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Clinical Trial

11/3/2021

8/2015-12/2019

Clinical Trials

5451


11/3/2021

N/A

Objectives

STRIDE was a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries.

Background

Among older Americans, falls are the leading cause of injury-related deaths. Approximately one in four older adults falls each year, and 20 to 30% of those who fall have moderate-to-severe injuries, resulting in approximately 30,000 deaths, 3 million emergency department visits, and 800,000 hospitalizations annually. Despite evidence from efficacy trials that many falls in older adults can be prevented, the quality of care for the prevention of falls remains low, and age-adjusted mortality attributable to falls has continued to rise. Barriers at multiple levels — health care systems, payers, providers, and patients — have contributed to suboptimal implementation of prevention strategies that have been shown in efficacy trials to reduce the risk of falls.

Study Design

The primary outcome, assessed in a time-to-event analysis, was the first adjudicated serious fall injury, which was defined as a fall resulting in a fracture (other than a thoracic or lumbar vertebral fracture), joint dislocation, or cut requiring closure or a fall resulting in hospitalization for a head injury, sprain or strain, bruising or swelling, or other serious injury. The secondary outcome, assessed in a time-to-event analysis, was the first participant-reported fall injury. Data on fall injuries were collected every 4 months by means of telephone interviews, which were conducted by personnel who were unaware of the treatment assignments. During these interviews, participants were also asked about hospital admissions, emergency department visits, and other health care utilization. A random subsample of 743 participants (384 intervention, 359 control) aged 75 and older were also assessed for concern about falling, anxiety, depression, physical function, and disability at the baseline, 12-month, and 24-month interviews. Serious fall injuries that were reported during telephone interviews were reviewed by an adjudication team that was unaware of the treatment assignments. The events were then verified with the use of administrative claims data (provided by trial sites) or encounter data (provided by the Centers for Medicare and Medicaid Services) or both or by review of electronic health records. Each case was reviewed independently by two physician adjudicators who were unaware of the treatment assignment. Events deemed as “definitely” or “highly likely” to be a serious fall injury on the basis of verification of participant report by at least one additional objective source were adjudicated as events that met the criteria for the primary outcome.

Interventions/Treatment Groups

A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries; there were 2802 in the intervention group and 2649 in the control group. Risk was determined on the basis of whether the participant had had a fall-related injury in the previous year or had fallen two or more times in the previous year or whether the participant was afraid of falling because of problems with balance or walking. Persons with clinically significant cognitive impairment, defined by four or more errors on the six-item Callahan screening instrument, could be included in the trial if they had a proxy who was willing to provide consent and assist them during the trial. Persons who were incapable of providing consent or assent (with proxy consent) or were unable to speak English or Spanish were excluded.

Outcomes

Primary: Fall-related Injury

Secondary: Physical Function, Disability, Anxiety, Depression, Fear of Falling 

Results/Conclusions

A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care.

Available Biospecimens

No biospecimens are available for this collection

Resources Available
Study Datasets
Materials Available

Data Only