Electronic Strategies for Tailored Exercise to Prevent FallS (eSTEPS)

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.

Study Overview

• Status: Completed
• Conditions: Fall Injury; Falls; Exercise Self-Efficacy; Falls Self-Efficacy
• Intervention / Treatment: Behavioral: eSTEPS CDS

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 Type: Interventional
• Enrollment (Actual): 11945
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 105 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eSTEPS Clinical Decision Support; Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care.	Behavioral: eSTEPS CDS; 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.
No Intervention: Usual Care; Usual primary care practices regarding exercise-related fall prevention planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the effect of the eSTEPS intervention on the rate of falls	Falls rate per 100 patient years	Up to 23 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from initial visit to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the effect of the eSTEPS intervention on the rate of death	Death	Up to 23 months
To determine the effect of the eSTEPS intervention the rate of fall injuries	Fractures	Up to 23 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022P001055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No