Skin Simulation ModelNCT01191294
Evaluation of a Simulation Training Tool to Identify Lesions Requiring Further Screening for Melanoma
A study testing Simulation teaching session in people with Skin Simulation Model and Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy, run by Northwestern University at 1 site in United States.
Trial summary
The investigators will design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Skin Simulation Model, Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy
- What is being tested?
- Simulation teaching session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical student in his primary care clerkship at Northwestern University
Who cannot join
- Not a medical student in his primary care clerkship at Northwestern University
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Simulation Training Module to Identify Lesions Requiring Further Visual Screen or Skin Biopsy for Melanoma
The investigators will design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents. This requires having a skin simulation model that presents a range of lesions from benign nevus to atypical nevus to melanoma in a distribution and density that mimics the clinical findings of those with 2 skin tones: fair-skin non- Hispanic white and Hispanic.
- Conditions
- Skin Simulation Model, Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy
- Being tested
- Simulation teaching session
- Keywords
- Melanoma, Simulation Training, Medical Students
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation teaching sessionOther
Simulation-based, mastery learning educational intervention in visual screening for melanoma
| Study group | Role | What they receive |
|---|---|---|
| Medical Students | Experimental | 3rd year medical students during their primary care clerkship Receives: Other: Simulation teaching session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulation curriculum for screening for melanoma
To design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents
Measured: 1 year
Secondary outcomes (1)
Change in melanoma detection skills
To measure changes in medical student and resident skills before and after the intervention, and determine if students achieve the zero error rate in recognizing the melanomas, namely no false negatives.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 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 Skin Simulation ModelStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June Robinson, MD, Principal investigator, Northwestern UniversityDennis P West, PhD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191294
- Sponsor's protocol ID
- JKR-011510
- Status last verified
- Sep 2014
- First submitted
- 27 Aug 2010
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jain N, Anderson MJ, Patel P, Blatt H, Davis L, Bierman J, McGaghie W, Brucker JB, Martini M, Robinson JK. Melanoma simulation model: promoting opportunistic screening and patient counseling. JAMA Dermatol. 2013 Jun;149(6):710-6. doi: 10.1001/jamadermatol.2013.2882.
PubMed 23552462
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Simulation Training Module to Identify Lesions Requiring Further Visual Screen or Skin Biopsy for Melanoma
- ClinicalTrials.gov ID
- NCT01191294
- Acronym / sponsor ID
- JKR-011510
- Conditions
- Skin Simulation Model, Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy
- Keywords
- Melanoma, Simulation Training, Medical Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Aug 2010 (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 a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents. This requires having a skin simulation model that presents a range of lesions from benign nevus to atypical nevus to melanoma in a distribution and density that mimics the clinical findings of those with 2 skin tones: fair-skin non- Hispanic white and Hispanic.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Students | Experimental | Other: Simulation teaching session3rd year medical students during their primary care clerkship |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student in his primary care clerkship at Northwestern University
Key exclusion criteria (1 listed)
- Not a medical student in his primary care clerkship at Northwestern University
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 |
|---|---|---|
| Simulation teaching sessionSimulation-based, mastery learning educational intervention in visual screening for melanoma | Other | Medical Students |
Primary outcome
Simulation curriculum for screening for melanoma
Time frame: 1 year
To design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents
1 secondary outcome
Change in melanoma detection skills
Time frame: 1 hour
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 25 Sep 2014.
- Derived from this study: PubMed 23552462Jain N, Anderson MJ, Patel P, Blatt H, Davis L, Bierman J, McGaghie W, Brucker JB, Martini M, Robinson JK. Melanoma simulation model: promoting opportunistic screening and patient counseling. JAMA Dermatol. 2013 Jun;149(6):710-6. doi: 10.1001/jamadermatol.2013.2882.
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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.
June Robinson, MD principal investigator
Northwestern University
Dennis P West, PhD study director
Northwestern 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 Simulation teaching session in people with Skin Simulation Model and Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy, run by Northwestern 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 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 25 Sep 2014. 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?
Simulation curriculum for screening for melanoma (time frame: 1 year). 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 NCT01191294, 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 25 Sep 2014.