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

Critical Illness Clinical Trial

— DESIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634451
• Other study ID #: 2012/R/AN/01
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: June 10, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1637
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Chief Scientist Office of the Scottish Government, GE Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Number of ventilation days		Cluster trial examining group effects over a 20 month period. Data available June 2014.	No
Secondary	ICU stay duration		Cluster trial examining group effects over a 20 month period. Data available June 2014.	No
Secondary	Number of days on sedation		Cluster trial examining group effects over a 20 month period. Data available June 2014.	No