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Creation and demonstration of a palliative care research cooperative group

姑息治疗研究合作小组的创建和示范

基本信息

批准号：
8047641
负责人：
AMY P. ABERNETHY
金额：
$ 717.53万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-30 至 2013-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8047641
关键词：
Address Adverse drug effect Adverse event Anxiety Biomedical Research Cardiovascular Diseases Cardiovascular system Caregivers Caring Cessation of life Chronic Disease Client satisfaction Clinical Clinical Research Clinical Trials Collaborations Communities Comorbidity Data Development Discipline Enrollment Ensure Event Fertilization Fostering Future Goals Grant Group Structure Growth Health Policy Hospitalization Individual Institute of Medicine (U.S.)Lead Life Lipids Living Costs Measures Medical Medicare Methods Multi-Institutional Clinical Trial Myocardial Infarction Outcome Oxidoreductase Palliative Care Palliative Medicine Patients Personal Satisfaction Pharmaceutical Preparations Polypharmacy Population Study Procedures Productivity Protocols documentation Quality of life Randomized Recommendation Recruitment Activity Research Research Design Research Infrastructure Research Personnel Research Priority Risk Secondary Prevention Services Site Source Stroke Structure Symptoms Testing Time Time Study Uncertainty United States base beneficiary clinical practice clinically relevant comparative effectiveness cost depressive symptoms design effectiveness research evidence base experience improved inhibitor/antagonist innovation multidisciplinary outcome forecast programs psychological distress randomized trial research study satisfaction

项目摘要

DESCRIPTION (provided by applicant): Palliative care, a relatively new subspecialty, needs to build its evidence base supporting clinical practice. The Institute of Medicine has identified palliative care as a comparative effectiveness research priority, but increased scientific productivity is impeded by challenges to research in this field. In addition to factors such as gate-keeping by clinicians/caregivers, patients' fragility, and short prognoses causing attrition, the lack of research infrastructure in palliative medicine presents a major hurdle. Without a "research engine," studies in palliative care are often not robust in design and methods, have difficulty recruiting, and produce data of questionable utility. Palliative care needs a structure for the conduct of high-quality clinical trials; this structure should be scalable, offer support and up-scaling to new investigators and sites, and answer important clinical questions. We propose to create such a structure - a national collaborative research network in palliative care - and to demonstrate the value of the collaborative for research productivity by conducting a multi-site clinical trial that studies a consensually selected, clinically relevant topic in palliative care. The grant's first aim focuses on establishing a unique, innovative, palliative care research cooperative (PCRC) group that: is sustainable; convenes and fosters collaboration between experienced multidisciplinary investigators; facilitates innovative, high-impact, clinically useful research; responds to recognized challenges faced by cooperative research groups in the past; and, serves as a venue for recruiting new investigators and new expertise into the palliative care research community. Further aims are defined within the context of a randomized comparative effectiveness study that will provide evidence regarding a standard, but unstudied, palliative care practice - discontinuation of medications for co-morbidities as death nears. The study population is patients with a life-limiting illness who are on lipid-lowering agents (HMG Co-A reductase inhibitors, a.k.a. statins) prescribed for primary or secondary prevention. Statins are common medications (prescribed for >25% of Medicare beneficiaries), and their discontinuation is a source of major debate. Enrolling patients at 11 sites nationally, the trial will determine if there is a difference in survival time (i.e., time to death) in patients who discontinue statins vs. continue on statins. Additionally, we will evaluate potential differences in adverse events (e.g., hospitalization for cardiovascular events), symptoms, polypharmacy, satisfaction with care, quality of life, and cost when statins are withdrawn vs. continued. This grant coalesces many medical disciplines and clinical researchers. For feasibility reasons, the trial is deliberately chosen to address a simple research question with a clean study design, while yielding information that is vitally important to clinical practice and health policy. Completion of the project will definitively answer an important clinical uncertainty, and also establish the cooperative group as a national infrastructure for the conduct of high-quality, multi-disciplinary, clinical trials in palliative care. PUBLIC HEALTH RELEVANCE: Many important clinical questions remain unanswered in palliative care, due to the lack of research infrastructure in this field. We will: (1) establish a national cooperative group to support high-quality, multi-site, collaborative research addressing clinically relevant topics in palliative care, and; (2) test the collaborative through a clinical trial addressing the question of whether or not to discontinue statins as patients near death.

描述（由申请人提供）：姑息治疗是一个相对较新的亚专业，需要建立其支持临床实践的证据基础。医学研究所已确定姑息治疗作为一个比较有效的研究优先事项，但提高科学生产力是阻碍了在这一领域的研究的挑战。除了临床医生/护理人员的把关、患者的脆弱性和导致减员的短期住院等因素外，姑息医学研究基础设施的缺乏也是一个主要障碍。如果没有一个“研究引擎”，姑息治疗的研究往往在设计和方法上不够稳健，难以招募，并产生效用可疑的数据。姑息治疗需要一个进行高质量临床试验的结构;这个结构应该是可扩展的，为新的研究者和研究中心提供支持和升级，并回答重要的临床问题。我们建议创建这样一个结构-姑息治疗的国家合作研究网络-并通过进行一项多中心临床试验来证明合作研究生产力的价值，该试验研究了姑息治疗中一致选择的临床相关主题。赠款的第一个目标是建立一个独特的，创新的，姑息治疗研究合作（PCRC）组：是可持续的;召集和促进经验丰富的多学科研究人员之间的合作;促进创新，高影响力，临床有用的研究;应对合作研究小组在过去面临的公认挑战;并且，作为一个场所，招募新的调查人员和新的专业知识到姑息治疗研究社区。进一步的目标是在随机比较有效性研究的背景下定义的，该研究将提供关于标准但未经研究的姑息治疗实践的证据-在死亡临近时停止合并症的药物治疗。研究人群是患有限制生命的疾病并正在服用降脂药（HMG Co-A还原酶抑制剂，又名他汀类药物）用于初级或二级预防。他汀类药物是常见的药物（处方>25%的医疗保险受益人），他们的停药是一个主要的争论来源。在全国11个地点招募患者，该试验将确定生存时间是否存在差异（即，死亡时间）。此外，我们将评估不良事件的潜在差异（例如，因心血管事件住院治疗）、症状、多种用药、护理满意度、生活质量和停用他汀类药物与继续使用他汀类药物时的费用。该基金联合了许多医学学科和临床研究人员。出于可行性的原因，该试验被故意选择以解决一个简单的研究问题，同时产生对临床实践和卫生政策至关重要的信息。该项目的完成将明确回答一个重要的临床不确定性，并建立合作小组作为一个国家基础设施，在姑息治疗中进行高质量，多学科的临床试验。公共卫生相关性：许多重要的临床问题仍然没有答案，在姑息治疗，由于缺乏研究基础设施在这一领域。我们将：（1）建立一个国家合作小组，以支持高质量，多地点，合作研究解决姑息治疗中的临床相关主题，（2）通过临床试验测试合作，解决是否停止他汀类药物作为患者濒临死亡的问题。

项目成果

期刊论文数量（14）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Building the palliative care evidence base: Lessons from a randomized controlled trial of oxygen vs room air for refractory dyspnea.

建立姑息治疗证据基础：氧气与室内空气治疗顽固性呼吸困难的随机对照试验的经验教训。

DOI：
10.6004/jnccn.2014.0095
发表时间：
2014
期刊：
Journal of the National Comprehensive Cancer Network : JNCCN
影响因子：
0
作者：
LeBlanc,ThomasW;Abernethy,AmyP
通讯作者：
Abernethy,AmyP

Achieving palliative care research efficiency through defining and benchmarking performance metrics.

通过定义和基准测试性能指标来实现姑息治疗研究效率。

DOI：
10.1097/spc.0b013e32835a7cb4
发表时间：
2012-12
期刊：
Current opinion in supportive and palliative care
影响因子：
2.1
作者：
Lodato JE;Aziz N;Bennett RE;Abernethy AP;Kutner JS
通讯作者：
Kutner JS

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

DOI：
10.1001/jamainternmed.2015.0289
发表时间：
2015-05
期刊：
JAMA internal medicine
影响因子：
39
作者：
Kutner JS;Blatchford PJ;Taylor DH Jr;Ritchie CS;Bull JH;Fairclough DL;Hanson LC;LeBlanc TW;Samsa GP;Wolf S;Aziz NM;Currow DC;Ferrell B;Wagner-Johnston N;Zafar SY;Cleary JF;Dev S;Goode PS;Kamal AH;Kassner C;Kvale EA;McCallum JG;Ogunseitan AB;Pantilat SZ;Portenoy RK;Prince-Paul M;Sloan JA;Swetz KM;Von Gunten CF;Abernethy AP
通讯作者：
Abernethy AP

A decision exercise to engage cancer patients and families in deliberation about Medicare coverage for advanced cancer care.