Infection
Conditions
Keywords
Long-Term Care, Nursing Homes, Infection Control, Multi-drug resistant pathogens, Long-term care residents with in-dwelling devices
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.
Interventions
BEHAVIORALTargeted 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of MDRO (Multidrug Resistant Organisms) 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 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 | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Recruitment details
Residents with an indwelling urinary catheter and/or feeding tube were recruited from 12 nursing homes, May 2010 - April 2013
Participants by arm
| Arm | Count |
|---|---|
| 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. | 154 |
| Control Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. | 162 |
| Total | 316 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 5 |
| Overall Study | Indwelling Device Removed | 41 | 48 |
| Overall Study | Withdrawal by Study | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Control | Total | Intervention: Targeted Infection Control Program |
|---|---|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 13.5 | 73.1 years STANDARD_DEVIATION 12.95 | 74.0 years STANDARD_DEVIATION 12.4 |
| Charlson's Comorbidity Score | 2.9 units on a scale STANDARD_DEVIATION 2.1 | 2.9 units on a scale STANDARD_DEVIATION 1.9 | 2.8 units on a scale STANDARD_DEVIATION 1.6 |
| Indwelling Device Use Both Urinary Catheter and Feeding Tube | 29 participants | 53 participants | 24 participants |
| Indwelling Device Use Feeding Tube | 54 participants | 100 participants | 46 participants |
| Indwelling Device Use Indwelling Urinary Catheter | 79 participants | 163 participants | 84 participants |
| Physical Self-Maintenance Scale | 22.1 units on a scale STANDARD_DEVIATION 4.1 | 22.4 units on a scale STANDARD_DEVIATION 4.1 | 22.6 units on a scale STANDARD_DEVIATION 4.1 |
| Race/Ethnicity, Customized Other Race | 18 participants | 40 participants | 22 participants |
| Race/Ethnicity, Customized White Race | 144 participants | 276 participants | 132 participants |
| Region of Enrollment United States | 162 participants | 316 participants | 154 participants |
| Sex: Female, Male Female | 69 Participants | 147 Participants | 78 Participants |
| Sex: Female, Male Male | 93 Participants | 169 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 203 | 0 / 215 |
| serious Total, serious adverse events | 0 / 203 | 0 / 215 |
Outcome results
Primary
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
Population: Participants with \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated | 185 Total Number of Ceftazidime-RGNB isolate |
| Control | Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated | 295 Total Number of Ceftazidime-RGNB isolate |
Comparison: A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.p-value: >0.0595% CI: [0.61, 1.44]Regression, Poisson
Primary
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
Population: Participants with \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated | 738 Total Number of Ciprofloxacin-RGNB |
| Control | Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated | 952 Total Number of Ciprofloxacin-RGNB |
Comparison: A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.p-value: <0.0595% CI: [0.58, 0.97]Regression, Poisson
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
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
Population: Residents enrolled with \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of MDRO (Multidrug Resistant Organisms) Isolated | 1299 Total Number of MDRO isolates |
| Control | Total Number of MDRO (Multidrug Resistant Organisms) Isolated | 1732 Total Number of MDRO isolates |
Comparison: A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.p-value: <0.0595% CI: [0.62, 0.94]Regression, Poisson
Primary
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
Population: Participants with \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated | 254 Total Number of MRSA isolates |
| Control | Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated | 323 Total Number of MRSA isolates |
Comparison: A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.p-value: <0.0595% CI: [0.64, 0.96]Regression, Poisson
Primary
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
Population: Participants with \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of VRE (Vancomycin Resistant Enterococci) Isolated | 122 Total Number of VRE isolates |
| Control | Total Number of VRE (Vancomycin Resistant Enterococci) Isolated | 162 Total Number of VRE isolates |
Comparison: A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.p-value: >0.0595% CI: [0.82, 1.75]Regression, Poisson
Secondary
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
Population: Participants with only an indwelling urinary catheter present and \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections | 56 Number of CAUTI |
| Control | Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections | 75 Number of CAUTI |
Secondary
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
Population: Participants with only a urinary catheter present and \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Number of First Incident Urinary Catheter-associated Urinary Tract Infections | 31 Number of First CAUTI |
| Control | Number of First Incident Urinary Catheter-associated Urinary Tract Infections | 43 Number of First CAUTI |
Comparison: A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.p-value: 0.0495% CI: [0.3, 0.97]Regression, Cox
Secondary
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
Population: Participants with indwelling feeding tube present (PEG tube), and had \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Number of Incident Feeding-tube Associated Pneumonias | 10 Number of feeding-tube associated pneu |
| Control | Number of Incident Feeding-tube Associated Pneumonias | 8 Number of feeding-tube associated pneu |
Comparison: A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.p-value: 0.3495% CI: [0.53, 6.31]Regression, Cox
Secondary
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
Population: Participants with an indwelling feeding tube present (PEG tube), and had \>1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections | 4 Numer of feeding-tube SSTIs |
| Control | Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections | 3 Numer of feeding-tube SSTIs |
Comparison: A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.p-value: 0.9295% CI: [0.22, 5.45]Regression, Cox
Secondary
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
Population: Participants with \>1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition | 54 Number of Residents with New MRSA |
| Control | Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition | 56 Number of Residents with New MRSA |
Comparison: A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.p-value: 0.0195% CI: [0.65, 0.95]Regression, Cox
Secondary
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
Population: Participants with \>1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition | 42 Number of Residents with New R-GNB |
| Control | Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition | 35 Number of Residents with New R-GNB |
p-value: 0.5995% CI: [0.6, 1.33]Regression, Cox
Secondary
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
Population: Participants with \> 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: Targeted Infection Control Program | Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition | 22 Number of Residents with New VRE |
| Control | Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition | 26 Number of Residents with New VRE |
Comparison: A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.p-value: 0.6195% CI: [0.45, 1.6]Regression, Cox