Trial Outcomes & Findings for Targeted Infection Control in Long-term Care (NCT NCT01062841)
NCT ID: NCT01062841
Last Updated: 2016-09-29
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
418 participants
Primary outcome timeframe
From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Results posted on
2016-09-29
Participant Flow
Residents with an indwelling urinary catheter and/or feeding tube were recruited from 12 nursing homes, May 2010 - April 2013
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
215
|
|
Overall Study
COMPLETED
|
154
|
162
|
|
Overall Study
NOT COMPLETED
|
49
|
53
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Indwelling Device Removed
|
41
|
48
|
|
Overall Study
Death
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Withdrawal by Study
|
3
|
0
|
Baseline Characteristics
Targeted Infection Control in Long-term Care
Baseline characteristics by cohort
| Measure |
Intervention: Targeted Infection Control Program
n=154 Participants
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
n=162 Participants
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
72.2 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
73.1 years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Race
|
132 participants
n=5 Participants
|
144 participants
n=7 Participants
|
276 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
162 participants
n=7 Participants
|
316 participants
n=5 Participants
|
|
Charlson's Comorbidity Score
|
2.8 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Physical Self-Maintenance Scale
|
22.6 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
22.1 units on a scale
STANDARD_DEVIATION 4.1 • n=7 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Indwelling Device Use
Indwelling Urinary Catheter
|
84 participants
n=5 Participants
|
79 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Indwelling Device Use
Feeding Tube
|
46 participants
n=5 Participants
|
54 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Indwelling Device Use
Both Urinary Catheter and Feeding Tube
|
24 participants
n=5 Participants
|
29 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Residents enrolled with \>1 follow-up visit
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
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=154 Participants
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.
|
Control
n=162 Participants
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of MDRO (Multidrug Resistant Organisms) Isolated
|
1299 Total Number of MDRO isolates
|
1732 Total Number of MDRO isolates
|
PRIMARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=154 Participants
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.
|
Control
n=162 Participants
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
|
254 Total Number of MRSA isolates
|
323 Total Number of MRSA isolates
|
PRIMARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=154 Participants
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.
|
Control
n=162 Participants
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of VRE (Vancomycin Resistant Enterococci) Isolated
|
122 Total Number of VRE isolates
|
162 Total Number of VRE isolates
|
PRIMARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=154 Participants
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.
|
Control
n=162 Participants
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated
|
185 Total Number of Ceftazidime-RGNB isolate
|
295 Total Number of Ceftazidime-RGNB isolate
|
PRIMARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=154 Participants
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.
|
Control
n=162 Participants
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated
|
738 Total Number of Ciprofloxacin-RGNB
|
952 Total Number of Ciprofloxacin-RGNB
|
SECONDARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with only a urinary catheter present and \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=5982 Device-Days
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.
|
Control
n=4292 Device-Days
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Number of First Incident Urinary Catheter-associated Urinary Tract Infections
|
31 Number of First CAUTI
|
43 Number of First CAUTI
|
SECONDARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with only an indwelling urinary catheter present and \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=9413 Device-days
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.
|
Control
n=8118 Device-days
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections
|
56 Number of CAUTI
|
75 Number of CAUTI
|
SECONDARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with an indwelling feeding tube present (PEG tube), and had \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=5635 Device-days
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.
|
Control
n=5062 Device-days
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections
|
4 Numer of feeding-tube SSTIs
|
3 Numer of feeding-tube SSTIs
|
SECONDARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with indwelling feeding tube present (PEG tube), and had \>1 follow-up visit
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=5635 Device-days
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.
|
Control
n=5062 Device-days
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Number of Incident Feeding-tube Associated Pneumonias
|
10 Number of feeding-tube associated pneu
|
8 Number of feeding-tube associated pneu
|
SECONDARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with \>1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline)
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=8722 Device-days at Risk
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.
|
Control
n=7115 Device-days at Risk
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition
|
54 Number of Residents with New MRSA
|
56 Number of Residents with New MRSA
|
SECONDARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with \> 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline)
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=12756 Device-days at Risk
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.
|
Control
n=11070 Device-days at Risk
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition
|
22 Number of Residents with New VRE
|
26 Number of Residents with New VRE
|
SECONDARY outcome
Timeframe: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of studyPopulation: Participants with \>1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline)
Outcome measures
| Measure |
Intervention: Targeted Infection Control Program
n=7524 Device-days at Risk
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.
|
Control
n=5685 Device-days at Risk
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
|
|---|---|---|
|
Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition
|
42 Number of Residents with New R-GNB
|
35 Number of Residents with New R-GNB
|
Adverse Events
Intervention: Targeted Infection Control Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place