Blood Stream InfectionsNCT01255943
Testing Spread and Implementation of Novel Methicillin Resistant Staphylococcal Aureus (MRSA)-Reducing Practices
An observational study of Blood Stream Infections and MRSA Infections, run by MaineHealth at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Stream Infections, MRSA Infections
- What is being tested?
- healthcare staff processes for infection prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: prevalent hemodialysis patients at two outpatient dialysis units
Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units
Exclusion Criteria:peritoneal dialysis patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing Spread and Implementation of Novel MRSA-Reducing Practices
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.
- Conditions
- Blood Stream Infections, MRSA Infections
- Being tested
- healthcare staff processes for infection prevention
- Keywords
- MRSA, bloodstream infections, hemodialysis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthcare staff processes for infection preventionBehavioural
Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement
| Study group | Role | What they receive |
|---|---|---|
| prevalent hemodialysis patients | These patients are observed in two outpatient dialysis units with a combined census of approximately 175 patients Receives: Behavioral: healthcare staff processes for infection prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bloodstream infections
Measured: 14 months
Secondary outcomes (1)
Incidence of MRSA infections
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stream InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Indiana University
- Responsible party
- Principal investigator, Mark Parker, MaineHealth
- Investigators
- Mark G Parker, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255943
- Sponsor's protocol ID
- HHSA290200600013
- Status last verified
- Nov 2021
- First submitted
- 6 Dec 2010
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Spread and Implementation of Novel MRSA-Reducing Practices
- ClinicalTrials.gov ID
- NCT01255943
- Acronym / sponsor ID
- HHSA290200600013
- Conditions
- Blood Stream Infections, MRSA Infections
- Keywords
- MRSA, bloodstream infections, hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Indiana University
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prevalent hemodialysis patients | – | Behavioral: healthcare staff processes for infection preventionThese patients are observed in two outpatient dialysis units with a combined census of approximately 175 patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- prevalent hemodialysis patients at two outpatient dialysis units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healthcare staff processes for infection preventionToyota lean and positive deviance discovery and action dialogues to facilitate process improvement | Behavioural | prevalent hemodialysis patients |
Primary outcome
Incidence of bloodstream infections
Time frame: 14 months
1 secondary outcome
Incidence of MRSA infections
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark G Parker, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Stream Infections and MRSA Infections, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bloodstream infections (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021; AzTrials last refreshed its copy on 1 Nov 2026.