Summary

Eligibility
for females ages 18-44 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Contraception, Contraception Behavior, Prepregnancy Health, Reproductive Health, Shared decision making, Primary care, Patient decision support, Patient-centered outcomes research, Reproductive autonomy, Patient-Centered Care, Provider-Patient Communication, MyPath Web-Based Informational and Decision Support Tool

Eligibility

You can join if…

Open to females ages 18-44

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

You CAN'T join if...

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

Locations

  • VA San Diego Healthcare System, San Diego, CA accepting new patients
    San Diego California 92161 United States
  • VA Salt Lake City Health Care System, Salt Lake City, UT accepting new patients
    Salt Lake City Utah 84148-0001 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT04584294
Study Type
Interventional
Participants
Expecting 456 study participants
Last Updated