Targeted Infection Control in Long-term Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections

Conditions
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Infection

Intervention / Treatment
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* Behavioral: Targeted Infection Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention: Targeted Infection Control<br>Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs. | Behavioral: Targeted Infection Control<br>* 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.<br>|
| No Intervention: Control<br>Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of MDRO (Multidrug Resistant Organisms) Isolated | 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 | 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 MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated |  | 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 VRE (Vancomycin Resistant Enterococci) Isolated |  | 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 |  | 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 |  | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-Term Care, Nursing Homes, Infection Control, Multi-drug resistant pathogens, Long-term care residents with in-dwelling devices