Innovative Model of Patient-Centered ConTraception

Contraception Clinical Trial

— IMPACCT  

Official title:

Implementation of Patient-Centered Contraception Provision in Community Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364037
• Other study ID #: 201402021
• Secondary ID: PCORI-CD-12-11-4
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1008
• Est. completion date: October 31, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Unintended Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memphis Health Center	Memphis	Tennessee
United States	Family Care Health Center Carondelet	Saint Louis	Missouri
United States	Family Care Health Center Forest Park	Saint Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	A Step Ahead Foundation, Family Care Health Centers, Memphis Health Center, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unintended Pregnancy	The number of self-reported unintended pregnancies.	12 months
Secondary	Contraceptive Method Use Upon Enrollment Completion	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
Secondary	Desired Contraceptive Method at Enrollment Visit	This could be a new method, an existing method, or nothing if participant did not choose a method	On the day of enrollment
Secondary	Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit	Number of women choosing an IUD or implant as their preferred contraceptive method	On the day of enrollment
Secondary	Same Day LARC Insertion	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