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临床试验/NCT03442322
NCT03442322已完成不适用

Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Wandering

研究概览

简要总结

Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. Medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. Therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. Two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all NH staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. While prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. This project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach.

This study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident.

This project is important because it will address a key clinical dilemma NH staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. Transforming the quality of dementia care in NHs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to the treatment arm the facility is randomly assigned to.

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible nursing home facilities will
  • lack any existing dementia program targeting reduction of off-label psychotropic medication use
  • each serve >60 long-term care residents with Alzheimer's or dementia
  • meet Center for Medicare & Medicaid Services' minimum requirements for NHs (e.g., meeting the mandated number of hours of staff training on dementia care, performing regularly scheduled resident assessments).

排除标准

  • Facilities will be excluded if they have
  • less than 60 long-stay residents
  • an existing formal dementia care program in place
  • an off-label psychotropic medication reduction program
  • is located in a state that requires more than the Center for Medicare & Medicaid Services' minimum for staff training requirements on the topic of dementia care

结局指标

主要结局

Wandering

时间窗: 18-month period (months 13-18)

Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention.

Rejection of Care

时间窗: 18-month period (months 13-18)

Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention.

Dispensing of Psychotropic Medications

时间窗: 18-month period (months 13-18)

Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention.

Behavioral Symptoms

时间窗: 18-month period (months 13-18)

Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention.

次要结局

  • Unintended Weight Loss(18-month period (months 13-18))
  • Falls(18-month period (months 13-18))
  • Depressive Symptoms(18-month period (months 13-18))
  • Physical Restraints Use(18-month period (months 13-18))

研究者

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

Natalie Leland

Professor

University of Pittsburgh

研究点 (2)

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