Patients, caregivers, clinicians, insurers, and policymakers all agree that fall injuries represent grievous events for older persons and a major public health problem. Thirty percent of persons over the age of 65 fall each year, and for those over 75 the rates are even higher. Serious fall injuries are a common source of disability and death among the elderly. This randomized trial - a collaboration among investigators, patients, and stakeholders from the 14 U.S. Claude D. Pepper Older Americans Independence Centers (OAICs) and 10 healthcare systems where patients will be recruited - will determine the effectiveness of an evidence-based, multifactorial, patient-centered intervention to reduce the risk of serious fall injuries among non-institutionalized older persons. The investigators, patient and stakeholders worked together via conference calls and focus groups to prepare the application, and will continue to work together within a structured collaborative frame- work to implement the trial, including its interim and final analyses, and the dissemination of its results Our integrated strategy to reduce serious fall injuries, guided by input from our patient advisors and stakeholders during conference calls and focus groups, includes several patient-centered components: (a) screening to identify persons at high risk for falls, (b) defining a person's specific risk factors, (c) implementing an evidence-based multifactorial, individually-tailored intervention aimed at mitigating specific risk factors, based on the patient-centered approach developed at Yale and incorporating elements of the CDC and American Geriatrics Society Guidelines (d) reducing the risk of injury if the person falls (e.g., osteoporosis treatment); (e) changing organizational and provider behavior to initiate care processes, based on ACOVE-2 practice redesign model. The trial will utilize a cluster randomization strategy for participant allocation, randomizing clinical practices to our multifactorial intervention or standard care. We propose to enroll 6,000 eligible participants at up to 10 trial sites that reflect geographic and sociodemographic diversity. Enrollment will take place over an 18-month period, and we will follow the participants for a maximum of 3 years. The primary outcome is serious fall injuries, defined as those leading to medical attention, including non- vertebral fractures, joint dislocation, head injury, lacerations, and other major sequalae (e.g. rhabdomyolysis, internal injuries, hypothermia). Secondary outcomes, identified by patients and stakeholders, include all injurious falls, all falls regardless of injury, and indicators of well-being - fall efficacy, physcal function and disability, anxiety, and depressive symptoms. During Year 1, the investigators, patients and stakeholders will collaboratively refine and pilot a strategy for identifying persons t risk for falling and optimize the study design and intervention. The trial will incorporate an adaptive design and a pre-specified mid-term analysis. In addition, the investigators, patients and stakeholders will together evaluate the post-trial scalability and sustainability of the fall injury prevention strategy.
Fall injuries are the leading cause of fractures, traumatic brain injury, death, and disability among the elderly, and a major concern of older adults, their caregivers, geriatricians, public health agencies and third part payers. The proposed multi-site, adaptive, cluster-randomized clinical trial - a collaboration among investigators, patients, and other key stakeholders from the fourteen Claude D. Pepper Older Americans Independence Centers (OAICs) and eleven healthcare systems where patients will be recruited - will determine the effectiveness of an evidence-based, multifactorial standardly-tailored intervention to reduce the risk of serious fall injuries among non-institutionalized older persons.
|Greene, Erich J (2017) A SAS Macro for Covariate-Constrained Randomization of General Cluster-Randomized and Unstratified Designs. J Stat Softw 77:|