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

June 10, 2015 updated by: University of Edinburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1637

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, Glasgow, Airdrie, Larbert, Dumfries, Dundee, United Kingdom
        • Royal Infirmary Edinburgh, Glasgow Royal Infirmary, Monklands Hospital, Victoria Infirmary Glasgow, Forth Valley Royal, Ninewells hospital, Dumfries Infirmary , Victoria Hospital Kirkcaldy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Education Package
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
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.
Other Names:
  • Bespoke Education Package
Active Comparator: Education and Feedback
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
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.
Other Names:
  • Sedation pecific outcome process feedback
Active Comparator: Education and Sedation Monitoring
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
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.
Other Names:
  • Responsiveness Monitoring
Active Comparator: Education, Feedback, Sedation Monitoring
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
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.
Other Names:
  • Sedation pecific outcome process feedback
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.
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
Time Frame: Cluster trial examining group effects over a 20 month period. Data available June 2014.

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
Time Frame
Number of ventilation days
Time Frame: Cluster trial examining group effects over a 20 month period. Data available June 2014.
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.
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.
Cluster trial examining group effects over a 20 month period. Data available June 2014.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

GE Healthcare
Chief Scientist Office of the Scottish Government

Investigators

  • Principal Investigator: Timothy S Walsh, MD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

July 2, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/R/AN/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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