ClinicalTrials.gov
ClinicalTrials.gov Menu

Targeted Infection Control in Long-term Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01062841
Recruitment Status : Completed
First Posted : February 4, 2010
Results First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Lona Mody, University of Michigan

February 2, 2010
February 4, 2010
November 30, 2015
September 29, 2016
September 29, 2016
May 2010
April 2013   (Final data collection date for primary outcome measure)
  • Total Number of MDRO (Multidrug Resistant Organisms) Isolated [ Time Frame: 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 MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study ]
Our primary outcome is reduction in MDRO colonization among NH residents with indwelling devices. [ Time Frame: Eligible residents will be cultured monthly ]
Complete list of historical versions of study NCT01062841 on ClinicalTrials.gov Archive Site
  • Number of First Incident Urinary Catheter-associated Urinary Tract Infections [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study ]
Our secondary outcome is reduction in infections in NH residents. [ Time Frame: Eligible residents will be cultured monthly ]
Not Provided
Not Provided
 
Targeted Infection Control in Long-term Care
Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Infection
Behavioral: Targeted Infection Control

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.

  • Active Comparator: Intervention: Targeted Infection Control
    Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
    Intervention: Behavioral: Targeted Infection Control
  • No Intervention: Control
    Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
418
800
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01062841
AG032298-01A1
No
Not Provided
Not Provided
Lona Mody, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Lona Mody, MD University of Michigan
University of Michigan
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP