Evaluating the Cost Effectiveness of STEADI

Not Applicable

Completed

• Conditions: Accidental Fall
• Interventions: 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

• Registration Number: NCT05390736
• Lead Sponsor: National Opinion Research Center

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. 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.

Detailed Description

The STEADI Options Trial (STEADI Trial) is a randomized control trial implemented in five Emory Healthcare primary care clinics during September 1, 2020, and December 31, 2021. The trial compared patients who received a one-time implementation of the STEADI-based fall prevention (intervention) to a control group receiving standard care. Patients were randomized based on the provider for their next scheduled routine primary care visit. Due to the COVID-19 pandemic, investigators adapted the intervention to implement it via video or phone supported telemedicine encounters conducted by a designated project nurse.

The study contacted eligible patients, screened them for fall risk using the Stay Independent Screener, consented and enrolled patients with a fall risk, conducted intervention assessments via video or phone (with video preferred), and transferred the results of the assessments to the patient's providers for intervention at the patient's next scheduled routine primary care visits. Primary care providers outside the study team were responsible for acting on assessment information.

Investigators collected data on recruitment, assessments, health service utilization, prescriptions, fall events, implementation costs, and all-cause outpatient and inpatient charges incurred over one year using administrative and electronic health records and patient surveys.

STEADI-based fall prevention was implemented in five primary care clinics operated as part of the Emory Healthcare System selected based on the willingness of their leadership to participate, geographic and sociodemographic diversity of their patient population within the Atlanta Metro Area, and size of the geriatric population they served. The CDC was responsible for project oversight and fall prevention expertise, NORC designed the study protocol and data collection instruments and managed the project, and Emory was responsible for clinical implementation.

Emory hired three clinical research interviewers (CRIs) and a clinical research nurse (CRN) to conduct recruitment, coordination, and assessments. CRIs were responsible for screening patients for fall risk, recruiting and enrolling those at risk, scheduling STEADI assessments, and conducting pre-assessment coordination calls. The CRN was responsible for conducting assessments, providing patient education, creating recommendations based on assessment information, and disseminating those recommendations to the patient's provider. Providers were responsible for acting on recommendations through the creation of clinical referrals to services or managing medications.

Providers were randomized each week 1:1 to either intervention or control study arms based on a dice roll and then assigned patients to study arm based on their scheduled provider. Providers were re-randomized each week; however, patient assignment remained the same even if they rescheduled an appointment to another week. After randomizing, a list of patients aged 65 years and older with a non-acute clinic visit scheduled three weeks in the future along with their provider-based assignment was generated and sent to the study manager for recruitment.

Three weeks prior to their scheduled primary care visit, patients received a text message link to an online SIS, which they were requested to complete prior to their upcoming scheduled primary care visit. Patients who screened at risk via the online SIS and patients who did not complete it were contacted by the study's CRIs up to three times before their primary care visit. Once reached, CRIs administered the SIS to patients who did not complete it online to determine eligibility based on fall risk. Patients with fall risk ascertained online or by phone were asked if they had 1) a computer/tablet/or phone with a camera and internet, or if not if they could participate by phone 2) space for a clear hallway and corner in their home, and 3) someone nearby they could call upon for help during the assessment. Patients who answered yes were then asked to provide informed consent to participate in the study.

Patients in the STEADI treatment groups were called by CRIs to evaluate whether their home was safe for the assessment and provided setup instructions based on a script. During this call, CRIs confirmed the patient had a stable internet connection and was able to start the video conferencing software (Zoom), and had a 10 foot path for the Timed up and go (TUG) physical therapy assessment, picked a corner for the 4-stage balance physical therapy assessment, and had an appropriate chair and wall space to set the chair against for the Chair Stand physical therapy assessment.

The CRN conducted relevant assessments based on the patient's treatment assignment to identify a patient's risk factors for falls. The CRN also reviewed health education materials with the patient and sent these materials in an email follow-up. CRNs compiled assessment results, the educational materials presented to the patient, and their recommendations for referrals and care management into the patient's EHR and sent assessment results and recommendations to the provider using the EHR messaging center.

Providers in each participating clinic were informed about the study protocol, communications methods, and actions they could take to act on information contained in the CRN report. Provider actions included ordering patient referrals to physical therapy, eye care, podiatry, the dizziness clinic, and occupational therapy, reviewing and changing patient medications, and testing patients for vitamin D levels. Providers acted on CRN recommendations at their clinical discretion.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-29
• Primary Completion: 2022-01-15
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Study Completion: 2023-09-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• 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:

  1. "Have you fallen in the past year?"
  2. "Do you feel unsteady when standing or walking?"
  3. "Do you worry about falling?"

• English proficient

• Access to an able-bodied person to help with gait and balance assessments

Exclusion criteria:

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEADI Intervention	Gait and balance assessment	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.
STEADI Intervention	Assessment of feet/footwear	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.
STEADI Intervention	Comorbidity review	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.
Physical Therapy Assessment Only	Gait and balance assessment	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.
STEADI Intervention	Home safety risk assessment	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.
STEADI Intervention	Vitamin D Deficiency	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.
STEADI Intervention	Medication review	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.
STEADI Intervention	Fall history	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.
STEADI Intervention	Assessment of visual acuity	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.
Medical management assessment only	Medication review	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.

Primary Outcome Measures

Name	Time	Method
Falls recorded in the Electronic Medical Record.	Within one year after patient completes STEADI assessment.	Falls identified in Emory Electronic Health Record as determined by the presence of ICD-10 diagnosis codes (W00-W19).
Non-medically treated falls reported in patient surveys	Within one year after patient completes STEADI assessment	Self-reports of falls that were not treated in a medical setting,
Medically treated falls reported in patient surveys	Within one year after patient completes STEADI assessment	Self-reports of falls that were treated in a medical setting (regardless of whether it was treated at a study affiliated site)
Total cost of all medical services	Within one year after patient completes STEADI assessment	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.

Secondary Outcome Measures

Name	Time	Method
Benzodiazepine dosage	Within one year after STEADI assessment	Recorded dosage for benzodiazepine in the electronic health record (0 = not taking the medication)
Use of eye care services	Within one year after STEADI assessment	Number of eye care visits
Antipsychotics usage	Within one year after STEADI assessment	Recorded usage of antipsychotics
Hypnotics usage	Within one year after STEADI assessment	Recorded usage of hypnotics for insomnia
Antidepressant usage	Within one year after STEADI assessment	Recorded usage of tricyclic antidepressants
Use of primary care medical services	Within one year after STEADI assessment	Number of recorded visits with primary care providers
Use of physical therapy medical services	Within one year after STEADI assessment	Number of PT visits recorded
Use of occupational therapy medical services	Within one year after STEADI assessment	Number of OT visits recorded
Use of podiatry services	Within one year after STEADI assessment	Number of podiatry visits
Level of polypharmacy	Within one year after STEADI assessment.	The total number of medications in use by patient
Antihistamine usage	Within one year after STEADI assessment	Recorded usage of antihistamines
Opioid dosage	Within one year after STEADI assessment	Recorded dosage for opioids in the electronic health record (0 = not taking the medication)

Trial Locations

Locations (1)

Emory Healthcare; 🇺🇸 Atlanta, Georgia, United States