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Electronic Strategies for Tailored Exercise to Prevent FallS (eSTEPS)

Mass General Brigham logo

Mass General Brigham

Status

Active, not recruiting

Conditions

Falls Self-Efficacy
Fall Injury
Falls
Exercise Self-Efficacy

Treatments

Behavioral: eSTEPS CDS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04993781
2020P002162

Details and patient eligibility

About

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.

Full 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.

Enrollment

12,328 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12,328 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Nancy Latham, PhD, PT; Patricia Dykes, PhD, RN

Data sourced from clinicaltrials.gov

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