Ventilator Associated PneumoniaABATEVAPNCT00434460
Study of Knowledge Translation of Clinical Practice Guidelines for Ventilator Associated Pneumonia
An observational study of Ventilator Associated Pneumonia, run by Canadian Critical Care Trials Group at 11 sites in 2 countries.
Trial summary
The purpose of this prospective, multicentre, time-series study is to develop, implement, refine, and evaluate a sustainable behaviour change strategy in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,320 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Apr 2007to Jul 2010
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients invasively mechanically ventilated > 48 hours in the critical care setting.
Who may be able to join
- Age >= 17 years old
- Mechanically ventilated > 48 hours < 96 hours
Who cannot join
- Previous enrollment in the study
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Canada10 sites
St. Joseph's Healthcare, McMaster University
Hamilton, Ontario, L8N 4A6
Kingston General Hospital, Queen's University
Kingston, Ontario, K7L 2V7
Royal Columbian Hospital, University of British Columbia
New Westminster, British Columbia, V3L 3W4
The Ottawa Hospital, University of Ottawa
Ottawa, Ontario, K1H 8L7
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Sunnybrook Health Sciences Centre, University of Toronto
Toronto, Ontario, M4N 3M5
William Osler Health Centre
Toronto, Ontario
St. Paul Hospital, University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
Vancouver Island Health Research Centre
Victoria, British Columbia, V8R 1J8
Hotel Dieu Grace Hospital
Windsor, Ontario, N4A 1E1
United States1 site
Geisinger Health Centre, Temple University
Danville, Pennsylvania, 17821-4400
About this study
Official title: Active Observational Study of the Adoption and Transfer of Clinical Practice Guidelines Through Education, for Ventilator Associated Pneumonia (ABATE VAP Study)
The purpose of this prospective, multicentre, time-series study is to develop, implement, refine, and evaluate a sustainable behaviour change strategy in the intensive care unit (ICU).
Read the detailed description
Background:
In order to improve the care of our patients, it is necessary for research evidence to be translated into clinical practice. There are gaps in our understanding of knowledge translation (KT) and this is evident in the Intensive Care Unit (ICU), specifically as it applies to the prevention, diagnosis and treatment of ventilator-associated pneumonia (VAP). VAP is associated with a high burden of illness in the critically ill and there is an extensive amount of research evidence on this disease. It has been demonstrated that best practice as defined by research evidence is not uniformly applied to VAP. In addition, recent advances in VAP knowledge need be disseminated and implemented in order to improve patient safety and outcomes from VAP. A systematic process of knowledge transfer is crucial to translate this research into evidence-based bedside practice and the development and implementation of evidence based Clinical Practice Guidelines (CPGs) may facilitate VAP knowledge uptake. In addition, there is a need to study knowledge translation (KT) in the ICU since there is little information about optimal KT and CPG implementation strategies in this environment and efforts that are effective in other clinical areas may not result in meaningful change in the ICU.
Research Question:
What is the effect of VAP CPGs implemented by a multidisciplinary behaviour change strategy (consisting of multifaceted educational strategies led by local opinion leaders and augmented with reminders) on VAP guideline concordance and on clinical VAP outcomes in the ICU?
Research Plan:
Data will only be collected on consecutive patients mechanically ventilated for at least 48 hours. The following health care professionals will be studied to assess the behaviour change strategy for the VAP CPGs: physicians (intensivists, ICU fellows, ICU rotating residents), nurses, respiratory therapists, dieticians, physiotherapists and ICU administrators.
The study will be conducted in 3 phases:
- Development of a behaviour change strategy consisting of three components:
- Local opinion leader team
- Educational strategy
- Reminder system
- Prospective implementation of the behaviour change strategy over a 24 month period
- Prospective evaluation of the behaviour change strategy over a 24 month period
- Concordance with VAP guidelines over time
- Factors associated with VAP guideline concordance
- Clinical VAP outcomes pre- and post-guideline implementation
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Education
- Keywords
- Ventilator Associated Pneumonia, Knowledge Translation, Clinical Practice Guidelines, Education, Behaviour Change
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Implementation of clinical practice guideline for ventilator associated pneumonia through education.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients receiving invasive mechanical ventilation > 48 hours. Receives: Behavioral: Education |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startApr 2007
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies 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
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Critical Care Trials Group
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Canadian Institutes of Health Research (CIHR), AstraZeneca, Bayer
- Investigators
- John Muscedere, MD, Study chair, Kingston General Hospital, Queen's UniversityTasmin Sinuff, MD, PhD, Study chair, Sunnybrook Health Sciences Centre, University of TorontoDaren Heyland, MD, Principal investigator, Kingston General Hospital, Queen's UniversityDeborah Cook, MD, Principal investigator, St. Joseph's Healthcare, McMaster UniversityPeter Dodek, MD, Principal investigator, St. Paul's University, University of British ColumbiaRedouane Bouali, MD, Principal investigator, The Ottawa Hospital, University of OttawaSean Keenan, MD, Principal investigator, Royal Columbian Hospital, University of British ColumbiaKevin Eva, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434460
- Sponsor's protocol ID
- ABATE VAP
- Acronym
- ABATEVAP
- Status last verified
- Aug 2010
- First submitted
- 12 Feb 2007
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Sinuff T, Muscedere J, Cook DJ, Dodek PM, Anderson W, Keenan SP, Wood G, Tan R, Haupt MT, Miletin M, Bouali R, Jiang X, Day AG, Overvelde J, Heyland DK; Canadian Critical Care Trials Group. Implementation of clinical practice guidelines for ventilator-associated pneumonia: a multicenter prospective study. Crit Care Med. 2013 Jan;41(1):15-23. doi: 10.1097/CCM.0b013e318265e874.
PubMed 23222254
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Observational Study of the Adoption and Transfer of Clinical Practice Guidelines Through Education, for Ventilator Associated Pneumonia (ABATE VAP Study)
- ClinicalTrials.gov ID
- NCT00434460
- Acronym / sponsor ID
- ABATEVAP / ABATE VAP
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Ventilator Associated Pneumonia, Knowledge Translation, Clinical Practice Guidelines, Education, Behaviour Change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Canadian Critical Care Trials GroupUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Canadian Institutes of Health Research (CIHR), AstraZeneca, Bayer
- Study start
- Apr 2007
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Feb 2007 (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 prospective, multicentre, time-series study is to develop, implement, refine, and evaluate a sustainable behaviour change strategy in the intensive care unit (ICU).
Detailed description
Background:
In order to improve the care of our patients, it is necessary for research evidence to be translated into clinical practice. There are gaps in our understanding of knowledge translation (KT) and this is evident in the Intensive Care Unit (ICU), specifically as it applies to the prevention, diagnosis and treatment of ventilator-associated pneumonia (VAP). VAP is associated with a high burden of illness in the critically ill and there is an extensive amount of research evidence on this disease. It has been demonstrated that best practice as defined by research evidence is not uniformly applied to VAP. In addition, recent advances in VAP knowledge need be disseminated and implemented in order to improve patient safety and outcomes from VAP. A systematic process of knowledge transfer is crucial to translate this research into evidence-based bedside practice and the development and implementation of evidence based Clinical Practice Guidelines (CPGs) may facilitate VAP knowledge uptake. In addition, there is a need to study knowledge translation (KT) in the ICU since there is little information about optimal KT and CPG implementation strategies in this environment and efforts that are effective in other clinical areas may not result in meaningful change in the ICU.
Research Question:
What is the effect of VAP CPGs implemented by a multidisciplinary behaviour change strategy (consisting of multifaceted educational strategies led by local opinion leaders and augmented with reminders) on VAP guideline concordance and on clinical VAP outcomes in the ICU?
Research Plan:
Data will only be collected on consecutive patients mechanically ventilated for at least 48 hours. The following health care professionals will be studied to assess the behaviour change strategy for the VAP CPGs: physicians (intensivists, ICU fellows, ICU rotating residents), nurses, respiratory therapists, dieticians, physiotherapists and ICU administrators.
The study will be conducted in 3 phases:
- Development of a behaviour change strategy consisting of three components:
- Local opinion leader team
- Educational strategy
- Reminder system
- Prospective implementation of the behaviour change strategy over a 24 month period
- Prospective evaluation of the behaviour change strategy over a 24 month period
- Concordance with VAP guidelines over time
- Factors associated with VAP guideline concordance
- Clinical VAP outcomes pre- and post-guideline implementation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: EducationPatients receiving invasive mechanical ventilation > 48 hours. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients invasively mechanically ventilated > 48 hours in the critical care setting.
Key inclusion criteria (2 listed)
- Age >= 17 years old
- Mechanically ventilated > 48 hours < 96 hours
Key exclusion criteria (1 listed)
- Previous enrollment in the study
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 |
|---|---|---|
| EducationImplementation of clinical practice guideline for ventilator associated pneumonia through education. | Behavioural | 1 |
Primary outcome
Not reported in the source record.
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 1 Sep 2010.
- Derived from this study: PubMed 23222254Sinuff T, Muscedere J, Cook DJ, Dodek PM, Anderson W, Keenan SP, Wood G, Tan R, Haupt MT, Miletin M, Bouali R, Jiang X, Day AG, Overvelde J, Heyland DK; Canadian Critical Care Trials Group. Implementation of clinical practice guidelines for ventilator-associated pneumonia: a multicenter prospective study. Crit Care Med. 2013 Jan;41(1):15-23. doi: 10.1097/CCM.0b013e318265e874.
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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.
John Muscedere, MD study chair
Kingston General Hospital, Queen's University
Tasmin Sinuff, MD, PhD study chair
Sunnybrook Health Sciences Centre, University of Toronto
Daren Heyland, MD principal investigator
Kingston General Hospital, Queen's University
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Canadian Critical Care Trials Group at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00434460, which also lists 1 linked publication.
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 1 Sep 2010.