Moderate Sedation TrainingNCT00708760
Moderate Sedation Educational Software
An observational study of Moderate Sedation Training, run by University of Utah at 1 site in United States.
Trial summary
We propose to develop and evaluate an interactive education software for administering moderate sedation by non-anesthesiologists. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate Sedation Training
- What is being tested?
- paper based training and web based training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to 1 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: nurses providing moderate sedation
Who may be able to join
- general nursing staff at the University of Utah
- currently required to obtain moderate sedation training
- an equal basis all clinicians in the respective departments
Who cannot join
- nurses and other personnel who do not administer moderate sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Moderate Sedation Education Software
We propose to develop and evaluate an interactive education software for administering moderate sedation by non-anesthesiologists.
Read the detailed description
The course will be founded upon JCAHO's and ASA's guidelines for sedation, emphasizing the concepts with animations, audio, scenarios, and quizzes. Interactive feedback will be incorporated to guide the clinician during the course. The course will be offered commercially over the World Wide Web, with successful completion providing continuing medical education (CME) credit. It will fulfill JCAHO recommended guidelines. In a controlled simulated environment, the hypothesis that the web based training protocol will provide the practitioner the knowledge base necessary to manage the four scenarios as well or better than practitioners completing the standard moderate sedation certification course will be tested.
- Evaluate the effectiveness of the course. The University of Utah Center for Patient Simulation is an ideal environment to evaluate the efficacy of a web-based training course. The new web-based course will be compared to standard course material and lessons. We will recruit 40 nurses who administer moderate sedation at the University of Utah Health Sciences Center. Half of the nurses will receive traditional training (typical course and guidelines published from the literature), and half will receive the web-based course. Users will be tested on their knowledge of moderate sedation with four moderate sedation scenarios, in which the simulated patient experiences over-sedation, apnea, and excessive pain.
- Conditions
- Moderate Sedation Training
- Being tested
- paper based training, web based training
- Keywords
- web based learning, moderate sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paper based trainingBehavioural
read selected material, test skills learned in simulator lab
web based trainingBehavioural
read and view selected web based material, test skills learned in simulator lab
| Study group | Role | What they receive |
|---|---|---|
| 2 | web based learning group Receives: Behavioral: web based training | |
| 1 | paper based learning group Receives: Behavioral: paper based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine which group - web based or paper based is more effective
Measured: at the end of simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startApr 2007
- Primary completion1 Aug 2012
- Study completion1 Aug 2012
Why it stopped: Vastly under enrolled due to delays in software development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Sedation TrainingStudies of the same condition, open and under way.
- 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
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Agutter, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708760
- Sponsor's protocol ID
- 23011
- Other IDs
- University of Utah VIP grant
- Status last verified
- Mar 2012
- First submitted
- 30 Jun 2008
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Sedation Education Software
- ClinicalTrials.gov ID
- NCT00708760
- Acronym / sponsor ID
- 23011
- Conditions
- Moderate Sedation Training
- Keywords
- web based learning, moderate sedation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Vastly under enrolled due to delays in software development
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Aug 2012 (actual)
- First posted
- 2 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.
We propose to develop and evaluate an interactive education software for administering moderate sedation by non-anesthesiologists.
Detailed description
The course will be founded upon JCAHO's and ASA's guidelines for sedation, emphasizing the concepts with animations, audio, scenarios, and quizzes. Interactive feedback will be incorporated to guide the clinician during the course. The course will be offered commercially over the World Wide Web, with successful completion providing continuing medical education (CME) credit. It will fulfill JCAHO recommended guidelines. In a controlled simulated environment, the hypothesis that the web based training protocol will provide the practitioner the knowledge base necessary to manage the four scenarios as well or better than practitioners completing the standard moderate sedation certification course will be tested.
- Evaluate the effectiveness of the course. The University of Utah Center for Patient Simulation is an ideal environment to evaluate the efficacy of a web-based training course. The new web-based course will be compared to standard course material and lessons. We will recruit 40 nurses who administer moderate sedation at the University of Utah Health Sciences Center. Half of the nurses will receive traditional training (typical course and guidelines published from the literature), and half will receive the web-based course. Users will be tested on their knowledge of moderate sedation with four moderate sedation scenarios, in which the simulated patient experiences over-sedation, apnea, and excessive pain.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Behavioral: web based trainingweb based learning group |
| 1 | – | Behavioral: paper based trainingpaper based learning group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- nurses providing moderate sedation
Key inclusion criteria (3 listed)
- general nursing staff at the University of Utah
- currently required to obtain moderate sedation training
- an equal basis all clinicians in the respective departments
Key exclusion criteria (1 listed)
- nurses and other personnel who do not administer moderate sedation
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 |
|---|---|---|
| paper based trainingread selected material, test skills learned in simulator lab | Behavioural | 1 |
| web based trainingread and view selected web based material, test skills learned in simulator lab | Behavioural | 2 |
Primary outcome
to determine which group - web based or paper based is more effective
Time frame: at the end of simulation
Results and safety
The study was stopped early (reason given: Vastly under enrolled due to delays in software development). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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.
James Agutter 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 Moderate Sedation Training, 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 3 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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 was stopped early (reason given: Vastly under enrolled due to delays in software development). Results are not available in the source record.
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?
to determine which group - web based or paper based is more effective (time frame: at the end of simulation). 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 18 Apr 2023.