The Effect of Remote Treatment on Medical Provider Creative Thinking and Patient Disclosure (MED-CREATE)

January 17, 2025 updated by: Ayoub Bouguettaya

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (for medical student cohort)

    1. English speaking
    2. Be enrolled in an Medical Doctorate or Doctor of Osteopathic Medicine degree
    3. Be in their final year of study

  • (for the acting participant cohort)

    1. Aged 18 or older
    2. Must state they have current healthcare coverage
    3. English speaking at native fluency level

Exclusion Criteria:

  • (for medical student cohort)

    1. Have previous experience as healthcare providers that is separate from their current medical training (e.g., being a nurse)
    2. Work in a technology sector
    3. Declare a conflict of interest
    4. Unable or unwilling to sign informed consent documents -(for the acting participant cohort)
    1. There is significant current or past psychiatric illness that may inhibit their ability to consent or participate (self-described)
    2. They are not willing or able to sign informed consent documents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Online interaction
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.
Behavioral: In person
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ayoub Bouguettaya

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cedars-Sinai Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayoub Bouguettaya, PhD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00003845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data, with the exception of the interview transcripts or recordings, will be made available. This includes participant demographics with random adjustments to ensure that participant confidentiality is not compromised.

IPD Sharing Time Frame

The study protocol will be public prior to the start of the study, which is anticipated to be Jul 2025

IPD Sharing Access Criteria

This will be available on Open Science Framework as downloadable files, with the full R code for analysis and a CSV (Comma Separated Value) file of the data.

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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Conditions

Rare Diseases

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Dietary Supplements

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