Influenza Vaccine Effect on Provider Decision-Making
Inflammation and Medical Provider Attitudes, Cognition, and Treatment Decisions Study
Recruiting
Phase 2Interventional Study
Decision-MakingPatient CareTreatment Decisions
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Health Services Research
Participants needed
210 (estimated)
Sponsor
University of Arkansas, Fayetteville · Other
Who this trial is looking for
This trial is looking for healthcare providers in emergency medicine or internal medicine. Participants will receive either a flu vaccine or a placebo and will complete assessments over two sessions to see how this affects their decision-making.
Are You a Good Fit for This Trial?
Must not be takingTamiflu
Rules you outHIV/AIDSGraft vs. Host Disease
You may be able to join if
I am currently employed in emergency medicine or internal medicine
I am a resident, fellow, attending, or advanced practice provider
I can travel to the research site for sessions
I have not had an acute viral or bacterial infection in the last 14 days
I have not taken antiviral medication in the last 48 hours
I have not taken corticosteroids or immunosuppressants in the last 30 days
You may not be able to join if
I do not want to receive a flu vaccine as part of the study
I have received a flu vaccine this season already
I have had a prior allergic reaction to a flu vaccine
I am allergic to eggs or have had a bad reaction to an egg-derived vaccine
I am pregnant or suspect I might be pregnant
I have a congenital or acquired immunodeficiency
I have an active blood cancer
I have Type 1 diabetes
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 receivin…
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.
Trial Locations
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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 …
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)
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