Evaluating the Cost Effectiveness of STEADI

NCT05390736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2023-11-09

No results posted yet for this study

Summary

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.

Conditions

  • Accidental Fall

Interventions

BEHAVIORAL

Gait and balance assessment

Patients are given Time Up and Go (TUG) tests, 30-second chair test, and 4-stage balance test (side-by-side, instep, tandem, and one foot).

BEHAVIORAL

Medication review

Patients' medication history in the EHR is assessed for polypharmacy (using 5 or more medications concurrently) and use of medication in the following classes: tricyclic antidepressants, antihistamines, antiemetics, antipsychotics, antispasmotics, muscle relaxants, benzodiazepines, hypnotics, and opioids. The CRN confirms prescriptions with the patient. The CRN reports the medication risk in her provider report and provides medication management educational materials to the patient. At the patient's upcoming primary care visit, providers evaluated whether the medications associated with increased fall risk could be adjusted.

BEHAVIORAL

Comorbidity review

The clinical research nurse reviews the patient's EHR problem list for diagnoses of comorbidities associated with increased fall risk including: cognition problems, Parkinson's disease, cardiac issues, depression, or incontinence. Comorbidities are shared with providers in the recommendation statement.

BEHAVIORAL

Fall history

The CRN asks how many times the patient had fallen in the past 12 months, whether those with falls sought medical attention, and if they experienced blackouts, loss of consciousness, or a broken/fractured bone(s) resulting from a fall. Fall history information is added to the provider report to increase the salience of fall prevention information.

BEHAVIORAL

Assessment of feet/footwear

The CRN observes or asks about the patient's current footwear, asks about foot pain or loss of sensation, and notes a diabetes diagnosis when applicable. Patient reports of foot pain, loss of sensation or diabetes result in a CRN note to the provider to examine the patient's feet and the potential need for a referral to podiatry. The CRN also reviewed a safe footwear handout with all patients regardless of their responses and emailed it to patients with other patient information following the call.

BEHAVIORAL

Assessment of visual acuity

The CRN projects a Banner eye chart on Zoom for the patient to read with their contacts or glasses from five feet away for both eyes together and each eye individually. Phone patients are asked to self-report any vision problems. If either the video screening or patient self-report indicated any vision problems, the CRN notes the result and recommendation for eye care referral for the patient's provider to review and order.

BEHAVIORAL

Home safety risk assessment

The CRN reviews the CDC brochure "Check for Safety: A Home Fall Prevention Checklist for Older Adults" with each patient. Check for Safety asks 17 questions about the home's floors, stairs and steps, kitchen, bathrooms, and bedrooms and suggests ideas for removing or reducing fall hazards. The CRN communicates home safety risks and a recommendation for occupational therapy to the provider for indicated patients.

BEHAVIORAL

Vitamin D Deficiency

The CRN asks the patient if they usually take a Vitamin D supplement with their other medications. If the patient does not take a Vitamin D supplement, the CRN recommends the provider check Vitamin D levels and consider supplementation if Vitamin D levels are less than 20 ng/mL.

Sponsors & Collaborators

Principal Investigators

  • David Rein, PhD · National Opinion Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2022-01-15
Completion
2023-09-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05390736 on ClinicalTrials.gov