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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Targeted Infection Control | Active Comparator | Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lona Mody, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan and partner nursing homes | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29489017 | Derived | 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. | |
| 26956588 | 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. |
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Residents with an indwelling urinary catheter and/or feeding tube were recruited from 12 nursing homes, May 2010 - April 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: Targeted Infection Control Program | Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs. Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) 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. |
| FG001 | Control | Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. Surveillance cultures and data was collected for outcome comparison only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Residents enrolled with >1 follow-up visit
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Targeted Infection Control Program | Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs. Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Residents enrolled with >1 follow-up visit | Posted | Number | Total Number of MDRO isolates | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study |
|
From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Adverse Events that were Definitely related, Probably related, Possibly related to the study were captured.
Adverse Events may include: Death, Inpatient hospitalization or prolongation of existing hospitalization, A persistent or significant disability/incapacity
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention: Targeted Infection Control Program | Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lona Mody, MD, MSc | University of Michigan | 734-764-8942 | lonamody@umich.edu |
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| ID | Term |
|---|---|
| D007239 | Infections |
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|
| 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 |
| 26782632 | 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. |
| 25775048 | 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. |
| Withdrawal by Subject |
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| Withdrawal by Study |
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| BG001 | Control | Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Charlson's Comorbidity Score | Charlson's comorbidity score is a weighted index that takes into account the number and seriousness of comorbid disease. It is a classification of comorbid conditions what might alter the risk of mortality in longitudinal studies. 19 conditions are scored with 1, 2, 3, or 6 points. Total Score Range 0 to 37, with increasing scores indicating increasing burden of comorbidity (by increased number of comorbid conditions present, or increased severity of conditions present). | Mean | Standard Deviation | units on a scale |
|
| Physical Self-Maintenance Scale | Functional disability was assessed using Lawton and Brody's physical self-maintenance scale. Patients are evaluated on their ability to perform six activities of daily living (toileting, feeding, dressing, grooming, bathing, physical ambulation), with 1 = independent, 2 = needs reminders, 3 = needs moderate assistance, 4 = needs extensive assistance, 5 = needs full assistance or resistant to care. The total physical self-maintenance scale ranges from 6 to 30, with increasing scores indicating increasing disability to perform activities of daily living. | Mean | Standard Deviation | units on a scale |
|
| Indwelling Device Use | Number | participants |
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| OG001 | Control | Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. |
|
|
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| Secondary | Number of First Incident Urinary Catheter-associated Urinary Tract Infections | Participants with only a urinary catheter present and >1 follow-up visit | Posted | Number | Number of First CAUTI | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | Device-Days | Participants |
|
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| Primary | Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated | Participants with >1 follow-up visit | Posted | Number | Total Number of MRSA isolates | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study |
|
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| Primary | Total Number of VRE (Vancomycin Resistant Enterococci) Isolated | Participants with >1 follow-up visit | Posted | Number | Total Number of VRE isolates | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study |
|
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| Primary | Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated | Participants with >1 follow-up visit | Posted | Number | Total Number of Ceftazidime-RGNB isolate | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study |
|
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| Primary | Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated | Participants with >1 follow-up visit | Posted | Number | Total Number of Ciprofloxacin-RGNB | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study |
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| Secondary | Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections | Participants with only an indwelling urinary catheter present and >1 follow-up visit | Posted | Number | Number of CAUTI | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | Device-days | Participants |
|
|
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| Secondary | Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections | Participants with an indwelling feeding tube present (PEG tube), and had >1 follow-up visit | Posted | Number | Numer of feeding-tube SSTIs | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | Device-days | Participants |
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| Secondary | Number of Incident Feeding-tube Associated Pneumonias | Participants with indwelling feeding tube present (PEG tube), and had >1 follow-up visit | Posted | Number | Number of feeding-tube associated pneu | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | Device-days | Participants |
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| Secondary | Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition | Participants with >1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline) | Posted | Number | Number of Residents with New MRSA | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | Device-days at Risk | Participants |
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| Secondary | Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition | Participants with > 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline) | Posted | Number | Number of Residents with New VRE | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | Device-days at Risk | Participants |
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| Secondary | Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition | Participants with >1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline) | Posted | Number | Number of Residents with New R-GNB | From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study | Device-days at Risk | Participants |
|
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|
| 0 |
| 203 |
| 0 |
| 203 |
| EG001 | Control | Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. | 0 | 215 | 0 | 215 |
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| Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |