NCT01255943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

December 6, 2010

Last Update Submit

November 8, 2021

Conditions

Blood Stream InfectionsMRSA Infections

Keywords

MRSAbloodstream infectionshemodialysis

Outcome Measures

Primary Outcomes (1)

  • Incidence of bloodstream infections

    14 months

Secondary Outcomes (1)

  • Incidence of MRSA infections

    14 months

Study Arms (1)

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

Interventions

healthcare staff processes for infection preventionBEHAVIORAL

Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement

prevalent hemodialysis patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

prevalent hemodialysis patients at two outpatient dialysis units

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark G Parker, MD

    MaineHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Nephrology and Transplantation

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 8, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations

US(1)