CClinicalTrials.gg
CompletedNCT04584294MyPathUpdated Nov 6, 2025Results posted

Patient-Centered Reproductive Decision Support Tool for Women Veterans

An interventional study of MyPath Web-Based Informational and Decision Support Tool in Contraception, Contraception Behavior and Prepregnancy Health, sponsored by VA Office of Research and Development. Completed at 12 sites in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-06.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
465
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Contraception
  • Contraception Behavior
  • Prepregnancy Health
  • Reproductive Health

Browse trials for

Keywords

  • Shared decision making
  • Primary care
  • Patient decision support
  • Patient-centered outcomes research
  • Reproductive autonomy
  • Patient-Centered Care
  • Provider-Patient Communication
03

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
465 participants (actual)

Study arms

  • Experimental
    Intervention (MyPath)

    Patients scheduled to see providers randomized to this arm will receive a weblink to the decision tool via text message after study enrollment and prior to their scheduled visit.

    Behavioral: MyPath Web-Based Informational and Decision Support Tool

  • No intervention
    Usual Care

    Patients scheduled to see providers randomized to the usual care arm will receive no intervention and will receive usual primary care.

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

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Other outcomes

  1. 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

  2. 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

06

Results

Posted Nov 6, 2025
Limitations and caveats
Limitations of the study that impacted our ability to assess the effectiveness of the intervention include (1) lower than expected adherence (use of the MyPath tool) and (2) higher than expected lost-to-follow-up for our primary outcome at the post-visit timeframe.

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.

Enrollment to Post-Visit - PATIENTS
Participant flow — Enrollment to Post-Visit - PATIENTS
MilestoneIntervention (MyPath)Usual Care Patients
Started209182
Completed190159
Not completed1923
Withdrew: Withdrawal by subject34
Withdrew: Did not attend scheduled appointment with primary care provider1618
Withdrew: Pregnancy01
3-month Follow-up - PATIENTS
Participant flow — 3-month Follow-up - PATIENTS
MilestoneIntervention (MyPath)Usual Care Patients
Started190159
Completed188158
Not completed21
Withdrew: Withdrawal by subject21
6-month Follow-up - PATIENTS
Participant flow — 6-month Follow-up - PATIENTS
MilestoneIntervention (MyPath)Usual Care Patients
Started188158
Completed184156
Not completed42
Withdrew: Withdrawal by subject42
Enrollment to Post-Visit - PROVIDERS
Participant flow — Enrollment to Post-Visit - PROVIDERS
MilestoneIntervention (MyPath)Usual Care Patients
Started3737
Completed3432
Not completed35
Withdrew: No veterans enrolled in study35

Outcome measures

PrimaryOccurrence 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
Reported as:
Count of participants · Participants
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
ParticipantsIntervention (MyPath)Usual Care
Yes (discussion with SDM occurred)2920
No (discussion with SDM did not occur)139119
Missing (lost to follow-up for the post-visit survey)2117
Missing (declined to answer one or more outcome measure questions)13
Statistical analysis
  • Intervention (MyPath) vs Usual Care · Regression, Logistic · p = 0.31 (The threshold for significance was set at p\<0.05.) · Odds ratio (or): 1.46 · 95% CI 0.70 to 3.06Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
  • Intervention (MyPath) vs Usual Care · Regression, LogisticModel adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
SecondaryOccurrence 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
Reported as:
Count of participants · Participants
Occurrence of Reproductive Needs Discussion
ParticipantsIntervention (MyPath)Usual Care
Yes (discussion occurred)11993
No (discussion did not occur)4949
Missing (lost to follow-up for post-visit survey)2117
Missing (declined one or more measure questions)10
Statistical analysis
  • Intervention (MyPath) vs Usual Care · Regression, Logistic · p = 0.26 (Threshold for significance was set at p\<0.05.) · Odds ratio (or): 1.37 · 95% CI 0.79 to 2.38Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
  • Intervention (MyPath) vs Usual Care · Regression, Logistic · p = 0.019 (Threshold for significance was set at p\<0.05.) · Odds ratio (or): 3.46 · 95% CI 1.23 to 9.76Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
SecondaryPerceived 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
Reported as:
Mean · Score
Perceived Self-efficacy in Communicating With Providers
ScoreIntervention (MyPath)Usual Care
Perceived Self-efficacy in Communicating With Providers19.8 ± 4.820.6 ± 4.4
Statistical analysis
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.27 (Threshold for significance was set at p\<0.05.) · Median difference (final values): -0.62 · 95% CI -1.71 to 0.48Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.42 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): -0.84 · 95% CI -2.91 to 1.22Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
SecondaryReproductive 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
Reported as:
Mean · Number correct
Reproductive Health Knowledge
Number correctIntervention (MyPath)Usual Care
Reproductive Health Knowledge7.94 ± 2.647.89 ± 2.36
Statistical analysis
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.45 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): 0.35 · 95% CI -0.56 to 1.26Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.09 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): 0.94 · 95% CI -0.15 to 2.02Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
SecondaryContraceptive 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
Reported as:
Mean · Score
Contraceptive Decision Conflict
ScoreIntervention (MyPath)Usual Care
Contraceptive Decision Conflict16.94 ± 17.5720.04 ± 20.67
Statistical analysis
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.56 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): -2.26 · 95% CI -9.94 to 5.42Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.02 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): -13.72 · 95% CI -25.37 to -2.06Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
SecondaryConfidence 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
Reported as:
Mean · Scores on a scale
Confidence That Contraceptive Method is "Right for me."
Scores on a scaleIntervention (MyPath)Usual Care
Confidence That Contraceptive Method is "Right for me."4.29 ± 1.054.29 ± 1.06
Statistical analysis
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.84 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): 0.04 · 95% CI -0.38 to 0.47
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.27 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): 0.45 · 95% CI -0.35 to 1.25
SecondaryChoice 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
Reported as:
Count of participants · Participants
Choice of Prescription or Procedural Contraceptive Method
ParticipantsIntervention (MyPath)Usual Care
Prescription or procedural method5235
Non-prescription or no method2517
Missing (lost to follow-up)710
Missing (did not answer question(s))22
SecondaryChoice 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
Reported as:
Count of participants · Participants
Choice of Procedural Contraceptive Method
ParticipantsIntervention (MyPath)Usual Care
Procedural method2820
Non-procedural or no method4932
Missing (lost to follow-up for post-visit survey)710
Missing (did not answer question(s))22
SecondaryUse 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
Reported as:
Count of participants · Participants
Use of Prescription or Procedural Contraceptive Method
ParticipantsIntervention (MyPath)Usual Care
Prescription or procedural method4128
Non-prescription or no method2314
Missing (lost to follow-up 6-month survey)2221
Missing (did not answer question(s) due to pregnancy)01
SecondaryUse 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
Reported as:
Count of participants · Participants
Use of Procedural Contraceptive Method
ParticipantsIntervention (MyPath)Usual Care
Procedural method2217
Non-procedural or no method4225
Missing (lost to follow-up 6-month survey)2221
Missing (did not answer question(s) due to pregnancy)01
SecondaryContinuous 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
Reported as:
Count of participants · Participants
Continuous Use of Any Contraception
ParticipantsIntervention (MyPath)Usual Care
Continuous use over 6 months6246
Non-continuous use over 6 months136
Missing (lost to follow-up for 6 month survey)1111
Missing (did not answer question(s) due to pregnancy)01
SecondaryContinuous 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
Reported as:
Count of participants · Participants
Continuous Use of Prescription or Procedural Contraception
ParticipantsIntervention (MyPath)Usual Care
Continuous Use of Rx/Procedural Contraception4531
Non-Continuous Use of Rx/Procedural Contraception3021
Missing (lost to follow-up for 6-month survey)1111
Missing (did not answer question(s) due to pregnancy)01
SecondaryContinuous 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
Reported as:
Count of participants · Participants
Continuous Use of Procedural Contraception
ParticipantsIntervention (MyPath)Usual Care
Continuous Use of Procedural Contraception2719
Non-continuous Use of Procedural Contraception4833
Missing (lost to follow-up for 6-month survey)1111
Missing (did not answer question(s) due to pregnancy)01
SecondaryContraceptive 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
Reported as:
Mean · Score
Contraceptive Method Satisfaction
ScoreIntervention (MyPath)Usual Care
Contraceptive Method Satisfaction4.28 ± 1.014.35 ± 0.95
SecondaryIncidence 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
Reported as:
Count of participants · Participants
Incidence of Unplanned Pregnancy
ParticipantsIntervention (MyPath)Usual Care
Unplanned pregnancy01
No unplanned pregnancy6442
Missing (lost to follow-up 6 month survey)2221
SecondaryConfidence 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
Reported as:
Mean · Scores on a scale
Confidence That Current Contraceptive Method is "Right for me."
Scores on a scaleIntervention (MyPath)Usual Care
Confidence That Current Contraceptive Method is "Right for me."4.26 ± 0.904.21 ± 0.98
Other pre-specifiedGoals-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
Reported as:
Count of participants · Participants
Goals-concordant Contraceptive Use
ParticipantsIntervention (MyPath)Usual Care
Yes (goals-concordant contraceptive use)5038
No (not goals-concordant contraceptive use)144
Missing (lost to follow-up at 6-months)2221
Missing (not asked question(s) due to pregnancy)01
Other pre-specifiedContraceptive 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
Reported as:
Mean · Score
Contraceptive Knowledge
ScoreIntervention (MyPath)Usual Care
Contraceptive Knowledge4.42 ± 1.724.15 ± 1.54
Statistical analysis
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.21 (threshold for significance set at \<0.05) · Mean difference (final values): 0.38 · 95% CI -0.22 to 0.99Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.
  • Intervention (MyPath) vs Usual Care · Regression, Linear · p = 0.04 (Threshold for significance was set at p\<0.05.) · Mean difference (final values): 0.89 · 95% CI 0.04 to 1.75Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.

Adverse events

Collected over from enrollment through 6 months follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention (MyPath) Patients0/209 (0%)0/209 (0%)0/209 (0%)
Usual Care Patients0/182 (0%)0/182 (0%)0/182 (0%)
Intervention (MyPath) Providers0/37 (0%)0/37 (0%)0/37 (0%)
Usual Care Providers0/37 (0%)0/37 (0%)0/37 (0%)

Baseline characteristics

Per the study protocol, 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.

Age, Categorical
Age, Categorical(Participants)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
<=18 years00000
Between 18 and 65 years1901593232413
>=65 years00202
Age, Continuous
Age, Continuous(years of age)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
Mean35.5 (21 to 45)35.1 (22 to 45)47.7 (29 to 67)47.7 (28 to 64)37.3 (21 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
Female1901593229410
Male00235
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
Hispanic or Latino40314277
Not Hispanic or Latino1501283030338
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
American Indian or Alaska Native80008
Asian3871129
Native Hawaiian or Other Pacific Islander11002
Black or African American845765152
White67731713170
More than one race1271020
Unknown or Not Reported15133334
Sexual Orientation
Sexual Orientation(Participants)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
Straight/Heterosexual14912000269
Lesbian/Gay14140028
Bisexual/Pansexual22190041
Other560011
Missing or Unknown00343266
Education
Education(Participants)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
Some high school or GED17110028
Some college or Associate's Degree816100142
Bachelor's Degree or Higher918700178
Missing or Unknown10343267
Health Insurance Status
Health Insurance Status(Participants)Intervention (MyPath) PatientsUsual Care PatientsIntervention (MyPath) ProvidersUsual Care ProvidersTotal
Yes (separate health insurance)956500160
No (VA coverage only)949400188
Missing or Unknown10343267

15 further baseline measures are reported on the registry.

07

Study locations

12 sites
  • VA San Diego Healthcare System, San Diego, CA
    San Diego, California 92161, United States
  • Rocky Mountain Regional VA Medical Center, Aurora, CO
    Aurora, Colorado 80045, United States
  • Orlando VA Medical Center, Orlando, FL
    Orlando, Florida 32803, United States
  • Atlanta VA Medical and Rehab Center, Decatur, GA
    Decatur, Georgia 30033, United States
  • Durham VA Medical Center, Durham, NC
    Durham, North Carolina 27705, United States
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania 15240, United States
  • El Paso VA Health Care System, El Paso, TX
    El Paso, Texas 79930-4211, United States
  • Michael E. DeBakey VA Medical Center, Houston, TX
    Houston, Texas 77030, United States
  • South Texas Health Care System, San Antonio, TX
    San Antonio, Texas 78229-4404, United States
  • Central Texas Veterans Health Care System, Temple, TX
    Temple, Texas 76504-7451, United States
  • VA Salt Lake City Health Care System, Salt Lake City, UT
    Salt Lake City, Utah 84148-0001, United States
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA
    Seattle, Washington 98108-1532, United States
08

References and documents

Publications

  • Callegari LS, Benson SK, Mahorter SS, Nelson KM, Arterburn DE, Hamilton AB, Taylor L, Hunter-Merrill R, Gawron LM, Dehlendorf C, Borrero S. Evaluating the MyPath web-based reproductive decision support tool in VA primary care: Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2022 Nov;122:106940. doi: 10.1016/j.cct.2022.106940. Epub 2022 Sep 28. PubMed 36179982 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 24, 2024
  • Informed consent form · Feb 23, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Veteran participant data will be deposited into the "Reproductive, Sexual, and Socio-Behavioral Health Data Repository and Registry" VA data repository and registry housed and managed at the VA Puget Sound Health Care System. The data will be stored indefinitely in accordance with VHA regulations under VA IRB and R\&D Committee oversight. Procedures are as follows.

09

Registry details

Key details

Study ID
NCT04584294
Lead sponsor
VA Office of Research and Development
Collaborators
Kaiser Permanente, University of California, San Francisco
Responsible party
Sponsor
First posted
Oct 12, 2020
Start date
Mar 1, 2021
Primary completion
Aug 30, 2024
Completion
Sep 30, 2025
Results posted
Nov 6, 2025
Last update
Nov 6, 2025

Study contacts

Lisa S Callegari, MD
principal investigator · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion