Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065871
Status:
UNKNOWN
Last Update Posted:
2007-04-06
First Post:
2003-08-01
Brief Title:
The Direct Access Study Access to Hormonal Birth Control Through Community Pharmacies
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Improving Contraceptive Practice and Delivery Through Community Pharmacists The Direct Access Study
Status:
UNKNOWN
Status Verified Date:
2004-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hormonal birth control methods include birth control pills patches and vaginal rings they are normally available only with a doctors 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 doctors 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 Medicines 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 womens 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None