RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: University of Arkansas, Fayetteville • ClinicalTrials.gov ID: NCT07842367

Registry updated: 2026-09-30

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Description

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.

Interventions

Influenza vaccine (Biological)
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)
Control group will receive a saline placebo injection at the end of Session 1

Eligibility criteria

Inclusion Criteria: * 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 * Has not taken an antiviral medication such as Tamiflu in the previous 48 hours * Has not taken corticosteroids or immunosuppressants in the previous 30 days Exclusion Criteria: * 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 * Is pregnant or suspects a possible pregnancy * Has congenital or acquired immunodeficiency such as common variable immunodeficiency (CVID) or HIV/AIDS * Has an active hematologic malignancy (like leukemia, lymphoma, myeloma) * Has Type 1 diabetes * Has Graft vs. Host Disease * Uses aspirin, ibuprofen (i.e., NSAIDs), acetaminophen, or naproxen daily * Uses corticosteroids or immunosuppressants daily * Is currently receiving systemic chemotherapy and/or immunotherapy * Has had changes in daily prescription medication in the last 3 months (starting, stopping, changing dose)

Conditions

Decision-Making Patient Care Treatment Decisions

Locations

University of Arkansas for Medical Sciences — Fayetteville, Arkansas, United States
University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
Carilion Medical Center — Roanoke, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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