| 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). | Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care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. | Posted | | Count of Participants | | Participants | | Within one month post-visit | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| Yes (discussion with SDM occurred) | | | No (discussion with SDM did not occur) | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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). | Regression, Logistic | Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status. | 0.31 | The threshold for significance was set at p<0.05. | Odds Ratio (OR) | 1.46 | | | 2-Sided | 95 | 0.70 | 3.06 | | | | | |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Within one month post-visit | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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). | 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. | Posted | | Mean | Standard Deviation | Score | | Within one month post-visit | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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). | 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). | Posted | | Mean | Standard Deviation | Number correct | | Within one month post-visit | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Score | | Within one month post-visit | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Scores on a scale | | Within one month post-visit | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | Within one month post-visit | | | | ID | Title | Description |
|---|
| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | Within one month post-visit | | | | ID | Title | Description |
|---|
| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Score | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Scores on a scale | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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| 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. | 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). | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 |
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| 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). | 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). | Posted | | Mean | Standard Deviation | Score | | Within one month post-visit | | | | ID | Title | Description |
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| OG000 | Intervention (MyPath) | 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. | | OG001 | Usual Care | Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care. |
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