An interventional study of Bespoke on-line sedation education package and Sedation specific outcome process feedback in Critical Illness, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-06-11.
Sponsored by University of Edinburgh · Not applicable and Interventional
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.
1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's enrollment of 1,637 is above the median of 90 across 1,003 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
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
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
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
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 · Device: Responsiveness monitoring; novel sedation monitor
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.
Also known as: Bespoke Education Package
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.
Also known as: Sedation pecific outcome process feedback
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.
Also known as: Responsiveness Monitoring
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
Time frame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
Number of ventilation days
Time frame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
ICU stay duration
Time frame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
Number of days on sedation
Time frame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
The record gives a start of Jun 2012, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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