Trial Outcomes & Findings for Patient-Centered Reproductive Decision Support Tool for Women Veterans (NCT NCT04584294)
NCT ID: NCT04584294
Last Updated: 2025-11-06
Results Overview
Self-report of whether a discussion occurred during the scheduled primary care visit about pregnancy goals, prepregnancy health, or contraception that included shared decision making (SDM). SDM is measured by participant self-report with the CollaboRATE scale, which uses three 5-point Likert scale questions to assess SDM (score 0-12, with higher scores indicating more shared decision making; SDM defined using a top box score).
COMPLETED
NA
465 participants
Within one month post-visit
2025-11-06
Participant Flow
VA primary care providers from 12 VA healthcare systems were enrolled and randomized to the intervention or control arm of the study. Veteran patients were subsequently recruited and enrolled into the study if they had an upcoming, scheduled appointment with a study provider. Veterans were automatically assigned to the study arm of the provider they were scheduled to see.
Participant milestones
| Measure |
Usual Care Patients
Providers were randomized to the intervention (MyPath) or usual care arm of the study. Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
Intervention (MyPath)
Providers were randomized to the intervention (MyPath) or usual care arm of the study. Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
|---|---|---|
|
Enrollment to Post-Visit - PATIENTS
STARTED
|
182
|
209
|
|
Enrollment to Post-Visit - PATIENTS
COMPLETED
|
159
|
190
|
|
Enrollment to Post-Visit - PATIENTS
NOT COMPLETED
|
23
|
19
|
|
3-month Follow-up - PATIENTS
STARTED
|
159
|
190
|
|
3-month Follow-up - PATIENTS
COMPLETED
|
158
|
188
|
|
3-month Follow-up - PATIENTS
NOT COMPLETED
|
1
|
2
|
|
6-month Follow-up - PATIENTS
STARTED
|
158
|
188
|
|
6-month Follow-up - PATIENTS
COMPLETED
|
156
|
184
|
|
6-month Follow-up - PATIENTS
NOT COMPLETED
|
2
|
4
|
|
Enrollment to Post-Visit - PROVIDERS
STARTED
|
37
|
37
|
|
Enrollment to Post-Visit - PROVIDERS
COMPLETED
|
32
|
34
|
|
Enrollment to Post-Visit - PROVIDERS
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Usual Care Patients
Providers were randomized to the intervention (MyPath) or usual care arm of the study. Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
Intervention (MyPath)
Providers were randomized to the intervention (MyPath) or usual care arm of the study. Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
|---|---|---|
|
Enrollment to Post-Visit - PATIENTS
Withdrawal by Subject
|
4
|
3
|
|
Enrollment to Post-Visit - PATIENTS
Did not attend scheduled appointment with primary care provider
|
18
|
16
|
|
Enrollment to Post-Visit - PATIENTS
Pregnancy
|
1
|
0
|
|
3-month Follow-up - PATIENTS
Withdrawal by Subject
|
1
|
2
|
|
6-month Follow-up - PATIENTS
Withdrawal by Subject
|
2
|
4
|
|
Enrollment to Post-Visit - PROVIDERS
No Veterans Enrolled in Study
|
5
|
3
|
Baseline Characteristics
Patient-Centered Reproductive Decision Support Tool for Women Veterans
Baseline characteristics by cohort
| Measure |
Intervention (MyPath) Patients
n=190 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care Patients
n=159 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
Intervention (MyPath) Providers
n=34 Participants
This arm includes providers who were randomized to the intervention arm of the study and had at least one patient subsequently enroll.
|
Usual Care Providers
n=32 Participants
This arm includes providers who were randomized to the usual care arm of the study and had at least one patient subsequently enroll.
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=49 Participants
|
31 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
77 Participants
n=12 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
190 Participants
n=49 Participants
|
159 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
413 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=12 Participants
|
|
Age, Continuous
|
35.5 years of age
n=49 Participants
|
35.1 years of age
n=50 Participants
|
47.7 years of age
n=50 Participants
|
47.7 years of age
n=50 Participants
|
37.3 years of age
n=12 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=49 Participants
|
159 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
29 Participants
n=50 Participants
|
410 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
5 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=49 Participants
|
7 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
20 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=49 Participants
|
128 Participants
n=50 Participants
|
30 Participants
n=50 Participants
|
30 Participants
n=50 Participants
|
338 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
8 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=49 Participants
|
8 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
29 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=49 Participants
|
57 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
152 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=49 Participants
|
73 Participants
n=50 Participants
|
17 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
170 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=49 Participants
|
13 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
34 Participants
n=12 Participants
|
|
Sexual Orientation
Straight/Heterosexual
|
149 Participants
n=49 Participants
|
120 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
269 Participants
n=12 Participants
|
|
Sexual Orientation
Lesbian/Gay
|
14 Participants
n=49 Participants
|
14 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
28 Participants
n=12 Participants
|
|
Sexual Orientation
Bisexual/Pansexual
|
22 Participants
n=49 Participants
|
19 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
41 Participants
n=12 Participants
|
|
Sexual Orientation
Other
|
5 Participants
n=49 Participants
|
6 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
11 Participants
n=12 Participants
|
|
Sexual Orientation
Missing or Unknown
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
66 Participants
n=12 Participants
|
|
Education
Some high school or GED
|
17 Participants
n=49 Participants
|
11 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
28 Participants
n=12 Participants
|
|
Education
Some college or Associate's Degree
|
81 Participants
n=49 Participants
|
61 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
142 Participants
n=12 Participants
|
|
Education
Bachelor's Degree or Higher
|
91 Participants
n=49 Participants
|
87 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
178 Participants
n=12 Participants
|
|
Education
Missing or Unknown
|
1 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
67 Participants
n=12 Participants
|
|
Health Insurance Status
Yes (separate health insurance)
|
95 Participants
n=49 Participants
|
65 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
160 Participants
n=12 Participants
|
|
Health Insurance Status
No (VA coverage only)
|
94 Participants
n=49 Participants
|
94 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
188 Participants
n=12 Participants
|
|
Health Insurance Status
Missing or Unknown
|
1 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
67 Participants
n=12 Participants
|
|
Current thoughts/desires regarding pregnancy
Desires pregnancy now
|
21 Participants
n=49 Participants
|
19 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
40 Participants
n=12 Participants
|
|
Current thoughts/desires regarding pregnancy
Not trying to get pregnant, but okay with it
|
23 Participants
n=49 Participants
|
27 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
50 Participants
n=12 Participants
|
|
Current thoughts/desires regarding pregnancy
Not now, but desires pregnancy in future
|
55 Participants
n=49 Participants
|
46 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
101 Participants
n=12 Participants
|
|
Current thoughts/desires regarding pregnancy
Does not desire a future pregnancy (ever)
|
60 Participants
n=49 Participants
|
45 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
105 Participants
n=12 Participants
|
|
Provider Type
Does not apply (patients)
|
190 Participants
n=49 Participants
|
159 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
349 Participants
n=12 Participants
|
|
Current thoughts/desires regarding pregnancy
Unsure about pregnancy desires
|
31 Participants
n=49 Participants
|
22 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
53 Participants
n=12 Participants
|
|
Current thoughts/desires regarding pregnancy
Missing or Unknown
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
66 Participants
n=12 Participants
|
|
Sex with a male partner, past 12 months
Yes
|
147 Participants
n=49 Participants
|
117 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
264 Participants
n=12 Participants
|
|
Sex with a male partner, past 12 months
No
|
43 Participants
n=49 Participants
|
41 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
84 Participants
n=12 Participants
|
|
Sex with a male partner, past 12 months
Missing or Unknown
|
0 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
67 Participants
n=12 Participants
|
|
Participants enrolled per study provider
|
5.6 Veteran participants per provider
n=49 Participants
|
5.0 Veteran participants per provider
n=50 Participants
|
5.6 Veteran participants per provider
n=50 Participants
|
5.0 Veteran participants per provider
n=50 Participants
|
5.3 Veteran participants per provider
n=12 Participants
|
|
Participants enrolled by study provider practice setting
Women's clinic provider
|
73 Participants
n=49 Participants
|
56 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
146 Participants
n=12 Participants
|
|
Participants enrolled by study provider practice setting
Non-women's clinic provider
|
117 Participants
n=49 Participants
|
103 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
24 Participants
n=50 Participants
|
269 Participants
n=12 Participants
|
|
Appointment modality
In-person appointment
|
156 Participants
n=49 Participants
|
122 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
278 Participants
n=12 Participants
|
|
Appointment modality
Virtual/telephone appointment
|
34 Participants
n=49 Participants
|
37 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
71 Participants
n=12 Participants
|
|
Appointment modality
Does not apply (for providers)
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
66 Participants
n=12 Participants
|
|
History of military deployment
Yes (deployed)
|
108 Participants
n=49 Participants
|
80 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
188 Participants
n=12 Participants
|
|
History of prior appointment(s) with study provider
Yes (prior appointment(s) documented)
|
135 Participants
n=49 Participants
|
136 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
271 Participants
n=12 Participants
|
|
History of prior appointment(s) with study provider
No (no prior appointment(s) documented)
|
55 Participants
n=49 Participants
|
23 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
78 Participants
n=12 Participants
|
|
History of prior appointment(s) with study provider
Does not apply (providers)
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
66 Participants
n=12 Participants
|
|
Annual household income
<$20,000
|
9 Participants
n=49 Participants
|
9 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
18 Participants
n=12 Participants
|
|
Annual household income
$20,000-$79,999
|
104 Participants
n=49 Participants
|
93 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
197 Participants
n=12 Participants
|
|
Annual household income
>=$80,000
|
67 Participants
n=49 Participants
|
52 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
119 Participants
n=12 Participants
|
|
Annual household income
Missing
|
10 Participants
n=49 Participants
|
5 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
81 Participants
n=12 Participants
|
|
History of military deployment
No (never deployed)
|
81 Participants
n=49 Participants
|
79 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
160 Participants
n=12 Participants
|
|
History of military deployment
Missing
|
1 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
67 Participants
n=12 Participants
|
|
History of military sexual trauma (MST)
Yes
|
78 Participants
n=49 Participants
|
71 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
149 Participants
n=12 Participants
|
|
History of military sexual trauma (MST)
No
|
112 Participants
n=49 Participants
|
88 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
200 Participants
n=12 Participants
|
|
History of military sexual trauma (MST)
Does not apply (providers)
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
66 Participants
n=12 Participants
|
|
Ever experienced racial discrimination in VA care
Yes
|
37 Participants
n=49 Participants
|
20 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
57 Participants
n=12 Participants
|
|
Ever experienced racial discrimination in VA care
No
|
150 Participants
n=49 Participants
|
137 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
287 Participants
n=12 Participants
|
|
Ever experienced racial discrimination in VA care
Missing
|
3 Participants
n=49 Participants
|
2 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
71 Participants
n=12 Participants
|
|
Satisfaction with VA care, past 12 months
Yes
|
116 Participants
n=49 Participants
|
104 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
220 Participants
n=12 Participants
|
|
Satisfaction with VA care, past 12 months
No
|
69 Participants
n=49 Participants
|
54 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
123 Participants
n=12 Participants
|
|
Satisfaction with VA care, past 12 months
Missing
|
5 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
72 Participants
n=12 Participants
|
|
Has >=1 chronic medical condition (self-report)
>=1 chronic medical condition
|
131 Participants
n=49 Participants
|
110 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
241 Participants
n=12 Participants
|
|
Has >=1 chronic medical condition (self-report)
No chronic medical condition
|
59 Participants
n=49 Participants
|
49 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
108 Participants
n=12 Participants
|
|
Has >=1 chronic medical condition (self-report)
Missing
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
66 Participants
n=12 Participants
|
|
Has >=1 mental health condition (self-report)
>=1 mental health condition
|
158 Participants
n=49 Participants
|
140 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
298 Participants
n=12 Participants
|
|
Has >=1 mental health condition (self-report)
No mental health condition
|
32 Participants
n=49 Participants
|
19 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
51 Participants
n=12 Participants
|
|
Has >=1 mental health condition (self-report)
Missing
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
34 Participants
n=50 Participants
|
32 Participants
n=50 Participants
|
66 Participants
n=12 Participants
|
|
Provider Type
Physician
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
21 Participants
n=50 Participants
|
24 Participants
n=50 Participants
|
45 Participants
n=12 Participants
|
|
Provider Type
Nurse Practitioner
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
16 Participants
n=12 Participants
|
|
Provider Type
Physician Assistant
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
5 Participants
n=12 Participants
|
|
Years practicing in VA
<5 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
21 Participants
n=12 Participants
|
|
Years practicing in VA
5-10 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
21 Participants
n=12 Participants
|
|
Years practicing in VA
>=10 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
23 Participants
n=12 Participants
|
|
Years practicing in VA
Missing
|
190 Participants
n=49 Participants
|
159 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
350 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Within one month post-visitPopulation: Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.
Self-report of whether a discussion occurred during the scheduled primary care visit about pregnancy goals, prepregnancy health, or contraception that included shared decision making (SDM). SDM is measured by participant self-report with the CollaboRATE scale, which uses three 5-point Likert scale questions to assess SDM (score 0-12, with higher scores indicating more shared decision making; SDM defined using a top box score).
Outcome measures
| Measure |
Intervention (MyPath)
n=190 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=159 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
Yes (discussion with SDM occurred)
|
29 Participants
|
20 Participants
|
|
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
No (discussion with SDM did not occur)
|
139 Participants
|
119 Participants
|
|
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
Missing (lost to follow-up for the post-visit survey)
|
21 Participants
|
17 Participants
|
|
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
Missing (declined to answer one or more outcome measure questions)
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within one month post-visitPopulation: Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.
Self-report of whether a discussion of pregnancy goals, prepregnancy health, or contraception occurred during the scheduled primary care visit, regardless of occurrence of SDM.
Outcome measures
| Measure |
Intervention (MyPath)
n=190 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=159 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Occurrence of Reproductive Needs Discussion
Missing (declined one or more measure questions)
|
1 Participants
|
0 Participants
|
|
Occurrence of Reproductive Needs Discussion
Yes (discussion occurred)
|
119 Participants
|
93 Participants
|
|
Occurrence of Reproductive Needs Discussion
No (discussion did not occur)
|
49 Participants
|
49 Participants
|
|
Occurrence of Reproductive Needs Discussion
Missing (lost to follow-up for post-visit survey)
|
21 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Within one month post-visitPopulation: Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.
Assessed with a modified version of the validated 5-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale, which uses five Likert scale questions ranging from 1 to 5 (score 5-25, with higher scores indicating higher levels of perceived efficacy).
Outcome measures
| Measure |
Intervention (MyPath)
n=190 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=159 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Perceived Self-efficacy in Communicating With Providers
|
19.8 Score
Standard Deviation 4.8
|
20.6 Score
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Within one month post-visitPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Participant responses to 14 items assessing knowledge of fertility, prepregnancy health, and contraception. The measure is self-developed and derived from previously published assessments of fertility and contraceptive knowledge. Responses will be coded as correct vs. incorrect, with "don't know" coded as incorrect (score 0-14, with higher scores indicating more accurate knowledge).
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Reproductive Health Knowledge
|
7.94 Number correct
Standard Deviation 2.64
|
7.89 Number correct
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: Within one month post-visitPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Assessed with the Decision Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16-items with 5-point Likert scale response options ranging from 0-4. Scores are converted to range from 0 (no decisional conflict) to 100 (highest decisional conflict). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Contraceptive Decision Conflict
|
16.94 Score
Standard Deviation 17.57
|
20.04 Score
Standard Deviation 20.67
|
SECONDARY outcome
Timeframe: Within one month post-visitPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Confidence That Contraceptive Method is "Right for me."
|
4.29 Scores on a scale
Standard Deviation 1.05
|
4.29 Scores on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Within one month post-visitPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Self-report of continuing or changing to a prescription or procedural method after their visit. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Choice of Prescription or Procedural Contraceptive Method
Non-prescription or no method
|
25 Participants
|
17 Participants
|
|
Choice of Prescription or Procedural Contraceptive Method
Missing (lost to follow-up)
|
7 Participants
|
10 Participants
|
|
Choice of Prescription or Procedural Contraceptive Method
Missing (did not answer question(s))
|
2 Participants
|
2 Participants
|
|
Choice of Prescription or Procedural Contraceptive Method
Prescription or procedural method
|
52 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Within one month post-visitPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Self-report of continuing or changing to a procedural method after their visit. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Choice of Procedural Contraceptive Method
Procedural method
|
28 Participants
|
20 Participants
|
|
Choice of Procedural Contraceptive Method
Non-procedural or no method
|
49 Participants
|
32 Participants
|
|
Choice of Procedural Contraceptive Method
Missing (lost to follow-up for post-visit survey)
|
7 Participants
|
10 Participants
|
|
Choice of Procedural Contraceptive Method
Missing (did not answer question(s))
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Self-reported use of a prescription or procedural method at follow-up. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Use of Prescription or Procedural Contraceptive Method
Prescription or procedural method
|
41 Participants
|
28 Participants
|
|
Use of Prescription or Procedural Contraceptive Method
Non-prescription or no method
|
23 Participants
|
14 Participants
|
|
Use of Prescription or Procedural Contraceptive Method
Missing (lost to follow-up 6-month survey)
|
22 Participants
|
21 Participants
|
|
Use of Prescription or Procedural Contraceptive Method
Missing (did not answer question(s) due to pregnancy)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Self-reported use of a procedural method at follow-up. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Use of Procedural Contraceptive Method
Procedural method
|
22 Participants
|
17 Participants
|
|
Use of Procedural Contraceptive Method
Non-procedural or no method
|
42 Participants
|
25 Participants
|
|
Use of Procedural Contraceptive Method
Missing (lost to follow-up 6-month survey)
|
22 Participants
|
21 Participants
|
|
Use of Procedural Contraceptive Method
Missing (did not answer question(s) due to pregnancy)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Self-reported use of a contraceptive method over the past 6 months without a gap of greater than 4 weeks. This combines self-reported use at 3 months and 6 months. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. For participants lost to follow-up at the 6 month timepoint, their 6-month values will be singly imputed, carrying forward 3-month continuous use reports when those data are available.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Continuous Use of Any Contraception
Continuous use over 6 months
|
62 Participants
|
46 Participants
|
|
Continuous Use of Any Contraception
Non-continuous use over 6 months
|
13 Participants
|
6 Participants
|
|
Continuous Use of Any Contraception
Missing (did not answer question(s) due to pregnancy)
|
0 Participants
|
1 Participants
|
|
Continuous Use of Any Contraception
Missing (lost to follow-up for 6 month survey)
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Self-reported use of a prescription or procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Continuous Use of Prescription or Procedural Contraception
Continuous Use of Rx/Procedural Contraception
|
45 Participants
|
31 Participants
|
|
Continuous Use of Prescription or Procedural Contraception
Non-Continuous Use of Rx/Procedural Contraception
|
30 Participants
|
21 Participants
|
|
Continuous Use of Prescription or Procedural Contraception
Missing (lost to follow-up for 6-month survey)
|
11 Participants
|
11 Participants
|
|
Continuous Use of Prescription or Procedural Contraception
Missing (did not answer question(s) due to pregnancy)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsSelf-reported use of a procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Continuous Use of Procedural Contraception
Continuous Use of Procedural Contraception
|
27 Participants
|
19 Participants
|
|
Continuous Use of Procedural Contraception
Non-continuous Use of Procedural Contraception
|
48 Participants
|
33 Participants
|
|
Continuous Use of Procedural Contraception
Missing (lost to follow-up for 6-month survey)
|
11 Participants
|
11 Participants
|
|
Continuous Use of Procedural Contraception
Missing (did not answer question(s) due to pregnancy)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Assessed using a single question ("How satisfied are you with your current birth control method") with Likert response options from 1 (very dissatisfied) to 5 (very satisfied). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. While this outcome was measured at 6 months, for participants lost to follow-up at 6 months, we singly imputed these data by pulling forward their 3-month satisfaction, when available.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Contraceptive Method Satisfaction
|
4.28 Score
Standard Deviation 1.01
|
4.35 Score
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Proportion of participants who self-report an unplanned pregnancy, as determined by responses to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items measuring attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of \<10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Incidence of Unplanned Pregnancy
Unplanned pregnancy
|
0 Participants
|
1 Participants
|
|
Incidence of Unplanned Pregnancy
No unplanned pregnancy
|
64 Participants
|
42 Participants
|
|
Incidence of Unplanned Pregnancy
Missing (lost to follow-up 6 month survey)
|
22 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Confidence That Current Contraceptive Method is "Right for me."
|
4.26 Scores on a scale
Standard Deviation 0.90
|
4.21 Scores on a scale
Standard Deviation 0.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Self-reported contraception use among participants at 6 months that is consistent with their orientation towards pregnancy at 6-months (desires pregnancy now, not trying but OK with it, desires pregnancy later but not now, never desires pregnancy, not sure), regardless of their intention at baseline. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. For Veterans who desire pregnancy now, goals-concordant contraceptive use is defined as not using contraception. For Veterans who desire pregnancy later, never, or are unsure, goals-concordant contraceptive use is defined as using contraception. For Veterans who are not trying to get pregnant but would be OK with it, goals-concordant contraceptive use is defined as either using or not using contraception.
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Goals-concordant Contraceptive Use
Yes (goals-concordant contraceptive use)
|
50 Participants
|
38 Participants
|
|
Goals-concordant Contraceptive Use
No (not goals-concordant contraceptive use)
|
14 Participants
|
4 Participants
|
|
Goals-concordant Contraceptive Use
Missing (lost to follow-up at 6-months)
|
22 Participants
|
21 Participants
|
|
Goals-concordant Contraceptive Use
Missing (not asked question(s) due to pregnancy)
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within one month post-visitPopulation: This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).
Participant responses to 8 items assessing knowledge of contraception. The measure derived from previously published assessments of contraceptive knowledge. Responses will be coded as correct vs. incorrect, with "don't know" coded as incorrect (score 0-8, with higher scores indicating more accurate knowledge).
Outcome measures
| Measure |
Intervention (MyPath)
n=86 Participants
Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.
|
Usual Care
n=64 Participants
Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.
|
|---|---|---|
|
Contraceptive Knowledge
|
4.42 Score
Standard Deviation 1.72
|
4.15 Score
Standard Deviation 1.54
|
Adverse Events
Intervention (MyPath) Patients
Usual Care Patients
Intervention (MyPath) Providers
Usual Care Providers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisa Callegari (Principal Investigator)
VA Puget Sound Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place