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.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Behavioral: Targeted Infection Control

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.

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan and partner nursing homes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention: Targeted Infection Control; Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.	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.
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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Lona Mody, MD, University of Michigan

Publications and helpful links

General Publications

• Hutton DW, Krein SL, Saint S, Graves N, Kolli A, Lynem R, Mody L. Economic Evaluation of a Catheter-Associated Urinary Tract Infection Prevention Program in Nursing Homes. J Am Geriatr Soc. 2018 Apr;66(4):742-747. doi: 10.1111/jgs.15316. Epub 2018 Feb 28.
• Cassone M, McNamara SE, Perri MB, Zervos M, Mody L. Impact of Intervention Measures on MRSA Clonal Type and Carriage Site Prevalence. mBio. 2016 Mar 8;7(2):e00218. doi: 10.1128/mBio.00218-16. No abstract available.
• Ismail MD, Luo T, McNamara S, Lansing B, Koo E, Mody L, Foxman B. Long-Term Carriage of Ciprofloxacin-Resistant Escherichia coli Isolates in High-Risk Nursing Home Residents. Infect Control Hosp Epidemiol. 2016 Apr;37(4):440-7. doi: 10.1017/ice.2015.326. Epub 2016 Jan 19.
• Mody L, Krein SL, Saint S, Min LC, Montoya A, Lansing B, McNamara SE, Symons K, Fisch J, Koo E, Rye RA, Galecki A, Kabeto MU, Fitzgerald JT, Olmsted RN, Kauffman CA, Bradley SF. A targeted infection prevention intervention in nursing home residents with indwelling devices: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):714-23. doi: 10.1001/jamainternmed.2015.132. Erratum In: JAMA Intern Med. 2015 Jul;175(7):1247.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: August 5, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Long-Term Care; Infection Control; Nursing Homes; Multi-drug resistant pathogens; Long-term care residents with in-dwelling devices
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: AG032298-01A1