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
Sponsor:
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
  Purpose

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.


Condition Intervention
Blood Stream Infections
MRSA Infections
Behavioral: healthcare staff processes for infection prevention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Testing Spread and Implementation of Novel MRSA-Reducing Practices

Resource links provided by NLM:


Further study details as provided by Maine Medical Center Research Institute:

Primary Outcome Measures:
  • Incidence of bloodstream infections [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of MRSA infections [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: July 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
prevalent hemodialysis patients
These patients are observed in two outpatient dialysis units with a combined census of approximately 175 patients
Behavioral: healthcare staff processes for infection prevention
Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

prevalent hemodialysis patients at two outpatient dialysis units

Criteria

Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units

Exclusion Criteria:peritoneal dialysis patients

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255943

Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center Research Institute
Indiana University School of Medicine
Investigators
Principal Investigator: Mark G Parker, MD Maine Medical Center Research Institute
  More Information

No publications provided

Responsible Party: Mark G. Parker, Maine Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01255943     History of Changes
Other Study ID Numbers: HHSA290200600013
Study First Received: December 6, 2010
Last Updated: December 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Maine Medical Center Research Institute:
MRSA
bloodstream infections
hemodialysis

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014