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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Anastasia Makhanova, PhD
- Número de telefone: 479-575-8798
- E-mail: ammakhan@uark.edu
Locais de estudo
-
-
Arkansas
-
Fayetteville, Arkansas, Estados Unidos, 72703
- Recrutamento
- University of Arkansas for Medical Sciences
-
Contato:
- Roy Kamoga, MD
- Número de telefone: 785-639-3110
- E-mail: gkamoga@uams.edu
-
Investigador principal:
- Roy Kamoga, MD
-
-
New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87106
- Recrutamento
- University of New Mexico Health Sciences Center
-
Contato:
- Joe Alcock, MD
- Número de telefone: 505 272-5062
- E-mail: JoAlcock@salud.unm.edu
-
Investigador principal:
- Joe Alcock, MD
-
-
Virginia
-
Roanoke, Virginia, Estados Unidos, 24016
- Recrutamento
- Carilion Medical Center
-
Investigador principal:
- Michael Wilson, MD
-
Contato:
- Michael Wilson, MD
- Número de telefone: 540-581-5376
- E-mail: mpwilson1@carilionclinic.org
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Comparador de 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Testing Automatic Judgments: "Implicit Association Test"
Prazo: 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"
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Questionnaire Assessing Social Avoidance: "Patient Sorting Task"
Prazo: 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"
Prazo: 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"
Prazo: 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"
Prazo: 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
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01MD019051 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .