Training Primary Care Physicians to Perform Melanoma Opportunistic Surveillance

NCT ID: NCT02385253

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-15
• Study Completion Date: 2017-07-23

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.

Detailed Description

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:

1. Knowledge Acquisition The Knowledge Acquisition phase will be delivered via personal computer/tablet. It will take about one hour to complete. The one-hour course consists of case histories and videos in which the following are presented: 1) threshold rules of visual inspection, 2) benefit of magnification with dermoscopy to assist with diagnosis, and 3) demonstration of the 3-point checklist of dermoscopy.

2. Skills Assessment The Skills Assessment phase will be delivered via smartphone. The program may be intermittently accessed taking up to two weeks to complete. The PCP will be asked to review and make simulated management decisions on 20 case vignettes with clinical images of body surfaces and dermoscopy of individual lesions. Clinical practice will be simulated with the requirement that you make a decision to refer to dermatology or a decision that a referral is not needed. If a biopsy is performed in the case vignette, the pathology report will be provided, and the PCP will be asked the next step in the patient's care. Performance feedback will be provided.

3. Deliberate Practice The Deliberate Practice phase will be delivered via smartphone. It will take between 1-8 weeks to complete. The PCP will be asked to review additional cases with visual inspection and dermoscopy to improve aspects of your performance that have demonstrated weakness. Individual strengths and weaknesses will be assessed, and personalized feedback will be provided. After achieving competency with the simulated cases, the research staff will provide the PCP with a DermScope device (a smartphone fitted with a dermoscope) to use in the next phase.

4. Clinical Proficiency The Clinical Proficiency phase will take place in the clinical practice of the PCP over the course of 1-8 weeks. The PCP will be asked to use the DermScope to capture and transmit at least 12 lesions. Informed consent will be obtained from each patient prior to obtaining the non-identifying images. During image capture, each photograph is marked by the DermScope program with the date, time, and the clinical assessment form (CAF). The image will be transmitted to the teleconsultant (PI), who will assign a unique identification number to the image and the data. The PI will render an opinion within 72 hours regarding the need to refer the patient to dermatology or reassure the patient. The PCP will be asked to make a decision regarding the management of the patient and communicate this decision as needed to the patient.

Conditions

Melanoma; Nevi; Skin Moles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Educational training program

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.

Group Type: ACTIVE_COMPARATOR

Educational training program

Intervention Type: BEHAVIORAL

The educational training program (intervention) consists of four sequential phases:

1. Knowledge Acquisition

2. Skills Assessment

3. Deliberate Practice

4. Clinical Proficiency

Control

PCPs randomized to the control group will have the option of receiving the educational training program at the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational training program

The educational training program (intervention) consists of four sequential phases:

1. Knowledge Acquisition

2. Skills Assessment

3. Deliberate Practice

4. Clinical Proficiency

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• is 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

Exclusion Criteria

• is NOT a practicing PCP in the section of General Internal Medicine of Northwestern Medicine

• is NOT a patient of a PCP enrolled in the study
• under 18 years of age
• unable to read at a 6th grade level

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

June Robinson

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

June K Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Medicine: Division of General Internal Medicine and Geriatrics

Chicago, Illinois, United States

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29404948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29637481 (View on PubMed)

Other Identifiers

STU00082564

Identifier Type: -

Identifier Source: org_study_id