Innovative Model of Patient-Centered ConTraception

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1008 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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

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Contraception Unintended Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

We used a prospective, controlled time-trend study design, a non-randomized design where outcomes are compared before and after a change in the healthcare setting.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Due to the controlled time-trend design and, therefore, the different time periods for enrollment and follow up for each group, we were unable to mask the research and clinical staff who administered surveys to the study group assignment when collecting data regarding the study outcomes.

Study Groups

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Phase 1: Enhanced Care

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.

Group Type OTHER

CHOICE Project Structured Contraceptive Counseling

Intervention Type BEHAVIORAL

Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.

Phase 2: Complete CHOICE

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.

Group Type OTHER

CHOICE Project Structured Contraceptive Counseling

Intervention Type BEHAVIORAL

Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.

Contraceptive Education Session

Intervention Type BEHAVIORAL

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.

Cost Support for IUDs and implants

Intervention Type DEVICE

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.

Interventions

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CHOICE Project Structured Contraceptive Counseling

Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes