Targeted Infection Control in Long-term Care

Not Applicable

Completed

Conditions: Infection

Interventions: Behavioral: Targeted Infection Control

Registration Number: NCT01062841

Lead Sponsor: University of Michigan

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 418

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Targeted Infection Control	Targeted Infection Control	Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.

Primary Outcome Measures

Name	Time	Method
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 MDRO (Multidrug Resistant Organisms) 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 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	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
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

Secondary Outcome Measures

Name	Time	Method
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