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Training Primary Care Physicians to Perform Melanoma Opportunistic Surveillance

5 giugno 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

89

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Selezione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Nessun intervento: Control
PCPs randomized to the control group will have the option of receiving the educational training program at the end of the study.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline performance at 5 months (difference-in-difference)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in number of pigmented lesions referrals from three months prior and three months post randomization (Difference-in-Difference estimator)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 settembre 2015

Completamento primario (Effettivo)

23 luglio 2017

Completamento dello studio (Effettivo)

23 luglio 2017

Date di iscrizione allo studio

Primo inviato

25 febbraio 2015

Primo inviato che soddisfa i criteri di controllo qualità

5 marzo 2015

Primo Inserito (Stima)

11 marzo 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2018

Ultimo verificato

1 settembre 2017

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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