Evaluating the Cost Effectiveness of STEADI

Accidental Fall Clinical Trial

— STEADI  

Official title:

Evaluating the Cost Effectiveness of STEADI Older Adult Fall Prevention in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05390736
• Other study ID #: HHSD2002013M53955B
• Status: Completed
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: September 18, 2023

Study information

• Verified date: November 2023
• Source: National Opinion Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: September 18, 2023
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Accidental Fall

Intervention

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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory Healthcare	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
National Opinion Research Center	Centers for Disease Control and Prevention, Emory Healthcare

Country where clinical trial is conducted

United States, 

Outcome

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