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

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ClinicalTrials.gov Identifier: NCT04584294
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : March 4, 2021
Sponsor:
Collaborators:
Kaiser Permanente
University of California, San Francisco
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Contraception Contraception Behavior Prepregnancy Health Reproductive Health Behavioral: MyPath Web-Based Informational and Decision Support Tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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



Primary Outcome Measures :
  1. Occurrence of reproductive needs discussion with shared decision making (SDM). [ Time Frame: Within one week post-visit ]
    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).


Secondary Outcome Measures :
  1. Occurrence of reproductive needs discussion. [ Time Frame: Within one week post-visit ]
    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.

  2. Perceived self-efficacy in communicating with providers. [ Time Frame: Within one week post-visit ]
    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).

  3. Knowledge. [ Time Frame: Within one week post-visit ]
    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).

  4. Contraceptive decision conflict. [ Time Frame: Within one week post-visit ]
    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.

  5. Confidence that chosen contraceptive method is "right for me." [ Time Frame: Within one week post-visit ]
    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. Choice of prescription or procedural contraceptive method. [ Time Frame: Within one week post-visit ]
    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.

  7. Choice of procedural contraceptive method. [ Time Frame: Within one week post-visit ]
    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.

  8. Use of prescription or procedural contraceptive method. [ Time Frame: 6 months ]
    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.

  9. Use of procedural contraceptive method. [ Time Frame: 6 months ]
    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.

  10. Continuous use of any contraception. [ Time Frame: 6 months ]
    Self-reported use of a contraceptive method over the past 6 months without a gap of greater than 4 weeks. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.

  11. Continuous use of prescription or procedural contraception. [ Time Frame: 6 months ]
    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.

  12. Continuous use of procedural contraception. [ Time Frame: 6 months ]
    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.

  13. Consistent use of contraception. [ Time Frame: 6 months ]
    Self-reported use of contraception every time they had sex during the past month. The questions used to assess this measure depend on the method(s) participants are using. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.

  14. Contraceptive method satisfaction. [ Time Frame: 6 months ]
    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.

  15. Incidence of unplanned pregnancy. [ Time Frame: 6 months ]
    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.

  16. Confidence that current contraceptive method is "right for me." [ Time Frame: 6 months ]
    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.


Other Outcome Measures:
  1. Occurrence of discussion about prepregnancy health risks. [ Time Frame: Post-visit and 6 months ]
    Self-reported discussion with healthcare team about prepregnancy health risks identified at study baseline. Prepregnancy health risks measured at baseline include: diagnosed mental health conditions, diagnosed medical comorbidities, obesity, use of potentially teratogenic medications, lack of folic acid supplementation, tobacco use, regular marijuana use , unhealthy alcohol use, substance use, housing instability, or food insecurity. This measure will be captured among a predefined subset of participants considering pregnancy.

  2. Receipt or use of services for prepregnancy health risks. [ Time Frame: Post-visit and 6 months ]
    Self-reported receipt or use of services (for example, treatment, referrals, or medications) to address prepregnancy health risks identified at study baseline. Prepregnancy health risks measured at baseline for which receipt of services is assessed include: obesity, tobacco use, unhealthy alcohol use, substance use, housing instability, or food insecurity. This measure will be captured among a predefined subset of participants considering pregnancy.

  3. Behaviors to modify prepregnancy health risks [ Time Frame: 6 months ]
    Self-reported behavior change or action to modify prepregnancy health risks identified at study baseline. Prepregnancy health risks measured at baseline determine which behaviors are assessed at follow-up. Prepregnancy health risks with corresponding behavior outcomes include: obesity, lack of folic acid supplementation, tobacco use, regular marijuana use, unhealthy alcohol use, substance use, housing instability, or food insecurity. This measure will be captured among a predefined subset of participants considering pregnancy.

  4. Goals-concordant continuous contraceptive use. [ Time Frame: 6 months ]
    Self-reported contraception use among participants over the past 6 months without a gap of greater than 4 weeks that is consistent with their orientation towards pregnancy over that time period (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.

  5. Goals-concordant consistent contraceptive use. [ Time Frame: 6 months ]
    Self-reported use of contraception every time participant had sex during the past month that is consistent with their current orientation towards pregnancy (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.

  6. Goals-concordant reproductive behaviors. [ Time Frame: 6 months ]
    Self-reported consistent use of contraception and/or folic acid supplementation that is concordant with their current self-reported orientation towards pregnancy (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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • Known reason unable to become pregnant, including never having a uterus (e.g., for women assigned male sex at birth); medical record or self-reported history of hysterectomy, bilateral oophorectomy, female sterilization; or diagnosed infertility for another reason.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584294


Contacts
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Contact: Lisa S Callegari, MD (206) 277-3129 ext 63129 lisa.callegari@va.gov
Contact: Samantha K Benson Samantha.Benson@va.gov

Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO Recruiting
Aurora, Colorado, United States, 80045
Contact: Kim Chen, MD       Kim.Chen@va.gov   
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Ursula Kelly, PhD       Ursula.Kelly@va.gov   
United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Karen Goldstein, MD       Karen.Goldstein@va.gov   
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Sonya Borrero, MD MS    412-360-2200    sonya.borrero@va.gov   
Sub-Investigator: Sonya Borrero, MD MS         
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Deleene Menefee, PhD       Deleene.Menefee@va.gov   
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Lori M Gawron, MD MPH    801-582-1565 ext 1239    Lori.Gawron@va.gov   
Sub-Investigator: Lori M. Gawron, MD MPH         
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Lisa S Callegari, MD    206-277-3129 ext 63129    lisa.callegari@va.gov   
Contact: Samantha K Benson       Samantha.Benson@va.gov   
Principal Investigator: Lisa S Callegari, MD         
Sponsors and Collaborators
VA Office of Research and Development
Kaiser Permanente
University of California, San Francisco
Investigators
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Principal Investigator: Lisa S Callegari, MD VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04584294    
Other Study ID Numbers: IIR 19-387
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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).


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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
Keywords provided by VA Office of Research and Development:
Shared decision making
Primary care
Patient decision support
Patient-centered outcomes research
Reproductive autonomy
Patient-Centered Care
Provider-Patient Communication