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C3: Contraceptive Choice Center

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02633631
Collaborator
Centers for Medicare and Medicaid Services (U.S. Fed)
2,664
Enrollment
1
Location
63
Actual Duration (Months)
42.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Contraceptive Choice Center will use an innovative-model of contraceptive care which was developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will deliver high-quality family planning services for women and reduce unintended pregnancies and births. This intervention will result in improved health for women, improved health care, and reduced costs to Medicaid.

The Center will provide care to women ages 14-45 years of age.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Center will provide high-quality contraceptive care using the innovative model of the

    Contraceptive CHOICE Project. Specifically, the model will provide the following components:
    1. Structured, evidence-based contraceptive counseling; 2) education of providers about long-acting reversible contraceptive (LARC) methods and evidence-based guidelines for contraceptive provision; 3) removal of patient barriers to family planning services; and 4) post-visit contraceptive support. The model addresses the barriers to contraceptive uptake.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2664 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Center for Contraceptive Excellence: an Innovative Health Services Delivery and Payment Model
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Apr 1, 2020
    Actual Study Completion Date :
    Apr 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Women seeking family planning services

    Women seeking family planning and gynecological services will be enrolled in our study.

    Outcome Measures

    Primary Outcome Measures

    1. Rate of unintended pregnancy [24 months]

      Reduce unintended pregnancy by 10% - # of pregnancies that are unintended per 1000 reproductive-age women (14-45 years)

    Secondary Outcome Measures

    1. Rate of unintended births [24 months]

      Reduce unintended births and associated costs by 15% - # of births that are unintended per 1000 reproductive age women

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Childbearing-age seeking family planning services

    • Negative pregnancy test

    • Willing and able to undergo informed consent

    Exclusion Criteria:

    • Current participation in a research study that would interfere with the conduct of this study

    • Currently pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Clinical Research at Washington University Saint Louis Missouri United States 63108

    Sponsors and Collaborators

    • Washington University School of Medicine
    • Centers for Medicare and Medicaid Services

    Investigators

    • Principal Investigator: Tessa Madden, MD,MPH, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02633631
    Other Study ID Numbers:
    • 201410028
    First Posted:
    Dec 17, 2015
    Last Update Posted:
    Jun 3, 2021
    Last Verified:
    Jun 1, 2021

    Study Results

    No Results Posted as of Jun 3, 2021