Development and Evaluation of the PPAL Bedside Commode for Safe Independent Toileting Transfers

项目概述：PPAL®二期

Project Summary: PPAL® Phase II Bathrooms are extremely hazardous for older adults and wheelchair users. Bathroom injuries, many related to toileting, occur at a rate of 266.6 per100,000 among persons aged ≥85 years and result in costly, injurious falls and numerous cascading adverse health consequences. Transfer assisting technologies are important tools that can be used to promote wellness, independence, community participation, and quality of life. New, easy-to-use technologies that enable more efficient and safer toilet transfers for patients and caregivers are desperately needed. This SBIR Phase II project proposes to refine and evaluate PPAL®, an assisted toileting device that enables persons at risk for toileting-related falls to safely transfer with less physical assistance from a caregiver. The proposed Phase II activities will refine and test theproof-of-concept prototype developed under an NIH Phase I project by QUA, Inc. PPAL is a patented, motorized, height adjustable bedside commode with integrated transfer boards. PPAL incorporates a transfer board that moves up and down as the Chair seat is raised or lowered so that the user can always perform a downhill transfer. This innovation will allow individuals with limited mobility who currently rely on caregiver assistance to transfer more independently. It will also decrease the risk of falls and injuries for users and caregivers. Phase I results show that to improve manufacturability and commercial potential, the initial prototype should offer more appropriate height levels for wheelchair users (WCUs), added seating and positioning features, and a more maneuverable, sleeker base that can be kept at bedside. The proposed Phase II study is organized around three aims. In Aim 1, we will develop a pre-production prototype that enables level and downhill transfers between a wheelchair or bed and the PPAL, is suitable for institutional and home use, and is designed for manufacturability. This will be accomplished by conducting design reviews with stakeholders, designing for manufacturability, conducting engineering testing in accordance with standards, performing in lab evaluations with stakeholders, and revising the prototypes based on feedback received. In Aim 2, we will assess the usability and utility of PPAL in real-world home settings and short-term impact on fall/near fall incidence, level of toileting assistance, fear of falling and caregiver burden. The PPAL will be placed in residences of WCUs and their formal or informal caregivers. Outcomes will be assessed at baseline and at the conclusion of a 6-week device trial. Aim 3 will develop and validate clinical guidelines for PPAL use. An interdisciplinary stakeholder group of expert clinicians and Safe Patient Handling and Movement (SPHM) professionals will be convened to assist with identifying clinical parameters for the safe prescription of the PPAL. The long-term commercial goal of the project is to provide a toileting solution that will increase user independence and decrease both user and caregiver injury. The PPAL will be suitable for deployment in homes, skilled nursing and rehabilitation facilities as well as hospitals.