Accidental FallSTEADINCT05390736
Evaluating the Cost Effectiveness of STEADI
A study testing Gait and balance assessment, Medication review and Comorbidity review in people with Accidental Fall, run by National Opinion Research Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Fall
- What is being tested?
- Gait and balance assessment, Medication review and Comorbidity review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2020to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Evidence in medical record of severe cognitive deficiencies (such as advanced Alzheimer's or dementia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Cost Effectiveness of STEADI Older Adult Fall Prevention in Primary Care Settings
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:
Read more
- Does STEADI significantly reduce falls among the target population compared to the standard of care?
- Does partial implementation of some selected STEADI modules, also significantly reduce falls among the target population as compared to the standard of care?
- 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.
Read the 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.
- Conditions
- Accidental Fall
- Being tested
- Gait and balance assessment, Medication review, Comorbidity review, Fall history, Assessment of feet/footwear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait and balance assessmentBehavioural
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 reviewBehavioural
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 reviewBehavioural
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 historyBehavioural
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/footwearBehavioural
Also called Podiatry / Diabetes assessment
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 acuityBehavioural
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 assessmentBehavioural
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 DeficiencyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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,
Measured: 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.
Measured: Within one year after patient completes STEADI assessment
Secondary outcomes (12)
Use of primary care medical services
Number of recorded visits with primary care providers
Measured: Within one year after STEADI assessment
Use of physical therapy medical services
Number of PT visits recorded
Measured: Within one year after STEADI assessment
Use of occupational therapy medical services
Number of OT visits recorded
Measured: Within one year after STEADI assessment
Use of eye care services
Number of eye care visits
Measured: Within one year after STEADI assessment
Use of podiatry services
Number of podiatry visits
Measured: Within one year after STEADI assessment
Level of polypharmacy
The total number of medications in use by patient
Measured: Within one year after STEADI assessment.
Benzodiazepine dosage
Recorded dosage for benzodiazepine in the electronic health record (0 = not taking the medication)
Measured: Within one year after STEADI assessment
Opioid dosage
Recorded dosage for opioids in the electronic health record (0 = not taking the medication)
Measured: Within one year after STEADI assessment
Antidepressant usage
Recorded usage of tricyclic antidepressants
Measured: Within one year after STEADI assessment
Antipsychotics usage
Recorded usage of antipsychotics
Measured: Within one year after STEADI assessment
Hypnotics usage
Recorded usage of hypnotics for insomnia
Measured: Within one year after STEADI assessment
Antihistamine usage
Recorded usage of antihistamines
Measured: Within one year after STEADI assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start29 Jul 2020
- Primary completion15 Jan 2022
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Opinion Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Emory Healthcare, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Dr. David Rein, National Opinion Research Center
- Investigators
- David Rein, PhD, Principal investigator, National Opinion Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390736
- Sponsor's protocol ID
- HHSD2002013M53955B
- Acronym
- STEADI
- Status last verified
- Nov 2023
- First submitted
- 5 May 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers.
Publications
Haddad YK, Brault MW, Moreland B, Peterson C, Zhang X, Thomas K, Sublett F, Dougherty M, Imhof L, Hackney ME, Vaughan CP, Johnson Ii TM, Phelan EA, Bergen G, Rein DB; Emory STEADI Implementation Team. Evaluating the effectiveness of a telemedicine-based STEADI implementation in primary care on fall outcomes: the STEADI options randomized controlled trial. Gerontologist. 2026 May 11;66(6):gnaf292. doi: 10.1093/geront/gnaf292.
PubMed 41349283Rein 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.
PubMed 38346180
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Cost Effectiveness of STEADI Older Adult Fall Prevention in Primary Care Settings
- ClinicalTrials.gov ID
- NCT05390736
- Acronym / sponsor ID
- STEADI / HHSD2002013M53955B
- Conditions
- Accidental Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- National Opinion Research CenterUniversity, hospital or other
- Collaborators
- Emory Healthcare, Centers for Disease Control and Prevention
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does STEADI significantly reduce falls among the target population compared to the standard of care?
- Does partial implementation of some selected STEADI modules, also significantly reduce falls among the target population as compared to the standard of care?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| STEADI Intervention | Experimental | 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 DeficiencyFor 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. |
| Control | No intervention | –After being enrolled in the study, the patient would receive usual care from their provider. |
| Physical Therapy Assessment Only | Experimental | Behavioral: Gait and balance assessmentFor 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. |
| Medical management assessment only | Experimental | Behavioral: Medication reviewFor 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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:
- English proficient
- Access to an able-bodied person to help with gait and balance assessments
Key exclusion criteria (1 listed)
- Evidence in medical record of severe cognitive deficiencies (such as advanced Alzheimer's or dementia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait and balance assessmentPatients 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). | Behavioural | Physical Therapy Assessment Only, STEADI Intervention |
| Medication reviewPatients' 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. | Behavioural | Medical management assessment only, STEADI Intervention |
| Comorbidity reviewThe 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. | Behavioural | STEADI Intervention |
| Fall historyThe 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. | Behavioural | STEADI Intervention |
| Assessment of feet/footwearAlso: Podiatry / Diabetes assessmentThe 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. | Behavioural | STEADI Intervention |
| Assessment of visual acuityThe 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. | Behavioural | STEADI Intervention |
| Home safety risk assessmentThe 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. | Behavioural | STEADI Intervention |
| Vitamin D DeficiencyThe 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. | Behavioural | STEADI Intervention |
Primary outcome
Falls recorded in the Electronic Medical Record.
Time frame: 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).
Medically treated falls reported in patient surveys
Time frame: 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)
Non-medically treated falls reported in patient surveys
Time frame: Within one year after patient completes STEADI assessment
Self-reports of falls that were not treated in a medical setting,
Total cost of all medical services
Time frame: 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.
12 secondary outcomes
Use of primary care medical services
Time frame: Within one year after STEADI assessment
Use of physical therapy medical services
Time frame: Within one year after STEADI assessment
Use of occupational therapy medical services
Time frame: Within one year after STEADI assessment
Use of eye care services
Time frame: Within one year after STEADI assessment
Use of podiatry services
Time frame: Within one year after STEADI assessment
Level of polypharmacy
Time frame: Within one year after STEADI assessment.
Benzodiazepine dosage
Time frame: Within one year after STEADI assessment
Opioid dosage
Time frame: Within one year after STEADI assessment
Antidepressant usage
Time frame: Within one year after STEADI assessment
Antipsychotics usage
Time frame: Within one year after STEADI assessment
Hypnotics usage
Time frame: Within one year after STEADI assessment
Antihistamine usage
Time frame: Within one year after STEADI assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Derived from this study: PubMed 41349283Haddad YK, Brault MW, Moreland B, Peterson C, Zhang X, Thomas K, Sublett F, Dougherty M, Imhof L, Hackney ME, Vaughan CP, Johnson Ii TM, Phelan EA, Bergen G, Rein DB; Emory STEADI Implementation Team. Evaluating the effectiveness of a telemedicine-based STEADI implementation in primary care on fall outcomes: the STEADI options randomized controlled trial. Gerontologist. 2026 May 11;66(6):gnaf292. doi: 10.1093/geront/gnaf292.
- Derived from this study: PubMed 38346180Rein 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.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rein, PhD principal investigator
National Opinion Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait and balance assessment, Medication review and Comorbidity review in people with Accidental Fall, run by National Opinion Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls recorded in the Electronic Medical Record. (time frame: Within one year after patient completes STEADI assessment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05390736, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.