Health TrialsbyHealthPanel

Inflammation and Medical Provider Attitudes, Cognition, and Treatment Decisions Study

ConditionsDecision-MakingPatient CareTreatment Decisions
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arkansas, Fayetteville

About this trial

This is a randomized, double-blind clinical trial involving emergency medicine and internal medicine healthcare providers as participants. The intervention involves the administration of the seasonal influenza vaccine or a saline placebo; this protocol is used in psychoneuro-immunology to simulate a state of mild illness. The primary aim is to examine whether acute inflammation induced by receiving the vaccine affects decision-making on standardized psychological reaction time tasks and questionnaires. Participants attend two laboratory sessions on consecutive days, receive either a seasonal influenza vaccine or a saline placebo at the first session, provide blood samples to measure inflammatory cytokines, and complete a series of standardized assessments of medical decision-making and social attitudes. Participants who received the placebo during the first session will receive the vaccine during the second session.

Overall, the study is designed to examine how adverse provider conditions particularly acute inflammation, burnout, and concerns about one's own health affect provider judgments and healthcare-related decision-making. The primary hypothesis is that providers experiencing greater adverse conditions at the time of research participation would have altered decision-making compared to those experiencing fewer adverse conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthcare providers currently employed in emergency medicine or internal medicine

Must be one of the following: Resident, fellow, attending, or advanced practice provider (NP, PA)

Individual is able to travel to the research site for sessions

Has not had an acute viral or bacterial infection within the previous 14 days

Disqualifiers

Does not want to receive a flu vaccine as part of the study

Has received a flu vaccine this season already (after August of current year)

Has had a prior allergic reaction or bad side effect, including Guillain-Barre, due to a flu vaccine or another vaccine

Is allergic to eggs or have had an adverse reaction to egg-derived vaccine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Influenza vaccine

    Biological/Vaccine

    A single administration of a seasonal trivalent cell-based influenza vaccine delivered by injection into the arm at the end of the first study session.

  • Placebo

    Other intervention

    Control group will receive a saline placebo injection at the end of Session 1

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Influenza Vaccine InjectionExperimental treatment 1 intervention
Group B: Placebo InjectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Testing Automatic Judgments: "Implicit Association Test"

This task calculates a "d" score across trials to quantify the strength of implicit associations. Higher d scores indicate more negative automatic attitudes.

Time frame
2 days
2

Testing Deliberate Judgments: "Feeling Thermometers"

Explicit attitudes are assessed via 100-point Feeling Thermometers that ask for feeling toward different patient groups. Lower values indicate more negative attitudes.

Time frame
2 days

Secondary outcomes

1

Questionnaire Assessing Social Avoidance: "Patient Sorting Task"

A behavioral decision-making task order patients within an array of three. The three patients are arranged in an order in which the participant would choose to see them. The outcome is the number of trials when a patient from a target group is seen later than a patient from a control group. Higher values indicate greater potential for treatment inconsistencies.

Time frame
1 day
2

Questionnaire Assessing Perception of Others' Pain: "Threshold for Detecting Pain on Faces"

Participants will see 11 images of targets of different racial groups that have each been morphed to go from no pain to high pain, responding to a yes/no question about whether the target is in pain in each image. The threshold at which participants begin perceiving pain will be calculated for each target and averaged within racial groups. Differences between groups indicate potential for greater treatment inconsistencies.

Time frame
2 days
3

Questionnaire Assessing Cognitive Depletion: "Stroop Task"

To measure the delay in reaction time between neutral and incongruent stimuli. The task calculates an interference score across many trials to show the difference in response latency between incongruent and congruent trials. Greater interference is a measure of cognitive depletion.

Time frame
2 days
4

Questionnaire Assessing Motivation: "Motivation to Respond without Prejudice Scale"

It is administered on a scale of 1 to 9, and the questions are about both internal and external motivation. Higher scores represent more motivation.

Time frame
2 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas, Fayetteville

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Carilion Clinic

Collaborator

Loma Linda University

Collaborator

The University of Texas Health Science Center at San Antonio

Collaborator

University of New Mexico

Collaborator

University of Arkansas

Collaborator

Source ClinicalTrials.gov
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