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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Residents with an indwelling urinary catheter and/or feeding tube were recruited from 12 nursing homes, May 2010 - April 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

Participant Flow:   Overall Study
    Intervention: Targeted Infection Control Program   Control
STARTED   203   215 
COMPLETED   154   162 
NOT COMPLETED   49   53 
Indwelling Device Removed                41                48 
Death                3                5 
Withdrawal by Subject                2                0 
Withdrawal by Study                3                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Residents enrolled with >1 follow-up visit

Reporting Groups
  Description
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.

Control Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
Total Total of all reporting groups

Baseline Measures
   Intervention: Targeted Infection Control Program   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 154   162   316 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.0  (12.4)   72.2  (13.5)   73.1  (12.95) 
Gender 
[Units: Participants]
     
Female   78   69   147 
Male   76   93   169 
Race/Ethnicity, Customized 
[Units: Participants]
     
White Race   132   144   276 
Other Race   22   18   40 
Region of Enrollment 
[Units: Participants]
     
United States   154   162   316 
Charlson's Comorbidity Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.8  (1.6)   2.9  (2.1)   2.9  (1.9) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 22.6  (4.1)   22.1  (4.1)   22.4  (4.1) 
[1] 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 
[Units: Participants]
     
Indwelling Urinary Catheter   84   79   163 
Feeding Tube   46   54   100 
Both Urinary Catheter and Feeding Tube   24   29   53 


  Outcome Measures

1.  Primary:   Total Number of MDRO (Multidrug Resistant Organisms) 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 ]

2.  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 ]

3.  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 ]

4.  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 ]

5.  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 ]

6.  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 ]

7.  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 ]

8.  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 ]

9.  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 ]

10.  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 ]

11.  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 ]

12.  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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: lonamody@umich.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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