Inflammation and Medical Provider Attitudes, Cognition, and Treatment Decisions Study
Part of paid clinical trials in Fayetteville, Arkansas.
- Sponsor
- University of Arkansas, Fayetteville
- Study ID
- NCT07842367
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Decision-Making
- Patient Care
- Treatment Decisions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Influenza vaccine — BIOLOGICALA 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 — OTHERControl group will receive a saline placebo injection at the end of Session 1
Study Details
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.
Key Dates
- First listed
- Sep 25, 2026
- Start date
- Sep 30, 2026
- Status verified
- Sep 2026
- Primary completion
- Oct 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 210 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Influenza Vaccine InjectionReceives the influenza vaccine at the end of Session 1
- Placebo Comparator: Placebo InjectionReceives a saline placebo injection at the end of Session 1
Primary Outcome Measure
Testing Automatic Judgments: "Implicit Association Test" [ Time Frame: 2 days ]
Central Contacts
- Anastasia Makhanova, PhD479-575-8798
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Fayetteville | Arkansas | 72703 | Roy Kamoga, MD (PRINCIPAL_INVESTIGATOR) |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87106 | Joe Alcock, MD (PRINCIPAL_INVESTIGATOR) |
| Carilion Medical Center | Roanoke | Virginia | 24016 | Michael Wilson, MD (PRINCIPAL_INVESTIGATOR) |