- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06784635
The Effect of Remote Treatment on Medical Provider Creative Thinking and Patient Disclosure (MED-CREATE)
The investigators will be doing this study to understand how the environment of communication (including talking about health) impact doctors' ability to find solutions and health issues to clinical problems for patients.
Participants are being asked to take part in this research study because they are either:
- A final year medical student
- OR a person willing to act out a diagnosis.
Participants will do a few tasks:
- Questionnaires: Participants will be asked to complete a questionnaire before and after a short interview. The investigators will ask participants questions to find out their general psychological traits and skills, which can affect clinical interviews. The investigators believe it should take about 10 to 15 minutes to complete the questionnaire.
- Demographic Information: The investigators will ask participants about demographics, which may include their age, gender identity, race and ethnicity.
Interview with a medical student/patient: This will be a recorded interview between a medical student and person acting as a patient. In this meeting, they will either meet online or in person, with white noise on or off, in a brightly lit room or a regularly lit room.
- Acting patients will be given a hypothetical condition, with a list of symptoms included. Besides this list, they will be asked to answer the medical questions as though they are themselves (e.g., height, weight)
- Medical students will be given a list of tip questions that will help with their diagnosis.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will link two participants: a final year medical student and an acting patient. Both will fill out consent forms outlining the study with the above purpose) standardized demographic information, and psychometric scales, including ones measuring empathy, extraversion, openness, working memory, health literacy, and fatigue. They will then be randomly put into a dyad (consisting of one medical student and one acting patient). The acting patient (who will required to be of good health- no chronic or current health issues) will be asked to pretend to have a rare or hard to diagnose health condition, having been given a document providing details of the health condition and presenting symptoms. They will be told that otherwise, they should respond to the questions as though they are themselves (for example, if the participant asked, "how tall are you", they can disclose their actual height). The medical student will be given instructions to ask all relevant questions, including a list of potential topics they should ask about, some of which are embarrassing but relevant (e.g., bowel movements).
They will then be assigned to meet the other member of their dyad in one of two conditions: online or in person (unknown to the participants). They will then act as though this is a clinical interview, to diagnose the condition. Participants will be told the investigators will be changing the lighting and background noise as a sham treatment (white noise machine and desk lamp), concealing the study's true purpose: to understand how online versus offline environments the creativity of medical providers and the tendency toward disclosure. The interview will be recorded and transcribed. At the end of the interview, participants will be debriefed by the investigators, with an explanation of the deception, and be given the ability to withdraw their data at that point.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elias Aboujaoude, MD
- Phone Number: 415-244-3724
- Email: elias.aboujaoude@cshs.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(for medical student cohort)
- English speaking
- Be enrolled in an Medical Doctorate or Doctor of Osteopathic Medicine degree
- Be in their final year of study
(for the acting participant cohort)
- Aged 18 or older
- Must state they have current healthcare coverage
- English speaking at native fluency level
Exclusion Criteria:
(for medical student cohort)
- Have previous experience as healthcare providers that is separate from their current medical training (e.g., being a nurse)
- Work in a technology sector
- Declare a conflict of interest
- Unable or unwilling to sign informed consent documents -(for the acting participant cohort)
- There is significant current or past psychiatric illness that may inhibit their ability to consent or participate (self-described)
- They are not willing or able to sign informed consent documents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online interaction
Participant allocated to this arm will meet online, although they will be in the same building.
They will have a conversation over an encrypted video platform.
|
Participant dyads will meet online in a mock clinical interview, via an encrypted video call, seated at a desk.
They will be in an office setting.
There will be a sham white noise and lamp device placed on the desk.
|
|
Experimental: In person interaction
Participant allocated to this arm will meet in person, in the same room.
They will have a conversation face to face in an office setting.
|
Participant dyads will meet in person for a mock clinical interview, seated at a desk opposite their counterpart.
They will be in an office setting.
There will be a sham white noise and lamp device placed on the desk.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Creativity in medical practice (medical student- number of possible diagnoses)
Time Frame: From time of enrollment to end of study duration (1 hour)
|
Creativity of medical practitioners will be measured using the number of possible diagnoses generated by the medical student.
|
From time of enrollment to end of study duration (1 hour)
|
|
Creativity in medical practice (medical student- correct diagnosis reached)
Time Frame: From time of enrollment to end of study duration (1 hour)
|
Creativity of medical practitioners will be measured by whether or not they get the correct diagnosis.
|
From time of enrollment to end of study duration (1 hour)
|
|
Tendency toward disclosure by patients
Time Frame: From time of enrollment to end of study duration (1 hour)
|
We will measure how many words the acting participants use to describe their health condition when asked an embarrassing question, without further prompting by the medical student.
|
From time of enrollment to end of study duration (1 hour)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayoub Bouguettaya, PhD, Cedars-Sinai Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00003845
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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