Exercise Self-Efficacy, Fall Injury, Falls, Falls Self-Efficacy
Conditions
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.
Interventions
BEHAVIORALeSTEPS 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.
Sponsors
Brigham and Women's Hospital
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Effect of the eSTEPS Intervention on the Rate of Falls | Up to 23 months | To determine the effect of the eSTEPS intervention on all falls per 100 patient years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Effect of the eSTEPS Intervention on Falls Self-efficacy (Fear of Falling) | Change from initial assessment to 6 months | 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. |
| To Determine the Effect of the eSTEPS Intervention on Self-efficacy for Exercise | Change from initial visit to 6 months | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 76.7 Years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1047 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10423 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 261 Participants |
| Falls Self-efficacy (fear of falling) | 8.7 Score STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Black/African American | 360 Participants |
| Race/Ethnicity, Customized Missing | 613 Participants |
| Race/Ethnicity, Customized Other | 131 Participants |
| Race/Ethnicity, Customized White | 9428 Participants |
| Self-efficacy for exercise | 7.3 Score STANDARD_DEVIATION 2.2 |
| Sex: Female, Male Female | 3853 Participants |
| Sex: Female, Male Male | 2073 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 433 / 5,681 | 402 / 6,264 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1,767 / 5,681 | 1,787 / 6,264 |
Outcome results
None listed