Decision MakingNCT00715507
Evaluation of Drug Display in Critical Care Setting
An observational study of Decision Making, run by University of Utah at 1 site in United States.
Trial summary
To assess the clinical utility of the graphical medication monitor, results of the anesthetics for which the display was present will be compared to the results of the anesthetics in which there was no display. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decision Making
- What is being tested?
- medication monitor
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Aug 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents
Who may be able to join
- Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents and have been trained on the graphic display
Who cannot join
- Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents that have not been trained on the graphic display
Trial locations and contacts
1 site in 1 country.
About this study
To assess the clinical utility of the graphical medication monitor, results of the anesthetics for which the display was present will be compared to the results of the anesthetics in which there was no display.
Read the detailed description
This study has two objectives: First, before the medication monitor is shown to anesthesiologists in a clinical setting, the PKPD models must be validated to assess the clinical reliability of the model-based predictions for patients undergoing general anesthesia. Second, once the PKPD models have been successfully validated, presenting it to anesthesiologists during administration of anesthesia will assess the impact of the graphical medication monitor. Differences in performance and patient care will be determined by comparing anesthesiologists who are presented with the monitor to those who care for patients without the monitor.
- Conditions
- Decision Making
- Being tested
- medication monitor
- Keywords
- decision making, graphic display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication monitorDevice
the medication monitor will aid in expertise and decision-making.
| Study group | Role | What they receive |
|---|---|---|
| 1 | For the phase of the study in which the utility of the graphical medication monitor is assessed, the monitor will not be shown to anesthesiologists placed in the control condition. | |
| 2 | In the experimental condition, anesthesiologists will be shown the medication monitor to aid their expertise and decision-making. Receives: Device: medication monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess differences between medication administration data and patient information with and without the use of the graphical medication monitor.
Measured: preoperative, intraoperative and postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2003
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Noah Syroid, University of Utah
- Investigators
- Ken Johnson, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715507
- Sponsor's protocol ID
- 10599
- Other IDs
- 1R43GM066615-01A2
- Status last verified
- Aug 2016
- First submitted
- 11 Jul 2008
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Drug Display in Critical Care Setting
- ClinicalTrials.gov ID
- NCT00715507
- Acronym / sponsor ID
- 10599
- Conditions
- Decision Making
- Keywords
- decision making, graphic display
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2003
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Jul 2008 (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.
To assess the clinical utility of the graphical medication monitor, results of the anesthetics for which the display was present will be compared to the results of the anesthetics in which there was no display.
Detailed description
This study has two objectives: First, before the medication monitor is shown to anesthesiologists in a clinical setting, the PKPD models must be validated to assess the clinical reliability of the model-based predictions for patients undergoing general anesthesia. Second, once the PKPD models have been successfully validated, presenting it to anesthesiologists during administration of anesthesia will assess the impact of the graphical medication monitor. Differences in performance and patient care will be determined by comparing anesthesiologists who are presented with the monitor to those who care for patients without the monitor.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –For the phase of the study in which the utility of the graphical medication monitor is assessed, the monitor will not be shown to anesthesiologists placed in the control condition. |
| 2 | – | Device: medication monitorIn the experimental condition, anesthesiologists will be shown the medication monitor to aid their expertise and decision-making. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents
Key inclusion criteria (1 listed)
- Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents and have been trained on the graphic display
Key exclusion criteria (1 listed)
- Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents that have not been trained on the graphic display
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 |
|---|---|---|
| medication monitorthe medication monitor will aid in expertise and decision-making. | Device | 2 |
Primary outcome
assess differences between medication administration data and patient information with and without the use of the graphical medication monitor.
Time frame: preoperative, intraoperative and postoperative
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 10 Aug 2016.
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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.
Ken Johnson principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decision Making, run by University of Utah at 1 site in United States.
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 1 inclusion and 1 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 10 Aug 2016. 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 States. 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?
assess differences between medication administration data and patient information with and without the use of the graphical medication monitor. (time frame: preoperative, intraoperative and postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2016.