Electronic Strategies for Tailored Exercise to Prevent FallS

Falls Clinical Trial

— eSTEPS  

Official title:

Electronic Strategies for Tailored Exercise to Prevent FallS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993781
• Other study ID #: 2020P002162
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: August 23, 2025

Study information

• Verified date: June 2023
• Source: Brigham and Women's Hospital
• Contact: Patricia Dykes, PhD, RN
• Phone: 617-525-6654
• Email: pdykes[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8352
• Est. completion date: August 23, 2025
• Est. primary completion date: February 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall Injury
• Falls

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore the effect of the eSTEPS intervention on the rate of death	Death	Up to 21 months
Other	To determine the effect of the eSTEPS intervention the rate of fall injuries	Fractures	Up to 21 months
Primary	To determine the effect of the eSTEPS intervention on the rate of falls	Falls rate per 100 patient years	Up to 21 months
Secondary	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.	Up to 21 months
Secondary	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.	Up to 21 months