Electronic Strategies for Tailored Exercise to Prevent FallS

NCT ID: NCT04993781

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11945 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-08
• Study Completion Date: 2025-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

eSTEPS Clinical Decision Support

Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care.

Group Type: EXPERIMENTAL

eSTEPS CDS

Intervention Type: 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.

Usual Care

Usual primary care practices regarding exercise-related fall prevention planning

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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):

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nancy Latham

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2022P001055

Identifier Type: -

Identifier Source: org_study_id