Innovative Model of Patient-Centered ConTraception

Study Overview
=================
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.

Official Title
-----------------
Implementation of Patient-Centered Contraception Provision in Community Settings

Conditions
-----------------
Contraception, Unintended Pregnancy

Intervention / Treatment
-----------------
* Behavioral: CHOICE Project Structured Contraceptive Counseling
* Behavioral: Contraceptive Education Session
* Device: Cost Support for IUDs and implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-45 years of age Does not desire pregnancy during the next 12 months Desires reversible contraception Sexually active with a man within the past 6 months or intend to have sex with a man in the next 3 months Willing and able to undergo informed consent Willing to comply with study protocol and 1-year follow-up schedule Not currently pregnant Current patient at Family Care Carondelet, Family Care Forest Park Southeast, Memphis Health Center Exclusion Criteria: Has undergone a female sterilization procedure such as tubal ligation or hysterectomy Has one sexual partner who has undergone a vasectomy procedure Speaks language other than English or Spanish Currently using an IUD or implant as her contraceptive method

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phase 1: Enhanced Care<br>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. | Behavioral: CHOICE Project Structured Contraceptive Counseling<br>* Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.<br>|
| Other: Phase 2: Complete CHOICE<br>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. | Behavioral: CHOICE Project Structured Contraceptive Counseling<br>* Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.<br>Behavioral: Contraceptive Education Session<br>* 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.<br>Device: Cost Support for IUDs and implants<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unintended Pregnancy | The number of self-reported unintended pregnancies. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine device, subdermal implant, contraceptive counseling