- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877757
Family Planning Elevated: Initiative Evaluation
Evaluation of the Family Planning Elevated Statewide Contraceptive Service Delivery Initiative
Study Overview
Status
Conditions
Detailed Description
Intervention clinics (FPE Contraceptive Access Program [FPE CAP]) receive a multifaceted contraceptive intervention, including:
- Training and technical assistance on contraceptive counseling and provision for FPE CAP providers, administrators, and health center support staff. FPE CAP staff will be required to attend an annual contraceptive training conference and receive additional remote and on-site technical support on counseling and provision of contraceptive methods. Methods include emergency contraception, oral contraceptive pills, contraceptive patch, vaginal ring, contraceptive injection, fertility awareness methods, condoms, contraceptive implant, hormonal IUDs, and non-hormonal IUD and other contraceptive methods, as feasible.
- FPE will provide FPE CAP members a cash grant to offset personnel and equipment costs associated with FPE CAP start-up and implementation.
- Monthly reimbursement for FPE CAP contraceptive services. As a result of the Medicaid Family Planning Waiver effective January 1, 2019, Utah health centers may claim Medicaid reimbursement for contraceptive services provided to Medicaid enrolled clients at ≤100% Federal Poverty Level. FPE CAP seeks to expand this coverage by providing reimbursement to FPE CAP health centers for contraceptive services provided to clients at 101% - 250% FPL (or 0% - 250% FPL for undocumented clients). Clients must be of reproductive age seeking female-user dependent methods and not be eligible for Medicaid/PCN.
- Contraceptive method stock. The high upfront cost of some contraceptive methods, particularly IUDs and implants, is often a barrier for health centers to maintain adequate contraceptive inventory. During the FPE CAP project period, members will be provided a stock of IUDs and implants to provide to eligible FPE CAP clients. Health centers will be also be reimbursed or provided vouchers for short-acting methods including oral contraceptive pills, vaginal rings, contraceptive injections, condoms, cycle beads, and emergency contraception. FPE will provide technical assistance to members to build a sustainable inventory of contraceptive methods for the post-FPE CAP project period. This will include training on drug forecasting and stocking, 340B Drug Discount Program, group purchasing organizations, and patient assistance programs.
- Evaluative Support: FPE CAP members will be responsible for providing routine data to FPE to help us assess the impact of the program. As part of this effort, FPE CAP members will receive evaluative support in developing and reporting data requirements both for the program and to fill existing clinical data needs around contraception. Additionally, data provided to the FPE team will be analyzed and returned back to the individual health centers as part of the dissemination strategy.
- Marketing campaign: FPE will produce a targeted media campaign to increase public awareness of expanded eligibility for contraceptive services, improve demand for contraceptive services at community health centers, and provide client education on available contraceptive options. FPE will support FPE CAP members by creating customized media campaigns for community outreach and education.
Control clinics are similar clinics (matched by clinic size, geography, and serving Medicaid clients) who are not interested in participating in Family Planning Elevated, but are willing to provide the monthly service delivery data for the same time periods as their matched intervention clinic.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rebecca Simmons, PhD
- Phone Number: 801-581-6170
- Email: rebecca.simmons@hsc.utah.edu
Study Contact Backup
- Name: Kyl Myers, PhD
- Phone Number: 801-581-6170
- Email: kyl.myers@hsc.utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah, Department of Obstetrics & Gynecology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women of reproductive age (age 18-50) who visited the intervention or control clinic within the allotted time frame.
Exclusion Criteria:
- Under age 18
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Family Planning Elevated Contraceptive Access Clinics Program
This group consists of community clinics who apply and are accepted for FPE CAP membership during the Family Planning Elevated initiative.
These clinics will receive the intervention and will provide monthly service delivery data to the FPE evaluation team.
|
Control Clinics
This group consists of non-participating community clinics matched on clinic size, geography, and client populations who are not interested in participating in the initiative but are willing to provide monthly service delivery data to the FPE evaluation team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total family planning services provided to women ages 18-49, as measured by monthly service delivery report
Time Frame: 12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention
|
Family planning services are defined as all family planning-related E/M, CPT, and HCPC codes within the FPE monthly service delivery report
|
12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in total long-acting reversible contraceptive services (LARC) provided to all women ages 18-49, as measured by monthly service delivery report
Time Frame: 12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention
|
Defined as all related E/M, CPT, and HCPC codes related to LARC methods within the FPE monthly service delivery report
|
12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Simmons, PhD, University of Utah, Department of OBGYN
Publications and helpful links
General Publications
- Cohen SR, Baayd J, Garcia G, Quade C, Gero A, Ekey M, Poggio C, Simmons R. Facility-based simulation as a programmatic tool for implementing a statewide contraceptive initiative. BMC Health Serv Res. 2022 Jul 29;22(1):965. doi: 10.1186/s12913-022-08332-4.
- Baayd J, Simmons RG. Protocol for a process evaluation of Family Planning Elevated: a statewide initiative to improve contraceptive access in Utah (USA). BMJ Open. 2020 Oct 1;10(10):e038049. doi: 10.1136/bmjopen-2020-038049.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 117213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contraception
-
Virginia Commonwealth UniversityCompletedPregnancy Related | Contraception | Contraception Behavior | Contraception Use
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Medical University of South CarolinaSociety of Family PlanningCompletedContraception | Contraception BehaviorUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedFemale Contraception | ContraceptionUnited States, Israel
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Janssen Pharmaceutica N.V., BelgiumCompleted
-
University of California, San FranciscoAgency for Healthcare Research and Quality (AHRQ); Essential Access HealthNot yet recruitingContraception | Contraception Behavior | Reproductive BehaviorUnited States