GP Response to Decontextualised Risk

Sponsor
University of Exeter (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05399511
Collaborator
(none)
20
12

Study Details

Study Description

Brief Summary

Decontextualised risk information is any information pertaining to diagnosis, which is introduced into a clinical consultation, or a diagnostic thought process, without being requested by the clinician. It can be risk scores, computerised warnings, or lab tests or diagnostic imaging requests ordered by other clinicians. It is a concept which (to our knowledge) has not been studied.

Clinical vignettes have been developed to simulate scenarios where decontextualised risk is introduced into a consultation. These will be presented to primary care clinicians via video, who will then undergo a structured interview to explore how their perception, processing and communication of risk is challenged and changed by decontextualised risk. The findings will be analysed used qualitative methods (Thematic Analysis).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The standard model of a medical consultation involves a patient describing their symptoms to a clinician who then performs a physical examination. At this point a decision is made with the patient whether further information regarding diagnosis is needed: this is often further tests, but can be "risk scores", where various metrics including observations, age etc combine to produce an output which helps clarify the diagnosis in question. This moment, when a clinician decides if further tests or scores (or "risk" information) should be done is significant. In several studies, the eventual discovery of severe disease (such as cancer) has been found to be associated to a greater degree with the decision to do a test, then the actual outcome of the test itself.

    If a clinician has not requested this new risk information, this could present a challenge to that professional's clinical thinking. I have called it "decontextualised risk information": risk information that is presented out of sync with when a clinician would normally gather such information, and out of the context of the normal diagnostic thought processes. Examples include the processing of tests a clinician has not ordered, the routine use of scores such as the NEWS2, and computer triggered electronic risk scores.

    In primary care the chance of a serious disease being present is less than in A&E or specialist settings. All tests are wrong some of the time and can produce false negative results (when the test is negative but the disease is there) and false positive results (when a test is positive, but the disease is not present). This second situation becomes more prevalent the rarer a condition is to begin with. It means that, in primary care, the decision not to perform a test or diagnostic score is both more common, and more likely to be a reasonable decision.

    This study will examine how "decontextualised risk information" affects clinicians' consideration of diagnostic risk and uncertainty. Clinical vignettes have been developed to simulate scenarios where decontextualised risk is introduced into a consultation. These will be presented to primary care clinicians via video, who will then undergo a structured interview to explore how their perception, processing and communication of risk is challenged and changed by decontextualised risk. The findings will be analysed used qualitative methods (Thematic Analysis).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    How Does Decontextualized Risk Information Affect Clinicians Understanding of Diagnostic Risk and Uncertainty in Primary Care Diagnosis? A Qualitative Study of Clinical Vignettes
    Anticipated Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Practising GPs

    GPs working in primary care setting.

    Outcome Measures

    Primary Outcome Measures

    1. Qualitative data [At time of interview]

      Qualitative information from "think aloud" and semi-structured interview

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • GPs working in primary care in the UK are eligible
    Exclusion Criteria:
    • No current direct patient contact in a primary care setting

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Exeter

    Investigators

    • Principal Investigator: Alex Burns, MBBS, University of Exeter

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Exeter
    ClinicalTrials.gov Identifier:
    NCT05399511
    Other Study ID Numbers:
    • 2021-22-25
    First Posted:
    Jun 1, 2022
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Exeter
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2022