Innovative Model of Patient-Centered ConTraception (IMPACCT)

The Washington University

Status: Completed

Conditions: Unintended Pregnancy; Contraception

Treatments: Behavioral: CHOICE Project Structured Contraceptive Counseling; Device: Cost Support for IUDs and implants; Behavioral: Contraceptive Education Session

Study type: Interventional

Funder types: Other

Identifiers

NCT02364037

201402021

PCORI-CD-12-11-4586 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,008 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,008 participants in 2 patient groups

Phase 1: Enhanced Care

Other group

Description:

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.

Treatment:

Behavioral: CHOICE Project Structured Contraceptive Counseling

Phase 2: Complete CHOICE

Other group

Description:

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.

Treatment:

Behavioral: Contraceptive Education Session

Device: Cost Support for IUDs and implants

Behavioral: CHOICE Project Structured Contraceptive Counseling