- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255943
Testing Spread and Implementation of Novel Methicillin Resistant Staphylococcal Aureus (MRSA)-Reducing Practices
November 8, 2021 updated by: Mark Parker, MaineHealth
Testing Spread and Implementation of Novel MRSA-Reducing Practices
The purpose of this study is to implement strategies for improved efficiency and waste reduction ("Toyota Lean") and positive deviance, a social behavioral change process, utilizing frontline healthcare personnel to reduce infection bloodstream infection and MRSA infection in outpatient dialysis care.
In two outpatient dialysis units, dialysis unit healthcare staff will be educated in Toyota lean techniques and conduct periodic "discovery and action" dialogues to identify and implement care process changes to reduce infection.
Outcomes to be monitored will include incidence of bloodstream infections and MRSA infections of all types.
Data will be assessed at quarterly intervals using interrupted time series analysis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
175
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
-
-
Maine
-
Portland, Maine, United States, 04102
- Maine Medical Center
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
prevalent hemodialysis patients at two outpatient dialysis units
Description
Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units
Exclusion Criteria:peritoneal dialysis patients
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
prevalent hemodialysis patients
These patients are observed in two outpatient dialysis units with a combined census of approximately 175 patients
|
Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of bloodstream infections
Time Frame: 14 months
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of MRSA infections
Time Frame: 14 months
|
14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark G Parker, MD, MaineHealth
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
July 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
December 6, 2010
First Submitted That Met QC Criteria
December 7, 2010
First Posted (Estimate)
December 8, 2010
Study Record Updates
Last Update Posted (Actual)
November 9, 2021
Last Update Submitted That Met QC Criteria
November 8, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHSA290200600013
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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