Contraception, Contraception Behavior, Prepregnancy Health, Reproductive Health
Conditions
Keywords
Shared decision making, Primary care, Patient decision support, Patient-centered outcomes research, Reproductive autonomy, Patient-Centered Care, Provider-Patient Communication
Brief summary
The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.
Detailed description
Counseling and care that supports individuals' ability to achieve their reproductive goals is an essential component of primary care. National organizations, including the Centers for Disease Control and Prevention (CDC), recommend that clinicians routinely engage in patient-centered conversations about reproductive goals and offer care to help optimize health and well-being prior to desired pregnancies and to prevent unwanted pregnancy and births. This counseling is particularly critical for women Veterans, who face elevated risks of adverse pregnancy and birth outcomes due to a high prevalence of chronic medical and mental health conditions as well as psychosocial stressors including sexual trauma histories, intimate partner violence, and homelessness. Moreover, stark racial/ethnic disparities in pregnancy outcomes are well-documented, and nearly half of reproductive-aged women Veterans are minority race/ethnicity. Despite these national recommendations, however, conversations about reproductive needs are often absent in primary care both outside and within the VA, and the conversations that do happen frequently fail to incorporate women's values and preferences. Interventions are needed to improve both the frequency and quality of counseling about reproductive needs in primary care settings. This study will investigate the effect of a novel, web-based, patient-facing decision support tool designed to be used prior to VA primary care visits to help women Veterans with reproductive capacity consider their reproductive goals; improve their knowledge about fertility, contraception, and prepregnancy health risks; align contraceptive decisions with their preferences and goals; and engage in shared decision making (SDM) with providers. The investigators will conduct a multi-site randomized controlled trial (RCT) clustered at the provider level among VA primary care providers and their reproductive-aged women Veteran patients. Study outcomes will be assessed among participants shortly after their scheduled appointment and at 3- and 6-months follow up. The study will test the primary hypothesis that participants who receive the tool weblink prior to visits will be more likely to report patient-centered conversations about their reproductive needs at their visit. The investigators also hypothesize that intervention participants will report higher perceived self-efficacy in communicating with providers, reproductive health knowledge, contraception decision quality, and contraception utilization. Exploratory outcomes include behaviors to modify preconception health risks among participants considering pregnancy in the future and intervention effects by race/ethnicity. The study will also collect quantitative and qualitative data to assess the feasibility of implementing the tool more widely in VA primary care settings.
Interventions
BEHAVIORALMyPath Web-Based Informational and Decision Support Tool
The MyPath Decision Support Tool includes the following sections and features: * Questions to capture reproductive goals and orientations towards a potential pregnancy * Education modules about the menstrual cycle, fertility, and prepregnancy health with the opportunity to flag topics that are relevant and of interest to the patient * A contraceptive decision module that provides education, elicits patient preferences about different aspects of contraception, and suggests methods most appropriate based on the patient's preferences * A feature for adding free-text questions that patients may have for their provider * An email with a summary page that the patient can bring to a visit to guide discussions with primary care providers about reproductive needs
Sponsors
Kaiser Permanente
University of California, San Francisco
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistants (RAs) who assess outcomes will remain blinded to provider study arm assignment throughout the trial. RAs will be blinded to patient study arm assignment during patient enrollment and baseline surveys but will become unblinded to individual patient study arm assignment during the course of outcome assessment.
Intervention model description
Provider participants are randomized to one of two groups - usual care or intervention group - at the start of the study, prior to any Veteran enrollment. Subsequently, Veterans scheduled to see these providers will be enrolled as patient participants and automatically allocated to the study group of their scheduled provider.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
Patients: * Female sex identified in medical record * 18 - 44 years old * Has a scheduled VA medical appointment with an enrolled study provider * Has at least one valid telephone number available in medical record * Interested in receiving information or talking with their provider about pregnancy and/or birth control Providers: * Primary Care Provider (MD, Nurse Practitioner, Physician Assistant) at a study site * Designated as a Women's Health Provider \[defined in VA directive 1330.01 as primary care providers who have demonstrated proficiency (e.g. pelvic exams and pap smears) in women's health and who have at least 10% of their panel comprised of women\] * Completed appointments with at least 30 unique female patients ages 18-44 in the past year at a study site
Exclusion criteria
Patients: * Currently pregnant * Medical record or self-reported history of hysterectomy, bilateral oophorectomy; or self-report of not having a uterus * Unable to communicate in English * Impaired decision-making * Used the decision tool prior to study enrollment (e.g. during pilot testing of the tool) Providers: * Previous involvement as a provider in MyPath pilot work (identified by the PI) * Medical trainee * Self-report that they have plans to leave VA, go on extended leave, retire, stop primary care practice, or change VA site in the 18 months following their enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | Within one month post-visit | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Reproductive Needs Discussion | Within one month post-visit | 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. |
| Perceived Self-efficacy in Communicating With Providers | Within one month post-visit | 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). |
| Reproductive Health Knowledge | Within one month post-visit | 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). |
| Contraceptive Decision Conflict | Within one month post-visit | 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. |
| Confidence That Contraceptive Method is Right for me. | Within one month post-visit | 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. |
| Choice of Prescription or Procedural Contraceptive Method | Within one month post-visit | 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. |
| Choice of Procedural Contraceptive Method | Within one month post-visit | 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. |
| Use of Prescription or Procedural Contraceptive Method | 6 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. |
| Incidence of Unplanned Pregnancy | 6 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. |
| Confidence That Current Contraceptive Method is Right for me. | 6 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. |
| Use of Procedural Contraceptive Method | 6 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. |
| Continuous Use of Any Contraception | 6 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. |
| Continuous Use of Prescription or Procedural Contraception | 6 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. |
| Continuous Use of Procedural Contraception | 6 months | Self-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. |
| Contraceptive Method Satisfaction | 6 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Goals-concordant Contraceptive Use | 6 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. |
| Contraceptive Knowledge | Within one month post-visit | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention (MyPath) Patients 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. | 190 |
| Usual Care Patients Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. | 159 |
| Intervention (MyPath) Providers This arm includes providers who were randomized to the intervention arm of the study and had at least one patient subsequently enroll. | 34 |
| Usual Care Providers This arm includes providers who were randomized to the usual care arm of the study and had at least one patient subsequently enroll. | 32 |
| Total | 415 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-month Follow-up - PATIENTS | Withdrawal by Subject | 2 | 1 |
| 6-month Follow-up - PATIENTS | Withdrawal by Subject | 4 | 2 |
| Enrollment to Post-Visit - PATIENTS | Did not attend scheduled appointment with primary care provider | 16 | 18 |
| Enrollment to Post-Visit - PATIENTS | Pregnancy | 0 | 1 |
| Enrollment to Post-Visit - PATIENTS | Withdrawal by Subject | 3 | 4 |
| Enrollment to Post-Visit - PROVIDERS | No Veterans Enrolled in Study | 3 | 5 |
Baseline characteristics
| Characteristic | Intervention (MyPath) Patients | Usual Care Patients | Intervention (MyPath) Providers | Usual Care Providers | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 190 Participants | 159 Participants | 32 Participants | 32 Participants | 413 Participants |
| Age, Continuous | 35.5 years of age | 35.1 years of age | 47.7 years of age | 47.7 years of age | 37.3 years of age |
| Annual household income <$20,000 | 9 Participants | 9 Participants | 0 Participants | 0 Participants | 18 Participants |
| Annual household income $20,000-$79,999 | 104 Participants | 93 Participants | 0 Participants | 0 Participants | 197 Participants |
| Annual household income >=$80,000 | 67 Participants | 52 Participants | 0 Participants | 0 Participants | 119 Participants |
| Annual household income Missing | 10 Participants | 5 Participants | 34 Participants | 32 Participants | 81 Participants |
| Appointment modality Does not apply (for providers) | 0 Participants | 0 Participants | 34 Participants | 32 Participants | 66 Participants |
| Appointment modality In-person appointment | 156 Participants | 122 Participants | 0 Participants | 0 Participants | 278 Participants |
| Appointment modality Virtual/telephone appointment | 34 Participants | 37 Participants | 0 Participants | 0 Participants | 71 Participants |
| Current thoughts/desires regarding pregnancy Desires pregnancy now | 21 Participants | 19 Participants | 0 Participants | 0 Participants | 40 Participants |
| Current thoughts/desires regarding pregnancy Does not desire a future pregnancy (ever) | 60 Participants | 45 Participants | 0 Participants | 0 Participants | 105 Participants |
| Current thoughts/desires regarding pregnancy Missing or Unknown | 0 Participants | 0 Participants | 34 Participants | 32 Participants | 66 Participants |
| Current thoughts/desires regarding pregnancy Not now, but desires pregnancy in future | 55 Participants | 46 Participants | 0 Participants | 0 Participants | 101 Participants |
| Current thoughts/desires regarding pregnancy Not trying to get pregnant, but okay with it | 23 Participants | 27 Participants | 0 Participants | 0 Participants | 50 Participants |
| Current thoughts/desires regarding pregnancy Unsure about pregnancy desires | 31 Participants | 22 Participants | 0 Participants | 0 Participants | 53 Participants |
| Education Bachelor's Degree or Higher | 91 Participants | 87 Participants | 0 Participants | 0 Participants | 178 Participants |
| Education Missing or Unknown | 1 Participants | 0 Participants | 34 Participants | 32 Participants | 67 Participants |
| Education Some college or Associate's Degree | 81 Participants | 61 Participants | 0 Participants | 0 Participants | 142 Participants |
| Education Some high school or GED | 17 Participants | 11 Participants | 0 Participants | 0 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 31 Participants | 4 Participants | 2 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 150 Participants | 128 Participants | 30 Participants | 30 Participants | 338 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ever experienced racial discrimination in VA care Missing | 3 Participants | 2 Participants | 34 Participants | 32 Participants | 71 Participants |
| Ever experienced racial discrimination in VA care No | 150 Participants | 137 Participants | 0 Participants | 0 Participants | 287 Participants |
| Ever experienced racial discrimination in VA care Yes | 37 Participants | 20 Participants | 0 Participants | 0 Participants | 57 Participants |
| Has >=1 chronic medical condition (self-report) >=1 chronic medical condition | 131 Participants | 110 Participants | 0 Participants | 0 Participants | 241 Participants |
| Has >=1 chronic medical condition (self-report) Missing | 0 Participants | 0 Participants | 34 Participants | 32 Participants | 66 Participants |
| Has >=1 chronic medical condition (self-report) No chronic medical condition | 59 Participants | 49 Participants | 0 Participants | 0 Participants | 108 Participants |
| Has >=1 mental health condition (self-report) >=1 mental health condition | 158 Participants | 140 Participants | 0 Participants | 0 Participants | 298 Participants |
| Has >=1 mental health condition (self-report) Missing | 0 Participants | 0 Participants | 34 Participants | 32 Participants | 66 Participants |
| Has >=1 mental health condition (self-report) No mental health condition | 32 Participants | 19 Participants | 0 Participants | 0 Participants | 51 Participants |
| Health Insurance Status Missing or Unknown | 1 Participants | 0 Participants | 34 Participants | 32 Participants | 67 Participants |
| Health Insurance Status No (VA coverage only) | 94 Participants | 94 Participants | 0 Participants | 0 Participants | 188 Participants |
| Health Insurance Status Yes (separate health insurance) | 95 Participants | 65 Participants | 0 Participants | 0 Participants | 160 Participants |
| History of military deployment Missing | 1 Participants | 0 Participants | 34 Participants | 32 Participants | 67 Participants |
| History of military deployment No (never deployed) | 81 Participants | 79 Participants | 0 Participants | 0 Participants | 160 Participants |
| History of military deployment Yes (deployed) | 108 Participants | 80 Participants | 0 Participants | 0 Participants | 188 Participants |
| History of military sexual trauma (MST) Does not apply (providers) | 0 Participants | 0 Participants | 34 Participants | 32 Participants | 66 Participants |
| History of military sexual trauma (MST) No | 112 Participants | 88 Participants | 0 Participants | 0 Participants | 200 Participants |
| History of military sexual trauma (MST) Yes | 78 Participants | 71 Participants | 0 Participants | 0 Participants | 149 Participants |
| History of prior appointment(s) with study provider Does not apply (providers) | 0 Participants | 0 Participants | 34 Participants | 32 Participants | 66 Participants |
| History of prior appointment(s) with study provider No (no prior appointment(s) documented) | 55 Participants | 23 Participants | 0 Participants | 0 Participants | 78 Participants |
| History of prior appointment(s) with study provider Yes (prior appointment(s) documented) | 135 Participants | 136 Participants | 0 Participants | 0 Participants | 271 Participants |
| Participants enrolled by study provider practice setting Non-women's clinic provider | 117 Participants | 103 Participants | 25 Participants | 24 Participants | 269 Participants |
| Participants enrolled by study provider practice setting Women's clinic provider | 73 Participants | 56 Participants | 9 Participants | 8 Participants | 146 Participants |
| Participants enrolled per study provider | 5.6 Veteran participants per provider | 5.0 Veteran participants per provider | 5.6 Veteran participants per provider | 5.0 Veteran participants per provider | 5.3 Veteran participants per provider |
| Provider Type Does not apply (patients) | 190 Participants | 159 Participants | 0 Participants | 0 Participants | 349 Participants |
| Provider Type Nurse Practitioner | 0 Participants | 0 Participants | 11 Participants | 5 Participants | 16 Participants |
| Provider Type Physician | 0 Participants | 0 Participants | 21 Participants | 24 Participants | 45 Participants |
| Provider Type Physician Assistant | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 8 Participants | 7 Participants | 11 Participants | 29 Participants |
| Race (NIH/OMB) Black or African American | 84 Participants | 57 Participants | 6 Participants | 5 Participants | 152 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 7 Participants | 1 Participants | 0 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 13 Participants | 3 Participants | 3 Participants | 34 Participants |
| Race (NIH/OMB) White | 67 Participants | 73 Participants | 17 Participants | 13 Participants | 170 Participants |
| Satisfaction with VA care, past 12 months Missing | 5 Participants | 1 Participants | 34 Participants | 32 Participants | 72 Participants |
| Satisfaction with VA care, past 12 months No | 69 Participants | 54 Participants | 0 Participants | 0 Participants | 123 Participants |
| Satisfaction with VA care, past 12 months Yes | 116 Participants | 104 Participants | 0 Participants | 0 Participants | 220 Participants |
| Sex: Female, Male Female | 190 Participants | 159 Participants | 32 Participants | 29 Participants | 410 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 5 Participants |
| Sexual Orientation Bisexual/Pansexual | 22 Participants | 19 Participants | 0 Participants | 0 Participants | 41 Participants |
| Sexual Orientation Lesbian/Gay | 14 Participants | 14 Participants | 0 Participants | 0 Participants | 28 Participants |
| Sexual Orientation Missing or Unknown | 0 Participants | 0 Participants | 34 Participants | 32 Participants | 66 Participants |
| Sexual Orientation Other | 5 Participants | 6 Participants | 0 Participants | 0 Participants | 11 Participants |
| Sexual Orientation Straight/Heterosexual | 149 Participants | 120 Participants | 0 Participants | 0 Participants | 269 Participants |
| Sex with a male partner, past 12 months Missing or Unknown | 0 Participants | 1 Participants | 34 Participants | 32 Participants | 67 Participants |
| Sex with a male partner, past 12 months No | 43 Participants | 41 Participants | 0 Participants | 0 Participants | 84 Participants |
| Sex with a male partner, past 12 months Yes | 147 Participants | 117 Participants | 0 Participants | 0 Participants | 264 Participants |
| Years practicing in VA >=10 years | 0 Participants | 0 Participants | 11 Participants | 12 Participants | 23 Participants |
| Years practicing in VA 5-10 years | 0 Participants | 0 Participants | 10 Participants | 11 Participants | 21 Participants |
| Years practicing in VA <5 years | 0 Participants | 0 Participants | 13 Participants | 8 Participants | 21 Participants |
| Years practicing in VA Missing | 190 Participants | 159 Participants | 0 Participants | 1 Participants | 350 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 209 | 0 / 182 | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 209 | 0 / 182 | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 209 | 0 / 182 | 0 / 37 | 0 / 37 |
Outcome results
Primary
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
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).
Time frame: Within one month post-visit
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | Yes (discussion with SDM occurred) | 29 Participants |
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | No (discussion with SDM did not occur) | 139 Participants |
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | Missing (lost to follow-up for the post-visit survey) | 21 Participants |
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | Missing (declined to answer one or more outcome measure questions) | 1 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | Missing (declined to answer one or more outcome measure questions) | 3 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | Yes (discussion with SDM occurred) | 20 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | Missing (lost to follow-up for the post-visit survey) | 17 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) | No (discussion with SDM did not occur) | 119 Participants |
Comparison: We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm. Analyses accounted for missing data in outcome and a priori adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).p-value: 0.3195% CI: [0.7, 3.06]Regression, Logistic
Comparison: Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R.Regression, Logistic
Secondary
Choice of Prescription or Procedural Contraceptive Method
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.
Time frame: Within one month post-visit
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Choice of Prescription or Procedural Contraceptive Method | Prescription or procedural method | 52 Participants |
| Intervention (MyPath) | Choice of Prescription or Procedural Contraceptive Method | Non-prescription or no method | 25 Participants |
| Intervention (MyPath) | Choice of Prescription or Procedural Contraceptive Method | Missing (lost to follow-up) | 7 Participants |
| Intervention (MyPath) | Choice of Prescription or Procedural Contraceptive Method | Missing (did not answer question(s)) | 2 Participants |
| Usual Care | Choice of Prescription or Procedural Contraceptive Method | Missing (did not answer question(s)) | 2 Participants |
| Usual Care | Choice of Prescription or Procedural Contraceptive Method | Prescription or procedural method | 35 Participants |
| Usual Care | Choice of Prescription or Procedural Contraceptive Method | Missing (lost to follow-up) | 10 Participants |
| Usual Care | Choice of Prescription or Procedural Contraceptive Method | Non-prescription or no method | 17 Participants |
Secondary
Choice of Procedural Contraceptive Method
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.
Time frame: Within one month post-visit
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Choice of Procedural Contraceptive Method | Procedural method | 28 Participants |
| Intervention (MyPath) | Choice of Procedural Contraceptive Method | Missing (lost to follow-up for post-visit survey) | 7 Participants |
| Intervention (MyPath) | Choice of Procedural Contraceptive Method | Non-procedural or no method | 49 Participants |
| Intervention (MyPath) | Choice of Procedural Contraceptive Method | Missing (did not answer question(s)) | 2 Participants |
| Usual Care | Choice of Procedural Contraceptive Method | Non-procedural or no method | 32 Participants |
| Usual Care | Choice of Procedural Contraceptive Method | Procedural method | 20 Participants |
| Usual Care | Choice of Procedural Contraceptive Method | Missing (did not answer question(s)) | 2 Participants |
| Usual Care | Choice of Procedural Contraceptive Method | Missing (lost to follow-up for post-visit survey) | 10 Participants |
Secondary
Confidence That Contraceptive Method is Right for me.
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.
Time frame: Within one month post-visit
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (MyPath) | Confidence That Contraceptive Method is Right for me. | 4.29 Scores on a scale | Standard Deviation 1.05 |
| Usual Care | Confidence That Contraceptive Method is Right for me. | 4.29 Scores on a scale | Standard Deviation 1.06 |
Comparison: We used a multilevel regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.p-value: 0.8495% CI: [-0.38, 0.47]Regression, Linear
Comparison: Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome.p-value: 0.2795% CI: [-0.35, 1.25]Regression, Linear
Secondary
Confidence That Current Contraceptive Method is Right for me.
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (MyPath) | Confidence That Current Contraceptive Method is Right for me. | 4.26 Scores on a scale | Standard Deviation 0.9 |
| Usual Care | Confidence That Current Contraceptive Method is Right for me. | 4.21 Scores on a scale | Standard Deviation 0.98 |
Secondary
Continuous Use of Any Contraception
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Continuous Use of Any Contraception | Continuous use over 6 months | 62 Participants |
| Intervention (MyPath) | Continuous Use of Any Contraception | Non-continuous use over 6 months | 13 Participants |
| Intervention (MyPath) | Continuous Use of Any Contraception | Missing (lost to follow-up for 6 month survey) | 11 Participants |
| Intervention (MyPath) | Continuous Use of Any Contraception | Missing (did not answer question(s) due to pregnancy) | 0 Participants |
| Usual Care | Continuous Use of Any Contraception | Missing (did not answer question(s) due to pregnancy) | 1 Participants |
| Usual Care | Continuous Use of Any Contraception | Continuous use over 6 months | 46 Participants |
| Usual Care | Continuous Use of Any Contraception | Missing (lost to follow-up for 6 month survey) | 11 Participants |
| Usual Care | Continuous Use of Any Contraception | Non-continuous use over 6 months | 6 Participants |
Secondary
Continuous Use of Prescription or Procedural Contraception
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Continuous Use of Prescription or Procedural Contraception | Continuous Use of Rx/Procedural Contraception | 45 Participants |
| Intervention (MyPath) | Continuous Use of Prescription or Procedural Contraception | Non-Continuous Use of Rx/Procedural Contraception | 30 Participants |
| Intervention (MyPath) | Continuous Use of Prescription or Procedural Contraception | Missing (lost to follow-up for 6-month survey) | 11 Participants |
| Intervention (MyPath) | Continuous Use of Prescription or Procedural Contraception | Missing (did not answer question(s) due to pregnancy) | 0 Participants |
| Usual Care | Continuous Use of Prescription or Procedural Contraception | Missing (did not answer question(s) due to pregnancy) | 1 Participants |
| Usual Care | Continuous Use of Prescription or Procedural Contraception | Continuous Use of Rx/Procedural Contraception | 31 Participants |
| Usual Care | Continuous Use of Prescription or Procedural Contraception | Missing (lost to follow-up for 6-month survey) | 11 Participants |
| Usual Care | Continuous Use of Prescription or Procedural Contraception | Non-Continuous Use of Rx/Procedural Contraception | 21 Participants |
Secondary
Continuous Use of Procedural Contraception
Self-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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Continuous Use of Procedural Contraception | Continuous Use of Procedural Contraception | 27 Participants |
| Intervention (MyPath) | Continuous Use of Procedural Contraception | Non-continuous Use of Procedural Contraception | 48 Participants |
| Intervention (MyPath) | Continuous Use of Procedural Contraception | Missing (lost to follow-up for 6-month survey) | 11 Participants |
| Intervention (MyPath) | Continuous Use of Procedural Contraception | Missing (did not answer question(s) due to pregnancy) | 0 Participants |
| Usual Care | Continuous Use of Procedural Contraception | Missing (did not answer question(s) due to pregnancy) | 1 Participants |
| Usual Care | Continuous Use of Procedural Contraception | Continuous Use of Procedural Contraception | 19 Participants |
| Usual Care | Continuous Use of Procedural Contraception | Missing (lost to follow-up for 6-month survey) | 11 Participants |
| Usual Care | Continuous Use of Procedural Contraception | Non-continuous Use of Procedural Contraception | 33 Participants |
Secondary
Contraceptive Decision Conflict
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.
Time frame: Within one month post-visit
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (MyPath) | Contraceptive Decision Conflict | 16.94 Score | Standard Deviation 17.57 |
| Usual Care | Contraceptive Decision Conflict | 20.04 Score | Standard Deviation 20.67 |
Comparison: We used a multilevel regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.p-value: 0.5695% CI: [-9.94, 5.42]Regression, Linear
Comparison: Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome.p-value: 0.0295% CI: [-25.37, -2.06]Regression, Linear
Secondary
Contraceptive Method Satisfaction
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (MyPath) | Contraceptive Method Satisfaction | 4.28 Score | Standard Deviation 1.01 |
| Usual Care | Contraceptive Method Satisfaction | 4.35 Score | Standard Deviation 0.95 |
Secondary
Incidence of Unplanned Pregnancy
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Incidence of Unplanned Pregnancy | Unplanned pregnancy | 0 Participants |
| Intervention (MyPath) | Incidence of Unplanned Pregnancy | No unplanned pregnancy | 64 Participants |
| Intervention (MyPath) | Incidence of Unplanned Pregnancy | Missing (lost to follow-up 6 month survey) | 22 Participants |
| Usual Care | Incidence of Unplanned Pregnancy | Unplanned pregnancy | 1 Participants |
| Usual Care | Incidence of Unplanned Pregnancy | No unplanned pregnancy | 42 Participants |
| Usual Care | Incidence of Unplanned Pregnancy | Missing (lost to follow-up 6 month survey) | 21 Participants |
Secondary
Occurrence of Reproductive Needs Discussion
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.
Time frame: Within one month post-visit
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion | Yes (discussion occurred) | 119 Participants |
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion | No (discussion did not occur) | 49 Participants |
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion | Missing (lost to follow-up for post-visit survey) | 21 Participants |
| Intervention (MyPath) | Occurrence of Reproductive Needs Discussion | Missing (declined one or more measure questions) | 1 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion | Missing (declined one or more measure questions) | 0 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion | Yes (discussion occurred) | 93 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion | Missing (lost to follow-up for post-visit survey) | 17 Participants |
| Usual Care | Occurrence of Reproductive Needs Discussion | No (discussion did not occur) | 49 Participants |
Comparison: We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach. Analyses accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).p-value: 0.2695% CI: [0.79, 2.38]Regression, Logistic
Comparison: Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R.p-value: 0.01995% CI: [1.23, 9.76]Regression, Logistic
Secondary
Perceived Self-efficacy in Communicating With Providers
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).
Time frame: Within one month post-visit
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (MyPath) | Perceived Self-efficacy in Communicating With Providers | 19.8 Score | Standard Deviation 4.8 |
| Usual Care | Perceived Self-efficacy in Communicating With Providers | 20.6 Score | Standard Deviation 4.4 |
Comparison: We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach. Analyses accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).p-value: 0.2795% CI: [-1.71, 0.48]Regression, Linear
Comparison: Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R.p-value: 0.4295% CI: [-2.91, 1.22]Regression, Linear
Secondary
Reproductive Health Knowledge
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).
Time frame: Within one month post-visit
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (MyPath) | Reproductive Health Knowledge | 7.94 Number correct | Standard Deviation 2.64 |
| Usual Care | Reproductive Health Knowledge | 7.89 Number correct | Standard Deviation 2.36 |
Comparison: We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.p-value: 0.4595% CI: [-0.56, 1.26]Regression, Linear
Comparison: Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome.p-value: 0.0995% CI: [-0.15, 2.02]Regression, Linear
Secondary
Use of Prescription or Procedural Contraceptive Method
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Use of Prescription or Procedural Contraceptive Method | Prescription or procedural method | 41 Participants |
| Intervention (MyPath) | Use of Prescription or Procedural Contraceptive Method | Non-prescription or no method | 23 Participants |
| Intervention (MyPath) | Use of Prescription or Procedural Contraceptive Method | Missing (lost to follow-up 6-month survey) | 22 Participants |
| Intervention (MyPath) | Use of Prescription or Procedural Contraceptive Method | Missing (did not answer question(s) due to pregnancy) | 0 Participants |
| Usual Care | Use of Prescription or Procedural Contraceptive Method | Missing (did not answer question(s) due to pregnancy) | 1 Participants |
| Usual Care | Use of Prescription or Procedural Contraceptive Method | Prescription or procedural method | 28 Participants |
| Usual Care | Use of Prescription or Procedural Contraceptive Method | Missing (lost to follow-up 6-month survey) | 21 Participants |
| Usual Care | Use of Prescription or Procedural Contraceptive Method | Non-prescription or no method | 14 Participants |
Secondary
Use of Procedural Contraceptive Method
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Use of Procedural Contraceptive Method | Procedural method | 22 Participants |
| Intervention (MyPath) | Use of Procedural Contraceptive Method | Non-procedural or no method | 42 Participants |
| Intervention (MyPath) | Use of Procedural Contraceptive Method | Missing (lost to follow-up 6-month survey) | 22 Participants |
| Intervention (MyPath) | Use of Procedural Contraceptive Method | Missing (did not answer question(s) due to pregnancy) | 0 Participants |
| Usual Care | Use of Procedural Contraceptive Method | Missing (did not answer question(s) due to pregnancy) | 1 Participants |
| Usual Care | Use of Procedural Contraceptive Method | Procedural method | 17 Participants |
| Usual Care | Use of Procedural Contraceptive Method | Missing (lost to follow-up 6-month survey) | 21 Participants |
| Usual Care | Use of Procedural Contraceptive Method | Non-procedural or no method | 25 Participants |
Other Pre-specified
Contraceptive Knowledge
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).
Time frame: Within one month post-visit
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (MyPath) | Contraceptive Knowledge | 4.42 Score | Standard Deviation 1.72 |
| Usual Care | Contraceptive Knowledge | 4.15 Score | Standard Deviation 1.54 |
Comparison: We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.p-value: 0.2195% CI: [-0.22, 0.99]Regression, Linear
Comparison: Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome.p-value: 0.0495% CI: [0.04, 1.75]Regression, Linear
Other Pre-specified
Goals-concordant Contraceptive Use
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (MyPath) | Goals-concordant Contraceptive Use | Missing (lost to follow-up at 6-months) | 22 Participants |
| Intervention (MyPath) | Goals-concordant Contraceptive Use | Yes (goals-concordant contraceptive use) | 50 Participants |
| Intervention (MyPath) | Goals-concordant Contraceptive Use | Missing (not asked question(s) due to pregnancy) | 0 Participants |
| Intervention (MyPath) | Goals-concordant Contraceptive Use | No (not goals-concordant contraceptive use) | 14 Participants |
| Usual Care | Goals-concordant Contraceptive Use | Missing (not asked question(s) due to pregnancy) | 1 Participants |
| Usual Care | Goals-concordant Contraceptive Use | Yes (goals-concordant contraceptive use) | 38 Participants |
| Usual Care | Goals-concordant Contraceptive Use | Missing (lost to follow-up at 6-months) | 21 Participants |
| Usual Care | Goals-concordant Contraceptive Use | No (not goals-concordant contraceptive use) | 4 Participants |