Innovative Model of Patient-Centered ConTraception
IMPACCT
Implementation of Patient-Centered Contraception Provision in Community Settings
2 other identifiers
interventional
1,008
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedResults Posted
Study results publicly available
October 3, 2018
CompletedJune 2, 2020
May 1, 2020
3.4 years
February 9, 2015
October 26, 2017
May 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unintended Pregnancy
The number of self-reported unintended pregnancies.
12 months
Secondary Outcomes (4)
Contraceptive Method Use Upon Enrollment Completion
On the day of enrollment
Desired Contraceptive Method at Enrollment Visit
On the day of enrollment
Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit
On the day of enrollment
Same Day LARC Insertion
On the day of enrollment
Study Arms (2)
Phase 1: Enhanced Care
OTHERWomen 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.
Phase 2: Complete CHOICE
OTHERWomen 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.
Interventions
Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Family Care Health Centerscollaborator
- Memphis Health Centercollaborator
- A Step Ahead Foundationcollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (3)
Family Care Health Center Forest Park
St Louis, Missouri, 63110, United States
Family Care Health Center Carondelet
St Louis, Missouri, 63111, United States
Memphis Health Center
Memphis, Tennessee, 38126, United States
Related Publications (2)
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.
PMID: 31132346DERIVEDBuckel 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.
PMID: 30685287DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachel Paul
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Tessa Madden, MD/MPH
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 16, 2015
Study Start
August 1, 2013
Primary Completion
January 1, 2017
Study Completion
October 31, 2017
Last Updated
June 2, 2020
Results First Posted
October 3, 2018
Record last verified: 2020-05