跳至主要内容
临床试验/NCT05807724
NCT05807724已完成不适用

Geriatric Emergency Department Fall Injury Prevention Project

Florida Atlantic University2 个研究点 分布在 1 个国家目标入组 644 人开始时间: 2023年4月1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
644
试验地点
2
主要终点
Fall-related injury at 6 months

研究概览

简要总结

This prospective randomized study will assess an emergency department (ED) based prevention strategy in geriatric patients at high risk for recurrent falls and injury. Falling is a major health hazard in older adults with a number of proposed but unproven protocols to prevent fall-related injuries. This study proposes to study one of these strategies, the CDC's Stopping Elderly Accidents, Deaths and Injuries program (the STEADI Program).

详细描述

The purpose of this study is to assess whether certain Emergency Department patients at high risk of recurrent falls and injuries related to falls will benefit from the recommendations of the Center for Disease Control and Prevention's (CDC) Stopping Elderly Accidents, Deaths and Injuries program (STEADI Program).

Study subjects will be randomized to one of 3 arms: 1) current care; 2) a phone-based fall-prevention strategy; or 3) a home-visit fall prevention strategy

  1. Current emergency department care
  2. STEADI recommendations administered via phone at 14 days
  3. STEADI recommendations administered via a home visit at 14 days

The STEADI recommendations include the following:

  • Follow-up with a primary care physician
  • An assessment of your risk of falling. This includes looking at your ability to walk, your strength and balance.
  • Assessment medications looking for potential medication interactions
  • Measuring your vital signs (blood pressure and heart rate)
  • Assessment of your vision
  • Assessment of your footwear
  • Recommendations to improve home safety (such as ensuring proper lighting, ensuring adequate hand-rails, and others)

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

  • Patients over the age of 65 with a ground level fall who live at home will be eligible for study inclusion

排除标准

  • Being transferred from another facility, trauma activation, hospice or palliative care participant, end-stage heart failure (two or more congestive heart failure hospitalizations in past 6 months), end stage emphysema (two or more chronic obstructive pulmonary disease hospitalizations in past 6 months), metastatic cancer, severe leukemia or multiple myeloma or lymphoma on treatment or requiring transfusion and end stage renal disease requiring dialysis. An additional exclusion criterion is patients with dementia, if the subject is unable to state name or unable to point to an object (for those with aphasia)

研究组 & 干预措施

Phone-based fall-prevention strategy

Experimental

The phone-based fall-prevention strategy is based on the CDC's Stopping Elderly Accidents Deaths & Injuries (STEADI) program (https://www.cdc.gov/steadi/index.html). The STEADI Algorithm will be the template for both fall-prevention strategies utilized in this study. In addition, the CDC Check For Safety-A Home Prevention Checklist for Older Adults pamphlet will be used.

At the time of study enrollment, the STEADI program written material will be provided and components of it will be discussed with the study subjects and caregivers, if present.

The phone-based strategy will provide the patient and caregiver easy to read materials before ED discharge and a structured phone call around 14 days post ED discharge.

干预措施: Phone-based fall-prevention strategy (Other)

Current care

No Intervention

Current care at the ED

Home-visit fall prevention strategy

Experimental

The specific components of the home-visit fall prevention strategy are similar to the Phone-Based Fall-Prevention Strategy. The essential difference is the in-person visit by the research associate to discuss and reinforce the fall-prevention strategy.

干预措施: Home-visit fall prevention strategy (Other)

结局指标

主要结局

Fall-related injury at 6 months

时间窗: 6 months

Number of Participants with 6 months ED Returns

Recurrent fall requiring ED revisit at 6 months

时间窗: 6 months

Number of Participants with 6 months ED Returns

次要结局

  • All-cause mortality(6 months)
  • Fall-related mortality(6 months)
  • Specific fall-related injury at 6 months(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Geriatric Emergency Department Fall Injury... | 临床试验