Training Primary Care Physicians to Perform Melanoma Opportunistic Surveillance

NCT02385253 | Completed DMC

• 1 other identifier: STU00082564
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Melanoma; Nevi; Skin Moles

Keywords

Training; Primary Health Care; Skin Cancer; Primary Care Physicians; Surveillance; Education

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: Educational training program

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.

Interventions

Educational training program BEHAVIORAL

The educational training program (intervention) consists of four sequential phases: 1. Knowledge Acquisition 2. Skills Assessment 3. Deliberate Practice 4. Clinical Proficiency

Educational training program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is a practicing PCP in the section of General Internal Medicine of Northwestern Medicine

You may not qualify if:

• is NOT a practicing PCP in the section of General Internal Medicine of Northwestern Medicine
• is a patient of a PCP enrolled in the study
• is at least 18 years old
• able to read at a 6th grade level or higher
• is NOT a patient of a PCP enrolled in the study
• under 18 years of age
• unable to read at a 6th grade level

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern Medicine: Division of General Internal Medicine and Geriatrics

Chicago, Illinois, 60611, United States

Location

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• 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.

  PMID: 29404948 BACKGROUND

• 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.

  PMID: 29637481 BACKGROUND

MeSH Terms

Conditions

Melanoma; Nevus; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• June K Robinson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 11, 2015
• Study Start: September 15, 2015
• Primary Completion: July 23, 2017
• Study Completion: July 23, 2017
• Last Updated: June 7, 2018

Record last verified: 2017-09

Locations

US (2)