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

Primary Purpose

Methicillin Resistant Staphylococcus Aureus

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Decolonization
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Methicillin Resistant Staphylococcus Aureus focused on measuring MRSA, Cluster Randomized Trial, Infection Control Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NorthShore University HealthSystem Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Intervention

control

Arm Description

Active surveillance testing for MRSA and decolonization of positive subjects

Usual standard of care

Outcomes

Primary Outcome Measures

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)
Infection Control cluster randomized trial: measuring the reduction in MRSA colonization prevalence (rate) in the intervention arm as compared to the control arm

Secondary Outcome Measures

To further develop an Infection Control Outreach Program designed to provide expert guidance on infectious disease prevention specific to LTCF's
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.

Full Information

First Posted
February 23, 2011
Last Updated
September 9, 2019
Sponsor
NorthShore University HealthSystem
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01302210
Brief Title
Detection, Education, Research and Decolonization Without Isolation in Long-term Care Facilities
Acronym
DERAIL_MRSA
Official Title
Detection, Education, Research and Decolonization Without Isolation in Long-term Care to Control(DERAIL)MRSA
Study Type
Observational

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin Resistant Staphylococcus Aureus
Keywords
MRSA, Cluster Randomized Trial, Infection Control Intervention

7. Study Design

Enrollment
22302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Description
Active surveillance testing for MRSA and decolonization of positive subjects
Arm Title
control
Arm Description
Usual standard of care
Intervention Type
Drug
Intervention Name(s)
Decolonization
Other Intervention Name(s)
Mupirocin
Intervention Description
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
Primary Outcome Measure Information:
Title
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)
Description
Infection Control cluster randomized trial: measuring the reduction in MRSA colonization prevalence (rate) in the intervention arm as compared to the control arm
Time Frame
12 months and 24 months
Secondary Outcome Measure Information:
Title
To further develop an Infection Control Outreach Program designed to provide expert guidance on infectious disease prevention specific to LTCF's
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance R Peterson, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem Research Institute
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Detection, Education, Research and Decolonization Without Isolation in Long-term Care Facilities

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