Evaluating the Cost Effectiveness of STEADI

NCT05390736 | Completed

• 1 other identifier: HHSD2002013M53955B
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does STEADI significantly reduce falls among the target population compared to the standard of care?
2. 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. 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?

Conditions

Accidental Fall

Outcome Measures

Primary Outcomes (4)

• Falls recorded in the Electronic Medical Record.

  Falls identified in Emory Electronic Health Record as determined by the presence of ICD-10 diagnosis codes (W00-W19).

  Within one year after patient completes STEADI assessment.

• Medically treated falls reported in patient surveys

  Self-reports of falls that were treated in a medical setting (regardless of whether it was treated at a study affiliated site)

  Within one year after patient completes STEADI assessment

• Non-medically treated falls reported in patient surveys

  Self-reports of falls that were not treated in a medical setting,

  Within one year after patient completes STEADI assessment

• Total cost of all medical services

  Cumulative health care allowable charges (or payments if available from claims data) for all patient services as observed in electronic health records, the estimated costs of services rendered outside of Emory Healthcare, the per person cost of screening and assessment, and the per person cost of STEADI-based fall prevention implementation.

  Within one year after patient completes STEADI assessment

Secondary Outcomes (12)

• Use of primary care medical services

  Within one year after STEADI assessment

• Use of physical therapy medical services

  Within one year after STEADI assessment

• Use of occupational therapy medical services

  Within one year after STEADI assessment

• Use of eye care services

  Within one year after STEADI assessment

• Use of podiatry services

  Within one year after STEADI assessment

Study Arms (4)

STEADI Intervention

EXPERIMENTAL

For those assigned to the STEADI intervention arm, the clinical research nurse conducted standardized assessments to identify a patient's risk factors for falls. The STEADI assessments included: 1) a review of comorbidities; 2) medication review; 3) review of patient's falls history; 4) assessment of feet and footwear; 5) assessment of visual acuity; and 6) assessment of gait and balance; 7) review of home safety risks; and 8) assessment of potential vitamin D deficiency. Nurses would use assessment results to make recommendations which would then be relayed to the patient through their provider at their upcoming primary care visit.

Behavioral: Gait and balance assessment; Behavioral: Medication review; Behavioral: Comorbidity review; Behavioral: Fall history; Behavioral: Assessment of feet/footwear; Behavioral: Assessment of visual acuity; Behavioral: Home safety risk assessment; Behavioral: Vitamin D Deficiency

Control

NO INTERVENTION

After being enrolled in the study, the patient would receive usual care from their provider.

Physical Therapy Assessment Only

EXPERIMENTAL

For those assigned to the PT assessment only arm, the clinical research nurse would only conduct gait and balance assessments and would make recommendations about need for physical therapy services, conveyed to primary care provider for referrals.

Behavioral: Gait and balance assessment

Medical management assessment only

EXPERIMENTAL

For those assign to the medical management assessment arm, only patients' medication usage would be assessed for polypharmacy (using 5 or more medications) or use of pharmaceutical classes that increase risk for falls. Recommendations for making changes to dosing levels or reducing number of medications would be conveyed to primary care provider.

Behavioral: Medication review

Interventions

Gait and balance assessment BEHAVIORAL

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).

Physical Therapy Assessment Only; STEADI Intervention

Medication review BEHAVIORAL

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.

Medical management assessment only; STEADI Intervention

Comorbidity review BEHAVIORAL

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.

STEADI Intervention

Fall history BEHAVIORAL

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.

STEADI Intervention

Assessment of feet/footwear BEHAVIORAL

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.

Also known as: Podiatry / Diabetes assessment

STEADI Intervention

Assessment of visual acuity BEHAVIORAL

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.

STEADI Intervention

Home safety risk assessment BEHAVIORAL

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.

STEADI Intervention

Vitamin D Deficiency BEHAVIORAL

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.

STEADI Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• With a non-acute outpatient visit scheduled at one of the five participating primary care clinics during the study period
• Stay Independent Screening (SIS) score of 4 or higher or an answer of "yes" to one of following three key questions in the SIS:
• "Have you fallen in the past year?"
• "Do you feel unsteady when standing or walking?"
• "Do you worry about falling?"
• English proficient
• Access to an able-bodied person to help with gait and balance assessments

You may not qualify if:

• Evidence in medical record of severe cognitive deficiencies (such as advanced Alzheimer's or dementia).

Sponsors & Collaborators

• National Opinion Research Center: lead
• Emory Healthcare: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Emory Healthcare

Atlanta, Georgia, 30033, United States

Location

Related Publications (1)

• Rein DB, Hackney ME, Haddad YK, Sublett FA, Moreland B, Imhof L, Peterson C, Legha JK, Mark J, Vaughan CP, Johnson Ii TM, Bergen G; Emory STEADI Implementation team. Telemedicine-Based Risk Program to Prevent Falls Among Older Adults: Protocol for a Randomized Quality Improvement Trial. JMIR Res Protoc. 2024 Mar 26;13:e54395. doi: 10.2196/54395.

  PMID: 38346180 DERIVED

MeSH Terms

Interventions

Gait; Medication Review

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• David Rein, PhD

  National Opinion Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Area Director

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 25, 2022
• Study Start: July 29, 2020
• Primary Completion: January 15, 2022
• Study Completion: September 18, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)