Clinical trial NCT05390736: Evaluating the Cost Effectiveness of STEADI
Official title: Evaluating the Cost Effectiveness of STEADI Older Adult Fall Prevention in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Lead sponsor: National Opinion Research Center
Sponsor class: OTHER
Collaborators: name: Emory Healthcare
name: Centers for Disease Control and Prevention
First posted: 2022-05-25
Enrollment: 780
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Falls recorded in the Electronic Medical Record.
timeFrame: Within one year after patient completes STEADI assessment.
measure: Medically treated falls reported in patient surveys
timeFrame: Within one year after patient completes STEADI assessment
measure: Non-medically treated falls reported in patient surveys
timeFrame: Within one year after patient completes STEADI assessment
measure: Total cost of all medical services
timeFrame: Within one year after patient completes STEADI assessment
Secondary outcomes:
measure: Use of primary care medical services
timeFrame: Within one year after STEADI assessment
measure: Use of physical therapy medical services
timeFrame: Within one year after STEADI assessment
measure: Use of occupational therapy medical services
timeFrame: Within one year after STEADI assessment
measure: Use of eye care services
timeFrame: Within one year after STEADI assessment
measure: Use of podiatry services
timeFrame: Within one year after STEADI assessment
measure: Level of polypharmacy
timeFrame: Within one year after STEADI assessment.
measure: Benzodiazepine dosage
timeFrame: Within one year after STEADI assessment
measure: Opioid dosage
timeFrame: Within one year after STEADI assessment
measure: Antidepressant usage
timeFrame: Within one year after STEADI assessment
measure: Antipsychotics usage
timeFrame: Within one year after STEADI assessment
measure: Hypnotics usage
timeFrame: Within one year after STEADI assessment
measure: Antihistamine usage
timeFrame: Within one year after STEADI assessment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
Study officials:
affiliation: National Opinion Research Center
name: David Rein, PhD
role: PRINCIPAL_INVESTIGATOR
References: