Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Prevalence density of multidrug-resistant organisms (MDRO)
研究概览
简要总结
Multidrug-resistant organisms (MDROs) are endemic in nursing homes (NHs) with prevalence rates surpassing those in hospitals. The aim of the study is to design and evaluate the effectiveness of a multi-component intervention to reduce new acquisition of MDROs in NH residents. The intervention will incorporate resident-level, environmental, and caregiver based strategies. Using a cluster-randomized study design, three NHs will be randomized to the intervention group and three to the control group. Control NHs will be allowed to continue standard infection prevention practices. Nursing homes will serve as the unit of allocation. Analyses will be performed both at the resident and the cluster level. The primary outcomes of the study are reduction in MDRO prevalence, and reduction in new MDRO acquisition .
详细描述
The NH intervention will incorporate resident-level, environmental, and caregiver based strategies, including: a. Standard precautions and hand hygiene for care of all residents. Enhanced barrier precautions including hand hygiene, glove use, and gown use for healthcare workers (HCW) when providing activities of daily living (ADL) assistance for residents at highest-risk (caregiver intervention); b. Hand hygiene education to residents and families (resident-level intervention); c. Standardized bathing practices including using chlorhexidine-based cloths to reduce resident MDRO colonization (resident-level intervention); d. Standardized environmental protocol and education to reduce contamination on inanimate objects and surfaces (environmental intervention); e. Feedback monthly of facility-level microbial data and new MDRO acquisition rates to infection preventionists, front-line healthcare personnel, and facility leadership (facility intervention).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Residing in a participating NH facility
- •Provided informed consent for participation
排除标准
- •Receiving end-of-life care
- •Non-English language speaking
研究组 & 干预措施
Control Arm
NHs randomized to the Control Arm will continue their current standard infection control practices.
Intervention Arm
NHs randomized to the Intervention Arm will implement a new multi-modal infection control program.
干预措施: Multi-modal Infection Control Program (Behavioral)
结局指标
主要结局
Prevalence density of multidrug-resistant organisms (MDRO)
时间窗: From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)
Total number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents over the duration of the study period
次要结局
- Incidence of multidrug-resistant organisms (MDRO)(From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death))
- Incidence of healthcare-associated infections(From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death))
研究者
Lona Mody
Principal Investigator, Professor of Internal Medicine
University of Michigan