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

12328 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the eSTEPS CDS treatment for fall prevention?

Research shows that structured fall-prevention programs, especially those including physical training and home hazard modifications, are effective in reducing falls among the elderly. These programs often combine multiple strategies, such as exercise and medication adjustments, which are similar to the components likely included in the eSTEPS CDS treatment. ^{1 2 3 4 5}

Is the eSTEPS Program for Fall Prevention generally safe for humans?

The available research emphasizes the importance of systematic safety planning and ongoing data review to ensure the safety of treatments like eSTEPS. While specific safety data for eSTEPS is not provided, the focus on early safety signal detection and risk characterization suggests a commitment to ensuring human safety. ^{6 7 8 9 10}

How is the eSTEPS CDS treatment different from other fall prevention treatments?

The eSTEPS CDS treatment is unique because it likely incorporates a digital or computerized decision support system, which may offer personalized recommendations or interventions for fall prevention, unlike traditional programs that focus on physical training or environmental modifications. ^{1 3 4 11 12}

Eligibility Criteria

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

I am 65 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ensuring evidence-based practices for falls prevention in a nursing home setting. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of falls clinics: an evaluation of outcomes and client adherence to recommended interventions. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Prevention of falls in the elderly--a review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Characteristics and effectiveness of fall prevention programs in nursing homes: a systematic review and meta-analysis of randomized controlled trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Assessing the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project--six sites, United States, January 1-June 15, 2004. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Performance of the Global Assessment of Pediatric Patient Safety (GAPPS) Tool. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. [2021]

11. Switzerland 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. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of intervention programs in preventing falls: a systematic review of recent 10 years and meta-analysis. [2018]