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

Completed

• Conditions: Methicillin Resistant Staphylococcus Aureus
• Interventions: Drug: Decolonization

• Registration Number: NCT01302210
• Lead Sponsor: NorthShore University HealthSystem

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2013-12
• Study Completion: 2014-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22302

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Decolonization	Active surveillance testing for MRSA and decolonization of positive subjects

Primary Outcome Measures

Name	Time	Method
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)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NorthShore University HealthSystem Research Institute; 🇺🇸 Evanston, Illinois, United States