The HOP-STEP Intervention: Improving Maternal Health in Women with Lupus through Improved Pregnancy Prevention and Planning

HOP-STEP 干预措施：通过改进妊娠预防和计划来改善狼疮女性的孕产妇健康

• 批准号: 10658976
• 负责人: Megan E.B. Clowse
• 金额: $ 213.75万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10658976
• 关键词: Address; Adoption; Adult; Affect; American; Autoimmune Diseases; Black race; Caring; Cessation of life; Chicago; Child; Childhood; Chronic Kidney Failure; Clinic; Communities; Contraceptive Agents; Contraceptive Usage; Counseling; Country; Data; Death Rate; Education; Effectiveness; Environment; Family; Frequencies; Goals; Grant; Guidelines; Hand; Health system; Healthcare; Hypertension; Infant; Infant Health; Intention; International; Intervention; Intervention Trial; Kidney Failure; Knowledge; Life; Low Income Population; Low income; Lupus; Maternal Health; Maternal-fetal medicine; Measures; Mental Health; Methods; Minority Groups; Modification; Morbidity - disease rate; Mothers; Multicenter Trials; Outcome; Patients; Persons; Physicians; Planned Pregnancy; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Pregnancy Rate; Pregnancy loss; Premature Birth; Primary Health Care; Process; Provider; Publishing; Reach Effectiveness Adoption Implementation and Maintenance; Recommendation; Registries; Reporting; Reproductive Health; Rest; Rheumatology; Risk; Risk Assessment; Systemic Lupus Erythematosus; Testing; Thrombosis; Time; Universities; Woman; abortion; adverse pregnancy outcome; base; black women; care outcomes; care providers; college; comorbidity; design; diversity and equity; empowered; evidence base; experience; health equity; healthy pregnancy; implementation framework; implementation measures; implementation science; implementation strategy; improved; infant morbidity; infant outcome; innovation; iterative design; lens; maternal morbidity; maternal outcome; medical specialties; multidisciplinary; offspring; patient oriented; personalized care; physical conditioning; pilot trial; pregnancy prevention; prepregnancy; prevent; programs; provider intervention; reproductive; rheumatologist; severe maternal morbidity; skills; therapy design; unintended pregnancy; women of color; young woman

ABSTRACT: Despite published guidelines, pregnancy prevention and planning for women with systemic lupus erythematosus (SLE) is often sub-standard, leading to life-long morbidity for women and their offspring. SLE is a multi-system autoimmune disease that primarily affects young women, and most severely, women of color, who suffer higher rates of renal failure, death, and severe pregnancy complications. Unplanned pregnancies are particularly risky with rates of pregnancy loss and preterm birth more than doubled due to active SLE and treatment divergent from the American College of Rheumatology Reproductive Health Guidelines. Effective pregnancy prevention & planning is essential to avoid tragic pregnancy complications, but gaps in current rheumatology care prevent women with SLE from receiving the accurate and personalized guidance they need to plan a safe pregnancy. The long-term goal is to enable all women with SLE to maintain a healthy pregnancy while enjoying a high level of mental and physical health as they build the families they want. To fill the existing gap in provider knowledge, skills, and practice, we created the simple in-clinic Healthy Outcomes in Pregnancy with SLE Through Education of Providers (HOP-STEP) intervention. This innovative intervention creates routine opportunities for guideline- aligned reproductive health care by 1.) restructuring the rheumatology clinic environment to collect patient-re- ported contraceptive use and pregnancy intention, then 2.) enabling accurate and personalized care with a Dis- cussion Guide, and 3.) providing informative hand-offs to collaborating physicians. In doing so, the intervention insures equitable, patient-centered reproductive care is provided to all women with SLE. The working hypothesis is that equipping rheumatology providers with this intervention will increase the frequency that women with SLE receive effective pregnancy prevention and planning care, which will result in more planned pregnancies and decrease tragic outcomes for both mother and baby. The objective of this grant is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes. Because of existing disparities in current SLE care and pregnancy outcomes, the intervention will be piloted within a predominantly Black and low-income population. Evidence-based implemen- tation strategies for the multi-center trial will be selected based on the impact each strategy has on the equity of reach, effectiveness, adoption, and fidelity. This pilot trial will be accompanied by analyses of pregnancy timing on maternal health among women with SLE, first in existing data from over 100 pregnancies, then in pregnancies that occur in the pilot intervention trial. The project will be guided by two national Community Collaborator teams, one comprised of women living with SLE and the other with rheumatologists, OB/GYN, and primary care provid- ers. At the completion of this study, we will be prepared for a multi-center trial of the intervention that focuses on equitable improvements in care, maternal health, and pregnancy outcomes. This study is the next, essential step to allow women with SLE to effectively plan their pregnancies, leading to healthier women, babies, and families.

摘要： 尽管发表了指南，但系统性红斑狼疮女性的妊娠预防和计划 (SLE)往往低于标准，导致妇女及其后代终身患病。SLE是一个多系统 自身免疫性疾病主要影响年轻女性，最严重的是有色人种的女性，她们遭受的痛苦更大。 肾衰竭、死亡和严重妊娠并发症的发生率。计划外怀孕的风险特别大 由于活动性SLE和治疗分歧， 美国流变学会生殖健康指南。有效的避孕和 计划对于避免悲剧性的妊娠并发症至关重要，但目前的风湿病护理存在差距， SLE患者接受准确和个性化的指导，他们需要计划一个安全的怀孕。 长期目标是使所有SLE患者在享受高水平的妊娠期护理的同时， 在建立他们想要的家庭的过程中，他们的精神和身体健康。为了填补供应商知识方面的现有空白， 技能和实践，我们通过教育创建了简单的临床SLE妊娠期健康结局 供应商（HOP-STEP）干预。这种创新的干预措施为指导方针创造了常规机会- 生殖健康护理（1）重建风湿病临床环境，收集患者反馈， 移植避孕药使用和怀孕意愿，然后2.）实现精确和个性化的护理， cussion指南，以及3.）为合作医生提供信息传递。在这样做时，干预 确保为所有SLE女性提供公平、以患者为中心的生殖保健。工作假设 为风湿病学提供者提供这种干预将增加SLE女性患者的频率， 获得有效的怀孕预防和计划生育护理，这将导致更多的计划生育， 减少母亲和婴儿的悲惨结局。该补助金的目的是为多中心做准备 通过拟合、试点实施和测量其潜力来试验HOP-STEP干预措施 对产妇结局的影响。由于目前SLE护理和妊娠结局存在差异， 干预措施将在黑人和低收入人群中试行。循证实施 多中心试验的分期策略将根据每种策略对以下公平性的影响进行选择： 覆盖范围、有效性、采用率和忠诚度。这项试点试验将伴随着妊娠时间的分析 SLE女性的孕产妇健康，首先是100多例妊娠的现有数据，然后是妊娠 发生在试点干预试验中。该项目将由两个国家社区合作者小组指导， 一组由SLE患者组成，另一组由风湿病学家、OB/GYN和初级保健提供者组成， 呃。在这项研究完成后，我们将准备进行一项多中心的干预试验，重点是 公平改善护理、孕产妇健康和妊娠结果。这项研究是下一步， 让SLE女性有效地计划怀孕，从而使女性、婴儿和家庭更加健康。