The Center for Disease Control and Prevention's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative offers health care providers tools and resources to assist with fall risk screening and multifactorial fall risk assessment and interventions. Its effectiveness has never been evaluated in a randomized trial. This study aims to describe the protocol for the STEADI Options Randomized Quality Improvement Trial (RQIT), which was designed to evaluate the impact on falls and all-cause health expenditures of a telemedicine-based form of STEADI implemented among older adults aged 65 years and older, within a primary care setting. STEADI Options was a pragmatic RQIT implemented within a health system comparing a telemedicine version of the STEADI fall risk assessment to the standard of care (SOC). Before screening, we randomized all eligible patients in participating clinics into the STEADI arm or SOC arm based on their scheduled provider. All received the Stay Independent screener (SIS) to determine fall risk. Patients were considered at risk for falls if they scored 4 or more on the SIS or answered affirmatively to any 1 of the 3 key questions within the SIS. Patients screened at risk for falls and randomized to the STEADI arm were offered a registered nurse (RN)-led STEADI assessment through telemedicine; the RN provided assessment results and recommendations to the providers, who were advised to discuss fall-prevention strategies with their patients. Patients screened at risk for falls and randomized to the SOC arm were asked to participate in study data collection only. Data on recruitment, STEADI assessments, use of recommended prevention services, medications, and fall occurrences were collected using electronic health records and patient surveys. Using staff time diaries and administrative records, the study prospectively collected data on STEADI implementation costs and all-cause outpatient and inpatient charges incurred over the year following enrollment. The study enrolled 720 patients (n=307, 42.6% STEADI arm; n=353, 49% SOC arm; and n=60, 8.3% discontinued arm) from September 2020 to December 2021. Follow-up data collection was completed in January 2023. As of February 2024, data analysis is complete, and results are expected to be published by the end of 2025. The STEADI RQIT evaluates the impact of a telemedicine-based, STEADI-based fall risk assessment on falls and all-cause health expenditures and can provide information on the intervention's effectiveness and cost-effectiveness. ClinicalTrials.gov NCT05390736, http://clinicaltrials.gov/ct2/show/NCT05390736. RR1-10.2196/54395.
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