Testing Spread and Implementation of Novel Methicillin Resistant Staphylococcal Aureus (MRSA)-Reducing Practices
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Maine Medical Center Research Institute.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Maine Medical Center Research Institute
Collaborators:
Indiana University School of Medicine
Information provided by:
Maine Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01255943
First received: December 6, 2010
Last updated: December 7, 2010
Last verified: July 2010
| Tracking Information | |||||
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| First Received Date ICMJE | December 6, 2010 | ||||
| Last Updated Date | December 7, 2010 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of bloodstream infections [ Time Frame: 14 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01255943 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Incidence of MRSA infections [ Time Frame: 14 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Testing Spread and Implementation of Novel Methicillin Resistant Staphylococcal Aureus (MRSA)-Reducing Practices | ||||
| Official Title ICMJE | Testing Spread and Implementation of Novel MRSA-Reducing Practices | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | prevalent hemodialysis patients at two outpatient dialysis units |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: healthcare staff processes for infection prevention
Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement |
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| Study Group/Cohort (s) | prevalent hemodialysis patients
These patients are observed in two outpatient dialysis units with a combined census of approximately 175 patients
Intervention: Behavioral: healthcare staff processes for infection prevention |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 175 | ||||
| Estimated Completion Date | October 2011 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units Exclusion Criteria:peritoneal dialysis patients |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01255943 | ||||
| Other Study ID Numbers ICMJE | HHSA290200600013 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mark G. Parker, Maine Medical Center Research Institute | ||||
| Study Sponsor ICMJE | Maine Medical Center Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Maine Medical Center Research Institute | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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