Contraceptive Choice Center

Contraception Clinical Trial

— C3  

Official title:

The Center for Contraceptive Excellence: an Innovative Health Services Delivery and Payment Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633631
• Other study ID #: 201410028
• Status: Completed
• Start date: January 2015
• Est. completion date: April 2020

Study information

• Verified date: June 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2664
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Family Planning
• Unintended Pregnancy

Locations

Country	Name	City	State
United States	Division of Clinical Research at Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of unintended pregnancy	Reduce unintended pregnancy by 10% - # of pregnancies that are unintended per 1000 reproductive-age women (14-45 years)	24 months
Secondary	Rate of unintended births	Reduce unintended births and associated costs by 15% - # of births that are unintended per 1000 reproductive age women	24 months