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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01255943
Other study ID # HHSA290200600013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2010
Est. completion date April 2012

Study information

Verified date November 2021
Source MaineHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units Exclusion Criteria:peritoneal dialysis patients

Study Design


Intervention

Behavioral:
healthcare staff processes for infection prevention
Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement

Locations

Country Name City State
United States Maine Medical Center Portland Maine

Sponsors (3)

Lead Sponsor Collaborator
MaineHealth Agency for Healthcare Research and Quality (AHRQ), Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of bloodstream infections 14 months
Secondary Incidence of MRSA infections 14 months
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