SBIR-STTR Award

Fall detection, assessment, and prevention is a challenging issue across the care continuum. Despite wide recognition as a considerable problem, fall-related injuries are still the most frequently reported adverse events in hospital inpatient settings, with 3-20% of patients falling at least once during their stay. According to the Agency for Healthcare Research and Quality reports, 30% to 51% of falls result in injury. In the United States alone, the number of inpatient falls exceeds 1 million per year, with elderly individuals being the most vulnerable. As a testament to its importance, fall research was listed as a top priority in the Institute of Medicine's report to Congress on national priorities. Diverse factors contribute to falls, including patient factors (e.g., cognitive state, muscle weakness, medications), environmental factors (e.g., bed/toilet positioning, trip hazards), and institutional factors (e.g., poor responsiveness to call bells or bed/chair alarms, inadequate fall prevention measures). Although hospitals em- ploy diverse programs to prevent falls and fall injuries, an essential component to a fall prevention program is accurate determination of fall events, as many falls are "unseen" and unreported. The body-worn FallCall system, proposed herein, will leverage powerful sensing capabilities to provide robust fall detection and to report fall locations without bothersome false alarms. The FallCall body-worn instrument will embody a reusable miniature electronics package that is encapsulated in a disposable, hypoallergenic adhesive patch. The patch can be placed anywhere on the torso to minimize interaction with other medical equipment or injury sites. The system will continuously monitor patients and issue a timely alert if a fall is detected, minimizing patient time on the ground, as well as injury assessment and treatment latencies. The FallCall system will also allow patient location to be determined (including the room and floor of the hospital) using a redundant wireless mesh network. The instrument will be powered by a miniature rechargeable battery that will last for at least one week. The FallCall system will also have the capability to issue wander and inactivity alerts. Additionally, the system can use its internal sensors to track measures of stability, providing objective data that may o er improved predictive value in identifying individuals at risk for falling and tracking fall risk longitudinally. The proposed system will represent one of the rst ways to objectively measure the response time of clinical sta when a fall occurs, and will be a key component in evaluating and improving fall prevention programs.

Public Health Relevance Statement:
The FallCall system will detect fall events and issue timely alerts (including fall location) when such events occur, in addition to providing stability and activity metrics to help ascertain an individual's fall risk and changes thereto. Use of the FallCall system will minimize response latency and "time on the ground" after a fall event, and provide objective measures of sta response time. Fall determination with high sensitivity and specificity is an essential component of effective fall assessment and prevention programs. The proposed tool will find a ready market, as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires health care organizations seeking accreditation to routinely assess and reassess each patient's risk for falling, and to take action to reduce the risk of falling. Furthermore, Medicare policy limits and, in some cases, prohibits reimbursement to institutions for the treatment of avoidable hospital-acquired conditions, including falls and fall-related trauma. These policy changes represent significant market pull and will accelerate the adoption of the FallCall instrument. Terms: Accreditation; Adhesives; Adoption; Elderly; senior citizen; older person; older adult; later life; late life; geriatric; elders; advanced age; Altitude; Award; Beds; Cations; Charge; Cities; Congresses; meeting reports; Continuity of Patient Care; Continuum of Care; Continuity of Care; Sterile coverings; Dressing; Electronics; electronic device; Equipment; Equipment Safety; Goals; Medicare; health insurance for disabled; Title 18; Health Insurance for Disabled Title 18; Health Insurance for Aged and Disabled, Title 18; Health Personnel; treatment provider; medical personnel; healthcare personnel; health workforce; health provider; health care worker; health care personnel; Healthcare worker; Healthcare Providers; Health Care Providers; Hospitals; Industry; Inpatients; Institute of Medicine (U.S.); NAS/IOM; Institute of Medicine; instrumentation; Joint Commission on Accreditation of Healthcare Organizations; Joint Commission on Accreditation, Health Care Organizations; JCAHO; Laboratories; Length of Stay; hospital stay; hospital length of stay; hospital days; Number of Days in Hospital; Motivation; Legal patent; Patents; Patient Monitoring; Patients; Polyurethanes; Polyisocyanates; Pellethane; Ostamer; Protective Devices; safety equipment; Reaction Time; psychomotor reaction time; Response Time; Response RT; Research; Safety; seal; Computer software; Software; Tablets; Technology; Time; United States; Universities; Virginia; Waxes; Wrist; Measures; United States Agency for Healthcare Research and Quality; United States Agency for Health Care Policy and Research; Agency for Healthcare Research and Quality; Agency for Health Care Policy and Research; AHRQ; AHCPR; falls; Hydrocolloid Bandages; Hydrocolloid Dressing; Fall prevention; preventing falls; Muscle Weakness; Muscular Weakness; Injury; base; sensor; improved; Site; Clinical; Encapsulated; Phase; Medical; Evaluation; Consciousness; Conscious; Individual; Policies; Response Latencies; mental status; mental state; Letters; tool; instrument; programs; Hour; Event; Home environment; Home; System; Location; non-compliance; noncompliant; noncompliance; non-compliant; Height; health care service organization; health care organization; hazard; intervention program; novel; Participant; Prevention program; Environmental Risk Factor; environmental risk; Environmental Factor; Prevention; Devices; Reporting; Positioning Attribute; Position; response; Adverse event; Adverse Experience; Skin; Cellular Phone; smartphone; smart phone; iPhone; Cellular Telephone; Cell Phone; fall risk; Hospital Nursing; Institution; Data; Detection; Predictive Value; Research Infrastructure; Infrastructure; Cognitive; Small Business Innovation Research; SBIR; Small Business Innovation Research Grant; wireless; Wireless Technology; Hot Spot; Hospital safety; designing; design; Population; Trauma; usability; prototype; commercialization; wireless network; Phase I Study; phase 1 study; Prevention Measures; Patient risk; activity tracker; activity monitor; accelerometry; Accelerometer; Fall injury; wearable sensor; wearable device

Fall detection, assessment, and prevention is a challenging issue for healthcare institutions. Despite wide recognition as a considerable problem, fall-related injuries are the most frequently reported adverse events in hospital inpatient settings|up to 20% of patients fall at least once during their stay. According to the Agency for Healthcare Research and Quality reports, 30% to 51% of falls result in injury, and up to 44% of those injuries lead to death. In the United States alone, the number of inpatient falls exceeds 1 million per year, with elderly individuals being the most vulnerable. As a testament to its importance, fall research was listed as a top priority in the Institute of Medicine's report to Congress on national priorities. Diverse factors contribute to falls: patient factors (e.g., cognitive state, muscle weakness, medications), environmental factors (e.g., bed/toilet positioning, trip hazards), and institutional factors (e.g., poor responsiveness to bed/chair alarms, inadequate fall assessment and prevention measures). Although hospitals employ programs to prevent falls, an essential component of a fall prevention program is accurate determination of fall events, as many falls are \unseen" and unreported. In their 2016 Claims Report, insurance company CNA stated that 66% of falls were unwitnessed and cited failure to monitor for falls in over half of closed legal claims. Alternative fall detection solutions have not been adopted in hospital settings due to poor fall sensitivity, high false-alarm rates, and lack of necessary supporting functions. Solution The body-worn FallCall system, proposed herein, will leverage powerful, novel sensing capabilities to provide robust fall detection and to report fall location without bothersome false alarms. The FallCall body-worn instrument will embody a miniature electronics package that is encapsulated in a disposable, hypoallergenic adhesive patch. The patch can be placed anywhere on the torso or upper arms to minimize interaction with other medical equipment or injury sites. The system will continuously monitor patients and issue a timely alert if a fall is detected, minimizing patient time on the ground, as well as injury assessment and treatment latencies. The FallCall system will allow patient location to be determined (including the room and floor of the hospital) using a reliable, robust wireless mesh network. Additionally, the FallCall system will have the capability to issue wander and inactivity alerts. The proposed system will be unique in its ability to objectively measure the response time of clinical staff when a fall occurs, and will be a key component in evaluating and improving fall prevention programs. Phase I Results The Phase I e ort built and evaluated the FallCall prototype in both a fall laboratory and real-world hospital setting using patients. The studies resulted in 100% of falls detected with zero false alarms. Location determination also achieved perfect accuracy. A formal usability study was conducted resulting in a grade in the top 5% based on normative data.

Public Health Relevance Statement:
Narrative The FallCall system will detect fall events and issue timely alerts (including fall location) when such events occur, in addition to providing activity metrics to help ascertain an individual's fall risk and changes thereto. Use of the FallCall system will minimize response latency and "time on the ground" after a fall event, and provide objective measures of staff response time. Fall determination with high sensitivity and specificity is an essential component of effective fall assessment and prevention programs. The proposed tool will nd a ready market, as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires healthcare organizations seeking accreditation to routinely assess and reassess each patient's risk for falling, and to take action to reduce injury when a fall occurs. Furthermore, Medicare policy limits and, in some cases, prohibits reimbursement to institutions for the treatment of falls and fall-related trauma. These policies have resulted in significant market pull, and will accelerate the adoption of the FallCall instrument. Terms: Accreditation; Adhesives; Adoption; Elderly; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Algorithms; Altitude; Beds; Charge; Choking; Cities; Clinical Research; Clinical Study; Congresses; meeting reports; Cessation of life; Death; Sterile coverings; Dressing; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electronics; electronic device; Environment; Equipment; Floor; Focus Groups; Freedom; Liberty; Goals; Medicare; Health Insurance for Aged and Disabled, Title 18; Health Insurance for Disabled Title 18; Title 18; health insurance for disabled; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Hospitals; Housing; Inpatients; Institute of Medicine (U.S.); Institute of Medicine; NAS/IOM; instrumentation; Insurance; Joint Commission on Accreditation of Healthcare Organizations; JCAHO; Joint Commission on Accreditation, Health Care Organizations; Laboratories; Lead; Pb element; heavy metal Pb; heavy metal lead; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; Legal patent; Patents; Patient Monitoring; Patients; Reaction Time; Response RT; Response Time; psychomotor reaction time; Research; research and development; Development and Research; R & D; R&D; Running; Safety; seal; Sleep; Computer software; Software; Time; United States; Measures; United States Agency for Healthcare Research and Quality; AHCPR; AHRQ; Agency for Health Care Policy and Research; Agency for Healthcare Research and Quality; United States Agency for Health Care Policy and Research; falls; Administrator; Healthcare; health care; Fall prevention; preventing falls; Muscle Weakness; Muscular Weakness; Injury; injuries; base; sensor; improved; Site; Clinical; Encapsulated; Phase; Medical; Evaluation; Failure; Individual; Policies; Response Latencies; tool; instrument; programs; Adopted; Event; Upper arm; System; Location; non-compliant; noncompliance; noncompliant; non-compliance; Height; data management; health care organization; healthcare organization; healthcare service organization; health care service organization; hazard; intervention program; novel; Prevention program; Laboratory Study; Environmental Factor; environmental risk; Environmental Risk Factor; Prevention; Devices; Reporting; Position; Positioning Attribute; response; Adverse Experience; Adverse event; Documentation; Skin; fall risk; Hospital Nursing; Institution; Legal; Data; Detection; Cognitive; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Wireless Technology; wireless; Monitor; Hot Spot; Health Professional; Health Care Professional; Healthcare professional; design; designing; next generation; prospective; Trauma; usability; prototype; wireless network; Prevention Measures; Patient risk; Accelerometer; accelerometry; activity monitor; activity tracker; fall injury; fall related injury; injurious falls; experimental study; experiment; experimental research; phase 1 designs; phase I designs; Infrastructure