FallseSTEPSNCT04993781
Electronic Strategies for Tailored Exercise to Prevent FallS
A study testing eSTEPS CDS in people with Falls and Fall Injury, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objectives of this proposal are to evaluate the eSTEPS CDS (eSTEPS) in a cluster randomized controlled trial. The intervention includes the following: 1) A machine learning-based fall injury risk screening algorithm to improve traditional fall risk screening. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls, Fall Injury, Exercise Self-Efficacy
- What is being tested?
- eSTEPS CDS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,945 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age 65 or above
- Patients enrolled in participating primary care intervention and control practices at MGB or enrolled in participating primary care replication trial intervention practices at UTMB
- Positive screen for fall risk at annual wellness visit
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Not community-dwelling (i.e. residents of long-term care facilities, prisoners etc.)
- Enrollment in the Subsample for Patient Reported Outcomes (PROs):
- A subsample of patients will be recruited and consented to participate in follow-up phone calls and surveys. Additional exclusion criteria for the subsample participants are:
- Unwilling or unable to provide verbal consent
- Not able to participate due to cognitive impairment (i.e., 4 or more errors on the Callahan Cognitive Screen assessment)
Show all 9Show fewer
- Has a terminal illness or other condition that indicates that the participant is not expected to survive for 1 year, such as receiving hospice or palliative care services.
- Not fluent in spoken English
- Does not have access to a working telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The objectives of this proposal are to evaluate the eSTEPS CDS (eSTEPS) in a cluster randomized controlled trial. The intervention includes the following: 1) A machine learning-based fall injury risk screening algorithm to improve traditional fall risk screening. 2) Provider BPA and/or Care Gap and Smart Set to provide CDS that helps primary care providers develop a tailored fall prevention exercise plan in the context of a Medicare Wellness Visit and 3) eSTEPS Patient App and exercise tools to provide older patients continued access to their interactive, tailored exercise plan.
Read the detailed description
This project will use traditional fall risk screening and machine learning approaches to accurately identify older adults at risk for falls. Investigators will then develop CDS that will be implemented into the electronic health record that helps primary care providers and older patients develop a tailored fall prevention exercise plan (eSTEPS). The eSTEPS CDS will be integrated into the widely implemented Epic EHR which will be accessible through the Care Gap and SmartSet to provide actionable CDS within primary care clinic workflows and facilitate the use of CDS with older patients during their annual wellness visit, ensuring that evidence-based recommendations are tailored to patients' preferences. The tailored exercise prescription will also be available through printouts, a website, and an app for use by patients at home. The eSTEPS intervention includes the provider CDS and the patient resources (printouts, website, exercise app) that will support primary care providers and patients with personalized exercise care planning during an annual Medicare Wellness visit. Investigators will conduct a cluster randomized controlled trial in urban primary care clinics to test the efficacy of the eSTEPS CDS intervention. Development of the eSTEPS CDS within the widely adopted Epic Electronic Health Record will support dissemination of evidence for older adults.
- Conditions
- Falls, Fall Injury, Exercise Self-Efficacy, Falls Self-Efficacy
- Being tested
- eSTEPS CDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSTEPS CDSBehavioural
Primary care clinics at Brigham and Women's Hospital will be randomized to receive the eSTEPS CDS or usual care. The University of Texas Medical Branch (UTMB) will be the replication site, with all participating primary care practices receiving the eSTEPS CDS.
| Study group | Role | What they receive |
|---|---|---|
| eSTEPS Clinical Decision Support | Experimental | Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care. Receives: Behavioral: eSTEPS CDS |
| Usual Care | No intervention | Usual primary care practices regarding exercise-related fall prevention planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Effect of the eSTEPS Intervention on the Rate of Falls
To determine the effect of the eSTEPS intervention on all falls per 100 patient years
Measured: Up to 23 months
Secondary outcomes (2)
To Determine the Effect of the eSTEPS Intervention on Falls Self-efficacy (Fear of Falling)
Falls self-efficacy (fear of falling) will be measured using the Modified Falls Efficacy Scale (mFES). This scale assesses confidence with completing a list of activities without falling and contains 14 items each measured on a scale of 0 to 10. 0 means "not confident at all", 5 means "fairly confident", and 10 means "completely confident." he total score is the average of all of the item scores and ranges from zero to ten. A higher score reflects more confidence and less fear of falling. Participants are classified as either fearful (MFES score < 8) or not fearful (MFES greater than or equal to 8). The total score range is 0 to 10.
Measured: Change from initial assessment to 6 months
To Determine the Effect of the eSTEPS Intervention on Self-efficacy for Exercise
Self-efficacy for exercise will be measured using the Self-Efficacy for Exercise (SEE) Scale. This scale consists of nine situations that may affect participation in exercise and ask participants to describe their current level of confidence that they could exercise 3 times a week for 20 minutes each time. 0 means "not confident", 5 means "fairly confident", and 10 means "very confident." The total score for the SEE scale is calculated by taking the numerical ratings for each statement and dividing by number of responses. The score indicates the strength of self-efficacy for exercise expectations. The higher the average score, the greater the participant's self-efficacy for exercise. The total score range is 0 to 10.
Measured: Change from initial visit to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start8 Jun 2023
- Primary completion8 May 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Model description
- The design is a cluster randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices. The unit of randomization is the practice.
- Masking
- None (open label)
- Enrolment
- 11,945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Nancy Latham, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993781
- Sponsor's protocol ID
- 2022P001055
- Acronym
- eSTEPS
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2021
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Latham NK, Hommel E, Kiesman M, Lipsitz SR, Bates DW, Carroll DL, Frost AC, Garabedian PM, Loewenthal JV, Sainlaire M, Samal L, Song W, Wien M, Dykes PC. Clinical Decision Support for Fall Prevention in Primary Care: The eSTEPS Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639240. doi: 10.1001/jamanetworkopen.2026.39240.
PubMed 42886484
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Strategies for Tailored Exercise to Prevent FallS
- ClinicalTrials.gov ID
- NCT04993781
- Acronym / sponsor ID
- eSTEPS / 2022P001055
- Conditions
- Falls, Fall Injury, Exercise Self-Efficacy, Falls Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,945 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this proposal are to evaluate the eSTEPS CDS (eSTEPS) in a cluster randomized controlled trial. The intervention includes the following: 1) A machine learning-based fall injury risk screening algorithm to improve traditional fall risk screening. 2) Provider BPA and/or Care Gap and Smart Set to provide CDS that helps primary care providers develop a tailored fall prevention exercise plan in the context of a Medicare Wellness Visit and 3) eSTEPS Patient App and exercise tools to provide older patients continued access to their interactive, tailored exercise plan.
Detailed description
This project will use traditional fall risk screening and machine learning approaches to accurately identify older adults at risk for falls. Investigators will then develop CDS that will be implemented into the electronic health record that helps primary care providers and older patients develop a tailored fall prevention exercise plan (eSTEPS). The eSTEPS CDS will be integrated into the widely implemented Epic EHR which will be accessible through the Care Gap and SmartSet to provide actionable CDS within primary care clinic workflows and facilitate the use of CDS with older patients during their annual wellness visit, ensuring that evidence-based recommendations are tailored to patients' preferences. The tailored exercise prescription will also be available through printouts, a website, and an app for use by patients at home. The eSTEPS intervention includes the provider CDS and the patient resources (printouts, website, exercise app) that will support primary care providers and patients with personalized exercise care planning during an annual Medicare Wellness visit. Investigators will conduct a cluster randomized controlled trial in urban primary care clinics to test the efficacy of the eSTEPS CDS intervention. Development of the eSTEPS CDS within the widely adopted Epic Electronic Health Record will support dissemination of evidence for older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design is a cluster randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices. The unit of randomization is the practice.
| Arm | Type | Receives |
|---|---|---|
| eSTEPS Clinical Decision Support | Experimental | Behavioral: eSTEPS CDSUse of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care. |
| Usual Care | No intervention | –Usual primary care practices regarding exercise-related fall prevention planning |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age 65 or above
- Patients enrolled in participating primary care intervention and control practices at MGB or enrolled in participating primary care replication trial intervention practices at UTMB
- Positive screen for fall risk at annual wellness visit
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Not community-dwelling (i.e. residents of long-term care facilities, prisoners etc.)
- A subsample of patients will be recruited and consented to participate in follow-up phone calls and surveys. Additional exclusion criteria for the subsample participants are:
- Unwilling or unable to provide verbal consent
- Not able to participate due to cognitive impairment (i.e., 4 or more errors on the Callahan Cognitive Screen assessment)
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 |
|---|---|---|
| eSTEPS CDSPrimary care clinics at Brigham and Women's Hospital will be randomized to receive the eSTEPS CDS or usual care. The University of Texas Medical Branch (UTMB) will be the replication site, with all participating primary care practices receiving the eSTEPS CDS. | Behavioural | eSTEPS Clinical Decision Support |
Primary outcome
To Determine the Effect of the eSTEPS Intervention on the Rate of Falls
Time frame: Up to 23 months
To determine the effect of the eSTEPS intervention on all falls per 100 patient years
2 secondary outcomes
To Determine the Effect of the eSTEPS Intervention on Falls Self-efficacy (Fear of Falling)
Time frame: Change from initial assessment to 6 months
To Determine the Effect of the eSTEPS Intervention on Self-efficacy for Exercise
Time frame: Change from initial visit to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42886484Latham NK, Hommel E, Kiesman M, Lipsitz SR, Bates DW, Carroll DL, Frost AC, Garabedian PM, Loewenthal JV, Sainlaire M, Samal L, Song W, Wien M, Dykes PC. Clinical Decision Support for Fall Prevention in Primary Care: The eSTEPS Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639240. doi: 10.1001/jamanetworkopen.2026.39240.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSTEPS CDS in people with Falls and Fall Injury, run by Brigham and Women's Hospital 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 4 inclusion and 9 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 8 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine the Effect of the eSTEPS Intervention on the Rate of Falls (time frame: Up to 23 months). 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 NCT04993781, which also lists 1 linked publication.
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 8 Jul 2026.