NCT00065871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 6, 2007

Status Verified

November 1, 2004

First QC Date

August 1, 2003

Last Update Submit

April 5, 2007

Conditions

Contraception

Keywords

Pharmacist prescribersIncreased accessHormonal contraceptionBirth control pillsBirth control patchVaginal contraceptive ring

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • 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.

Interventions

Contraceptive Screening by PharmacistBEHAVIORAL
Contraceptive Prescribing by PharmacistBEHAVIORAL

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fred Meyer Pharmacy

Kent, Washington, United States

Location

Fred Meyer Pharmacy

Kirkland, Washington, United States

Location

Fred Meyer Pharmacy

Puyallup-South Hill, Washington, United States

Location

Bartell Drugs, University Village

Seattle, Washington, United States

Location

Fred Meyer Pharmacy

Seattle-Broadway, Washington, United States

Location

Related Publications (3)

  • 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.

    PMID: 11325325BACKGROUND

  • 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.

    PMID: 11496935BACKGROUND

  • 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.

    PMID: 10819591BACKGROUND

Study Officials

  • Jacqueline Gardner, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

June 1, 2003

Study Completion

February 1, 2006

Last Updated

April 6, 2007

Record last verified: 2004-11

Locations

US(5)