ContraceptionNCT03877757
Family Planning Elevated: Initiative Evaluation
An observational study of Contraception, run by University of Utah at 1 site in United States.
Trial summary
Family Planning Elevated (FPE) is a statewide contraceptive initiative with two primary aims: 1) supporting existing and proposed legislative policy that expands family planning services in Utah among low-income individuals covered by contraceptive legislation (currently individuals at ≤100% federal poverty) and 2)… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Contraception
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 28 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The intervention occurs at the clinic level. Participating clinics are Utah health systems and individual clinics across Utah.
Who may be able to join
- Women of reproductive age (age 18-50) who visited the intervention or control clinic within the allotted time frame.
Who cannot join
- Under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, Department of Obstetrics & Gynecology
Salt Lake City, Utah, 84132
About this study
Official title: Evaluation of the Family Planning Elevated Statewide Contraceptive Service Delivery Initiative
Family Planning Elevated (FPE) is a statewide contraceptive initiative with two primary aims: 1) supporting existing and proposed legislative policy that expands family planning services in Utah among low-income individuals covered by contraceptive legislation (currently individuals at ≤100% federal poverty) and 2) demonstrating additional existing service need among low-income individuals who currently fall in the contraceptive coverage gap (101%-250% federal poverty). Family Planning Elevated provides contraceptive grants, education and training, and technical assistance on comprehensive contraceptive care to participating clinics. The purpose of this evaluation is to assess the effect of FPE on clinic-level family planning service delivery among low-income women who fall in the contraceptive coverage gap compared to those receiving services from matched control clinics which did not receive the intervention. To assess these effects, FPE will collect monthly family planning service delivery data from both intervention and control clinics, beginning 12 months prior to the FPE intervention, and following for 12 months after the FPE intervention ends. A difference-in-difference analysis will compare trends and level-changes in family planning services provided to intervention and control groups.
Read the 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.
- Conditions
- Contraception
- Keywords
- Family Planning, Implementation science, Evaluation, Contraceptive initiative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in total family planning services provided to women ages 18-49, as measured by monthly service delivery report
Family planning services are defined as all family planning-related E/M, CPT, and HCPC codes within the FPE monthly service delivery report
Measured: 12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention
Secondary outcomes (1)
Changes in total long-acting reversible contraceptive services (LARC) provided to all women ages 18-49, as measured by monthly service delivery report
Defined as all related E/M, CPT, and HCPC codes related to LARC methods within the FPE monthly service delivery report
Measured: 12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Feb 2019
- Primary completion14 Jun 2024
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Simmons, PhD, Principal investigator, University of Utah, Department of OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877757
- Sponsor's protocol ID
- 117213
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2019
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35906656Baayd 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.
PubMed 33004395
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Family Planning Elevated Statewide Contraceptive Service Delivery Initiative
- ClinicalTrials.gov ID
- NCT03877757
- Acronym / sponsor ID
- 117213
- Conditions
- Contraception
- Keywords
- Family Planning, Implementation science, Evaluation, Contraceptive initiative
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 18 Mar 2019 (actual)
- 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.
Family Planning Elevated (FPE) is a statewide contraceptive initiative with two primary aims: 1) supporting existing and proposed legislative policy that expands family planning services in Utah among low-income individuals covered by contraceptive legislation (currently individuals at ≤100% federal poverty) and 2) demonstrating additional existing service need among low-income individuals who currently fall in the contraceptive coverage gap (101%-250% federal poverty). Family Planning Elevated provides contraceptive grants, education and training, and technical assistance on comprehensive contraceptive care to participating clinics. The purpose of this evaluation is to assess the effect of FPE on clinic-level family planning service delivery among low-income women who fall in the contraceptive coverage gap compared to those receiving services from matched control clinics which did not receive the intervention. To assess these effects, FPE will collect monthly family planning service delivery data from both intervention and control clinics, beginning 12 months prior to the FPE intervention, and following for 12 months after the FPE intervention ends. A difference-in-difference analysis will compare trends and level-changes in family planning services provided to intervention and control groups.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The intervention occurs at the clinic level. Participating clinics are Utah health systems and individual clinics across Utah.
Key inclusion criteria (1 listed)
- Women of reproductive age (age 18-50) who visited the intervention or control clinic within the allotted time frame.
Key exclusion criteria (1 listed)
- Under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 35906656Cohen 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.
- Derived from this study: PubMed 33004395Baayd 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.
- Individual participant dataSharing planned: No
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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.
Rebecca Simmons, PhD principal investigator
University of Utah, Department of OBGYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by University of Utah at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
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). 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 NCT03877757, which also lists 2 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 11 Dec 2024.