Detection, Education, Research and Decolonization Without Isolation in Long-term Care Facilities (DERAIL_MRSA)

September 9, 2019 updated by: NorthShore University HealthSystem

Detection, Education, Research and Decolonization Without Isolation in Long-term Care to Control(DERAIL)MRSA

Our hypothesis for the DERAIL MRSA program is that one can safely remove the colonization risk from nearly all residents (patients) in a way that does not interfere with the desired life-style for persons in these facilities and thereby reduce the risk of infection and lower the cost of care by avoiding preventable disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary endpoint will be measuring the reduction in MRSA colonization prevalence (percentage rate) in the intervention arm as compared to the control arm. One secondary endpoint is to compare the rate of MRSA disease (number of infections per 1,000 patients and 10,000 patient days) in the intervention and control arms. The other secondary endpoint is to determine the cost of MRSA screening and decolonization and compare it to the cost of MRSA disease treatment (both medication cost and the expense of any needed hospitalization for therapy of MRSA infection therapy) in the control arm. Achieving our primary goal of MRSA control will also demonstrate two secondary goals wthe investigators aim to achieve: one being that a scientific, planned approach to the issue of specific healthcare-associated infection in LTCFs can resolve these problems and the other that a partnership between acute and long-term care (e.g., ongoing relationship spanning at least 5 years) is beneficial in dealing with patient safety and quality practices across the United Sates Healthcare continuum.

Study Type

Observational

Enrollment (Actual)

22302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients in 18 LTCF nursing units randomly selected as intervention or control units

Exclusion Criteria:

  • Patients that choose not to be included in the program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
Active surveillance testing for MRSA and decolonization of positive subjects
Drug: Decolonization
5 day regimen of mupirocin calcium 2% twice daily to the nares and any open wound plus bath or shower with 4% chlorhexidine used as a liquid soap
Other Names:
  • Mupirocin
control
Usual standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To record the effectiveness of an admission testing and immediate decolonization of positive persons protocol for reducing MRSA colonization prevalence in long term care facilities (LTCF's)
Time Frame: 12 months and 24 months
Infection Control cluster randomized trial: measuring the reduction in MRSA colonization prevalence (rate) in the intervention arm as compared to the control arm
12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To further develop an Infection Control Outreach Program designed to provide expert guidance on infectious disease prevention specific to LTCF's
Time Frame: 2 years
Compare the rate of MRSA disease in the intervention and control arms. Determine the cost of MRSA screening and decolonization and compare it to the cost of MRSA disease treatment (both medication cost and the expense of any needed hospitalization for therapy of MRSA infection therapy) in the control arm.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 23, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHRQ 1R18HSO19968-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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