IMPACCT: Innovative Model of Patient-Centered ConTraception

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02364037
• Collaborator: Family Care Health Centers (Other), Memphis Health Center (Other), A Step Ahead Foundation (Other), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 1,008
• Locations: 3
• Arms: 2
• Duration (Months): 51
• Patients Per Site: 336
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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.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: Aug 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Oct 31, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Unintended Pregnancy [12 months]

   The number of self-reported unintended pregnancies.

Secondary Outcome Measures

1. Contraceptive Method Use Upon Enrollment Completion [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.

2. Desired Contraceptive Method at Enrollment Visit [On the day of enrollment]

   This could be a new method, an existing method, or nothing if participant did not choose a method

3. Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit [On the day of enrollment]

   Number of women choosing an IUD or implant as their preferred contraceptive method

4. Same Day LARC Insertion [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Family Care Health Center Forest Park	Saint Louis	Missouri	United States	63110
2	Family Care Health Center Carondelet	Saint Louis	Missouri	United States	63111
3	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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02364037
• Other Study ID Numbers: 201402021; PCORI-CD-12-11-4586
• First Posted: Feb 16, 2015
• Last Update Posted: Jun 2, 2020
• Last Verified: May 1, 2020

• Keywords provided by Washington University School of Medicine: intrauterine device; subdermal implant; contraceptive counseling
• Additional relevant MeSH terms: Contraceptive Agents

Study Results

Participant Flow

Arm/Group Title	Phase 1: Enhanced Care	Phase 2: Complete CHOICE
Arm/Group Description	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.	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 intrauterine devices (IUDs) and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.
Period Title: Overall Study
STARTED	502	506
COMPLETED	458	453
NOT COMPLETED	44	53

Baseline Characteristics

Arm/Group Title	Phase 1: Enhanced Care	Phase 2: Complete CHOICE	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	502	506	1008
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (6.5)	26.8 (7.4)	26.1 (7.0)
Age, Customized (Count of Participants)
<20 years old	88 17.5%	92 18.2%	180 17.9%
>=20 years old	414 82.5%	414 81.8%	828 82.1%
Sex: Female, Male (Count of Participants)
Female	502 100%	506 100%	1008 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	39 7.8%	66 13%	105 10.4%
Not Hispanic or Latino	460 91.6%	439 86.8%	899 89.2%
Unknown or Not Reported	3 0.6%	1 0.2%	4 0.4%
Race/Ethnicity, Customized (Count of Participants)
Black	374 74.5%	320 63.2%	694 68.8%
White	96 19.1%	159 31.4%	255 25.3%
Other	32 6.4%	27 5.3%	59 5.9%
Region of Enrollment (Count of Participants)
United States	502 100%	506 100%	1008 100%
Education (Count of Participants)
=<High School	317 63.1%	345 68.2%	662 65.7%
Some College	153 30.5%	123 24.3%	276 27.4%
=>College Degree	32 6.4%	38 7.5%	70 6.9%
Marital Status (Count of Participants)
Never Married	394 78.5%	341 67.4%	735 72.9%
Married/Living with Partner	85 16.9%	132 26.1%	217 21.5%
Separated/Divorced/Widowed	23 4.6%	33 6.5%	56 5.6%
Federal Poverty Level (Count of Participants)
<=100% FPL	382 76.1%	384 75.9%	766 76%
101%-200% FPL	102 20.3%	95 18.8%	197 19.5%
>=201% FPL	16 3.2%	24 4.7%	40 4%
Unknown or Not Reported	2 0.4%	3 0.6%	5 0.5%
Parity (Count of Participants)
0	161 32.1%	165 32.6%	326 32.3%
1-2	245 48.8%	221 43.7%	466 46.2%
3+	96 19.1%	120 23.7%	216 21.4%
Unintended Pregnancy (Count of Participants)
At least one prior pregnancy was unintended	257 51.2%	222 43.9%	479 47.5%
No prior pregnancy was unintended	101 20.1%	147 29.1%	248 24.6%
Never pregnant	143 28.5%	135 26.7%	278 27.6%
Missing	1 0.2%	2 0.4%	3 0.3%
Insurance Status (Count of Participants)
None	120 23.9%	149 29.4%	269 26.7%
Public	311 62%	274 54.2%	585 58%
Commercial	70 13.9%	82 16.2%	152 15.1%
Missing	1 0.2%	1 0.2%	2 0.2%
Participant feelings about becoming pregnant in next 12 months (Count of Participants)
Upset	322 64.1%	293 57.9%	615 61%
Neutral	102 20.3%	101 20%	203 20.1%
Pleased	49 9.8%	60 11.9%	109 10.8%
Unsure	29 5.8%	52 10.3%	81 8%
Contraceptive method used immediately prior to enrollment visit (Count of Participants)
IUD/Implant	19 3.8%	46 9.1%	65 6.4%
Depot Medroxyprogesterone Acetate (DMPA)	185 36.9%	125 24.7%	310 30.8%
Contraceptive Pills/Patch/Ring	67 13.3%	37 7.3%	104 10.3%
Condoms	46 9.2%	77 15.2%	123 12.2%
Other	19 3.8%	15 3%	34 3.4%
Nothing	166 33.1%	206 40.7%	372 36.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1: Enhanced Care	Phase 2: Complete CHOICE
Arm/Group Description	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.	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.
Measure Participants	502	506
Count of Participants [Participants]	46 9.2%	25 4.9%

2. Secondary Outcome

Title	Contraceptive Method Use Upon Enrollment Completion
Description	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.
Time Frame	On the day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1: Enhanced Care	Phase 2: Complete CHOICE
Arm/Group Description	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.	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.
Measure Participants	502	506
Hormonal IUD	10 2%	40 7.9%
Copper IUD	2 0.4%	11 2.2%
Implant	17 3.4%	110 21.7%
DMPA	220 43.8%	145 28.7%
Pills/Patch/Ring	113 22.5%	66 13%
Condoms	35 7%	57 11.3%
Other	13 2.6%	8 1.6%
Nothing	92 18.3%	69 13.6%

3. Secondary Outcome

Title	Desired Contraceptive Method at Enrollment Visit
Description	This could be a new method, an existing method, or nothing if participant did not choose a method
Time Frame	On the day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1: Enhanced Care	Phase 2: Complete CHOICE
Arm/Group Description	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.	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.
Measure Participants	502	506
Hormonal IUD	41 8.2%	85 16.8%
Copper IUD	27 5.4%	26 5.1%
Implant	85 16.9%	162 32%
DMPA	192 38.2%	127 25.1%
Pills/Patch/Ring	104 20.7%	53 10.5%
Condoms	13 2.6%	16 3.2%
Other	5 1%	2 0.4%
Nothing	35 7%	35 6.9%

4. Secondary Outcome

Title	Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit
Description	Number of women choosing an IUD or implant as their preferred contraceptive method
Time Frame	On the day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1: Enhanced Care	Phase 2: Complete CHOICE
Arm/Group Description	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.	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.
Measure Participants	502	506
Count of Participants [Participants]	153 30.5%	273 54%

5. Secondary Outcome

Title	Same Day LARC Insertion
Description	Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit.
Time Frame	On the day of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1: Enhanced Care	Phase 2: Complete CHOICE
Arm/Group Description	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.	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.
Measure Participants	153	273
Count of Participants [Participants]	21 4.2%	147 29.1%

Adverse Events

Arm/Group Title	Phase 1: Enhanced Care		Phase 2: Complete CHOICE
Arm/Group Description	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.		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.
All Cause Mortality
	Phase 1: Enhanced Care		Phase 2: Complete CHOICE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Phase 1: Enhanced Care		Phase 2: Complete CHOICE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/502 (0%)		0/506 (0%)
Other (Not Including Serious) Adverse Events
	Phase 1: Enhanced Care		Phase 2: Complete CHOICE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/502 (0%)		0/506 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.