MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 465
- 试验地点
- 24
- 主要终点
- Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 44 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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)
- •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
研究组 & 干预措施
Usual Care
Patients scheduled to see providers randomized to the usual care arm will receive no intervention and will receive usual primary care.
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.
干预措施: MyPath Web-Based Informational and Decision Support Tool (Behavioral)
结局指标
主要结局
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
时间窗: Within one month 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; SDM defined using a top box score).
次要结局
- 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)
- Choice of Prescription or Procedural Contraceptive Method(Within one month post-visit)
- Choice of Procedural Contraceptive Method(Within one month post-visit)
- Use of Prescription or Procedural Contraceptive Method(6 months)
- Use of Procedural Contraceptive Method(6 months)
- Continuous Use of Any Contraception(6 months)
- Continuous Use of Prescription or Procedural Contraception(6 months)
- Continuous Use of Procedural Contraception(6 months)
- Contraceptive Method Satisfaction(6 months)
- Incidence of Unplanned Pregnancy(6 months)
- Confidence That Current Contraceptive Method is "Right for me."(6 months)
