ORAL MEDICATION DELIVERY DEVICE FOR PAIN MANAGEMENT

用于疼痛管理的口服药物输送装置

• 批准号: 6737083
• 负责人: Norma Sharon Conley
• 金额: $ 9.95万
• 依托单位: AVANCEN, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-15 至 2005-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6737083
• 关键词: analgesia; biomedical equipment development; clinical biomedical equipment; clinical research; clinical trials; computer assisted patient care; computer human interaction; computer program /software; computer system design /evaluation; drug delivery systems; focus groups; hospital equipment /supply; hospitals; human subject; nursing; nursing personnel; oncology nursing; oral administration; pain; patient oriented research; pharmacy; questionnaires; satisfaction

DESCRIPTION (provided by applicant): An innovative medical device has been designed which allows patients the ability to access their oral as-needed pain medications at the bedside without the need to wait for nursing to deliver each medication dose in the current time-consuming manner. Key NIH priorities are improvements in pain control, patient care and outcomes, and savings in health care dollars. The successful development and employment of this device will significantly contribute to these goals. This Phase I grant is requested to evaluate (1) the feasibility of the mechanical and software design of the device, (2) the improvement in pain control achieved by the patient's ability to directly access pain medications without delay, and (3) time savings experienced by nursing and pharmacy by using the device. The research plan first employs a focus group to study the device design for ease of use and reliability of function. The device will be further improved from the focus group experience and multiple identical devices will be used in a clinical trial. The clinical trial will employ the device to deliver prn oral pain medications in an inpatient oncology ward. Satisfaction data will be acquired from patients, nursing, and pharmacy. Data analysis will discover which design features need further modifications. The patients' pain control will be evaluated compared with the usual route of pain medication delivery. Nursing and pharmacy will be queried for any timesavings that may occur with the device use. The outcome of the Phase I plan will be a successful device to improve patient pain management in a hospital setting while saving valuable nursing and pharmacy time. Savings in staff time will translate into savings in national health care dollars. The first manufactured device will be a standalone design developed in the Phase I application. The device evolution and its commercialization will be addressed in a future Phase II application. Ultimately, the device will be modified for barcode reading for entry. By partnering with existing automated pharmacy systems, the device will evolve into a wireless bedside satellite device as part of a larger hospital-wide pharmacy delivery and inventory system.

描述（由申请人提供）：已经设计了一种创新的医疗设备，该设备使患者能够在床边进入口服疼痛药物，而无需等待护理以当前耗时的方式提供每种药物剂量。 NIH的关键优先事项是改善疼痛控制，患者护理和结果以及节省医疗保健资金。该设备的成功开发和就业将极大地促进这些目标。要求此阶段I赠款评估（1）设备的机械和软件设计的可行性，（2）患者能够不延迟直接进入止痛药的能力来改善疼痛控制的改善，以及（3）通过使用该设备通过护理和药房节省的时间。该研究计划首先采用焦点小组来研究设备设计，以易于使用和功能可靠性。该设备将从焦点小组的经验中进一步改进，并且将在临床试验中使用多个相同的设备。临床试验将采用该设备在住院肿瘤病房中提供PRN口服止痛药。满意度数据将从患者，护理和药房中获取。数据分析将发现哪些设计功能需要进一步修改。与通常的疼痛药物递送途径相比，将评估患者的疼痛控制。护理和药房将对设备使用时可能发生的任何时间避免。 I阶段计划的结果将是一种成功的装置，以改善医院环境中的患者疼痛管理，同时节省宝贵的护理和药房时间。储蓄员工时间将转化为国民保健美元的节省。第一个制造的设备将是在I期应用程序中开发的独立设计。设备的演变及其商业化将在未来的II阶段应用中解决。最终，将修改该设备以进行条目读取。通过与现有的自动化药房系统合作，该设备将演变为无线床头卫星设备，作为较大医院范围内的药房交付和库存系统的一部分。