Clinical trial NCT01634451: Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care
Official title: Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Sedation
Quality
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
name: GE Healthcare
First posted: 2012-07-06
Enrollment: 1637
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline the effect of individual and combinations of the interventions named on achievement of optimal sedation practice
timeFrame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
Secondary outcomes:
measure: Number of ventilation days
timeFrame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
measure: ICU stay duration
timeFrame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
measure: Number of days on sedation
timeFrame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
Other outcomes:
Locations:
city: Edinburgh, Glasgow, Airdrie, Larbert, Dumfries, Dundee
country: United Kingdom
facility: Royal Infirmary Edinburgh, Glasgow Royal Infirmary, Monklands Hospital, Victoria Infirmary Glasgow, Forth Valley Royal, Ninewells hospital, Dumfries Infirmary , Victoria Hospital Kirkcaldy
Study officials:
affiliation: University of Edinburgh
name: Timothy S Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kydonaki K, Hanley J, Huby G, Antonelli J, Walsh TS; Development and Evaluation of Strategies to Improve Sedation practice in inTensive care (DESIST) study investigators. Challenges and barriers to optimising sedation in intensive care: a qualitative study in eight Scottish intensive care units. BMJ Open. 2019 May 24;9(5):e024549. doi: 10.1136/bmjopen-2018-024549.
citation: Walsh TS, Kydonaki K, Antonelli J, Stephen J, Lee RJ, Everingham K, Hanley J, Phillips EC, Uutela K, Peltola P, Cole S, Quasim T, Ruddy J, McDougall M, Davidson A, Rutherford J, Richards J, Weir CJ; Development and Evaluation of Strategies to Improve Sedation Practice in Intensive Care (DESIST) study investigators. Staff education, regular sedation and analgesia quality feedback, and a sedation monitoring technology for improving sedation and analgesia quality for critically ill, mechanically ventilated patients: a cluster randomised trial. Lancet Respir Med. 2016 Oct;4(10):807-817. doi: 10.1016/S2213-2600(16)30178-3. Epub 2016 Jul 26.
citation: Walsh TS, Kydonaki K, Antonelli J, Stephen J, Lee RJ, Everingham K, Hanley J, Uutelo K, Peltola P, Weir CJ; Development and Evaluation of Strategies to Improve Sedation practice in in Tensive care Study Investigators. Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study). BMJ Open. 2016 Mar 4;6(3):e010148. doi: 10.1136/bmjopen-2015-010148.