Patient-Centered Reproductive Decision Support Tool for Women Veterans (MyPath)

MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Contraception Behavior; Reproductive Health; Prepregnancy Health
• Intervention / Treatment: Behavioral: MyPath Web-Based Informational and Decision Support Tool

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.

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Within one month post-visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within one month post-visit
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).	Within one month post-visit
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).	Within one month post-visit
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.	Within one month post-visit
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.	Within one month post-visit
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.	Within one month post-visit
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.	Within one month post-visit
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.	6 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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).	Within one month post-visit

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of California, San Francisco; Kaiser Permanente
• Investigators: Principal Investigator: Lisa S Callegari, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Primary care; Shared decision making; Patient-Centered Care; Patient decision support; Patient-centered outcomes research; Reproductive autonomy; Provider-Patient Communication
• Additional Relevant MeSH Terms: Behavior; Reproductive Behavior; Contraception Behavior
• Other Study ID Numbers: IIR 19-387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing Time Frame

Data will be deposited into the data repository and registry described above at study closure. It is the intention of the repository team to store the data in the repository indefinitely.

In accordance with VHA regulations, the repository will be terminated only under the direction of the VA IRB or R&D Committee responsible for the oversight of the repository. If the repository is terminated, the data will only be re-used or transferred to another data repository if the IRB and/or R&D approves of the transfer. The repository data may need to be destroyed if appropriate control of the data and compliance with VA and VHA requirements cannot be maintained.

If the repository is terminated, the data will be destroyed in accordance with all VA and VHA records disposition requirements. We will retain these data for the minimum period required for records retention in accordance with the National Archives and Records Administration (NARA) VHA Record Control Schedule (RCS).

IPD Sharing Access Criteria

Study data may be requested by VA investigators (all investigators must receive regulatory approval and sign a Data Use Agreement before gaining access to the data). The data repository will only be used to answer questions for approved studies and/or for activities preparatory to research. For activities preparatory to research, staff may only use aggregate data, and only for background information, to justify the research, or to verify proposed sample size requirements.

Data from this study will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted to the VA Puget Sound FOIA Officer, or submitted and passed down to the facility FOIA Officer from higher VA authority (e.g. VISN 20 or Central Office). Research publications will be made available to the public via the National Library of Medicine PubMed Central website within one year after publication date(s).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No