NCT02385253|CompletedDMC
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Sponsor study identifier
interventional
89
1 country
2
Study Start
September 15, 2015
Actual (reported)Primary Completion
July 23, 2017
Actual (reported)Study Completion
July 23, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 23, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 25, 2015
Actual (reported)March 11, 2015
Actual (reported)September 15, 2015
Actual (reported)July 23, 2017
Actual (reported)July 23, 2017
Actual (reported)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
Change in number of pigmented lesions referrals from three months prior and three months post randomization (Difference-in-Difference estimator)
Three months prior randomization, Three months post intervention
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.
PCPs randomized to the control group will have the option of receiving the educational training program at the end of the study.
The educational training program (intervention) consists of four sequential phases: 1. Knowledge Acquisition 2. Skills Assessment 3. Deliberate Practice 4. Clinical Proficiency
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Northwestern Medicine: Division of General Internal Medicine and Geriatrics
Chicago, Illinois, 60611, United States
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611, United States
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.
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.
June K Robinson, MD
Northwestern University
89 participants (actual enrollment reported by the registry).
First Submitted
February 25, 2015
First Posted
March 11, 2015
Study Start
September 15, 2015
Actual (reported)Teaching Skin Self-Examination to First-degree Relatives of Melanoma Patients Using Mobile App Technology
Contact the study team to confirm eligibility.
Primary Completion
July 23, 2017
Actual (reported)Study Completion
July 23, 2017
Actual (reported)Last Updated
June 7, 2018
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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