Gut FeelingsEGFGPNCT05175157
Assessment of "Gut Feelings" Accuracy Regarding the Effect of Professional Experience in General Practitioners in Clinical Decision Making
An observational study of Gut Feelings, run by University Hospital, Brest at 1 site in France.
Trial summary
Knowledge, experience and professional development limit the risk of diagnostic error for the clinician in daily practice. However, research has shown that other non-analytical factors are involved in clinical decision making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gut Feelings
- What is being tested?
- Gut Fellings questionnaire
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2022to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * General practitioners established for more than 3 years * Interns in the first year of the third cycle of the diploma of specialized studies in general medicine of the Universities of Brest and Rouen
Who may be able to join
- GP population: General practitioners established for more than 3 years
- Intern population: Interns in general medicine in the first year of the third cycle of the diploma of specialized studies in general medicine
Who cannot join
- For the 2 populations: Refusal to participate
- Intern population: Interns in the second and third year of the diploma of specialized studies in general medicine
Trial locations and contacts
1 site in 1 country.
About this study
Knowledge, experience and professional development limit the risk of diagnostic error for the clinician in daily practice. However, research has shown that other non-analytical factors are involved in clinical decision making. Intuition (or "gut feelings") is a subjective element involved in medical decision-making, and its place and relevance are being explored. The concept of "gut feelings" comes from General Practitioners (GPs) themselves and their description of their own practice. Several studies have shown its place in medical decision-making models, particularly in the face of diagnostic uncertainty.
A questionnaire used as a standardized measurement tool for gut feelings was created to address this issue. The Gut Feelings Questionnaire (GFQ) has been translated into French, German and Polish during a standardized linguistic validation procedure. It is currently validated and available in five languages. The QGF has been tested and validated in clinical practice by Belgian, French and Dutch physicians. Its feasibility has been evaluated in these three health systems.
The Gut Feelings Questionnaire was used in a prospective study to determine the accuracy of the sense of alarm in patients consulting their GP for chest pain and/or dyspnea. But the role of the practitioner's experience has not been studied: is the gut feeling more accurate in experienced GPs than in first semester interns in general practice?
- Conditions
- Gut Feelings
- Being tested
- Gut Fellings questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut Fellings questionnaireOther
Answer the Gut Fellings questionnaire
| Study group | Role | What they receive |
|---|---|---|
| General practitioner | Answer the Gut Fellings questionnaire Receives: Other: Gut Fellings questionnaire | |
| Internal | Answer the Gut Fellings questionnaire Receives: Other: Gut Fellings questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error assessment
Gut Feelings Questionnaire response score comparaison for each of 12 clinical vignettes. Gut Feelings Questionnaire is a 10-item questionnaire based on the definitions of the sense of alarm and the sense of reassurance. The purpose of the Gut Feelings Questionnaire is to determine the presence or absence of gut feelings in the diagnostic reasoning. These gut feelings are defined as a 'sense of alarm' and a 'sense of reassurance'. A 'sense of alarm' implies that a GP worries about a patient's health status, even though he/she has found no specific indications yet; it is a sense that 'there's something wrong here'. A 'sense of reassurance' means that a GP feels secure about the further management and course of a patient's problem, even though he/she may not be certain about the diagnosis: everything fits in.
Measured: Day 1
Secondary outcomes (3)
Types of professional activity of installed GPs
To study the relationship between professional variables and GFQ response score errors in the GP population. Professional variables are be : University training supervisor (yes/no); type of activity (group of physicians, alone, multiprofessional group); place of practice (town of <2000 inhabitants, between 2000 and 5000, over 5000); number of years of practice in general medicine.
Measured: Day 1
Type of care
Care proposed at the end of each clinical vignette (answers to question n°11 of the questionnaire)
Measured: Day 1
Practitioner's orientation
Items highlighted by each participant within the clinical vignette that contributed to the practitioner's orientation (identification of a sense of alarm or a sense of reassurance) to complete the Gut Fellings Questionnaire.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start28 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut FeelingsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175157
- Sponsor's protocol ID
- 29BRC21.0359 (EGFGP)
- Acronym
- EGFGP
- Status last verified
- May 2022
- First submitted
- 14 Dec 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of "Gut Feelings" Accuracy Regarding the Effect of Professional Experience in General Practitioners in Clinical Decision Making
- ClinicalTrials.gov ID
- NCT05175157
- Acronym / sponsor ID
- EGFGP / 29BRC21.0359 (EGFGP)
- Conditions
- Gut Feelings
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knowledge, experience and professional development limit the risk of diagnostic error for the clinician in daily practice. However, research has shown that other non-analytical factors are involved in clinical decision making. Intuition (or "gut feelings") is a subjective element involved in medical decision-making, and its place and relevance are being explored. The concept of "gut feelings" comes from General Practitioners (GPs) themselves and their description of their own practice. Several studies have shown its place in medical decision-making models, particularly in the face of diagnostic uncertainty.
A questionnaire used as a standardized measurement tool for gut feelings was created to address this issue. The Gut Feelings Questionnaire (GFQ) has been translated into French, German and Polish during a standardized linguistic validation procedure. It is currently validated and available in five languages. The QGF has been tested and validated in clinical practice by Belgian, French and Dutch physicians. Its feasibility has been evaluated in these three health systems.
The Gut Feelings Questionnaire was used in a prospective study to determine the accuracy of the sense of alarm in patients consulting their GP for chest pain and/or dyspnea. But the role of the practitioner's experience has not been studied: is the gut feeling more accurate in experienced GPs than in first semester interns in general practice?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General practitioner | – | Other: Gut Fellings questionnaireAnswer the Gut Fellings questionnaire |
| Internal | – | Other: Gut Fellings questionnaireAnswer the Gut Fellings questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * General practitioners established for more than 3 years * Interns in the first year of the third cycle of the diploma of specialized studies in general medicine of the Universities of Brest and Rouen
Key inclusion criteria (2 listed)
- GP population: General practitioners established for more than 3 years
- Intern population: Interns in general medicine in the first year of the third cycle of the diploma of specialized studies in general medicine
Key exclusion criteria (2 listed)
- For the 2 populations: Refusal to participate
- Intern population: Interns in the second and third year of the diploma of specialized studies in general medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut Fellings questionnaireAnswer the Gut Fellings questionnaire | Other | General practitioner, Internal |
Primary outcome
Error assessment
Time frame: Day 1
Gut Feelings Questionnaire response score comparaison for each of 12 clinical vignettes. Gut Feelings Questionnaire is a 10-item questionnaire based on the definitions of the sense of alarm and the sense of reassurance. The purpose of the Gut Feelings Questionnaire is to determine the presence or absence of gut feelings in the diagnostic reasoning. These gut feelings are defined as a 'sense of alarm' and a 'sense of reassurance'. A 'sense of alarm' implies that a GP worries about a patient's health status, even though he/she has found no specific indications yet; it is a sense that 'there's something wrong here'. A 'sense of reassurance' means that a GP feels secure about the further management and course of a patient's problem, even though he/she may not be certain about the diagnosis: everything fits in.
3 secondary outcomes
Types of professional activity of installed GPs
Time frame: Day 1
Type of care
Time frame: Day 1
Practitioner's orientation
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Gut Feelings
Recruiting
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Sleep Disturbance, Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Feelings, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Barais (06 98 18 96 81, marie.barais@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error assessment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.