The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
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
- 是
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
PREVENT model
干预措施: PREVENT Program (Behavioral)
Control Group
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
Alexandra Papaioannou
Executive Director, GERAS Centre for Aging Research, Hamilton Health Sciences
McMaster University
