ContraceptionNCT00065871
The Direct Access Study: Access to Hormonal Birth Control Through Community Pharmacies
A study testing Contraceptive Screening by Pharmacist and Contraceptive Prescribing by Pharmacist in people with Contraception, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Contraceptive Screening by Pharmacist and Contraceptive Prescribing by Pharmacist
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2003to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At risk for unintended pregnancy
- Access to participating Fred Meyer Pharmacy
- English-speaking
- Health insurance or ability to pay for contraceptive care
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Fred Meyer Pharmacy
Kent, Washington
Fred Meyer Pharmacy
Kirkland, Washington
Fred Meyer Pharmacy
Puyallup-South Hill, Washington
Bartell Drugs, University Village
Seattle, Washington
Fred Meyer Pharmacy
Seattle-Broadway, Washington
About this study
Official title: 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.
Read the 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
- Being tested
- Contraceptive Screening by Pharmacist, Contraceptive Prescribing by Pharmacist
- Keywords
- Pharmacist prescribers, Increased access, Hormonal contraception, Birth control pills, Birth control patch, Vaginal contraceptive ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive Screening by PharmacistBehavioural
Contraceptive Prescribing by PharmacistBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startJun 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jacqueline Gardner, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065871
- Sponsor's protocol ID
- HD42427
- Status last verified
- Nov 2004
- First submitted
- 1 Aug 2003
- Last updated
- 6 Apr 2007
- Results posted
- No
Publications
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.
PubMed 11325325Gardner 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.
PubMed 11496935Faculty 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.
PubMed 10819591
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Contraceptive Practice and Delivery Through Community Pharmacists: The Direct Access Study
- ClinicalTrials.gov ID
- NCT00065871
- Acronym / sponsor ID
- HD42427
- Conditions
- Contraception
- Keywords
- Pharmacist prescribers, Increased access, Hormonal contraception, Birth control pills, Birth control patch, Vaginal contraceptive ring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2003
- Study completion
- Feb 2006
- First posted
- 5 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At risk for unintended pregnancy
- Access to participating Fred Meyer Pharmacy
- English-speaking
- Health insurance or ability to pay for contraceptive care
Key exclusion criteria (7 listed)
- Age less than 18 years
- Age greater than 45 years
- Unable to become pregnant
- Not English speaking
- Not planning to remain in area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraceptive Screening by Pharmacist | Behavioural | – |
| Contraceptive Prescribing by Pharmacist | Behavioural | – |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
- Background: PubMed 11325325Stewart 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.
- Background: PubMed 11496935Gardner 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.
- Background: PubMed 10819591Faculty 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.
Related trials for Contraception
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
Recruiting
Estimating the Impact of Comprehensive SRHR Services on Health and Development in South Sudan for the Family Planning Impact Lab
Contraceptive Behavior, Self Administration
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
Not yet recruiting
Safety of a Contraceptive Copper Vaginal Ring
Contraception, Birth Control
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Gardner, PhD principal investigator
University of Washington
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraceptive Screening by Pharmacist and Contraceptive Prescribing by Pharmacist in people with Contraception, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and characteristics of women who seek hormonal contraceptives from pharmacists as evidenced by study consent or enrollment.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065871, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2007.