Clinical trial NCT02364037: Innovative Model of Patient-Centered ConTraception
Official title: Implementation of Patient-Centered Contraception Provision in Community Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Unintended Pregnancy
Keywords: intrauterine device
subdermal implant
contraceptive counseling
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Family Care Health Centers
name: Memphis Health Center
name: A Step Ahead Foundation
name: Patient-Centered Outcomes Research Institute
First posted: 2015-02-16
Enrollment: 1008
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unintended Pregnancy
timeFrame: 12 months
Secondary outcomes:
measure: Contraceptive Method Use Upon Enrollment Completion
timeFrame: On the day of enrollment
measure: Desired Contraceptive Method at Enrollment Visit
timeFrame: On the day of enrollment
measure: Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit
timeFrame: On the day of enrollment
measure: Same Day LARC Insertion
timeFrame: On the day of enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Family Care Health Center Forest Park
state: Missouri
city: Saint Louis
country: United States
facility: Family Care Health Center Carondelet
state: Missouri
city: Memphis
country: United States
facility: Memphis Health Center
state: Tennessee
Study officials:
affiliation: Washington University School of Medicine
name: Tessa Madden, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madden T, Paul R, Maddipati R, Buckel C, Goodman M, Peipert JF. Comparison of unintended pregnancy at 12 months between two contraceptive care programs; a controlled time-trend design. Contraception. 2019 Sep;100(3):196-201. doi: 10.1016/j.contraception.2019.05.009. Epub 2019 May 24.
citation: Buckel C, Maddipati R, Goodman M, Peipert JF, Madden T. Effect of staff training and cost support on provision of long-acting reversible contraception in community health centers. Contraception. 2019 Apr;99(4):222-227. doi: 10.1016/j.contraception.2018.12.005. Epub 2019 Jan 24.