Clinical trial NCT01062841: Targeted Infection Control in Long-term Care
Official title: Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: Long-Term Care
Nursing Homes
Infection Control
Multi-drug resistant pathogens
Long-term care residents with in-dwelling devices
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Number of MDRO (Multidrug Resistant Organisms) Isolated
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Total Number of VRE (Vancomycin Resistant Enterococci) Isolated
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated
timeFrame: 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:
measure: Number of First Incident Urinary Catheter-associated Urinary Tract Infections
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Number of Incident Feeding-tube Associated Pneumonias
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
measure: Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition
timeFrame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan and partner nursing homes
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lona Mody, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.