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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065871
First received: August 1, 2003
Last updated: April 5, 2007
Last verified: November 2004
  Purpose

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.


Condition Intervention
Contraception
Behavioral: Contraceptive Screening by Pharmacist
Behavioral: Contraceptive Prescribing by Pharmacist

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Contraceptive Practice and Delivery Through Community Pharmacists: The Direct Access Study

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 250
Study Start Date: June 2003
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065871

Locations
United States, Washington
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
Sponsors and Collaborators
Investigators
Principal Investigator: Jacqueline Gardner, PhD University of Washington
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00065871     History of Changes
Other Study ID Numbers: HD42427
Study First Received: August 1, 2003
Last Updated: April 5, 2007
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Pharmacist prescribers
Increased access
Hormonal contraception
Birth control pills
Birth control patch
Vaginal contraceptive ring

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014