eSTEPS Program for Fall Prevention

(eSTEPS Trial)

Overseen By Nancy Latham, PhD, PT

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Long-term care, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called eSTEPS CDS to help prevent falls in older adults. A smart algorithm identifies individuals at risk of falling and provides doctors with a plan to create personalized exercise routines during Medicare Wellness Visits. Participants will use an app to access their tailored exercise plans at home. Individuals aged 65 or older, who visit certain primary care practices, and have been identified as at risk for falls during a wellness check may be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could improve fall prevention strategies for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the eSTEPS CDS is safe for fall prevention?

Research shows that the eSTEPS Clinical Decision Support (CDS) system aims to reduce falls and injuries in older adults. Studies have found that using these systems in hospitals can effectively involve patients in fall prevention. One study, in particular, linked a well-designed CDS with electronic tools to fewer injuries from falls.

While these findings are encouraging, they don't specify any negative effects. The trial's "Not Applicable" phase designation likely indicates a non-invasive approach focusing on exercise and digital tools, suggesting the intervention is generally safe and poses low risk. Concerns should be discussed with the study team or a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eSTEPS Clinical Decision Support (CDS) program for fall prevention because it offers a tailored approach to exercise planning that integrates clinical decision support. Unlike standard care, which often relies on general exercise guidelines, eSTEPS CDS uses personalized data to craft specific exercise plans aimed at reducing falls. This innovative method could lead to more effective fall prevention by aligning care plans more closely with individual patient needs. The potential for improving patient outcomes with a customized, data-driven strategy is what makes this approach particularly promising.

What evidence suggests that the eSTEPS CDS is effective for fall prevention?

Research shows that the eSTEPS Clinical Decision Support (CDS) tool, which participants in this trial may receive, can help prevent falls in primary care settings. One study found that electronic tools for creating personalized exercise plans can fill gaps in care, making fall prevention more effective. Previous research has shown that referring patients to fall prevention programs can reduce the risk of falling at home by 38%. This suggests that personalized, evidence-based exercise plans can help reduce falls among older adults. The eSTEPS tool provides primary care providers with resources to create customized exercise plans during Medicare Wellness Visits, potentially improving fall prevention efforts. This trial will compare the effectiveness of the eSTEPS CDS tool to usual care practices in exercise-related fall prevention planning. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who are at risk of falling, as determined during an annual wellness visit. They must be living in the community (not in long-term care facilities) and enrolled in certain primary care practices participating in the study.

Inclusion Criteria

Positive screen for fall risk at annual wellness visit

Patients enrolled in participating primary care intervention and control practices at MGB or enrolled in participating primary care replication trial intervention practices at UTMB

I am 65 years old or older.

Exclusion Criteria

I am not fluent in spoken English.

I do not have significant cognitive impairment.

Enrollment in the Subsample for Patient Reported Outcomes (PROs):

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of eSTEPS CDS to assist in exercise-related fall prevention care planning during annual Medicare Wellness visits

21 months

Annual Medicare Wellness visits

Follow-up

Participants are monitored for safety and effectiveness after intervention

21 months

What Are the Treatments Tested in This Trial?

Interventions

• eSTEPS CDS

Trial Overview The eSTEPS CDS program is being tested to see if it can help prevent falls among seniors. It uses a machine learning algorithm for fall risk screening and provides doctors with decision support tools to create personalized exercise plans, which patients can follow using an app.

How Is the Trial Designed?

Group I: eSTEPS Clinical Decision Support Experimental Treatment 1 Intervention

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

Group II: Usual Care Active Control 1 Intervention

Usual primary care practices regarding exercise-related fall prevention planning

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Essentia Health

Collaborator

Trials

27

Recruited

107,000+

Published Research Related to This Trial

Multifactorial fall prevention programs are more effective for older adults with a history of falls compared to those without such a history, highlighting the importance of tailored interventions.

Exercise programs that include muscle strengthening, balance, and endurance training for at least 12 weeks are effective in reducing falls among community-dwelling older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on falls prevention for community-dwelling older adults: review of single and multifactorial intervention programs. Costello, E., Edelstein, JE.[2009]

A study involving 454 older adults (average age 77.9) at 13 outpatient falls clinics in Victoria, Australia, revealed that 78% had experienced falls in the previous 6 months, highlighting a significant risk of falls in this population.

After implementing multifactorial interventions, there was over a 50% reduction in falls and fall-related injuries after 6 months, along with improvements in balance, leg strength, and gait speed, indicating the effectiveness of falls clinic programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of falls clinics: an evaluation of outcomes and client adherence to recommended interventions. Hill, KD., Moore, KJ., Dorevitch, MI., et al.[2019]

A modified version of the Otago Exercise Program was implemented for 15 adults with intellectual and developmental disorders (IDD) over 7 weeks, showing improvements in balance and mobility without any reported falls during the study.

The results suggest that this exercise program could be a promising fall prevention strategy for adults with IDD, highlighting the need for further research with larger and more diverse participant groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Evidence-Based Fall Prevention Programs for Adults with Intellectual and/or Developmental Disorders: A Modified Otago Exercise Program. Renfro, M., Bainbridge, DB., Smith, ML.[2020]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

Recent regulatory guidance emphasizes the importance of aggregate safety monitoring during drug development, shifting the focus towards comprehensive evaluations of safety data from ongoing studies.

A multidisciplinary team approach is essential for effectively reviewing safety data, as it enhances early signal detection and reduces the likelihood of false alarms in drug safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of cross-disciplinary scientific engagement in the development of quantitative procedures for aggregate safety assessments. Ball, G., Lievano, F.[2020]

The Aggregate Safety Assessment Plan (ASAP) is designed to enhance safety planning and ongoing data review throughout a drug's life-cycle, promoting a systematic approach to understanding product safety.

By implementing the ASAP process, drug developers can improve early detection of safety signals, better characterize risks, and ensure consistent safety messaging across studies, ultimately aiding in informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. Hendrickson, BA., Wang, W., Ball, G., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10785844/

Development and Usability Testing of an Exercise-Based ... This article describes the development and usability testing of a clinical decision support (CDS) tool for fall prevention exercise.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9242739/

Clinical Decision Support for Fall Prevention: Defining End- ... Conclusion Our findings suggest that there are many care gaps in fall prevention management in primary care and that personalized, actionable, and evidence- ...

3. researchexperts.utmb.edu researchexperts.utmb.edu/en/projects/electronic-strategies-for-tailored-exercise-to-prevent-falls-este-2

Electronic Strategies for Tailored Exercise to Prevent Falls ... Fall prevention is inadequately addressed in primary care leading to disparities in outcomes. Many primary care providers (PCPs) are unaware of their patients' ...

4. ctv.veeva.com ctv.veeva.com/study/electronic-strategies-for-tailored-exercise-to-prevent-falls

Electronic Strategies for Tailored Exercise to Prevent FallS The objectives of this proposal are to evaluate the eSTEPS CDS (eSTEPS) in a cluster randomized controlled trial.

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074823003116

Effectiveness of an Emergency Department–Based ... Previous work has shown that ED referrals to falls interventions can reduce the risk of an at-home fall by 38%. Screening patients at risk for a ...

6. academic.oup.com academic.oup.com/jamiaopen/article/6/2/ooad019/7110248

Evaluation of an approach to clinical decision support for ... This study suggests that a well-designed CDS intervention employing electronic analytics was associated with a decrease in fall-related injuries.

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0289385

Effects of a clinical decision support system and patient portal ... Fall-calendars will be used for measuring the time to first injurious fall (primary outcome) and secondary fall outcomes during one year. Other ...