Innovative Model of Patient-Centered ConTraception

Not Applicable

Completed

• Conditions: Contraception; Unintended Pregnancy
• Interventions: Behavioral: CHOICE Project Structured Contraceptive Counseling; Behavioral: Contraceptive Education Session; Device: Cost Support for IUDs and implants

• Registration Number: NCT02364037
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-16
• Primary Completion: 2017-01-01
• Results First Submitted: 2017-10-26
• Study Completion: 2017-10-31
• Results First Submitted QC: 2018-09-05
• Results First Posted: 2018-10-03
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1008

Inclusion Criteria

1. 14-45 years of age
2. Does not desire pregnancy during the next 12 months
3. Desires reversible contraception
4. Sexually active with a man within the past 6 months or intend to have sex with a man in the next 3 months
5. Willing and able to undergo informed consent
6. Willing to comply with study protocol and 1-year follow-up schedule
7. Not currently pregnant
8. Current patient at Family Care Carondelet, Family Care Forest Park Southeast, Memphis Health Center

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Exclusion Criteria

1. Has undergone a female sterilization procedure such as tubal ligation or hysterectomy
2. Has one sexual partner who has undergone a vasectomy procedure
3. Speaks language other than English or Spanish
4. Currently using an IUD or implant as her contraceptive method

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1: Enhanced Care	CHOICE Project Structured Contraceptive Counseling	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.
Phase 2: Complete CHOICE	CHOICE Project Structured Contraceptive Counseling	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.
Phase 2: Complete CHOICE	Cost Support for IUDs and implants	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.
Phase 2: Complete CHOICE	Contraceptive Education Session	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.

Primary Outcome Measures

Name	Time	Method
Unintended Pregnancy	12 months	The number of self-reported unintended pregnancies.

Secondary Outcome Measures

Name	Time	Method
Desired Contraceptive Method at Enrollment Visit	On the day of enrollment	This could be a new method, an existing method, or nothing if participant did not choose a method
Same Day LARC Insertion	On the day of enrollment	Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit.
Contraceptive Method Use Upon Enrollment Completion	On the day of enrollment	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.
Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit	On the day of enrollment	Number of women choosing an IUD or implant as their preferred contraceptive method

Trial Locations

Locations (3)

Family Care Health Center Forest Park; 🇺🇸 Saint Louis, Missouri, United States

Family Care Health Center Carondelet; 🇺🇸 Saint Louis, Missouri, United States

Memphis Health Center; 🇺🇸 Memphis, Tennessee, United States