Decision-MakingPhase 2IMPACTNCT07842367
Inflammation and Medical Provider Attitudes, Cognition, and Treatment Decisions Study
A Phase 2 study testing Influenza vaccine in people with Decision-Making and Patient Care, run by University of Arkansas, Fayetteville at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decision-Making, Patient Care, Treatment Decisions
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
Joe Alcock, MD, 505 272-5062, JoAlcock@salud.unm.edu
Joe Alcock, MD
- Recruiting
University of Arkansas for Medical Sciences
Fayetteville, Arkansas, 72703
Roy Kamoga, MD, 785-639-3110, gkamoga@uams.edu
Roy Kamoga, MD
- Recruiting
Carilion Medical Center
Roanoke, Virginia, 24016
Michael Wilson, MD, 540-581-5376, mpwilson1@carilionclinic.org
Michael Wilson, MD
About this study
Official title: The Impacts of Adverse Provider Conditions on Medical Decision-Making and Patient Care
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.
Read the detailed description
Participants will provide informed consent during a call (Zoom, Teams, Phone) with the University of Arkansas research team. The research team member will explain the study procedures to the participants and will give them the opportunity to ask questions. During the call, they will review the electronic consent form and will sign the form after all of their questions have been answered. They will receive a paper copy of the consent documents to review one more time when they arrive at the first research session at their site.
Participants will complete two lab sessions on consecutive days (scheduled as close to 24-hours apart as possible) at a collaborating research site. At each site, a member of the local team will coordinate the sessions, including providing instructions before participants complete various study tasks. During each session, participants will complete standardized measures of decision-making that will allow us to comprehensively document how adverse provider conditions (acute inflammation, burnout, stress, concern about own health) affect objectivity in decision-making across multiple domains. These standardized measures include reaction time tasks and questionnaires. Participants will also complete questionnaires that assess demographic information, personality information, and questions about their experiences with adverse provider conditions (burnout, stress, other workplace demands, mood, concerns about own health). During each session, participants will provide blood samples (~3mL) that will be assayed for pro-inflammatory cytokines interleukin-6 and interleukin-1beta. Participants will be randomly assigned to either the experimental or control condition using stratified permuted block randomization. Those in the experimental condition will receive the influenza vaccine at the end of Session 1 and those in the control condition will receive a saline placebo injection instead. We will use a double-blind design so that neither the participant nor the research assistant administering the decision-making tasks will know the condition.
At the end of the second session, participants will be debriefed and informed about the condition they were assigned to (up until this point, the research coordinator and participant will be blind to participant condition). Those in the control condition will receive the vaccine before they leave.
- Conditions
- Decision-Making, Patient Care, Treatment Decisions
- Being tested
- Influenza vaccine, Placebo
- Keywords
- Decision making, Patient Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
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.
PlaceboOther
Control group will receive a saline placebo injection at the end of Session 1
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine Injection | Experimental | Receives the influenza vaccine at the end of Session 1 Receives: Biological: Influenza vaccine |
| Placebo Injection | Placebo comparator | Receives a saline placebo injection at the end of Session 1 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 days
Secondary outcomes (4)
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.
Measured: 1 day
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.
Measured: 2 days
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.
Measured: 2 days
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision-MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Carilion Clinic, Loma Linda University, The University of Texas Health Science Center at San Antonio, University of New Mexico, University of Arkansas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842367
- Sponsor's protocol ID
- R01MD019051
- Other IDs
- R01MD019051
- Acronym
- IMPACT
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Adverse Provider Conditions on Medical Decision-Making and Patient Care
- ClinicalTrials.gov ID
- NCT07842367
- Acronym / sponsor ID
- IMPACT / R01MD019051
- Conditions
- Decision-Making, Patient Care, Treatment Decisions
- Keywords
- Decision making, Patient Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Carilion Clinic, Loma Linda University, The University of Texas Health Science Center at San Antonio, University of New Mexico, University of Arkansas
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will provide informed consent during a call (Zoom, Teams, Phone) with the University of Arkansas research team. The research team member will explain the study procedures to the participants and will give them the opportunity to ask questions. During the call, they will review the electronic consent form and will sign the form after all of their questions have been answered. They will receive a paper copy of the consent documents to review one more time when they arrive at the first research session at their site.
Participants will complete two lab sessions on consecutive days (scheduled as close to 24-hours apart as possible) at a collaborating research site. At each site, a member of the local team will coordinate the sessions, including providing instructions before participants complete various study tasks. During each session, participants will complete standardized measures of decision-making that will allow us to comprehensively document how adverse provider conditions (acute inflammation, burnout, stress, concern about own health) affect objectivity in decision-making across multiple domains. These standardized measures include reaction time tasks and questionnaires. Participants will also complete questionnaires that assess demographic information, personality information, and questions about their experiences with adverse provider conditions (burnout, stress, other workplace demands, mood, concerns about own health). During each session, participants will provide blood samples (~3mL) that will be assayed for pro-inflammatory cytokines interleukin-6 and interleukin-1beta. Participants will be randomly assigned to either the experimental or control condition using stratified permuted block randomization. Those in the experimental condition will receive the influenza vaccine at the end of Session 1 and those in the control condition will receive a saline placebo injection instead. We will use a double-blind design so that neither the participant nor the research assistant administering the decision-making tasks will know the condition.
At the end of the second session, participants will be debriefed and informed about the condition they were assigned to (up until this point, the research coordinator and participant will be blind to participant condition). Those in the control condition will receive the vaccine before they leave.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine Injection | Experimental | Biological: Influenza vaccineReceives the influenza vaccine at the end of Session 1 |
| Placebo Injection | Placebo comparator | Other: PlaceboReceives a saline placebo injection at the end of Session 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccineA single administration of a seasonal trivalent cell-based influenza vaccine delivered by injection into the arm at the end of the first study session. | Biological | Influenza Vaccine Injection |
| PlaceboControl group will receive a saline placebo injection at the end of Session 1 | Other | Placebo Injection |
Primary outcome
Testing Automatic Judgments: "Implicit Association Test"
Time frame: 2 days
This task calculates a "d" score across trials to quantify the strength of implicit associations. Higher d scores indicate more negative automatic attitudes.
Testing Deliberate Judgments: "Feeling Thermometers"
Time frame: 2 days
Explicit attitudes are assessed via 100-point Feeling Thermometers that ask for feeling toward different patient groups. Lower values indicate more negative attitudes.
4 secondary outcomes
Questionnaire Assessing Social Avoidance: "Patient Sorting Task"
Time frame: 1 day
Questionnaire Assessing Perception of Others' Pain: "Threshold for Detecting Pain on Faces"
Time frame: 2 days
Questionnaire Assessing Cognitive Depletion: "Stroop Task"
Time frame: 2 days
Questionnaire Assessing Motivation: "Motivation to Respond without Prejudice Scale"
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza vaccine in people with Decision-Making and Patient Care, run by University of Arkansas, Fayetteville at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Makhanova, PhD (479-575-8798, ammakhan@uark.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing Automatic Judgments: "Implicit Association Test" (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.