study information

• Verified date: November 2004
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• Contraceptive Screening by Pharmacist

• Contraceptive Prescribing by Pharmacist

Locations

Country	Name	City	State
United States	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

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and characteristics of women who seek hormonal contraceptives from pharmacists as evidenced by study consent or enrollment.
Primary	The number and characteristics of women not able to obtain hormonal contraceptives due to contraindications, costs, etc.
Primary	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.
Primary	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	The number and characteristics of women who choose hormonal contraceptives for the first time compared to national literature.
Secondary	The amount of time required for pharmacists to be trained and to conduct the defined interventions in the course of their ongoing pharmach practice.
Secondary	The number and characteristics of eligible Medicaid waiver applicants enrolled by pharmacists compared with state figures for other providers.
Secondary	The proportion of billed insurance claims that are paid.
Secondary	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.