Clinical trial NCT04584294: Patient-Centered Reproductive Decision Support Tool for Women Veterans
Official title: MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Kaiser Permanente
name: University of California, San Francisco
First posted: 2020-10-12
Enrollment: 391
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Occurrence of reproductive needs discussion with shared decision making (SDM).
timeFrame: Within one week post-visit
Secondary outcomes:
measure: Occurrence of reproductive needs discussion.
timeFrame: Within one week post-visit
measure: Perceived self-efficacy in communicating with providers.
timeFrame: Within one week post-visit
measure: Knowledge.
timeFrame: Within one week post-visit
measure: Contraceptive decision conflict.
timeFrame: Within one week post-visit
measure: Confidence that chosen contraceptive method is "right for me."
timeFrame: Within one week post-visit
measure: Choice of prescription or procedural contraceptive method.
timeFrame: Within one week post-visit
measure: Choice of procedural contraceptive method.
timeFrame: Within one week post-visit
measure: Use of prescription or procedural contraceptive method.
timeFrame: 6 months
measure: Use of procedural contraceptive method.
timeFrame: 6 months
measure: Continuous use of any contraception.
timeFrame: 6 months
measure: Continuous use of prescription or procedural contraception.
timeFrame: 6 months
measure: Continuous use of procedural contraception.
timeFrame: 6 months
measure: Consistent use of contraception.
timeFrame: 6 months
measure: Contraceptive method satisfaction.
timeFrame: 6 months
measure: Incidence of unplanned pregnancy.
timeFrame: 6 months
measure: Confidence that current contraceptive method is "right for me."
timeFrame: 6 months
Other outcomes:
measure: Occurrence of discussion about prepregnancy health risks.
timeFrame: Post-visit and 6 months
measure: Receipt or use of services for prepregnancy health risks.
timeFrame: Post-visit and 6 months
measure: Behaviors to modify prepregnancy health risks
timeFrame: 6 months
measure: Goals-concordant continuous contraceptive use.
timeFrame: 6 months
measure: Goals-concordant consistent contraceptive use.
timeFrame: 6 months
measure: Goals-concordant reproductive behaviors.
timeFrame: 6 months
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Orlando
country: United States
facility: Orlando VA Medical Center, Orlando, FL
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
city: El Paso
country: United States
facility: El Paso VA Health Care System, El Paso, TX
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Lisa S Callegari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.