Implementation of Patient-Centered Contraception Provision in Community Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,008
- 试验地点
- 3
- 主要终点
- Unintended Pregnancy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CHOICE Project Structured Contraceptive Counseling (Behavioral)
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.
干预措施: CHOICE Project Structured Contraceptive Counseling (Behavioral)
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.
干预措施: Contraceptive Education Session (Behavioral)
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.
干预措施: Cost Support for IUDs and implants (Device)
结局指标
主要结局
Unintended Pregnancy
时间窗: 12 months
The number of self-reported unintended pregnancies.
次要结局
- Desired Contraceptive Method at Enrollment Visit(On the day of enrollment)
- Same Day LARC Insertion(On the day of enrollment)
- Contraceptive Method Use Upon Enrollment Completion(On the day of enrollment)
- Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit(On the day of enrollment)