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Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care (DESIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01634451
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : June 11, 2015
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
GE Healthcare
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
Intensive Care Units (ICUs) across Scotland are working with the Scottish Patient Safety Programme (SPSP) to reduce healthcare associated infections (HAls). This is being done through implementation of "care bundles". Ensuring that ICU patients get the correct amount of sedation (medicine that makes patients sleepy) is part of this bundle, but is proving the most difficult to get right. It's important healthcare staff (nurses and doctors) get sedation levels correct because too much sedation is linked with increased hospital acquired infections (HAIs), longer intensive care (ICU) and hospital stays, and possibly higher death rates. This quality improvement project will develop and introduce three interventions that may improve sedation practice: first, an ICU sedation education package; second, feedback of sedation-related performance data (graphs and charts); and third, introduction of a CE (Conformité Européenne - With the CE marking on a product, the manufacturer ensures that the product conforms with the essential requirements of European regulations) marked new technology designed to improve sedation management. The investigators will study the effect these interventions, in different combinations, have on sedation management and quality in the participating ICUs. Eight ICUs in Scotland will take part in the project, pairs (2 ICUs) will be assigned randomly to different combinations as follows: 1.Enhanced education alone, 2. Education plus process/outcome measure feedback (graphs and charts), 3. Education plus introduction of a new sedation monitoring technology, or 4. Education,process/outcome measure feedback, and sedation monitoring technology. The investigators will evaluate which combinations of education, feedback, and technology provide the most patient benefit in the NHS. In addition both nursing & medical staff will be observed in clinical practice & interviewed about their clinical practice to increase understanding about sedation management from different view points and inform the education package content. These data will also help implement the findings after the research is completed if a benefit is found.

Condition or disease Intervention/treatment Phase
Critical Illness Other: Bespoke on-line sedation education package Other: Sedation specific outcome process feedback Device: Responsiveness monitoring; novel sedation monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care
Study Start Date : June 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Active Comparator: Education Package
2 ICUs; one large and one small. Randomised to receive bespoke education package for the 9 month intervention period
Other: Bespoke on-line sedation education package
A bespoke on-line education package has been developed and will be accessible by all ICU nursing staff. They will have unique logins and the system will track their use and completion of the education package. There is a small multiple choice assessment at the end of the package.
Other Name: Bespoke Education Package

Active Comparator: Education and Feedback
2 ICUs; one large and one small. Randomised to receive a bespoke education package and real-time,site specific, outcome process feedback they will disseminate to their staff for the 9 month intervention period.
Other: Sedation specific outcome process feedback
Using statistical process charts, the data gathered from the Sedation quality Tools (SQATs) completed each shift by the ICU nurses, will be fed back highlighting sedation specific outcomes e.g. number of over sedated days per 1000 ventilator days.
Other Name: Sedation pecific outcome process feedback

Active Comparator: Education and Sedation Monitoring
2 ICUs; one large and one small. Randomised to receive a bespoke education package and a new novel sedation (responsiveness) monitor for the 9 month intervention period.
Device: Responsiveness monitoring; novel sedation monitor
Responsiveness monitoring (developed by GE Healthcare) is a novel technology used to monitor patient responsiveness and essentially alert ICU nursing staff when their patients may be over sedated.
Other Name: Responsiveness Monitoring

Active Comparator: Education, Feedback, Sedation Monitoring
2 ICUs; one large and one small. Randomised to receive a bespoke education package, real-time,site specific, outcome process feedback they will disseminate to their staff and a new novel sedation (responsiveness) monitor for the 9 month intervention period.
Other: Sedation specific outcome process feedback
Using statistical process charts, the data gathered from the Sedation quality Tools (SQATs) completed each shift by the ICU nurses, will be fed back highlighting sedation specific outcomes e.g. number of over sedated days per 1000 ventilator days.
Other Name: Sedation pecific outcome process feedback

Device: Responsiveness monitoring; novel sedation monitor
Responsiveness monitoring (developed by GE Healthcare) is a novel technology used to monitor patient responsiveness and essentially alert ICU nursing staff when their patients may be over sedated.
Other Name: Responsiveness Monitoring




Primary Outcome Measures :
  1. Change from baseline the effect of individual and combinations of the interventions named on achievement of optimal sedation practice [ Time Frame: Cluster trial examining group effects over a 20 month period. Data available June 2014. ]

    The % of ventilated patient days with optimal sedation will be compared across and between the groups. A sedation quality assessment tool has been developed for the purpose of the study:

    Group 1 -Education package only (bespoke sedation education) Group 2 -Education package and real time (site specific) process feedback about sedation practices Group 3 - Education and responsiveness (sedation) technology Group 4 - Education package, real time (site specific) process feedback about sedation practices and responsiveness (sedation) technology



Secondary Outcome Measures :
  1. Number of ventilation days [ Time Frame: Cluster trial examining group effects over a 20 month period. Data available June 2014. ]
  2. ICU stay duration [ Time Frame: Cluster trial examining group effects over a 20 month period. Data available June 2014. ]
  3. Number of days on sedation [ Time Frame: Cluster trial examining group effects over a 20 month period. Data available June 2014. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients admitted to ICU mechanically ventilated and intubated.
  2. All patients in whom mechanical ventilation via an endotracheal tube is instituted at some time after ICU admission will also be eligible for inclusion from the time intubation and mechanical ventilation begins.

Exclusion Criteria:

  1. Patients who are not receiving mechanical ventilation via an endotracheal tube
  2. Patients who received mechanical ventilation following ICU admission but this has been discontinued at the time of screening for study inclusion
  3. Patients in whom discontinuation of mechanical ventilation is anticipated in the next 4 hours
  4. Patients in whom a decision to withdraw active therapy has been made
  5. Patients who have already been enrolled in the during the same hospital admission
  6. Patients whom have been mechanically ventilated and intubated for greater than 24 hrs by the time relatives are approached for consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634451


Locations
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United Kingdom
Royal Infirmary Edinburgh, Glasgow Royal Infirmary, Monklands Hospital, Victoria Infirmary Glasgow, Forth Valley Royal, Ninewells hospital, Dumfries Infirmary , Victoria Hospital Kirkcaldy
Edinburgh, Glasgow, Airdrie, Larbert, Dumfries, Dundee, United Kingdom
Sponsors and Collaborators
University of Edinburgh
Chief Scientist Office of the Scottish Government
GE Healthcare
Investigators
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Principal Investigator: Timothy S Walsh, MD University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01634451    
Other Study ID Numbers: 2012/R/AN/01
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Keywords provided by University of Edinburgh:
Sedation
Quality
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes