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This is a four-phase educational intervention for primary care practitioners (PCPs) to perform opportunistic melanoma surveillance. Based on prior research, the investigator will develop an interactive melanoma early detection skills training program for PCPs according to the principals of mastery learning. The proposed educational intervention will improve practicing PCPs' knowledge, competence, confidence, and diagnostic performance regarding pigmented lesions and attitude concerning importance of skin surveillance. In addition, this research aims to examine the clinical proficiency of PCPs regarding pigmented lesions. The proposed educational intervention will reduce the percentage of benign lesions referred to dermatology.
Cutaneous melanoma is considered a potentially curable disease if detected early. Primary care physicians (PCPs) are well positioned to detect early melanomas by performing opportunistic melanoma surveillance on the at-risk population during physical examination. Opportunistic surveillance means physician performance of visual inspection of skin exposed during your physical examination focused on the presenting condition. Opportunistic surveillance requires skills in both visual inspection of the skin and with magnification of the skin by a hand-held device, a dermoscope. (This research aims to 1) develop an easily disseminated, interactive melanoma early detection skills training program for PCPs and to 2) to examine the clinical proficiency of PCPs regarding pigmented lesions.
The knowledge to be gained by PCPs is essential to the development and successful introduction of a method for physicians to learn how to perform opportunistic surveillance for melanoma. By evaluating means of encouraging and facilitating opportunistic surveillance for melanoma, an educational program may eventually be brought into widespread use in training PCPs.
In addition to a Pre-training Test and Post-training Test, each of the phases of the educational training program is described below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational training program | Active Comparator | PCPs randomized to the intervention group will receive the educational training program at the beginning of the study, extending over a maximum of five months. |
|
| Control | No Intervention | PCPs randomized to the control group will have the option of receiving the educational training program at the end of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational training program | Behavioral | The educational training program (intervention) consists of four sequential phases:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline performance at 5 months (difference-in-difference) | The difference-in-difference (DID) approach will be used to test the hypothesis that the educational intervention improved knowledge, attitude concerning importance of skin exam, competence, confidence, and diagnostic performance. The difference-in-difference estimator compares outcomes between pre-tests and post-tests between PCPs who received the educational intervention and those who did not. Each PCP will be the unit of observation. We will choose an appropriate functional form for each outcome.For each outcome, a DID estimator that is significant at p < 0.05 will support the hypothesis that the educational intervention improved outcomes. This analysis will be repeated for each of the five outcomes. We will use the Bonferroni correction for multiple comparisons. | Baseline and 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of pigmented lesions referrals from three months prior and three months post randomization (Difference-in-Difference estimator) | The difference-in-difference (DID) approach will be used to test the hypothesis that the intervention reduced referrals of benign lesions. The model will be estimated using a random effects logistic regression to account for clustering due to repeated measures for each PCP (about 8 referrals before randomization and another 8 after the intervention). A 95% confidence interval for the odds ratio of α3 that falls below one will support the hypothesis. |
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Inclusion Criteria for PCPs:
Exclusion Criteria for PCPs:
Inclusion Criteria for Patients providing lesions to be photographed:
Exclusion Criteria for Patients providing lesions to be photographed:
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| Name | Affiliation | Role |
|---|---|---|
| June K Robinson, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine: Division of General Internal Medicine and Geriatrics | Chicago | Illinois | 60611 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29404948 | Background | Robinson JK, Jain N, Marghoob AA, McGaghie W, MacLean M, Gerami P, Hultgren B, Turrisi R, Mallett K, Martin GJ. A Randomized Trial on the Efficacy of Mastery Learning for Primary Care Provider Melanoma Opportunistic Screening Skills and Practice. J Gen Intern Med. 2018 Jun;33(6):855-862. doi: 10.1007/s11606-018-4311-3. Epub 2018 Feb 5. | |
| 29637481 |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009506 | Nevus |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Three months prior randomization, Three months post intervention |
| Northwestern University Feinberg School of Medicine Department of Dermatology |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Robinson JK, MacLean M, Reavy R, Turrisi R, Mallett K, Martin GJ. Dermoscopy of Concerning Pigmented Lesions and Primary Care Providers' Referrals at Intervals After Randomized Trial of Mastery Learning. J Gen Intern Med. 2018 Jun;33(6):799-800. doi: 10.1007/s11606-018-4419-5. No abstract available. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |