跳至主要内容
临床试验/NCT04947722
NCT04947722进行中(未招募)不适用

The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

McMaster University2 个研究点 分布在 1 个国家目标入组 3,060 人开始时间: 2024年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,060
试验地点
2
主要终点
Number of hip-fractures

研究概览

简要总结

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

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
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Both profit and non-profit long-term care homes in Ontario, Canada.
  • Homes must have a minimum of 50 occupied beds to participate; there is no maximum home size for participation.
  • For both control and intervention homes, resident eligibility (and study cohorts) will be determined via the RAI-MDS 2.0 database.

排除标准

  • Residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).

研究组 & 干预措施

PREVENT Program

Experimental

PREVENT model

干预措施: PREVENT Program (Behavioral)

Control Group

No Intervention

Residents in homes allocated to the control group will receive usual care as provided within their home.

结局指标

主要结局

Number of hip-fractures

时间窗: One year

Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.

次要结局

  • Number of non-hip fractures (wrist, spine, pelvis, humerus)(One year)
  • Number of hospital transfers (emergency department and admissions)(One year)
  • Number of deaths(One year)
  • Change in number of falls(Baseline, 3, 6, 9 and 12 months)
  • Change in medications(Baseline, 3, 6, 9 and 12 months)
  • Change in level of pain(Baseline, 3, 6, 9 and 12 months)
  • Change in responsive behaviours(Baseline, 3, 6, 9 and 12 months)
  • Change in mobility(Baseline, 3, 6, 9 and 12 months)
  • Change in health related quality of life(Baseline, 3, 6, 9 and 12 months)
  • Health quality indicators(Baseline, 3, 6, 9 and 12 months.)
  • Number of deaths(One year)
  • Change in number of falls(Baseline, 3, 6, 9 and 12 months)
  • Number of non-hip fractures (wrist, spine, pelvis, humerus)(One year)
  • Number of hospital transfers (emergency department and admissions)(One year)
  • Change in level of pain(Baseline, 3, 6, 9 and 12 months)
  • Change in mobility(Baseline, 3, 6, 9 and 12 months)
  • Change in responsive behaviours(Baseline, 3, 6, 9 and 12 months)
  • Change in health related quality of life(Baseline, 3, 6, 9 and 12 months)

研究者

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

Alexandra Papaioannou

Executive Director, GERAS Centre for Aging Research, Hamilton Health Sciences

McMaster University

研究点 (2)

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