跳至主要内容
临床试验/NCT05950607
NCT05950607招募中不适用

Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2.0)

Hebrew SeniorLife1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2023年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
750
试验地点
1
主要终点
Antimicrobial use in residents with moderate to advanced dementia

研究概览

简要总结

The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.

详细描述

This 52-month study (8 months preparation; 34 months trial conduct; 10 months data analyses and manuscript preparation)is a parallel cluster ePCT of an intervention to improve infection management for suspected infections among residents with moderate to advanced dementia (N=600; N=300/arm) living in NHs (N=50; N=25/arm). Facilities are members of a provider managed care network, Iowa Health Care Quality Network ('Network'). The intervention will be similar to the original TRAIN-AD program, but adapted for moderate to advanced dementia and rolled out in the Network. At each intervention NH, the intervention will be implemented for 24-months. Control NHs will employ usual care. In all NHs, there will be a 2-month startup period, 12-month resident enrollment period, and 24-months data collection period (Figure 2). Eligible residents with dementia will be identified using the EHR and Minimum DataSet (MDS) and followed up to 12 months. Outcome data will be ascertained from the EHR. Randomization and program roll out will be at the facility level. Analyses at the resident level. Clinical outcomes compared between arms at 12 months will be: 1. Antimicrobial courses/person-year in residents with moderate to advanced dementia (primary outcome) and all residents with dementia (secondary outcome) (Aim 1); and 2. Number of burdensome procedures/person-year used to manage suspected infections among residents with moderate to advanced dementia and those at all stages of dementia including: hospital transfers, urine specimens, chest x-rays, and blood cultures (secondary outcomes) (Aim 2). A process evaluation of implementation will be conducted in the intervention arm based on the RE-AIM framework1 (Aim 3) using quantitative and qualitative data (stakeholder interviews).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 106 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of dementia (any type)
  • Cognitive Functional Scale (CFS) > 1
  • NH length of stay >90 days
  • The CFS score categorizes cognitive impairment status based on data in the electronic health record into:
  • Moderate, and
  • Severe (advanced). For the primary outcome, the analysis will be restricted to residents with a CFS score of 3 or 4.

排除标准

  • Less than 60 years of age
  • Living in nursing home for less than 90 days
  • Does not have diagnosis of dementia
  • Does not meet CFS >1 score

研究组 & 干预措施

TRAIN AD 2.0

Experimental

Nursing homes randomized to the experimental arm will emply a multicomponent intervention among their providers designed to improve the management of suspected infections in residents with dementia. The components include: a.Orientation sessions for providers, b.On-line case based course for providers, c.Infection management algorithms for providers, d. Guidelines for providers to communicate with proxies, and e. Education booklet about infections in dementia for providers.

干预措施: TRAIN AD 2.0 (Behavioral)

Usual Care

Active Comparator

Nursing homes randomized to the conrol arm will employ usual care to manage nursing home residents with dementia with suspected infections.

干预措施: TRAIN AD 2.0 (Behavioral)

结局指标

主要结局

Antimicrobial use in residents with moderate to advanced dementia

时间窗: 12 months

Number of antimicrobial courses/person-year among residents with moderate to advanced dementia.

次要结局

  • Burdensome interventions in residents with moderate to advanced dementia(12 months)
  • Antimicrobial use in residents with dementia(12 months)
  • Burdensome interventions in residents with dementia(12 months)

研究者

发起方
Hebrew SeniorLife
申办方类型
Other
责任方
Sponsor

研究点 (1)

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