Inflammation and Medical Provider Attitudes, Cognition, and Treatment Decisions Study (IMPACT)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Anastasia Makhanova, PhD
- Numéro de téléphone: 479-575-8798
- E-mail: ammakhan@uark.edu
Lieux d'étude
-
-
Arkansas
-
Fayetteville, Arkansas, États-Unis, 72703
- Recrutement
- University of Arkansas for Medical Sciences
-
Contact:
- Roy Kamoga, MD
- Numéro de téléphone: 785-639-3110
- E-mail: gkamoga@uams.edu
-
Chercheur principal:
- Roy Kamoga, MD
-
-
New Mexico
-
Albuquerque, New Mexico, États-Unis, 87106
- Recrutement
- University of New Mexico Health Sciences Center
-
Contact:
- Joe Alcock, MD
- Numéro de téléphone: 505 272-5062
- E-mail: JoAlcock@salud.unm.edu
-
Chercheur principal:
- Joe Alcock, MD
-
-
Virginia
-
Roanoke, Virginia, États-Unis, 24016
- Recrutement
- Carilion Medical Center
-
Chercheur principal:
- Michael Wilson, MD
-
Contact:
- Michael Wilson, MD
- Numéro de téléphone: 540-581-5376
- E-mail: mpwilson1@carilionclinic.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Influenza Vaccine Injection
Receives the influenza vaccine at the end of Session 1 |
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. |
|
Comparateur placebo: Placebo Injection
Receives a saline placebo injection at the end of Session 1 |
Control group will receive a saline placebo injection at the end of Session 1 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Testing Automatic Judgments: "Implicit Association Test"
Délai: 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. |
2 days
|
|
Testing Deliberate Judgments: "Feeling Thermometers"
Délai: 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. |
2 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Questionnaire Assessing Social Avoidance: "Patient Sorting Task"
Délai: 1 day
|
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. |
1 day
|
|
Questionnaire Assessing Perception of Others' Pain: "Threshold for Detecting Pain on Faces"
Délai: 2 days
|
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. |
2 days
|
|
Questionnaire Assessing Cognitive Depletion: "Stroop Task"
Délai: 2 days
|
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. |
2 days
|
|
Questionnaire Assessing Motivation: "Motivation to Respond without Prejudice Scale"
Délai: 2 days
|
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. |
2 days
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MD019051 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .