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Targeted Infection Control in Long-term Care

Primary Purpose

Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Infection Control
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infection focused on measuring Long-Term Care, Nursing Homes, Infection Control, Multi-drug resistant pathogens, Long-term care residents with in-dwelling devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan and partner nursing homes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention: Targeted Infection Control

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
Total Number of VRE (Vancomycin Resistant Enterococci) Isolated
Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated
Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated

Secondary Outcome Measures

Number of First Incident Urinary Catheter-associated Urinary Tract Infections
Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections
Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections
Number of Incident Feeding-tube Associated Pneumonias
Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition
Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition
Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition

Full Information

First Posted
February 2, 2010
Last Updated
August 5, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01062841
Brief Title
Targeted Infection Control in Long-term Care
Official Title
Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Long-Term Care, Nursing Homes, Infection Control, Multi-drug resistant pathogens, Long-term care residents with in-dwelling devices

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Targeted Infection Control
Arm Type
Active Comparator
Arm Description
Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Intervention Type
Behavioral
Intervention Name(s)
Targeted Infection Control
Intervention 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.
Primary Outcome Measure Information:
Title
Total Number of MDRO (Multidrug Resistant Organisms) Isolated
Description
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
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
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lona Mody, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan and partner nursing homes
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29489017
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.
Results Reference
derived
PubMed Identifier
26956588
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.
Results Reference
derived
PubMed Identifier
26782632
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.
Results Reference
derived
PubMed Identifier
25775048
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. Erratum In: JAMA Intern Med. 2015 Jul;175(7):1247.
Results Reference
derived

Learn more about this trial

Targeted Infection Control in Long-term Care

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