AnesthesiaNCT03008863
Educating Anesthesia Residents to Improve Perioperative Care for the Elderly
A study testing Education in people with Anesthesia, run by Duke University at 1 site in United States.
Trial summary
1. The investigators will design, test and implement a education curriculum for anesthesia residents teaching geriatric anesthesiology. 2. The investigators will randomize 42 anesthesia residents so that half receive an innovative, e-learning curriculum while the other half receives the current standard curriculum. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 30 Jun 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Duke Anesthesiology Resident
- Willing to comply with study activities and guidelines
Who cannot join
- Unable to comply with study activities and guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina
About this study
- The investigators will design, test and implement a education curriculum for anesthesia residents teaching geriatric anesthesiology.
- The investigators will randomize 42 anesthesia residents so that half receive an innovative, e-learning curriculum while the other half receives the current standard curriculum. We will assess their medical knowledge, and the amount of anesthesia delivered to patients after the curriculum is implemented.
- The investigators will analyze any changes in clinical practice of residents in the care of elderly patients. Enrollment will be voluntary for all residents. Also, the investigators will not interfere with clinical management of any patients by residents which are done under direct supervision of faculty.
- Conditions
- Anesthesia
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Education Intervention | Experimental | The investigators will use an electronic learning (E-learning) curriculum with an educational video and a user-centered checklist for anesthesia residents. This E-learning curriculum will cover how to care for geriatric patients in the preoperative, intraoperative and postoperative settings, and specific interventions that have been shown to improve postoperative outcomes in older patients.
The checklist will be user-centered. It will remind providers of what they learned in the video and online curriculum, and how to apply these lessons in real-time while they are caring for older patients. Receives: Other: Education |
| Control | No intervention | Residents randomized to this group will receive the current, standard education provided for all Duke Anesthesiology residents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
average minimum alveolar concentration (MAC) fraction in patients over age 65 given general anesthesia by residents
Measured: 6 months
Secondary outcomes (4)
change in residents' geriatric anesthesia knowledge base to be measured using a pre- and post-test
Measured: 6 months
mean bispectral index value in patients over age 65 given monitored sedation by residents
Measured: 6 months
frequency of use of medications known to increase delirium risk given to patients over age 65 by residents
Measured: 6 months
mean doses of medications known to increase delirium risk given to patients over age 65 by residents
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miles Berger, MD, Phd, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008863
- Sponsor's protocol ID
- Pro00069462
- Status last verified
- Dec 2018
- First submitted
- 28 Dec 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
Publications
Berger M, Eleswarpu SS, Cooter Wright M, Ray AM, Wingfield SA, Heflin MT, Bengali S, Udani AD. Developing a Real-Time Electroencephalogram-Guided Anesthesia-Management Curriculum for Educating Residents: A Single-Center Randomized Controlled Trial. Anesth Analg. 2022 Jan 1;134(1):159-170. doi: 10.1213/ANE.0000000000005677.
PubMed 34709008
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Anesthesia Residents to Improve Perioperative Care for the Elderly
- ClinicalTrials.gov ID
- NCT03008863
- Acronym / sponsor ID
- Pro00069462
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 4 Jan 2017 (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.
- The investigators will design, test and implement a education curriculum for anesthesia residents teaching geriatric anesthesiology.
- The investigators will randomize 42 anesthesia residents so that half receive an innovative, e-learning curriculum while the other half receives the current standard curriculum. We will assess their medical knowledge, and the amount of anesthesia delivered to patients after the curriculum is implemented.
- The investigators will analyze any changes in clinical practice of residents in the care of elderly patients. Enrollment will be voluntary for all residents. Also, the investigators will not interfere with clinical management of any patients by residents which are done under direct supervision of faculty.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Intervention | Experimental | Other: EducationThe investigators will use an electronic learning (E-learning) curriculum with an educational video and a user-centered checklist for anesthesia residents. This E-learning curriculum will cover how to care for geriatric patients in the preoperative, intraoperative and postoperative settings, and specific interventions that have been shown to improve postoperative outcomes in older patients. The checklist will be user-centered. It will remind providers of what they learned in the video and online curriculum, and how to apply these lessons in real-time while they are caring for older patients. |
| Control | No intervention | –Residents randomized to this group will receive the current, standard education provided for all Duke Anesthesiology residents. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Duke Anesthesiology Resident
- Willing to comply with study activities and guidelines
Key exclusion criteria (1 listed)
- Unable to comply with study activities and guidelines
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 |
|---|---|---|
| Education | Other | Education Intervention |
Primary outcome
average minimum alveolar concentration (MAC) fraction in patients over age 65 given general anesthesia by residents
Time frame: 6 months
4 secondary outcomes
change in residents' geriatric anesthesia knowledge base to be measured using a pre- and post-test
Time frame: 6 months
mean bispectral index value in patients over age 65 given monitored sedation by residents
Time frame: 6 months
frequency of use of medications known to increase delirium risk given to patients over age 65 by residents
Time frame: 6 months
mean doses of medications known to increase delirium risk given to patients over age 65 by residents
Time frame: 6 months
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 24 Dec 2018.
- Derived from this study: PubMed 34709008Berger M, Eleswarpu SS, Cooter Wright M, Ray AM, Wingfield SA, Heflin MT, Bengali S, Udani AD. Developing a Real-Time Electroencephalogram-Guided Anesthesia-Management Curriculum for Educating Residents: A Single-Center Randomized Controlled Trial. Anesth Analg. 2022 Jan 1;134(1):159-170. doi: 10.1213/ANE.0000000000005677.
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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.
Miles Berger, MD, Phd principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Anesthesia, run by Duke University 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 2 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 24 Dec 2018. 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?
average minimum alveolar concentration (MAC) fraction in patients over age 65 given general anesthesia by residents (time frame: 6 months). 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 NCT03008863, which also lists 1 linked publication.
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 24 Dec 2018.