210 Participants NeededMy employer runs this trial

Influenza Vaccine for Decision Making in Healthcare Providers

(IMPACT Trial)

Recruiting at 2 trial locations
AM
Overseen ByAnastasia Makhanova, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a flu vaccine might affect the decision-making abilities of healthcare providers, such as doctors and nurse practitioners, when experiencing mild inflammation (a temporary body reaction). Participants will receive either the flu shot or a saline placebo (a harmless saltwater injection) and then answer questions and take tests to assess any changes in decision-making. It is ideal for emergency or internal medicine healthcare providers who have not received a flu shot this season and can attend two research sessions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical insights.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have commonly shown that healthcare workers use the flu vaccine. Research indicates that many healthcare workers receive the flu shot annually, with up to 94.6% of pharmacists and 92.6% of doctors getting vaccinated. The vaccine is generally well-tolerated, with common side effects including soreness at the injection site and mild fever. Serious side effects are rare. The vaccine has proven effective in lowering the chance of contracting the flu and helps reduce sick days from work. This suggests that the flu vaccine is a safe choice for most people.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it is exploring how the influenza vaccine can influence decision-making in healthcare providers. Unlike the typical focus on patient immune response, this study looks at the vaccine's potential broader impact on healthcare professionals' choices and actions, which is a unique angle. This could lead to a deeper understanding of how vaccines might indirectly affect healthcare delivery and outcomes.

What evidence suggests that this protocol is effective for influencing decision-making in healthcare providers?

Research shows that the seasonal flu vaccine effectively prevents the flu. In this trial, some participants will receive the influenza vaccine, while others will receive a placebo injection. Studies have found that when the vaccine matches the flu strains well, it can be up to 90% effective in healthcare workers. One study showed that fewer people experienced flu-like symptoms in the vaccinated group, with only 18% getting sick compared to 36% in those who weren't vaccinated. The flu vaccine also reduces the severity of the illness, lowering the chances of serious outcomes like needing intensive care or dying by 23%. These findings suggest that the flu vaccine effectively prevents the flu and reduces its severity.678910

Are You a Good Fit for This Trial?

This trial is for emergency medicine and internal medicine healthcare providers. Participants should be able to attend two lab sessions on consecutive days. There are no detailed inclusion or exclusion criteria listed.

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)
I have not taken antiviral medication in the past 48 hours.
See 3 more

Exclusion Criteria

I take corticosteroids or immunosuppressants every day.
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
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (virtual)

Treatment

Participants attend two lab sessions on consecutive days, receive either a seasonal influenza vaccine or a saline placebo, provide blood samples, and complete standardized assessments of medical decision-making and social attitudes.

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Influenza vaccine

Trial Overview

The study tests whether getting a flu vaccine (which causes mild inflammation) affects how healthcare providers make decisions, compared to a placebo shot. It uses a randomized, double-blind design where all participants eventually receive the vaccine.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Influenza Vaccine InjectionExperimental Treatment1 Intervention
Group II: Placebo InjectionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials
24
Recruited
2,100+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials
486
Recruited
92,500+

University of New Mexico

Collaborator

Trials
393
Recruited
3,526,000+

University of Arkansas

Collaborator

Trials
500
Recruited
153,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Carilion Clinic

Collaborator

Trials
85
Recruited
15,400+

Loma Linda University

Collaborator

Trials
322
Recruited
267,000+

Citations

Survey of Adult Influenza Vaccination Practices and ... - PMC

Response rate was 67% (620/930). Ninety-eight percent always/almost always recommended influenza vaccine to adults ≥ 65 years, 90% for adults ...

Published Large U.S. Study Finds Comparable ...

There were 836 cases of PCR-confirmed influenza (3.9 per 1,000 persons) identified after adjuvanted vaccine and 867 cases (4.0 per 1,000 persons) ...

Effectiveness of seasonal influenza vaccination in ...

Although studies may provide contradictory conclusions, vaccine efficacy in HWs has been shown to be as high as 90% for well-matched seasonal influenza vaccines ...

Protective Impact of Influenza Vaccination on Healthcare ...

Results: The incidence of influenza-like illness was significantly lower in the vaccinated (18%) compared to the control group (36%; p = 0.046; OR = 0.39; 95% ...

Interim Effectiveness of the Influenza Vaccine for the 2024- ...

Results Among 53321 employees, 43771 (82.1%) had received the influenza vaccine by the end of the study. Influenza occurred in 324 (0.6%) during ...

Importance of Influenza Vaccination for Health Care ...

One hospital evaluated the impact of vaccination on HCP and hospitalized patients and saw an increase in immunization coverage from 4% to 67% ...

Increasing influenza immunization rates among healthcare ...

Of the 102 respondents, nearly 30% reported within i.e. HCP) vaccinated for influenza each season.

Workplace Strategies May Improve Flu, COVID-19 Vaccine ...

Pharmacists (94.6%), physicians (92.6%), and HCP in hospital settings (88.3%) demonstrated the highest influenza vaccination coverage.

Mandatory Flu Vaccine for Healthcare Workers: Not Worthwhile

The relative risk reduction for influenza infection associated with influenza vaccine was 59%. However, the absolute risk reduction was only 1.4 ...

Infection control group emphasizes health worker flu vaccination

In a report on flu vaccine uptake among healthcare workers during the 2010-11 flu season, the CDC said 63.5% were immunized, a small increase ...