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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.

项目总结/摘要据预测，在美国，癌症患者人数将显著增加，特别是≥65岁的患者。在接下来的20年里。这些患者中的大多数将进入延长的治疗后生存期护理阶段。然而，我们目前在生存护理提供方面面临着前所未有的挑战。现已查明幸存者护理方面存在严重差距，包括未充分使用指南建议的癌症监测服务，如乳腺癌幸存者的年度乳房X光检查和结肠镜检查，结直肠癌（CRC）幸存者，以及推荐的预防保健服务使用不足，疫苗接种、血脂检测和心血管风险管理以及疾病筛查。混合这些然而，我们目前的肿瘤学工作人员不足以照顾迅速增长的幸存者人口。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。观察性研究表明，接受涉及PCP的护理的幸存者获得了更高质量的护理;国际比较PCP和肿瘤学生存护理的随机试验显示，及时检测癌症复发或早期幸存者的生活质量。然而，对美国生存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，我们将进行一项前瞻性的随机分组试验，在早期、低水平和低水平的癌症患者中进行两种癌症生存护理模式，乳腺癌和CRC风险幸存者在以社区为基础的综合医疗保健环境中得到护理。建筑在我们的试点工作中，我们将借鉴经验文献，检验嵌入式PCP模型的有效性（实验条件），其中PCP嵌入肿瘤学实践中，并将照顾低风险将在治疗后12个月过渡的幸存者。这些PCP将接受癌症培训幸存者护理侧重于癌症监测和慢性病预防。该模型将比较现有的肿瘤学医生模型（常规护理），这是该医疗保健系统中的默认条件。的主要结果将是接受指南推荐的护理（例如，癌症监测、预防性护理），在36个月的时间内进行评估。次要结局将包括使用经验证的患者与提供者沟通、护理协调、生活质量、管理护理的自我效能的衡量标准，和其他措施。我们还将比较计划外护理（住院，紧急护理）的利用率，接受非推荐护理。我们将探讨PCP对提供生存率的信心在乎我们将在综合医疗保健系统的8个大型医院医疗中心进行这项试验， Kaiser Permanente Southern加州，约有2,000名早期乳腺癌和CRC幸存者。我们研究结果将为PCP导致的生存率的可扩展模型的有效性提供更明确的证据治疗，解决肿瘤提供者的严重短缺，同时保持或提高质量。