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

Study Overview
=================
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.

Official Title
-----------------
Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: Bespoke on-line sedation education package
* Other: Sedation specific outcome process feedback
* Device: Responsiveness monitoring; novel sedation monitor


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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education Package<br>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<br>* 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.<br>* Other names: Bespoke Education Package;|
| Active Comparator: Education and Feedback<br>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<br>* 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.<br>* Other names: Sedation pecific outcome process feedback;|
| Active Comparator: Education and Sedation Monitoring<br>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<br>* 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.<br>* Other names: Responsiveness Monitoring;|
| Active Comparator: Education, Feedback, Sedation Monitoring<br>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<br>* 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.<br>* Other names: Sedation pecific outcome process feedback;Device: Responsiveness monitoring; novel sedation monitor<br>* 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.<br>* Other names: Responsiveness Monitoring;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline the effect of individual and combinations of the interventions named on achievement of optimal sedation practice | 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 | Cluster trial examining group effects over a 20 month period. Data available June 2014. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilation days |  | Cluster trial examining group effects over a 20 month period. Data available June 2014. | 
| ICU stay duration |  | Cluster trial examining group effects over a 20 month period. Data available June 2014. | 
| Number of days on sedation |  | Cluster trial examining group effects over a 20 month period. Data available June 2014. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, Quality