NCT05390736: STEADI

Evaluating the Cost Effectiveness of STEADI

Completed NA Last updated 9 November 2023

What this trial tests

NA trial testing Gait and balance assessment in Accidental Fall in 780 participants. Completed in 18 September 2023.

Timeline

29 July 2020

Primary endpoint
15 January 2022

18 September 2023

Quick facts

Lead sponsor	National Opinion Research Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	780
Start date	29 July 2020
Primary completion	15 January 2022
Estimated completion	18 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Gait and balance assessment
• Medication review
• Comorbidity review
• Fall history
• Assessment of feet/footwear
• Assessment of visual acuity
• Home safety risk assessment
• Vitamin D Deficiency — full drug profile →

Conditions studied

• Accidental Fall — all drugs for Accidental Fall →

Sponsor

National Opinion Research Center

Who can join

65 and older, any sex, with Accidental Fall. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stopping Elderly Accidents, Deaths, and Injuries (STEADI) is an intervention to prevent falls among older adults developed by the Centers for Disease Control \& Prevention (CDC). Studies piloting the intervention have shown promising results; however, more evidence is needed to show that the intervention can be implemented cost-effectively on a larger scale in a real-world integrated health system. To this end, NORC partnered with Emory University School of Medicine to evaluate the effectiveness and cost-effectiveness of the STEADI intervention.

This study aims to answer the following research questions to fill remaining knowledge gaps about STEADI:

1. Does STEADI significantly reduce falls among the target population compared to the standard of care?
2. Does partial implementation of some selected STEADI modules, also significantly reduce falls among the target population as compared to the standard of care?
3. Does the net present value of falls and resulting injuries averted by STEADI implementation exceed the net present value of the costs of STEADI implementation and the incremental costs that result from it?

Using a mixture of qualitative interview and quantitative performance measures, the study evaluates and describes this case of STEADI implementation within selected primary care clinics of Emory Healthcare. NORC partnered with Emory University School of Medicine to implement different aspects of STEADI in a real-world primary care setting, document experiences implementing the intervention, measure implementation costs, and compare the outcomes of the STEADI intervention compared to control version of the intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Telemedicine-Based Risk Program to Prevent Falls Among Older Adults: Protocol for a Randomized Quality Improvement Trial.
   Rein DB, Hackney ME, Haddad YK, Sublett FA, et al · · 2024 · cited 2× · PMID 38346180 · DOI 10.2196/54395