N/A
N=418
Targeted Infection Control in Long-term Care
Infection
Bottom Line
View on ClinicalTrials.gov: NCT01062841 ↗Enrolled (actual)
418
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Total Number of MDRO (Multidrug Resistant Organisms) Isolated — 1299; 1732 Total Number of MDRO isolates — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Targeted Infection Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of MDRO (Multidrug Resistant Organisms) Isolated |
1299; 1732 | <0.05 sig |
| PRIMARY Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated |
254; 323 | <0.05 sig |
| PRIMARY Total Number of VRE (Vancomycin Resistant Enterococci) Isolated |
122; 162 | >0.05 |
| PRIMARY Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated |
185; 295 | >0.05 |
| PRIMARY Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated |
738; 952 | <0.05 sig |
| SECONDARY Number of First Incident Urinary Catheter-associated Urinary Tract Infections |
31; 43 | 0.04 sig |
| SECONDARY Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections |
56; 75 | — |
| SECONDARY Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections |
4; 3 | 0.92 |
| SECONDARY Number of Incident Feeding-tube Associated Pneumonias |
10; 8 | 0.34 |
| SECONDARY Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition |
54; 56 | 0.01 sig |
| SECONDARY Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition |
22; 26 | 0.61 |
| SECONDARY Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition |
42; 35 | 0.59 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01062841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.