Testing Spread and Implementation of Novel Methicillin Re... | NCT01255943

Studies
Testing Spread and Implementation of Novel Methicillin Resistant Staphylococcal Aureus (MRSA)-Reducing Practices

NCT01255943

Sponsor

MaineHealth

Status

Completed

Last Update Posted

Nov 9, 2021Actual

Enrollment

175Actual

Phase

Not provided

Conditions

Blood Stream Infections
MRSA Infections

Interventions

healthcare staff processes for infection prevention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Dec 6, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2021

Last Update Posted Date

Nov 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark Parker, Director, Division of Nephrology and Transplantation, MaineHealthPrincipal Investigator

Lead Sponsor

MaineHealthOTHER

Collaborators

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED
Indiana University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
healthcare staff processes for infection prevention	Behavioral	Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement	prevalent hemodialysis patients

Measure	Description	Time Frame
Incidence of bloodstream infections		14 months

Measure	Description	Time Frame
Incidence of MRSA infections		14 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units

Exclusion Criteria:peritoneal dialysis patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

prevalent hemodialysis patients at two outpatient dialysis units

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark G Parker, MD	MaineHealth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maine Medical Center		Portland	Maine	04102	United States

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided