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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-CD-12-11-4586 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Family Care Health Centers | UNKNOWN |
| Memphis Health Center | UNKNOWN |
| A Step Ahead Foundation | OTHER |
| Patient-Centered Outcomes Research Institute |
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This study is testing models of contraceptive care that were developed as part of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women designed to: 1) promote the use of long-acting reversible contraceptive (LARC) methods which include interuterine devices (IUD) and subdermal implants; 2) remove financial barriers to contraception; 3) evaluate continuation of and satisfaction with reversible methods; and 4) reduce unintended pregnancies in the St. Louis region. CHOICE demonstrated that interventions such as comprehensive contraceptive counseling, increased access, and removal of financial barriers increase the uptake of LARC methods and reduce unintended pregnancy. The investigators objective is to determine whether the CHOICE model of contraceptive care can be equally successful in the real world of community clinics.
This project involves comparing two models of contraceptive care; 'enhanced care' which is usual care plus the CHOICE structured contraceptive counseling, and the 'complete CHOICE' group which includes the structured contraceptive counseling as well as provider training and cost support for IUDs and implants. Participants will be enrolled at three partner community clinics by a staff member (site coordinator) dedicated to the research study. All participants will undergo contraceptive counseling as well as a baseline survey with the coordinator. Participants will complete telephone surveys at 3, 6, and 12 months post-enrollment and will be asked about contraceptive method chosen, satisfaction and continuation of the method, and any pregnancies experienced since enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Enhanced Care | Other | Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs. |
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| Phase 2: Complete CHOICE | Other | Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHOICE Project Structured Contraceptive Counseling | Behavioral | Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project. |
| Measure | Description | Time Frame |
|---|---|---|
| Unintended Pregnancy | The number of self-reported unintended pregnancies. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Method Use Upon Enrollment Completion | This measure indicates the contraceptive method that the patient left with after the clinical visit on the day of enrollment. Patients could have received desired new method, received a bridge method, stayed on current method, or received no method. | On the day of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tessa Madden, MD/MPH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Care Health Center Forest Park | St Louis | Missouri | 63110 | United States | ||
| Family Care Health Center Carondelet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31132346 | Derived | Madden T, Paul R, Maddipati R, Buckel C, Goodman M, Peipert JF. Comparison of unintended pregnancy at 12 months between two contraceptive care programs; a controlled time-trend design. Contraception. 2019 Sep;100(3):196-201. doi: 10.1016/j.contraception.2019.05.009. Epub 2019 May 24. | |
| 30685287 | Derived | Buckel C, Maddipati R, Goodman M, Peipert JF, Madden T. Effect of staff training and cost support on provision of long-acting reversible contraception in community health centers. Contraception. 2019 Apr;99(4):222-227. doi: 10.1016/j.contraception.2018.12.005. Epub 2019 Jan 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Enhanced Care | Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs. |
| FG001 | Phase 2: Complete CHOICE | Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for intrauterine devices (IUDs) and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Enhanced Care | Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unintended Pregnancy | The number of self-reported unintended pregnancies. | Posted | Count of Participants | Participants | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Enhanced Care | Women in Phase 1 of the prospective study will receive the CHOICE Project structured contraceptive counseling in addition to usual care by their health care provider. Contraceptive coverage will be by the usual mechanism such as insurance or financial assistance programs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Paul | Washington University School of Medicine | 3147478176 | paulr@wustl.edu |
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| ID | Term |
|---|---|
| D007434 | Intrauterine Devices |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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| OTHER |
We used a prospective, controlled time-trend study design, a non-randomized design where outcomes are compared before and after a change in the healthcare setting.
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Due to the controlled time-trend design and, therefore, the different time periods for enrollment and follow up for each group, we were unable to mask the research and clinical staff who administered surveys to the study group assignment when collecting data regarding the study outcomes.
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| Contraceptive Education Session | Behavioral | Prior to Phase 2, health care providers at the recruitment sites will undergo a contraceptive education session with a focus on evidence-based provision of contraception including LARC (IUDs and implant) and same-day insertion. |
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| Cost Support for IUDs and implants | Device | Women in Phase 2 of the study who desire an IUD or implant can receive one through the study at no cost if they do not have insurance coverage. If women have insurance that covers the device, her insurance will be billed for the cost of the device. |
|
| Desired Contraceptive Method at Enrollment Visit |
This could be a new method, an existing method, or nothing if participant did not choose a method |
| On the day of enrollment |
| Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit | Number of women choosing an IUD or implant as their preferred contraceptive method | On the day of enrollment |
| Same Day LARC Insertion | Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit. | On the day of enrollment |
| St Louis |
| Missouri |
| 63111 |
| United States |
| Memphis Health Center | Memphis | Tennessee | 38126 | United States |
| Phase 2: Complete CHOICE |
Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Federal Poverty Level | Count of Participants | Participants |
|
| Parity | Number of times a participant has given birth | Count of Participants | Participants |
|
| Unintended Pregnancy | Count of Participants | Participants |
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| Insurance Status | Count of Participants | Participants |
|
| Participant feelings about becoming pregnant in next 12 months | Count of Participants | Participants |
|
| Contraceptive method used immediately prior to enrollment visit | Count of Participants | Participants |
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|
|
| Secondary | Contraceptive Method Use Upon Enrollment Completion | This measure indicates the contraceptive method that the patient left with after the clinical visit on the day of enrollment. Patients could have received desired new method, received a bridge method, stayed on current method, or received no method. | Posted | Count of Participants | Participants | On the day of enrollment |
|
|
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| Secondary | Desired Contraceptive Method at Enrollment Visit | This could be a new method, an existing method, or nothing if participant did not choose a method | Posted | Count of Participants | Participants | On the day of enrollment |
|
|
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| Secondary | Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit | Number of women choosing an IUD or implant as their preferred contraceptive method | Posted | Count of Participants | Participants | On the day of enrollment |
|
|
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| Secondary | Same Day LARC Insertion | Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit. | Posted | Count of Participants | Participants | On the day of enrollment |
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|
|
| 0 |
| 502 |
| 0 |
| 502 |
| EG001 | Phase 2: Complete CHOICE | Women in Phase 2 of the prospective study (Complete CHOICE) will receive the CHOICE Project structured contraceptive counseling. Immediately prior to the start of Phase 2, health care providers in participating health centers will undergo a contraceptive education session with a focus on evidence-based guideline for LARC provision and same-day insertion. Participating women will receive cost support for IUDs and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage. | 0 | 506 | 0 | 506 |
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| Implant |
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| DMPA |
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| Pills/Patch/Ring |
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| Condoms |
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| Other |
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| Nothing |
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| Implant |
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| DMPA |
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| Pills/Patch/Ring |
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| Condoms |
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| Other |
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| Nothing |
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