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Training Primary Care Physicians to Perform Melanoma Opportunistic Surveillance

5. Juni 2018 aktualisiert von: June Robinson, Northwestern University
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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

89

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Northwestern University Feinberg School of Medicine Department of Dermatology
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Northwestern Medicine: Division of General Internal Medicine and Geriatrics

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria for PCPs:

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

Exclusion Criteria for PCPs:

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

Inclusion Criteria for Patients providing lesions to be photographed:

  • 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 for Patients providing lesions to be photographed:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.

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

  1. Knowledge Acquisition
  2. Skills Assessment
  3. Deliberate Practice
  4. Clinical Proficiency
Kein Eingriff: Control
PCPs randomized to the control group will have the option of receiving the educational training program at the end of the study.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline performance at 5 months (difference-in-difference)
Zeitfenster: Baseline and 5 months

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in number of pigmented lesions referrals from three months prior and three months post randomization (Difference-in-Difference estimator)
Zeitfenster: Three months prior randomization, Three months post intervention
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.
Three months prior randomization, Three months post intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. September 2015

Primärer Abschluss (Tatsächlich)

23. Juli 2017

Studienabschluss (Tatsächlich)

23. Juli 2017

Studienanmeldedaten

Zuerst eingereicht

25. Februar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. März 2015

Zuerst gepostet (Schätzen)

11. März 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juni 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juni 2018

Zuletzt verifiziert

1. September 2017

Mehr Informationen

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