Innovative Model of Patient-Centered ConTraception (IMPACCT)

May 26, 2020 updated by: Washington University School of Medicine

Implementation of Patient-Centered Contraception Provision in Community Settings

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1008

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Family Care Health Center Forest Park
      • Saint Louis, Missouri, United States, 63111
        • Family Care Health Center Carondelet
    • Tennessee
      • Memphis, Tennessee, United States, 38126
        • Memphis Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: CHOICE Project Structured Contraceptive Counseling
Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
Other: 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.
Behavioral: CHOICE Project Structured Contraceptive Counseling
Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contraceptive Method Use Upon Enrollment Completion
Time Frame: On the day of enrollment
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
Time Frame: On the day of enrollment
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
Time Frame: On the day of enrollment
Number of women choosing an IUD or implant as their preferred contraceptive method
On the day of enrollment
Same Day LARC Insertion
Time Frame: On the day of enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Patient-Centered Outcomes Research Institute
Family Care Health Centers
Memphis Health Center
A Step Ahead Foundation

Investigators

  • Principal Investigator: Tessa Madden, MD/MPH, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201402021
  • PCORI-CD-12-11-4586 (Other Grant/Funding Number: PCORI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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