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NCT Number: NCT01062841

Targeted Infection Control in Long-term Care

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan and partner nursing homes

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Infection Control

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2010
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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