NCT02364037

Innovative Model of Patient-Centered ConTraception

Implementation of Patient-Centered Contraception Provision in Community Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,008 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Contraception
• Unintended Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	CHOICE Project Structured Contraceptive Counseling	Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
BEHAVIORAL	Contraceptive Education Session	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.
DEVICE	Cost Support for IUDs and implants	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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-01-01
• Completion: 2017-10-31
• First posted: 2015-02-16
• Last updated: 2020-06-02
• Results posted: 2018-10-03

Locations

3 sites across 1 country: United States