SurgeryWISENCT01322230
Trial of Educational Outcomes of WISE-MD
A study testing WISEMD Original, Social Networking and Social Networking plus Emotional Design in people with Surgery, run by NYU Langone Health at 7 sites in United States.
Trial summary
The purpose of this study is to compare the educational efficacy of instructional design enhancements in on-line learning modules in the context of clinical medical education. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- WISEMD Original, Social Networking and Social Networking plus Emotional Design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,363 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2008to Sep 2011
- 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
- All third-year medical students at all of the 7 collaborating schools (N= 2308) rotating through the surgery clerkship from July 2009 and September 2011.
Who cannot join
- Students who do not consent to participate and who decide to withdraw from participation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Medical College of Georgia
Augusta, Georgia, 30912
SUNY Downstate Medical Center
Brooklyn, New York, 11203
University of Vermont
Burlington, Vermont, 05405
New York University School of Medicine
New York, New York, 10016
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Jefferson Medical College
Philadelphia, Pennsylvania, 19107
New York Medical College
Valhalla, New York, 10595
About this study
Official title: Randomized Trial of Educational Outcomes of WISE-MD
The purpose of this study is to compare the educational efficacy of instructional design enhancements in on-line learning modules in the context of clinical medical education.
Read the detailed description
This study involved medical students from seven US medical schools participating in a trial of two WISE-MD computer-based learning modules. Students were randomized to 1 of 4 study arms. The 4 content-equivalent conditions were: screen shots with voiceover and no interactivity; learner control of pacing through multi-media content; social networking features; and social networking features plus user interface enhancements.
- Conditions
- Surgery
- Being tested
- Control, WISEMD Original, Social Networking, Social Networking plus Emotional Design
- Keywords
- Instructional Design, Online learning module, Surgical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Multimedia Control
Multimedia Control
WISEMD OriginalOther
Current WISEMD
Social NetworkingOther
Social networking feature
Social Networking plus Emotional DesignOther
social networking features plus user interface enhancements
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Screen shots with voiceover and no interactivity Receives: Other: Control |
| WISEMD Original | Experimental | Learner control of pacing through multi-media content Receives: Other: WISEMD Original |
| Social Networking | Experimental | social networking features (Forum and Social Presence) Receives: Other: Social Networking |
| Social Networking plus Emotional Design | Experimental | Social networking features plus user interface enhancements Receives: Other: Social Networking plus Emotional Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Post Knowledge Test
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
Measured: Week 2
Mid-clerkship Knowledge Test
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
Measured: Week 4
Mid-clerkship Clinical Reasoning Test
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
Measured: Week 4
End-clerkship Clinical Reasoning Test
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
Measured: Week 8
Secondary outcomes (1)
Students Baseline Characteristics
The baseline characteristics measure include measures of self-regulation, surgery specific self-efficacy, surgery specific task values, and goal orientation.
Measured: Immediately after consenting to participate - Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionSep 2011
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 SurgeryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,363 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University, University of Nebraska, University of Vermont, New York Medical College, State University of New York - Downstate Medical Center, Jefferson Medical College of Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Adina Kalet, M.D., M.P.H., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322230
- Sponsor's protocol ID
- 1LM009538-R01
- Acronym
- WISE
- Status last verified
- Nov 2016
- First submitted
- 21 Mar 2011
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kalet AL, Coady SH, Hopkins MA, Hochberg MS, Riles TS. Preliminary evaluation of the Web Initiative for Surgical Education (WISE-MD). Am J Surg. 2007 Jul;194(1):89-93. doi: 10.1016/j.amjsurg.2006.12.035.
PubMed 17560916
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Educational Outcomes of WISE-MD
- ClinicalTrials.gov ID
- NCT01322230
- Acronym / sponsor ID
- WISE / 1LM009538-R01
- Conditions
- Surgery
- Keywords
- Instructional Design, Online learning module, Surgical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,363 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Augusta University, University of Nebraska, University of Vermont, New York Medical College, State University of New York - Downstate Medical Center, Jefferson Medical College of Thomas Jefferson University
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Mar 2011 (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 purpose of this study is to compare the educational efficacy of instructional design enhancements in on-line learning modules in the context of clinical medical education.
Detailed description
This study involved medical students from seven US medical schools participating in a trial of two WISE-MD computer-based learning modules. Students were randomized to 1 of 4 study arms. The 4 content-equivalent conditions were: screen shots with voiceover and no interactivity; learner control of pacing through multi-media content; social networking features; and social networking features plus user interface enhancements.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlScreen shots with voiceover and no interactivity |
| WISEMD Original | Experimental | Other: WISEMD OriginalLearner control of pacing through multi-media content |
| Social Networking | Experimental | Other: Social Networkingsocial networking features (Forum and Social Presence) |
| Social Networking plus Emotional Design | Experimental | Other: Social Networking plus Emotional DesignSocial networking features plus user interface enhancements |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All third-year medical students at all of the 7 collaborating schools (N= 2308) rotating through the surgery clerkship from July 2009 and September 2011.
Key exclusion criteria (1 listed)
- Students who do not consent to participate and who decide to withdraw from participation.
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 |
|---|---|---|
| ControlAlso: Multimedia ControlMultimedia Control | Other | Control |
| WISEMD OriginalCurrent WISEMD | Other | WISEMD Original |
| Social NetworkingSocial networking feature | Other | Social Networking |
| Social Networking plus Emotional Designsocial networking features plus user interface enhancements | Other | Social Networking plus Emotional Design |
Primary outcome
Immediate Post Knowledge Test
Time frame: Week 2
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
Mid-clerkship Knowledge Test
Time frame: Week 4
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
Mid-clerkship Clinical Reasoning Test
Time frame: Week 4
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
End-clerkship Clinical Reasoning Test
Time frame: Week 8
An 8 week-long Surgery Clerkship (Jefferson University is 12 weeks) occurs 6 times (JU 4 times) per year. Students enroll on day 1, complete the baseline surveys in week 1, access the intervention modules by week 2. Learning outcomes (knowledge test) are measured immediately after the modules, at week 4 they complete online multiple-choice tests and a clinical reasoning measure, week 8, week 12 at JU, students complete a clinical reasoning measure.
1 secondary outcome
Students Baseline Characteristics
Time frame: Immediately after consenting to participate - Day 1
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 Nov 2016.
- Background: PubMed 17560916Kalet AL, Coady SH, Hopkins MA, Hochberg MS, Riles TS. Preliminary evaluation of the Web Initiative for Surgical Education (WISE-MD). Am J Surg. 2007 Jul;194(1):89-93. doi: 10.1016/j.amjsurg.2006.12.035.
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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.
Adina Kalet, M.D., M.P.H. principal investigator
NYU Langone Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WISEMD Original, Social Networking and Social Networking plus Emotional Design in people with Surgery, run by NYU Langone Health at 7 sites 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 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Immediate Post Knowledge Test (time frame: Week 2). The study lists 4 primary outcomes in all. 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 NCT01322230, 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 11 Nov 2016.