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

NCT07842367 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: R01MD019051
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Decision-Making; Patient Care; Treatment Decisions

Keywords

Decision making; Patient Care

Outcome Measures

Primary Outcomes (2)

• 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.

  2 days

• 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.

  2 days

Secondary Outcomes (4)

• Questionnaire Assessing Social Avoidance: "Patient Sorting Task"

  1 day

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

  2 days

• Questionnaire Assessing Cognitive Depletion: "Stroop Task"

  2 days

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

  2 days

Study Arms (2)

Influenza Vaccine Injection

EXPERIMENTAL

Receives the influenza vaccine at the end of Session 1

Biological: Influenza vaccine

Placebo Injection

PLACEBO COMPARATOR

Receives a saline placebo injection at the end of Session 1

Other: Placebo

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.

Influenza Vaccine Injection

Placebo OTHER

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

Placebo Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead
• Carilion Clinic: collaborator
• Loma Linda University: collaborator
• University of New Mexico: collaborator
• University of Arkansas: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (3)

University of Arkansas for Medical Sciences

Fayetteville, Arkansas, 72703, United States

RECRUITING

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Carilion Medical Center

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Anastasia Makhanova, PhD

CONTACT

479-575-8798; ammakhan@uark.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)