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The EPICS (Engaging Primary care in Cancer Survivorship) study: A trial of novel models of care for cancer survivors

EPICS（癌症幸存者的初级保健）研究：癌症幸存者护理新模式的试验

基本信息

批准号：
10418631
负责人：
Erin Elizabeth Hahn
金额：
$ 73.97万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10418631
关键词：
Address Aftercare Age Breast Cancer Risk Factor Breast Cancer survivor California Cancer Detection Cancer Model Cancer Patient Cancer Survivor Cancer Survivorship Caring Chronic Disease Cluster randomized trial Colonoscopy Colorectal Cancer Communication Communities Complex Computerized Medical Record Data Detection Disease Effectiveness Growth Guidelines Healthcare Healthcare Systems Hospitalization Hospitals Individual Institution Integrated Health Care Systems International Knowledge Late Effects Lipids Literature Localized Disease Long-Term Effects Malignant Neoplasms Mammography Measures Medical Medical center Modeling Nature Newly Diagnosed Observational Study Oncology Outcome Patient Outcomes Assessments Patients Perception Phase Physicians Pilot Projects Population Preventive care Primary Health Care Provider Quality of Care Quality of life Recurrence Reporting Research Resources Risk Risk Management Self Efficacy Services Structure Survivors System Testing Time Training Vaccination Work base cancer care cancer recurrence cancer therapy cardiovascular risk factor care coordination care delivery care providers care systems comorbidity disorder prevention efficacy testing health care settings improved malignant breast neoplasm novel patient population patient-clinician communication preference primary outcome prospective psychosocial randomized trial risk stratification secondary outcome survivorship treatment as usual trial comparing urgent care

项目摘要

PROJECT SUMMARY/ABSTRACT Significant growth in the number of cancer patients, particularly those ≥65 years, is predicted within the U.S over the next 20 years. The majority of these patients will enter into a prolonged post-treatment survivorship phase of care. However, we are currently facing unprecedented challenges in survivorship care delivery. Serious gaps in the care of survivors have been identified, including underuse of guideline-recommended cancer surveillance services, such as annual mammography for breast cancer survivors and colonoscopy for colorectal cancer (CRC) survivors, and underuse of recommended preventive care services such as vaccinations, lipid testing and cardiovascular risk management, and disease screenings. Compounding these issues, our current oncology workforce is insufficient to care for the rapidly growing population of survivors. Primary care provider (PCP)-led survivorship care is a feasible model of survivorship care. In observational studies, survivors who receive care that involves PCPs received higher quality of care; international randomized trials comparing PCP-led to oncology-led survivorship care have shown no significant differences in time to detection of cancer recurrence or quality of life for early-stage survivors. However, there is a paucity of high-quality research on models of survivorship care in the U.S, particularly in community-based settings, seriously limiting our ability to provide high-quality cancer survivorship care. To address these issues, we will conduct a prospective cluster randomized trial of two models of cancer survivorship care in early-stage, low- risk breast cancer and CRC survivors cared for in a community-based, integrated health care setting. Building on our pilot work and drawing on the empirical literature, we will test the efficacy of an embedded PCP model (experimental condition) in which PCPs are embedded within an oncology practice and will care for low-risk survivors who will be transitioned at 12 months post-treatment. These PCPs will be given training in cancer survivorship care focused on cancer surveillance and chronic disease prevention. This model will be compared to the extant oncology physician model (usual care) that is the default condition in this healthcare system. The primary outcome will be receipt of guideline-recommended care (e.g., cancer surveillance, preventive care), assessed over a 36-month period. Secondary outcomes will include patient-reported outcomes using validated measures of patient-provider communication, care coordination, quality of life, self-efficacy in managing care, and other measures. We will also compare utilization of unplanned care (hospitalizations, urgent care) and receipt of non-recommended care. We will explore PCP perceptions of confidence in delivery of survivorship care. We will conduct this trial in 8 large, hospital-based medical centers of an integrated health care system, Kaiser Permanente Southern California, with approximately 2,000 early-stage breast and CRC survivors. Our results will provide more definitive evidence on the effectiveness of a scalable model of PCP-led survivorship care, addressing the critical shortage of oncology providers while maintaining or improving quality.

项目概要/摘要预计美国癌症患者数量将显着增长，尤其是 65 岁以上的患者未来20年。这些患者中的大多数将进入长期治疗后生存期护理阶段。然而，我们目前在幸存者护理服务方面面临着前所未有的挑战。已发现幸存者护理方面存在严重差距，包括未充分利用指南建议的措施癌症监测服务，例如每年为乳腺癌幸存者进行乳房X光检查，为乳腺癌幸存者提供结肠镜检查结直肠癌 (CRC) 幸存者，以及未充分利用推荐的预防性护理服务，例如疫苗接种、血脂检测和心血管风险管理以及疾病筛查。复合这些问题在于，我们目前的肿瘤学人力不足以照顾快速增长的幸存者群体。初级保健提供者（PCP）主导的生存护理是一种可行的生存护理模式。在观察中研究表明，接受 PCP 参与护理的幸存者获得了更高质量的护理；国际的比较 PCP 主导的生存护理与肿瘤学主导的生存护理的随机试验显示没有显着差异及时检测癌症复发或早期幸存者的生活质量。然而，还有一个不足对美国幸存者护理模式的高质量研究，特别是在社区环境中，严重限制了我们提供高质量癌症生存护理的能力。为了解决这些问题，我们将对早期、低水平癌症生存护理的两种模式进行前瞻性整群随机试验高危乳腺癌和结直肠癌幸存者在基于社区的综合医疗保健环境中得到护理。建筑根据我们的试点工作并借鉴实证文献，我们将测试嵌入式 PCP 模型的有效性（实验条件）PCP 融入肿瘤学实践并将照顾低风险幸存者将在治疗后 12 个月发生转变。这些 PCP 将接受癌症培训生存护理的重点是癌症监测和慢性病预防。这个模型将被比较现有的肿瘤医生模式（常规护理）是该医疗保健系统的默认条件。这主要结局将是接受指南推荐的护理（例如癌症监测、预防性护理），评估为期 36 个月。次要结果将包括使用经过验证的患者报告的结果患者与提供者沟通、护理协调、生活质量、护理管理自我效能的衡量标准，及其他措施。我们还将比较计划外护理（住院、紧急护理）和接受非推荐的护理。我们将探讨 PCP 对生还者信心的看法关心。我们将在 8 个大型综合医疗保健系统的医院医疗中心进行这项试验，南加州 Kaiser Permanente 拥有大约 2,000 名早期乳腺癌和结直肠癌幸存者。我们的结果将为 PCP 主导的可扩展生存模型的有效性提供更明确的证据护理，解决肿瘤学提供者的严重短缺问题，同时保持或提高质量。