Electronic Strategies for Tailored Exercise to Prevent FallS

NCT04993781 | Completed DMC

• 1 other identifier: 2022P001055
• Study Type: interventional
• Target: 11,945
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Falls; Fall Injury; Exercise Self-Efficacy; Falls Self-Efficacy

Outcome Measures

Primary Outcomes (1)

• To determine the effect of the eSTEPS intervention on the rate of falls

  Falls rate per 100 patient years

  Up to 23 months

Secondary Outcomes (2)

• To determine the effect of the eSTEPS intervention on falls self-efficacy (fear of falling)

  Change from initial assessment to 6 months

• To determine the effect of the eSTEPS intervention on self-efficacy for exercise

  Change from initial visit to 6 months

Other Outcomes (2)

• To explore the effect of the eSTEPS intervention on the rate of death

  Up to 23 months

• To determine the effect of the eSTEPS intervention the rate of fall injuries

  Up to 23 months

Study Arms (2)

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.

Behavioral: eSTEPS CDS

Usual Care

NO INTERVENTION

Usual primary care practices regarding exercise-related fall prevention planning

Interventions

eSTEPS CDS BEHAVIORAL

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.

eSTEPS Clinical Decision Support

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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):
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: August 6, 2021
• Study Start: June 8, 2023
• Primary Completion: May 8, 2025
• Study Completion: August 31, 2025
• Last Updated: February 11, 2026

Record last verified: 2025-12

Locations

US (1)