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Targeted Infection Control in Long-term Care

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ClinicalTrials.gov Identifier: NCT01062841
Recruitment Status : Completed
First Posted : February 4, 2010
Results First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Lona Mody, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Infection
Intervention Behavioral: Targeted Infection Control
Enrollment 418
Recruitment Details Residents with an indwelling urinary catheter and/or feeding tube were recruited from 12 nursing homes, May 2010 - April 2013
Pre-assignment Details  
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 203 215
Completed 154 162
Not Completed 49 53
Reason Not Completed
Indwelling Device Removed             41             48
Death             3             5
Withdrawal by Subject             2             0
Withdrawal by Study             3             0
Arm/Group Title Intervention: Targeted Infection Control Program Control Total
Hide Arm/Group Description

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. Total of all reporting groups
Overall Number of Baseline Participants 154 162 316
Hide Baseline Analysis Population Description
Residents enrolled with >1 follow-up visit
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 162 participants 316 participants
74.0  (12.4) 72.2  (13.5) 73.1  (12.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 162 participants 316 participants
Female
78
  50.6%
69
  42.6%
147
  46.5%
Male
76
  49.4%
93
  57.4%
169
  53.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 154 participants 162 participants 316 participants
White Race 132 144 276
Other Race 22 18 40
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 154 participants 162 participants 316 participants
154 162 316
Charlson's Comorbidity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 154 participants 162 participants 316 participants
2.8  (1.6) 2.9  (2.1) 2.9  (1.9)
[1]
Measure Description: 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).
Physical Self-Maintenance Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 154 participants 162 participants 316 participants
22.6  (4.1) 22.1  (4.1) 22.4  (4.1)
[1]
Measure Description: 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.
Indwelling Device Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 154 participants 162 participants 316 participants
Indwelling Urinary Catheter 84 79 163
Feeding Tube 46 54 100
Both Urinary Catheter and Feeding Tube 24 29 53
1.Primary Outcome
Title Total Number of MDRO (Multidrug Resistant Organisms) Isolated
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Residents enrolled with >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Measure Type: Number
Unit of Measure: Total Number of MDRO isolates
1299 1732
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.62 to 0.94
Estimation Comments [Not Specified]
2.Primary Outcome
Title Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Measure Type: Number
Unit of Measure: Total Number of MRSA isolates
254 323
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.64 to 0.96
Estimation Comments [Not Specified]
3.Primary Outcome
Title Total Number of VRE (Vancomycin Resistant Enterococci) Isolated
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Measure Type: Number
Unit of Measure: Total Number of VRE isolates
122 162
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.82 to 1.75
Estimation Comments [Not Specified]
4.Primary Outcome
Title Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Measure Type: Number
Unit of Measure: Total Number of Ceftazidime-RGNB isolate
185 295
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.61 to 1.44
Estimation Comments [Not Specified]
5.Primary Outcome
Title Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Measure Type: Number
Unit of Measure: Total Number of Ciprofloxacin-RGNB
738 952
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.58 to 0.97
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of First Incident Urinary Catheter-associated Urinary Tract Infections
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with only a urinary catheter present and >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 86 80
Overall Number of Units Analyzed
Type of Units Analyzed: Device-Days
5982 4292
Measure Type: Number
Unit of Measure: Number of First CAUTI
31 43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.30 to 0.97
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with only an indwelling urinary catheter present and >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 86 80
Overall Number of Units Analyzed
Type of Units Analyzed: Device-days
9413 8118
Measure Type: Number
Unit of Measure: Number of CAUTI
56 75
8.Secondary Outcome
Title Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an indwelling feeding tube present (PEG tube), and had >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 55 63
Overall Number of Units Analyzed
Type of Units Analyzed: Device-days
5635 5062
Measure Type: Number
Unit of Measure: Numer of feeding-tube SSTIs
4 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.22 to 5.45
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Incident Feeding-tube Associated Pneumonias
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with indwelling feeding tube present (PEG tube), and had >1 follow-up visit
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 55 63
Overall Number of Units Analyzed
Type of Units Analyzed: Device-days
5635 5062
Measure Type: Number
Unit of Measure: Number of feeding-tube associated pneu
10 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.83
Confidence Interval (2-Sided) 95%
0.53 to 6.31
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with >1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline)
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Overall Number of Units Analyzed
Type of Units Analyzed: Device-days at Risk
8722 7115
Measure Type: Number
Unit of Measure: Number of Residents with New MRSA
54 56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.65 to 0.95
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with > 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline)
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Overall Number of Units Analyzed
Type of Units Analyzed: Device-days at Risk
12756 11070
Measure Type: Number
Unit of Measure: Number of Residents with New VRE
22 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.45 to 1.60
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with >1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline)
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description:

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Overall Number of Participants Analyzed 154 162
Overall Number of Units Analyzed
Type of Units Analyzed: Device-days at Risk
7524 5685
Measure Type: Number
Unit of Measure: Number of Residents with New R-GNB
42 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention: Targeted Infection Control Program, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.60 to 1.33
Estimation Comments [Not Specified]
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
Adverse Event Reporting Description

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

 
Arm/Group Title Intervention: Targeted Infection Control Program Control
Hide Arm/Group Description

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.

Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
All-Cause Mortality
Intervention: Targeted Infection Control Program Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention: Targeted Infection Control Program Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/203 (0.00%)   0/215 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention: Targeted Infection Control Program Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/203 (0.00%)   0/215 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lona Mody, MD, MSc
Organization: University of Michigan
Phone: 734-764-8942
Responsible Party: Lona Mody, University of Michigan
ClinicalTrials.gov Identifier: NCT01062841     History of Changes
Other Study ID Numbers: AG032298-01A1
First Submitted: February 2, 2010
First Posted: February 4, 2010
Results First Submitted: November 30, 2015
Results First Posted: September 29, 2016
Last Update Posted: September 29, 2016