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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eSTEPS Clinical Decision Support | Experimental | Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care. |
|
| Usual Care | No Intervention | Usual primary care practices regarding exercise-related fall prevention planning |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSTEPS CDS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Effect of the eSTEPS Intervention on the Rate of Falls | To determine the effect of the eSTEPS intervention on all falls per 100 patient years | Up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To Explore the Effect of the eSTEPS Intervention on Death | To explore the effect of the esteps intervention on the rate of death (mortality) in the intervention versus control groups | Up to 23 months |
| To Determine the Effect of the eSTEPS Intervention the Rate of Fall-related Injuries |
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | eSTEPS Clinical Decision Support | Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care. |
| FG001 | Usual Care | Usual primary care practices regarding exercise-related fall prevention planning |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | eSTEPS Clinical Decision Support | Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine the Effect of the eSTEPS Intervention on the Rate of Falls | To determine the effect of the eSTEPS intervention on all falls per 100 patient years | Posted | Number | 95% Confidence Interval | Falls per 100 person years | Up to 23 months |
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Baseline to 23 months
In this pragmatic trial, only serious adverse were monitored
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eSTEPS Clinical Decision Support | Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization and/or death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Latham | Brigham and Women's Hosptial | 617-999-9195 | nklatham@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2024 | May 5, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2024 | Feb 6, 2026 | ICF_000.pdf |
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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.
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|
| Change from initial assessment to 6 months |
| 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. | Change from initial visit to 6 months |
To determine the effect of the eSTEPS intervention on the rate of fall injuries calculated as fall-related injuries per 100 person years |
| Up to 23 months |
Usual primary care practices regarding exercise-related fall prevention planning
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | The rows are showing the data broken down by sex (male or female) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial | Mean | Standard Deviation | Score |
|
| 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. | This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial | Mean | Standard Deviation | Score |
|
| Counts |
|---|
| Participants |
|
|
|
| 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. | This outcome was collected on a pre-planned randomly selected subgroup of participants who provided consent for telephone interviews | Posted | Mean | Standard Deviation | Change in Mean Score | Change from initial assessment to 6 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. | This outcome was collected on a pre-planned randomly selected subgroup of participants who provided consent for telephone interviews | Posted | Mean | Standard Deviation | Change in Mean score | Change from initial visit to 6 months |
|
|
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| Other Pre-specified | To Explore the Effect of the eSTEPS Intervention on Death | To explore the effect of the esteps intervention on the rate of death (mortality) in the intervention versus control groups | Posted | Number | 95% Confidence Interval | Death per 100 person years | Up to 23 months |
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| Other Pre-specified | To Determine the Effect of the eSTEPS Intervention the Rate of Fall-related Injuries | To determine the effect of the eSTEPS intervention on the rate of fall injuries calculated as fall-related injuries per 100 person years | Posted | Number | 95% Confidence Interval | Fall-related injuries /100 person years | Up to 23 months |
|
|
|
| 433 |
| 5,681 |
| 1,767 |
| 5,681 |
| 0 |
| 0 |
| EG001 | Usual Care | Usual primary care practices regarding exercise-related fall prevention planning | 402 | 6,264 | 1,787 | 6,264 | 0 | 0 |
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| Unknown or Not Reported |
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| Other |
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| Missing |
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