Trial Outcomes & Findings for Innovative Model of Patient-Centered ConTraception (NCT NCT02364037)
NCT ID: NCT02364037
Last Updated: 2020-06-02
Results Overview
The number of self-reported unintended pregnancies.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1008 participants
Primary outcome timeframe
12 months
Results posted on
2020-06-02
Participant Flow
Participant milestones
| Measure |
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.
|
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 intrauterine devices (IUDs) and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.
|
|---|---|---|
|
Overall Study
STARTED
|
502
|
506
|
|
Overall Study
COMPLETED
|
458
|
453
|
|
Overall Study
NOT COMPLETED
|
44
|
53
|
Reasons for withdrawal
| Measure |
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.
|
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 intrauterine devices (IUDs) and implants if she chooses either as her contraceptive method and does not have appropriate insurance coverage.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
37
|
49
|
Baseline Characteristics
Innovative Model of Patient-Centered ConTraception
Baseline characteristics by cohort
| Measure |
Phase 1: Enhanced Care
n=502 Participants
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.
|
Phase 2: Complete CHOICE
n=506 Participants
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
n=1008 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
26.8 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
26.1 years
STANDARD_DEVIATION 7.0 • n=206 Participants
|
|
Age, Customized
Age · <20 years old
|
88 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Age, Customized
Age · >=20 years old
|
414 Participants
n=99 Participants
|
414 Participants
n=107 Participants
|
828 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
502 Participants
n=99 Participants
|
506 Participants
n=107 Participants
|
1008 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
460 Participants
n=99 Participants
|
439 Participants
n=107 Participants
|
899 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
374 Participants
n=99 Participants
|
320 Participants
n=107 Participants
|
694 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
96 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
255 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
502 Participants
n=99 Participants
|
506 Participants
n=107 Participants
|
1008 Participants
n=206 Participants
|
|
Education
=<High School
|
317 Participants
n=99 Participants
|
345 Participants
n=107 Participants
|
662 Participants
n=206 Participants
|
|
Education
Some College
|
153 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
|
Education
=>College Degree
|
32 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Marital Status
Never Married
|
394 Participants
n=99 Participants
|
341 Participants
n=107 Participants
|
735 Participants
n=206 Participants
|
|
Marital Status
Married/Living with Partner
|
85 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
Marital Status
Separated/Divorced/Widowed
|
23 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Federal Poverty Level
<=100% FPL
|
382 Participants
n=99 Participants
|
384 Participants
n=107 Participants
|
766 Participants
n=206 Participants
|
|
Federal Poverty Level
101%-200% FPL
|
102 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Federal Poverty Level
>=201% FPL
|
16 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Federal Poverty Level
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Parity
0
|
161 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
326 Participants
n=206 Participants
|
|
Parity
1-2
|
245 Participants
n=99 Participants
|
221 Participants
n=107 Participants
|
466 Participants
n=206 Participants
|
|
Parity
3+
|
96 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
|
Unintended Pregnancy
At least one prior pregnancy was unintended
|
257 Participants
n=99 Participants
|
222 Participants
n=107 Participants
|
479 Participants
n=206 Participants
|
|
Unintended Pregnancy
No prior pregnancy was unintended
|
101 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Unintended Pregnancy
Never pregnant
|
143 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
278 Participants
n=206 Participants
|
|
Unintended Pregnancy
Missing
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Insurance Status
None
|
120 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
269 Participants
n=206 Participants
|
|
Insurance Status
Public
|
311 Participants
n=99 Participants
|
274 Participants
n=107 Participants
|
585 Participants
n=206 Participants
|
|
Insurance Status
Commercial
|
70 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
152 Participants
n=206 Participants
|
|
Insurance Status
Missing
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Participant feelings about becoming pregnant in next 12 months
Upset
|
322 Participants
n=99 Participants
|
293 Participants
n=107 Participants
|
615 Participants
n=206 Participants
|
|
Participant feelings about becoming pregnant in next 12 months
Neutral
|
102 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
|
Participant feelings about becoming pregnant in next 12 months
Pleased
|
49 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Participant feelings about becoming pregnant in next 12 months
Unsure
|
29 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Contraceptive method used immediately prior to enrollment visit
IUD/Implant
|
19 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Contraceptive method used immediately prior to enrollment visit
Depot Medroxyprogesterone Acetate (DMPA)
|
185 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
310 Participants
n=206 Participants
|
|
Contraceptive method used immediately prior to enrollment visit
Contraceptive Pills/Patch/Ring
|
67 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Contraceptive method used immediately prior to enrollment visit
Condoms
|
46 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Contraceptive method used immediately prior to enrollment visit
Other
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Contraceptive method used immediately prior to enrollment visit
Nothing
|
166 Participants
n=99 Participants
|
206 Participants
n=107 Participants
|
372 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe number of self-reported unintended pregnancies.
Outcome measures
| Measure |
Phase 1: Enhanced Care
n=502 Participants
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.
|
Phase 2: Complete CHOICE
n=506 Participants
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.
|
|---|---|---|
|
Unintended Pregnancy
|
46 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: On the day of enrollmentThis 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.
Outcome measures
| Measure |
Phase 1: Enhanced Care
n=502 Participants
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.
|
Phase 2: Complete CHOICE
n=506 Participants
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.
|
|---|---|---|
|
Contraceptive Method Use Upon Enrollment Completion
Hormonal IUD
|
10 Participants
|
40 Participants
|
|
Contraceptive Method Use Upon Enrollment Completion
Copper IUD
|
2 Participants
|
11 Participants
|
|
Contraceptive Method Use Upon Enrollment Completion
Implant
|
17 Participants
|
110 Participants
|
|
Contraceptive Method Use Upon Enrollment Completion
DMPA
|
220 Participants
|
145 Participants
|
|
Contraceptive Method Use Upon Enrollment Completion
Pills/Patch/Ring
|
113 Participants
|
66 Participants
|
|
Contraceptive Method Use Upon Enrollment Completion
Condoms
|
35 Participants
|
57 Participants
|
|
Contraceptive Method Use Upon Enrollment Completion
Other
|
13 Participants
|
8 Participants
|
|
Contraceptive Method Use Upon Enrollment Completion
Nothing
|
92 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: On the day of enrollmentThis could be a new method, an existing method, or nothing if participant did not choose a method
Outcome measures
| Measure |
Phase 1: Enhanced Care
n=502 Participants
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.
|
Phase 2: Complete CHOICE
n=506 Participants
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.
|
|---|---|---|
|
Desired Contraceptive Method at Enrollment Visit
Hormonal IUD
|
41 Participants
|
85 Participants
|
|
Desired Contraceptive Method at Enrollment Visit
Copper IUD
|
27 Participants
|
26 Participants
|
|
Desired Contraceptive Method at Enrollment Visit
Implant
|
85 Participants
|
162 Participants
|
|
Desired Contraceptive Method at Enrollment Visit
DMPA
|
192 Participants
|
127 Participants
|
|
Desired Contraceptive Method at Enrollment Visit
Pills/Patch/Ring
|
104 Participants
|
53 Participants
|
|
Desired Contraceptive Method at Enrollment Visit
Condoms
|
13 Participants
|
16 Participants
|
|
Desired Contraceptive Method at Enrollment Visit
Other
|
5 Participants
|
2 Participants
|
|
Desired Contraceptive Method at Enrollment Visit
Nothing
|
35 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: On the day of enrollmentNumber of women choosing an IUD or implant as their preferred contraceptive method
Outcome measures
| Measure |
Phase 1: Enhanced Care
n=502 Participants
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.
|
Phase 2: Complete CHOICE
n=506 Participants
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.
|
|---|---|---|
|
Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit
|
153 Participants
|
273 Participants
|
SECONDARY outcome
Timeframe: On the day of enrollmentOf the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit.
Outcome measures
| Measure |
Phase 1: Enhanced Care
n=153 Participants
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.
|
Phase 2: Complete CHOICE
n=273 Participants
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.
|
|---|---|---|
|
Same Day LARC Insertion
|
21 Participants
|
147 Participants
|
Adverse Events
Phase 1: Enhanced Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Complete CHOICE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place