Patient-Centered Reproductive Decision Support Tool for Women Veterans

NCT04584294 | Completed Results

• 1 other identifier: IIR 19-387
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 12

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.

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

Outcome Measures

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).

  Within one month post-visit

Secondary Outcomes (15)

• Occurrence of Reproductive Needs Discussion

  Within one month post-visit

• Perceived Self-efficacy in Communicating With Providers

  Within one month post-visit

• Reproductive Health Knowledge

  Within one month post-visit

• Contraceptive Decision Conflict

  Within one month post-visit

• Confidence That Contraceptive Method is "Right for me."

  Within one month post-visit

Other Outcomes (2)

• Goals-concordant Contraceptive Use

  6 months

• Contraceptive Knowledge

  Within one month post-visit

Study Arms (2)

Intervention (MyPath)

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

MyPath Web-Based Informational and Decision Support Tool 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

Intervention (MyPath)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients:
• Female sex identified in medical record
• 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 may not qualify 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Kaiser Permanente: collaborator
• University of California, San Francisco: collaborator

Study Sites (12)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Orlando VA Medical Center, Orlando, FL

Orlando, Florida, 32803, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

El Paso VA Health Care System, El Paso, TX

El Paso, Texas, 79930-4211, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229-4404, United States

Location

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504-7451, United States

Location

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

Salt Lake City, Utah, 84148-0001, United States

Location

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

Seattle, Washington, 98108-1532, United States

Location

Related Publications (1)

• 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.

  PMID: 36179982 RESULT

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

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.

Results Point of Contact

• Title: Lisa Callegari (Principal Investigator)
• Organization: VA Puget Sound Health Care System

Lisa.Callegari@va.gov

206-277-3129

Study Officials

• Lisa S Callegari, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants (RAs) who assess outcomes will remain blinded to provider study arm assignment throughout the trial. RAs will be blinded to patient study arm assignment during patient enrollment and baseline surveys but will become unblinded to individual patient study arm assignment during the course of outcome assessment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Provider participants are randomized to one of two groups - usual care or intervention group - at the start of the study, prior to any Veteran enrollment. Subsequently, Veterans scheduled to see these providers will be enrolled as patient participants and automatically allocated to the study group of their scheduled provider.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: March 1, 2021
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2025
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• 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).
• 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).

Locations

US (12)