Comparing Acute Pain Management Protocols for Patients with Sickle Cell Disease

镰状细胞病患者急性疼痛管理方案的比较

• 批准号: 8768023
• 负责人: Paula Tanabe
• 金额: $ 38.82万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8768023
• 关键词: Accident and Emergency department; Acute Pain; Adherence; Admission activity; Adult; African American; Analgesics; Chronic Disease; Client satisfaction; Clinical; Clinical Trials; Computerized Medical Record; Consensus; Data; Development; Dose; Education; Enrollment; Ensure; Evaluation; Generic Drugs; Goals; Guidelines; Hereditary Disease; Home environment; Hospitalization; Hospitals; Individual; Intervention; Life Expectancy; Logistics; Measures; Medical; Medication Management; Method Acceptability; Methodology; Methods; National Heart, Lung, and Blood Institute; Opioid; Outcome; Outcome Study; Pain; Pain management; Participant; Patients; Perception; Persons; Phase; Pilot Projects; Process; Protocols documentation; Provider; Published Comment; Randomized; Recommendation; Research; Safety; Sample Size; Sickle Cell; Sickle Cell Anemia; Surveys; Testing; Time; United States; United States National Institutes of Health; Visit; arm; base; bone; design; evidence base; evidence based guidelines; experience; hemodynamics; improved; member; patient oriented; public health relevance; respiratory; success

DESCRIPTION (provided by applicant): The goal of this research is to improve emergency department (ED) pain management for adults with sickle cell disease (SCD). Patients present to the ED for treatment of severe, painful vaso-occlusive crisis (VOC). There is no standard, evidence based approach to treating painful VOC. In August 2012 the National Heart, Lung, and Blood Institute released for public comment their "Management of Sickle Cell Disease" evidence- based recommendations that were developed with consensus panel expertise. Because of a lack of empirical data, most of the recommendations specific to VOC were based on consensus panel expertise. Recommendations included the use of a patient specific protocol (specific agents and doses for an individual patient) or a standard VOC analgesic protocol. Using the NHLBI expert panel recommended protocols, we will conduct a pilot RCT at two EDs and enroll 77 patients with approximately 160 ED visits. The purpose of this pilot RCT application is to collect the data necessary to design and execute a definitive RCT comparing patient specific protocols to a SCD standard protocol. Study outcomes are to examine the difference in the reduction in pain score from arrival in the ED to discharge (home or hospital admission), hospital admission, and other clinical (i.e., time to pain relief, improvement in pain score, patient satisfaction) and safety (respiratory and hemodynamic) outcomes. Study aims are to: 1. Develop and implement patient specific VOC protocols for patients randomized to this treatment arm; 2. Conduct a pilot RCT to determine the necessary sample size needed for a large RCT to compare the difference in reduction in pain score from arrival to discharge, hospitalization , clinical and safety outcomes, between subjects assigned randomly to a (1) standard SCD specific analgesic protocol, (control) and (2) patient-specific analgesic protocols. 3. Measure feasibility of methods and acceptability of and fidelity to protocols by evaluating optimal recruitment and retention strategies, and assessing ED providers (RN and MD) perceptions of facilitators and barriers to protocol use and protocol adherence. Upon completion, we will either be prepared to conduct a RCT implementing a specific VOC protocol or we will be able to provide additional evidence to support dissemination of the draft sickle cell guidelines.

描述（由申请人提供）：这项研究的目的是改善镰状细胞病（SCD）的急诊科（ED）疼痛管理。出现在急诊室的患者治疗严重的，疼痛的血管熟悉危机（VOC）。没有标准的，基于证据的方法来治疗痛苦的VOC。 2012年8月，国家心脏，肺部和血液研究所发行了公众评论他们的“镰状细胞疾病管理”循证建议，这些建议是通过共识小组专业知识提出的。由于缺乏经验数据，大多数针对VOC的建议都是基于共识专业知识。建议包括使用特定于患者方案（针对单个患者的特定药物和剂量）或标准VOC镇痛方案。使用NHLBI专家小组建议的方案，我们将以两种EDS进行试点RCT，并招募77名ED访问的患者。该试验RCT应用程序的目的是收集设计和执行确定的RCT所需的数据，将患者特定协议与SCD标准协议进行比较。研究成果是检查疼痛评分从急诊室到达（出院或住院），住院或其他临床（即缓解疼痛的时间，疼痛评分的改善，患者满意度）和安全性（呼吸和血液动力学）的差异。研究目的是：1。为随机分配到该治疗部门的患者开发和实施特定于患者的VOC方案； 2。进行试点RCT，以确定大RCT所需的必要样本量，以比较从到达到出院，住院，临床和安全结果的疼痛评分差异，在分配给（1）标准SCD特定镇痛方案的受试者之间，（控制）和（2）患者特异性镇定方案。 3.通过评估最佳招聘和保留策略，评估ED提供商（RN和MD）对协助者的看法以及协议使用和协议依从性的障碍，来衡量方法的可行性以及对协议的可接受性和对协议的可接受性。完成后，我们要么准备进行实施特定VOC协议的RCT，要么我们能够提供其他证据来支持镰状细胞草案的传播 指南。