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临床试验/NCT04993781
NCT04993781已完成不适用

Electronic Strategies for Tailored Exercise to Prevent FallS

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 11,945 人开始时间: 2023年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11,945
试验地点
1
主要终点
To Determine the Effect of the eSTEPS Intervention on the Rate of Falls

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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:
  • Unwilling or unable to provide verbal consent
  • Not able to participate due to cognitive impairment (i.e., 4 or more errors on the Callahan Cognitive Screen assessment)
  • Has a terminal illness or other condition that indicates that the participant is not expected to survive for 1 year, such as receiving hospice or palliative care services.
  • Not fluent in spoken English
  • Does not have access to a working telephone

研究组 & 干预措施

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.

干预措施: eSTEPS CDS (Behavioral)

Usual Care

No Intervention

Usual primary care practices regarding exercise-related fall prevention planning

结局指标

主要结局

To Determine the Effect of the eSTEPS Intervention on the Rate of Falls

时间窗: Up to 23 months

To determine the effect of the eSTEPS intervention on all falls per 100 patient years

To determine the effect of the eSTEPS intervention on the rate of falls

时间窗: Up to 23 months

Falls rate per 100 patient years

次要结局

  • To Determine the Effect of the eSTEPS Intervention on Falls Self-efficacy (Fear of Falling)(Change from initial assessment to 6 months)
  • To Determine the Effect of the eSTEPS Intervention on Self-efficacy for Exercise(Change from initial visit to 6 months)
  • To determine the effect of the eSTEPS intervention on falls self-efficacy (fear of falling)(Change from initial assessment to 6 months)
  • To determine the effect of the eSTEPS intervention on self-efficacy for exercise(Change from initial visit to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Latham

PI

Brigham and Women's Hospital

研究点 (1)

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