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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Anastasia Makhanova, PhD
- 电话号码：479-575-8798
- 邮箱：ammakhan@uark.edu
学习地点
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Arkansas
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Fayetteville、Arkansas、美国、72703
- 招聘中
- University of Arkansas for Medical Sciences
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接触：
- Roy Kamoga, MD
- 电话号码：785-639-3110
- 邮箱：gkamoga@uams.edu
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首席研究员：
- Roy Kamoga, MD
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New Mexico
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Albuquerque、New Mexico、美国、87106
- 招聘中
- University of New Mexico Health Sciences Center
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接触：
- Joe Alcock, MD
- 电话号码：505 272-5062
- 邮箱：JoAlcock@salud.unm.edu
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首席研究员：
- Joe Alcock, MD
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Virginia
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Roanoke、Virginia、美国、24016
- 招聘中
- Carilion Medical Center
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首席研究员：
- Michael Wilson, MD
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接触：
- Michael Wilson, MD
- 电话号码：540-581-5376
- 邮箱：mpwilson1@carilionclinic.org
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
安慰剂比较：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 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Testing Automatic Judgments: "Implicit Association Test"
大体时间：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"
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Questionnaire Assessing Social Avoidance: "Patient Sorting Task"
大体时间：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"
大体时间：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"
大体时间：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
|
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Questionnaire Assessing Motivation: "Motivation to Respond without Prejudice Scale"
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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