跳至主要内容
临床试验/NCT03360305
NCT03360305已完成不适用

GAPcare: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年1月25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
110
试验地点
2
主要终点
Feasibility of Implementing Intervention in Emergency Department

研究概览

简要总结

GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that enrolls older adults who present to the Emergency Department after a fall to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults.

详细描述

Falls are the leading cause of fatal and non-fatal injury among older adults. EDs frequently evaluate older adults after their falls, but the typical evaluation consists of an injury assessment alone. There is a critical need for an ED-based intervention that addresses reasons for the fall and provides on-the-spot assessment and guidance to prevent subsequent falls. Failure to prevent subsequent falls will result in increased morbidity, mortality, healthcare utilization, loss of independence, and rising health care costs as the population of older adults increases.

Participants in GAPcare will be older adults (≥65 years-old) who present to the ED for a fall. We will pursue the following specific aims to test and further refine the GAPcare intervention: (1) Examine the feasibility of recruitment and retention of eligible patients into the GAPcare intervention, (2) determine the initial efficacy of the GAPcare intervention in reducing subsequent falls and healthcare utilization at 6 months. Our long-term goal is to prevent the early morbidity and mortality of older adults who present to the ED after a fall. The overall objective of this survey is to gather preliminary data on the feasibility of an ED based fall prevention project.

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
Single (Outcomes Assessor)

盲法说明

Data extractors will be blinded to the specific study arm each participant has been randomized to.

入排标准

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

入选标准

  • •Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
  • •Able to communicate in English
  • •Fall not due to syncope or external force (i.e., struck by car or assault)
  • •Fall not due to serious illness (i.e. stroke, acute myocardial infarction)
  • •Will be discharged to home, assisted living, or rehabilitation at completion of ED visit (i.e., not admitted)
  • •Legally authorized representative present to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four)

排除标准

  • •Unable to give informed consent due to intoxication or altered mental status
  • •Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)

研究组 & 干预措施

Usual care

No Intervention

The ED clinician will perform a standard medical evaluation. This evaluation includes a focused history and exam to identify injuries. Laboratory tests and radiologic imaging may be ordered. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics). The research assistant (RA) will read the CDC STEADI brochure to the patient and provide them with a printed copy at the conclusion of their visit. The RA will solicit feedback from the clinician and the patient at the conclusion of the visit using the post-visit survey.

Intervention

Experimental
  1. ED clinician will perform standard medical evaluation, including focused history and exam to identify injuries. RA will solicit feedback from clinician and patient via post-visit survey at conclusion of visit.
  2. PT will perform services, including integrative mobility training and lower extremity strength training and recommending outpatient services/referrals. Specific assessments and treatments will be tailored to patient.
  3. Pharmacist will perform a medication review using the updated BEERS criteria and CDC's STEADI instrument and recommend changes to potential fall risk increasing medication. Recommendations will be communicated to ED treatment team.
  4. Seniors will return home with standardized checklist containing details of their assessment and action plan. The checklist addresses patient's personal risk factors for the fall and required further actions.

干预措施: GAPcare intervention (Behavioral)

结局指标

主要结局

Feasibility of Implementing Intervention in Emergency Department

时间窗: 12 Months

Assess the feasibility of implementing this intervention in an ED setting. We will report enrollment, reasons for accepting or declining enrollment, and drop-out from the study using the CONSORT approach. We will compare the demographic characteristics of the GAPcare participants in both arms using Chi-square or Fisher's exact test for categorical variables and Student's t-test or Wilcoxon's test for continuous variables, as appropriate. We will use Wilcoxon's test to compare the median ED length of stay between participants of both study arms.

次要结局

  • Feedback(21-24 Months)
  • Initial efficacy(12 Months)

研究者

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

Elizabeth Goldberg

Assistant Professor of Emergency Medicine

Rhode Island Hospital

研究点 (2)

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