Targeted Infection Control in Long-term Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lona Mody, University of Michigan
ClinicalTrials.gov Identifier:
NCT01062841
First received: February 2, 2010
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Infection
Behavioral: Targeted Infection Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Our primary outcome is reduction in MDRO colonization among NH residents with indwelling devices. [ Time Frame: Eligible residents will be cultured monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Our secondary outcome is reduction in infections in NH residents. [ Time Frame: Eligible residents will be cultured monthly ] [ Designated as safety issue: No ]

Enrollment: 1830
Study Start Date: May 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention: Targeted Infection Control
Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.
Behavioral: 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.

No Intervention: Control
Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062841

Locations
United States, Michigan
University of Michigan and partner nursing homes
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Lona Mody, MD University of Michigan
  More Information

No publications provided

Responsible Party: Lona Mody, Associate Professor, Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01062841     History of Changes
Other Study ID Numbers: AG032298-01A1
Study First Received: February 2, 2010
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Long-Term Care
Nursing Homes
Infection Control
Multi-drug resistant pathogens
Long-term care residents with in-dwelling devices

ClinicalTrials.gov processed this record on July 10, 2014