NCT05399511

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

May 26, 2022

Last Update Submit

April 23, 2025

Conditions

Keywords

Uncertainty, Clinical Thinking, Diagnosis, Risk

Outcome Measures

Primary Outcomes (1)

  • Qualitative data

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

    At time of interview

Study Arms (1)

Practising GPs

GPs working in primary care setting.

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Given the possibility that there may be variable responses from clinicians from different backgrounds, experience and type of practice, the sampling will be purposeful. It will aim to include the following "profile" mix: Gender Early career and late career clinicians Small and large practice size Part time and full time Self-described high and low risk tolerant GPs

You may qualify if:

  • GPs working in primary care in the UK are eligible

You may not qualify if:

  • No current direct patient contact in a primary care setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine and Health, University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alex Burns, MBBS

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

July 1, 2024

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations