The STRIDE Study is a cluster randomized, parallel group superiority trial to determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy.
Each person in the trial will be assessed for his or her risk of falling, and receive either the current standard of care—primarily information about preventing falls—or the experimental study intervention in which individualized care plans will be developed and administered. The care plans will be presented to the participant’s primary care physician for review, modification, and approval and will include proven fall risk reduction interventions that can be implemented by the research team, physicians and other health care providers, caregivers and community-based organizations. The intervention centers on the concept of a falls care manager working with each participant’s primary care provider to develop the plans and monitor success.
The design is a cluster randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices. The unit of randomization is the practice.
The research team plans to enroll 6,000 adults age 75 and older, living in the community, with one or more modifiable risk factors for falls. The first year of the study was a pilot phase, during which many aspects of the intervention were tested with small numbers of people across 10 clinical sites. The enrollment for the full trial started on August 1, 2015 and will take place over 18 months. The participants will be followed for up to three years.
The primary trial outcome is reduction in serious fall injuries, including non-spinal fractures, joint dislocation, head injuries, lacerations, internal injuries, and hypothermia. Secondary outcomes include reduction in all falls that cause injuries; all falls regardless of injury, indicators of well-being, physical function and disability, and anxiety and depression.
Patients and other stakeholder partner’s with the investigators in national and local councils throughout the study’s design, implementation, and oversight at national and site levels. The patients and stakeholders bring their unique personal perspective of how falls and fall injuries affect their lives, the difficulties they face in adhering to interventions, what outcomes are important to them, and what attributes of the interventions render them feasible, scalable, and sustainable. These contributors have advised the research team on several important study features.
Ten trial sites across the country have been chosen to address geographic, rural/urban, academic/non-academic, and racial/ethnic diversity, and to include a range of health care systems and models of care. The 14 NIA-funded Claude D. Pepper Older Americans Independence Centers, which include the nation’s premier research programs in complex geriatric syndromes helped to develop the trial protocol and will participate in the study.