Patient-Centered Reproductive Decision Support Tool for Women Veterans

NCT ID: NCT04584294

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2025-09-30

Brief Summary

The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.

Detailed Description

Counseling and care that supports individuals' ability to achieve their reproductive goals is an essential component of primary care. National organizations, including the Centers for Disease Control and Prevention (CDC), recommend that clinicians routinely engage in patient-centered conversations about reproductive goals and offer care to help optimize health and well-being prior to desired pregnancies and to prevent unwanted pregnancy and births. This counseling is particularly critical for women Veterans, who face elevated risks of adverse pregnancy and birth outcomes due to a high prevalence of chronic medical and mental health conditions as well as psychosocial stressors including sexual trauma histories, intimate partner violence, and homelessness. Moreover, stark racial/ethnic disparities in pregnancy outcomes are well-documented, and nearly half of reproductive-aged women Veterans are minority race/ethnicity. Despite these national recommendations, however, conversations about reproductive needs are often absent in primary care both outside and within the VA, and the conversations that do happen frequently fail to incorporate women's values and preferences. Interventions are needed to improve both the frequency and quality of counseling about reproductive needs in primary care settings.

This study will investigate the effect of a novel, web-based, patient-facing decision support tool designed to be used prior to VA primary care visits to help women Veterans with reproductive capacity consider their reproductive goals; improve their knowledge about fertility, contraception, and prepregnancy health risks; align contraceptive decisions with their preferences and goals; and engage in shared decision making (SDM) with providers.

The investigators will conduct a multi-site randomized controlled trial (RCT) clustered at the provider level among VA primary care providers and their reproductive-aged women Veteran patients. Study outcomes will be assessed among participants shortly after their scheduled appointment and at 3- and 6-months follow up. The study will test the primary hypothesis that participants who receive the tool weblink prior to visits will be more likely to report patient-centered conversations about their reproductive needs at their visit. The investigators also hypothesize that intervention participants will report higher perceived self-efficacy in communicating with providers, reproductive health knowledge, contraception decision quality, and contraception utilization. Exploratory outcomes include behaviors to modify preconception health risks among participants considering pregnancy in the future and intervention effects by race/ethnicity. The study will also collect quantitative and qualitative data to assess the feasibility of implementing the tool more widely in VA primary care settings.

Conditions

Contraception; Contraception Behavior; Prepregnancy Health; Reproductive Health

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MyPath Web-Based Informational and Decision Support Tool

Intervention Type: BEHAVIORAL

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

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa S Callegari, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Orlando VA Medical Center, Orlando, FL

Orlando, Florida, United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

El Paso VA Health Care System, El Paso, TX

El Paso, Texas, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 36179982 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IIR 19-387

Identifier Type: -

Identifier Source: org_study_id