Critical IllnessDESISTNCT01634451
Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care
A study testing Bespoke on-line sedation education package, Sedation specific outcome process feedback and Responsiveness monitoring; novel sedation monitor in people with Critical Illness, run by University of Edinburgh at 1 site in United Kingdom.
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". Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Bespoke on-line sedation education package, Sedation specific outcome process feedback and Responsiveness monitoring; novel sedation monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,637 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to ICU mechanically ventilated and intubated.
- 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.
Who cannot join
- Patients who are not receiving mechanical ventilation via an endotracheal tube
- Patients who received mechanical ventilation following ICU admission but this has been discontinued at the time of screening for study inclusion
- Patients in whom discontinuation of mechanical ventilation is anticipated in the next 4 hours
- Patients in whom a decision to withdraw active therapy has been made
- Patients who have already been enrolled in the during the same hospital admission
- Patients whom have been mechanically ventilated and intubated for greater than 24 hrs by the time relatives are approached for consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
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
About this study
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.
- Conditions
- Critical Illness
- Being tested
- Bespoke on-line sedation education package, Sedation specific outcome process feedback, Responsiveness monitoring; novel sedation monitor
- Keywords
- Sedation, Quality
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bespoke on-line sedation education packageOther
Also called Bespoke 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 feedbackOther
Also called Sedation pecific 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.
Responsiveness monitoring; novel sedation monitorDevice
Also called Responsiveness Monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| Education Package | Active comparator | 2 ICUs; one large and one small. Randomised to receive bespoke education package for the 9 month intervention period Receives: Other: Bespoke on-line sedation education package |
| Education and Feedback | Active comparator | 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. Receives: Other: Sedation specific outcome process feedback |
| Education and Sedation Monitoring | Active comparator | 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. Receives: Device: Responsiveness monitoring; novel sedation monitor |
| Education, Feedback, Sedation Monitoring | Active comparator | 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. Receives: Other: Sedation specific outcome process feedback; Device: Responsiveness monitoring; novel sedation monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Cluster trial examining group effects over a 20 month period. Data available June 2014.
Secondary outcomes (3)
Number of ventilation days
Measured: Cluster trial examining group effects over a 20 month period. Data available June 2014.
ICU stay duration
Measured: Cluster trial examining group effects over a 20 month period. Data available June 2014.
Number of days on sedation
Measured: Cluster trial examining group effects over a 20 month period. Data available June 2014.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,637 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Timothy S Walsh, MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634451
- Sponsor's protocol ID
- 2012/R/AN/01
- Acronym
- DESIST
- Status last verified
- Jun 2015
- First submitted
- 20 Jun 2012
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31129576Walsh 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.
PubMed 27473760Walsh 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.
PubMed 26944693
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care
- ClinicalTrials.gov ID
- NCT01634451
- Acronym / sponsor ID
- DESIST / 2012/R/AN/01
- Conditions
- Critical Illness
- Keywords
- Sedation, Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,637 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, GE Healthcare
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Education Package | Active comparator | Other: Bespoke on-line sedation education package2 ICUs; one large and one small. Randomised to receive bespoke education package for the 9 month intervention period |
| Education and Feedback | Active comparator | Other: Sedation specific outcome process feedback2 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. |
| Education and Sedation Monitoring | Active comparator | Device: Responsiveness monitoring; novel sedation monitor2 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. |
| Education, Feedback, Sedation Monitoring | Active comparator | Other: Sedation specific outcome process feedback, Device: Responsiveness monitoring; novel sedation monitor2 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to ICU mechanically ventilated and intubated.
- 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.
Key exclusion criteria (6 listed)
- Patients who are not receiving mechanical ventilation via an endotracheal tube
- Patients who received mechanical ventilation following ICU admission but this has been discontinued at the time of screening for study inclusion
- Patients in whom discontinuation of mechanical ventilation is anticipated in the next 4 hours
- Patients in whom a decision to withdraw active therapy has been made
- Patients who have already been enrolled in the during the same hospital admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bespoke on-line sedation education packageAlso: Bespoke Education PackageA 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 | Education Package |
| Sedation specific outcome process feedbackAlso: Sedation pecific outcome process feedbackUsing 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 | Education and Feedback, Education, Feedback, Sedation Monitoring |
| Responsiveness monitoring; novel sedation monitorAlso: Responsiveness MonitoringResponsiveness 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. | Device | Education and Sedation Monitoring, Education, Feedback, Sedation Monitoring |
Primary outcome
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
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Derived from this study: PubMed 31129576Kydonaki 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.
- Derived from this study: PubMed 27473760Walsh 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.
- Derived from this study: PubMed 26944693Walsh 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.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy S Walsh, MD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bespoke on-line sedation education package, Sedation specific outcome process feedback and Responsiveness monitoring; novel sedation monitor in people with Critical Illness, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01634451, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.