Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Innovative Model of Patient-Centered ConTraception (IMPACCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02364037
Recruitment Status : Completed
First Posted : February 16, 2015
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Collaborators:
Family Care Health Centers
Memphis Health Center
A Step Ahead Foundation
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Contraception Unintended Pregnancy Behavioral: CHOICE Project Structured Contraceptive Counseling Behavioral: Contraceptive Education Session Device: Cost Support for IUDs and implants Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1008 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Implementation of Patient-Centered Contraception Provision in Community Settings
Study Start Date : August 2013
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364037


Locations
Layout table for location information
United States, Missouri
Family Care Health Center Forest Park
Saint Louis, Missouri, United States, 63110
Family Care Health Center Carondelet
Saint Louis, Missouri, United States, 63111
United States, Tennessee
Memphis Health Center
Memphis, Tennessee, United States, 38126
Sponsors and Collaborators
Washington University School of Medicine
Family Care Health Centers
Memphis Health Center
A Step Ahead Foundation
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Tessa Madden, MD/MPH Washington University School of Medicine

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02364037     History of Changes
Other Study ID Numbers: 201402021
PCORI-CD-12-11-4586 ( Other Grant/Funding Number: PCORI )
First Posted: February 16, 2015    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: September 2018
Keywords provided by Washington University School of Medicine:
intrauterine device
subdermal implant
contraceptive counseling
Additional relevant MeSH terms:
Layout table for MeSH terms
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs