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.
