Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
研究概览
简要总结
This is an interventional study aimed at reducing multi-drug resistance and infections in nursing home (NH) residents. Each year, a staggering 1.5-2.0 million infections occur in NHs. Many of these infections are caused by multiple drug resistant organisms (MDROs) including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and multidrug resistant Gram-negative bacilli (R-GNB). Antimicrobial resistance among common bacteria are adversely affecting the clinical course and exponentially increasing healthcare costs. Recognizing a need for action, legislators, policy makers, and consumer groups are advocating for pathogen-based universal preemptive screening for these MDROs, particularly MRSA in hospitals and NHs. However, implementing this sweeping mandate is controversial, costly, reactive, and not based on empirical evidence. It can result in a 10-20-fold increase in the number of NH residents placed in isolation precautions with the potential for reduced attention by healthcare workers, isolation and functional decline. The investigators proposal evaluates a novel focused approach between 'do nothing' and 'search all and destroy' strategies by targeting a subgroup of NH residents with indwelling devices who are at a high risk of acquiring MDROs and infections.
The investigators hypothesize that the investigators targeted infection control program (TIP) will reduce MDRO colonization and infections in NH residents with indwelling devices. This cluster randomized trial will involve 12 NHs; 6 will be randomized to the TIP arm and 6 to the routine care arm. The investigators TIP intervention will include four components.
详细描述
Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program.
Component 4: A structured educational program pertaining to indwelling device care for healthcare workers.
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
- 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
- •Any short- or long-stay resident with an indwelling urinary catheter or feeding tube for more than 72 hours
- •Ability to get informed consent from either the resident or his/her durable power of attorney
排除标准
- •Having an indwelling device for less than 72 hours
- •Refusal of consent to get surveillance cultures and data collection by the resident or his/her durable power of attorney
- •Residents who are receiving end-of-life care
研究组 & 干预措施
Intervention: Targeted Infection Control
Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
干预措施: Targeted Infection Control (Behavioral)
Control
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
结局指标
主要结局
Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
时间窗: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of MDRO (Multidrug Resistant Organisms) Isolated
时间窗: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents with indwelling devices over the duration of the study period
Total Number of VRE (Vancomycin Resistant Enterococci) Isolated
时间窗: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated
时间窗: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated
时间窗: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
次要结局
- Number of First Incident Urinary Catheter-associated Urinary Tract Infections(From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study)
- Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition(From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study)
- Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition(From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study)
- Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections(From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study)
- Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections(From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study)
- Number of Incident Feeding-tube Associated Pneumonias(From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study)
- Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition(From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study)
研究者
Lona Mody
Associate Professor, Internal Medicine, Division of Geriatric and Palliative Medicine
University of Michigan