Clinical trial NCT04993781: Electronic Strategies for Tailored Exercise to Prevent FallS
Official title: Electronic Strategies for Tailored Exercise to Prevent FallS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Falls
Fall Injury
Exercise Self-Efficacy
Falls Self-Efficacy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2021-08-06
Enrollment: 12328
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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):

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

Primary outcomes:
measure: To determine the effect of the eSTEPS intervention on the rate of falls
timeFrame: Up to 21 months
Secondary outcomes:
measure: To determine the effect of the eSTEPS intervention on falls self-efficacy (fear of falling)
timeFrame: Up to 21 months
measure: To determine the effect of the eSTEPS intervention on self-efficacy for exercise
timeFrame: Up to 21 months
Other outcomes:
measure: To explore the effect of the eSTEPS intervention on the rate of death
timeFrame: Up to 21 months
measure: To determine the effect of the eSTEPS intervention the rate of fall injuries
timeFrame: Up to 21 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: