eSTEPS: Electronic Strategies for Tailored Exercise to Prevent FallS

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04993781
Collaborator
National Institute on Aging (NIA) (NIH), National Institutes of Health (NIH) (NIH), Essentia Health (Other)
8,353
2
31

Study Details

Study Description

Brief Summary

The goals of this project are to 1) develop primary care clinical eSTEPS decision support (CDS) to ensure that older adults at risk of falling receive appropriate exercise referrals, education and support from their provider and 2) to conduct a cluster randomized control trial in urban and rural primary care clinics to test the efficacy of the eSTEPS CDS intervention on falls and injurious falls in patients over age 65 at high risk for falls.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: eSTEPS CDS
N/A

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 implemented into the electronic health record that helps primary care providers and older patients develop a tailored fall prevention exercise plan (eSTEPS). Investigators will conduct a cluster randomized control trial in urban and rural 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, with a focus on rural elders.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8353 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Electronic Strategies for Tailored Exercise to Prevent FallS
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: eSTEPS Clinical Decision Support

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

Behavioral: eSTEPS CDS
Primary care clinics at Brigham and Women's Hospital and Essentia Health will be randomized to receive the eSTEPS CDS or usual care

No Intervention: Usual Care

Usual primary care practices regarding exercise-related fall prevention planning

Outcome Measures

Primary Outcome Measures

  1. All Falls [Up to 21 months]

    Number of falls by treatment group

Secondary Outcome Measures

  1. Time to first fall [Up to 21 months]

    Time to first fall by treatment group

  2. Fall-related injuries [Up to 21 months]

    Number of fall-related injuries by treatment group

  3. Time to Fall-related injuries [Up to 21 months]

    Time to fall-related injuries by treatment group

  4. Self-Efficacy for Exercise [Up to 4 months]

    Self-efficacy for Exercise (SEE) change from baseline to final interview by treatment group. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.

  5. Outcome Expectancy for Exercise [Up to 4 months]

    Multidimensional Outcome Expectations for Exercise (OEE) scale change from baseline to final interview by treatment group. This scale has a range of total scores from 15-75. A higher score indicates higher outcome expectancy for exercise.

  6. Overall Physical Activity Participation [Up to 4 months]

    Telephone Assessment of Physical Activity (TAPA) change from baseline to final interview by treatment group

  7. Fall Prevention Exercise Participation [Up to 4 months]

    Number of exercise sessions completed per week by treatment group

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult patient enrolled in participating practice

  • Age 65 or above

  • Positive screen for falls in annual wellness visit

Exclusion Criteria:
  • Not fluent in English

  • Unable to read or write

  • Not community-dwelling (i.e. residents of long-term care facilities, prisoners etc.)

  • Not able to provide consent due to cognitive impairment or other issues

  • Terminal illness, not expected to survive for 1 year

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patricia C. Dykes, Sr. Nurse Scientist and Director, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04993781
Other Study ID Numbers:
  • 2020P002162
First Posted:
Aug 6, 2021
Last Update Posted:
Aug 6, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 6, 2021