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

University of Edinburgh

Status: Completed

Conditions: Critical Illness

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01634451

2012/R/AN/01

Details and patient eligibility

About

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.

Enrollment: 1,637 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,637 participants in 4 patient groups

Education Package

Active Comparator group

Description:

2 ICUs; one large and one small. Randomised to receive bespoke education package for the 9 month intervention period

Treatment:

Other: Bespoke on-line sedation education package

Education and Feedback

Active Comparator group

Description:

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.

Treatment:

Other: Sedation specific outcome process feedback

Education and Sedation Monitoring

Active Comparator group

Description:

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.

Treatment:

Device: Responsiveness monitoring; novel sedation monitor

Education, Feedback, Sedation Monitoring

Active Comparator group

Description:

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.

Treatment:

Other: Sedation specific outcome process feedback

Device: Responsiveness monitoring; novel sedation monitor