Targeted Infection Control in Long-term Care

NCT01062841 | Completed Results

• 1 other identifier: AG032298-01A1
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Long-Term Care; Nursing Homes; Infection Control; Multi-drug resistant pathogens; Long-term care residents with in-dwelling devices

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (2)

Intervention: Targeted Infection Control

ACTIVE COMPARATOR

Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.

Behavioral: Targeted Infection Control

Control

NO INTERVENTION

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.

Interventions

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.

Intervention: Targeted Infection Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan and partner nursing homes

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (4)

• 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.

  PMID: 29489017 DERIVED

• 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.

  PMID: 26956588 DERIVED

• 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.

  PMID: 26782632 DERIVED

• 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.

  PMID: 25775048 DERIVED

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Lona Mody, MD, MSc
• Organization: University of Michigan

lonamody@umich.edu

734-764-8942

Study Officials

• Lona Mody, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Internal Medicine, Division of Geriatric and Palliative Medicine

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 29, 2016
• Results First Posted: September 29, 2016

Record last verified: 2016-08

Locations

US (1)