Trial Summary
What is the purpose of this trial?
The study will test two tactics to improve uptake of two vaccines in adults. The vaccines prevent COVID-19 and influenza. Both are common and harmful. Most adults do not get either vaccine. This is despite strong recommendations that all adults get both vaccines. The study will involve adult patients at eight Mayo Clinic primary care practices in Rochester and Kasson. The study will test the two tactics together. Four clinics will get the two tactics. The other four clinics will not. The study will randomly assign the two tactics to the clinics. One tactic is to send a letter by US mail to the patient. The letter will state strong recommendations on getting both vaccines now. It will tell patients how to get the vaccines now. The second tactic is to send monthly emails to clinicians. It will remind them to use every visit to vaccinate patients against COVID-19 and influenza. The study will compare the uptake of the two vaccines after six months in the clinics with and without the two tactics.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on vaccination strategies, so it's unlikely that your medications will be affected.
What data supports the effectiveness of the treatment Clinician communication, Patient letter for increasing COVID-19 and flu vaccination rates?
Research shows that effective clinician communication, including setting communication goals and reducing patient distress, leads to better patient outcomes and satisfaction. Additionally, direct-to-patient letters, although needing improved readability, have increased during the pandemic, suggesting a growing emphasis on patient-centered communication.12345
Is the communication strategy for increasing COVID-19 and flu vaccination rates safe for humans?
How does the treatment in the trial 'Communication Strategies for COVID-19 and Flu Vaccination Rates' differ from other treatments for increasing vaccination rates?
This treatment is unique because it focuses on communication strategies, such as empathy, transparency, and tailored communication, to increase COVID-19 and flu vaccination rates, rather than relying solely on medical interventions. It emphasizes the role of healthcare providers as trusted sources of information and the importance of addressing vaccine hesitancy through effective communication.1112131415
Eligibility Criteria
This trial is for adults aged 19 or older who are registered with one of eight specific adult primary care practices. It aims to increase the rate at which these individuals receive vaccinations against COVID-19 and influenza.Inclusion Criteria
I am a patient at one of the 8 specified primary care practices since September 2024.
I am 19 years old or older.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Implementation of two tactics: mailing letters to patients and sending monthly emails to clinicians to improve vaccine uptake
6 months
Ongoing visits as per clinic schedule
Follow-up
Participants are monitored for vaccine uptake rates and effectiveness of the intervention
3 months
Treatment Details
Interventions
- Clinician communication (Behavioral Intervention)
- Patient letter (Behavioral Intervention)
Trial OverviewThe study is testing two methods to boost vaccination rates: sending recommendation letters about vaccines to patients via US mail, and monthly email reminders to clinicians prompting them to vaccinate during visits. The effectiveness will be compared across clinics after six months.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient letter and clinician communicationExperimental Treatment1 Intervention
Each patient will be mailed a letter and each patient's clinician will receive a monthly email communicating information about making a strong recommendation for influenza and COVID-19 vaccination
Group II: No interventionActive Control1 Intervention
No intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
ModernaTX, Inc.Industry Sponsor
References
The Impact of COVID-19 on Patient Experience Within a Midwest Hospital System: A Case Study. [2021]Patient-centered communication and patient-provider relationships directly affect patient outcomes. The purpose of this study was to compare inpatient perception of provider/nurse communication in both COVID versus non-COVID diagnoses groups. A qualitative retrospective study was conducted by performing a priori coding analysis on Hospital Consumer Assessment of Healthcare Providers and Systems surveys from 4 different hospitals for both COVID and non-COVID diagnoses. Five themes emerged from non-COVID patient data: inconsistent health care provider communication, variable patient-provider education, pandemic influenced patient satisfaction and mental health stress, inconsistent hospital services, and stable provider professionalism. Five themes arose from the COVID patient data: provider gratitude, controversial communication methods, consistent patient education, lack of quality patient care, and poor timeliness. There is evidence of shared patient perceptions between both COVID and non-COVID patients, but also differences including timeliness and quality of care. The pandemic influenced all patients by creating non-mutually exclusive themes including overall gratitude and patient satisfaction. Future research should focus on a quantitative analysis of pandemic-related patient-provider communication effects on patient outcomes.
The secret of the care of the patient is in knowing and applying the evidence about effective clinical communication. [2016]American physicians and dentists conduct approximately 140 000-160 000 patient interviews in a practice lifetime, making the interview the most frequently performed medical procedure. Over the past 75 years, a steadily growing stream of scientific research has confirmed the fact that patient-clinician communication affects the course, direction, and both biomedical and functional outcomes of care. The field of clinical communication research has matured from anecdotes and aphorisms about 'bedside manner' to sophisticated randomized control trials and evidence-based outcomes that have been translated into reliable practice guidelines. Several key skills or habits of practice have been identified and studied in terms of their efficacy and effectiveness. These include the importance of agenda-setting, eliciting patients' perspectives about the nature of their ailments, communicating caring and concern, and testing for patient comprehension and agreement with proposed treatments. In addition to being effective, interpersonal communication can be deeply satisfying as well as offering a lower probability of law suits in the event of an adverse outcome.
The Readability of Outpatient Plastic Surgery Clinic Letters: Are We Adhering to Plain English Writing Standards? [2021]The readability of letters sent to patients plays a pivotal role in facilitating joint decision making and positive health outcomes. Guidance suggests that all correspondence should be directed to patients. Covid-19 led to an increase in direct-to-patient communication. This study aims to determine the quantity and quality of plastic surgery clinic letters sent to patients before and during the Covid-19 pandemic. A total of 127 pre-Covid clinic letters from November to December 2019 and 103 peri-Covid clinic letters from April to May 2020 were identified and assessed for readability. Text was analyzed using a standardized set of commonly used readability formulae, including SMOG, Flesch Reading Ease, and the Coleman-Liao Index. A total of 100 pre-Covid and 58 peri-Covid letters were suitable for inclusion. Median results for formulae that output a U.S. grade score ranged between 9 and 12.9 for letters written prior to Covid-19 and 9 and 13.2 for those written during Covid-19. Eight percent of letters were sent to patients pre-Covid, increasing to 28% during the pandemic. Letters sent to patients had a median grade score of between 8 and 12 prior to Covid-19 and 8 and 10.6 during Covid-19. Letters sent to clinicians ranged between 9 and 13 and 9 and 13.3, respectively. Outpatient plastic surgery letters are written at a readability level too high to facilitate understanding among the general population. The increase in direct-to-patient contact during the Covid-19 outbreak has not led to a significant improvement in the readability of clinic letters. The authors suggest an increase in letter standardization and raising awareness of readability when writing clinic letters.
Outcomes of Physicians' Communication Goals During Patient Interactions. [2021]During healthcare visits, physicians may set communication goals such as providing their patient with information about treatment; however, no recommendations exist regarding which goals physicians should prioritize during their often-brief interactions with patients. Two studies examined five communication goals (providing information, reducing distress, increasing patient satisfaction, increasing patient adherence, and encouraging hope) in the context of physician-patient interactions and their relationship with patient and physician outcomes. In Study 1, audio-recordings of physician-patient interactions were coded by research assistants for goal-related content. In Study 2, patients reported their physician's use of each goal during the interaction. In both studies, patients and physicians reported visit outcomes. Within-study meta-analyses suggested that the goal of reducing distress, but not the other goals, was consistently related to improved outcomes in Study 1. All goals were related to improved outcomes in Study 2. We then computed sample-size-weighted meta-analytic effects of each goal on each outcome across both studies. These results suggested that all of the goals had similar-sized positive relationships with patient and physician outcomes across studies. These findings suggest that physicians should generally approach consultations with communication goals in mind, but prioritizing efforts to reduce distress may be particularly beneficial.
Enhancing Physician's Toolkit: Integrating Storytelling in Medical Practice. [2021]Traditional communication of medical literature using evidence-based terminologies are inadequate as the body of COVID-19 literature increases thereby requiring alternate methods of communication like podcasts, webinars, social media. A common theme in all these alternate forms of communication is the art of storytelling that allows physicians to make a connection with a patient by understanding their perspectives. Apart from few situations where story telling can be distracting in many situations where the patient's history is complex and require great listening skills and empathy.. Learning to be a good storyteller can help the physician help patients be a great change agent for them. Communicating with these patients can be done effectively using standard communication tools and using effective storytelling techniques can reinforce the patients trust in the provider and strengthen patient physician relationship. This could have a salutatory result both for the patient by increasing patient satisfaction and compliance with treatment and physician satisfaction by increasing to understand their patient's true concerns.
Data Mining Pipeline for COVID-19 Vaccine Safety Analysis Using a Large Electronic Health Record. [2023]We developed a novel data mining pipeline that automatically extracts potential COVID-19 vaccine-related adverse events from a large Electronic Health Record (EHR) dataset. We applied this pipeline to Optum® de-identified COVID-19 EHR dataset containing COVID-19 vaccine records between December 11, 2020 and January 20, 2022. We compared post-vaccination diagnoses between the COVID-19 vaccine group and the influenza vaccine group among 553,682 individuals without COVID-19 infection. We extracted 1,414 ICD-10 diagnosis categories (first three ICD10 digits) within 180 days after the first dose of the COVID-19 vaccine. We then ranked the diagnosis codes using the adverse event rates and adjusted odds ratio based on the self-controlled case series analysis. Using inverse probability of censoring weighting, we estimated the right-censored time-to-event records. Our results show that the COVID-19 vaccine has a similar adverse events rate to the influenza vaccine. We found 20 types of potential COVID-19 vaccine-related adverse events that may need further investigation.
How to communicate with vaccine-hesitant parents. [2022]Development of safe and effective vaccines is one the greatest medical triumphs. However, despite high immunization rates in the United States, 85% of health care providers (HCPs) will have a parent refuse a vaccine for his or her child each year. HCPs have the greatest influence on a parent's decision to vaccinate his or her child. To effectively communicate with vaccine-hesitant parents, HCPs must first understand the concerns of parents regarding immunization and understand influences that can lead to misinformation about the safety and effectiveness of vaccines. HCPs should establish an open, nonconfrontational dialogue with vaccine-hesitant parents at an early stage and provide unambiguous, easily comprehensible answers about known vaccine adverse events and provide accurate information about vaccination. Personal stories and visual images of patients and parents affected by vaccine-preventable diseases and reports of disease outbreaks serve as useful reminders of the need to maintain high immunization rates. Ongoing dialogue including provider recommendations may successfully reassure vaccine-hesitant parents that immunization is the best and safest option for their child.
Transparency and the Food and Drug Administration--a quantitative study. [2013]In Europe and North America, there is increasing political pressure being put on health regulatory agencies to become more transparent. To date, however, there has been little academic evaluation--let alone analysis--of these transparency initiatives from a risk communication perspective. This review examines whether the U.S. Food and Drug Administration's Adverse Event Reporting System quarterly signal postings, put in place after the passage of the Food and Drug Administration Amendments Act 2007, will assist patients and doctors in their decision-making processes, on the basis of results of a quantitative Internet survey of 433 physicians and 1,000 American adults. The results indicate that there is significant disagreement between physicians and the public about when medical safety issues should be communicated in the first place, with physicians opposed to early signal postings while the public in general is in favor. In addition the findings show that if the public were to find their drugs listed on the Adverse Event Reporting System signals web postings, more than a quarter would stop taking their medicine. Going forward, the Food and Drug Administration needs to work to a greater degree with social scientists in developing scientific-based communication strategies, rather than developing transparency initiatives on the basis of stakeholder consultations.
Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? [2018]Healthcare provider (HCP) reporting to the Vaccine Adverse Event Reporting System (VAERS) is important to assuring the safety of U.S. licensed vaccines. HCP awareness of and practices regarding reporting of adverse events following immunization (AEFI) is understudied.
Editorial: What Can be Learned from National and International Vaccine Adverse Event Reporting Systems During the COVID-19 Pandemic? [2022]Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant national reporting agencies as part of the process of post-marketing drug safety monitoring. In the US, the Vaccine Adverse Event Reporting System (VAERS) is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Data from VAERS and other national and global reporting systems show very low rates of adverse events related to currently approved SARS-CoV-2 vaccines. Populations studies have supported the findings from adverse event reporting systems. The presentation, monitoring, and reporting of adverse events related to SARS-CoV-2 vaccines may have future applications in vaccine monitoring for several other potential pandemic zoonotic infections. This editorial aims to summarize the current understanding of adverse events from current COVID-19 vaccines from global adverse event reporting systems, rather than individual case reports or anecdotal reporting in the media.
A meta-analysis of influenza vaccination following correspondence: Considerations for COVID-19. [2022]High vaccination rates are needed to protect against influenza and to end the COVID-19 pandemic. Health authorities need to know if supplementing mass communications with direct correspondence to the community would increase uptake.
Communicating with Patients about COVID-19 Vaccination: A Qualitative Study on Vaccinators in Tuscany Region, Italy. [2023]The rapid development of the vaccine and the infodemia have challenged communication about COVID-19 vaccines. This study aims to characterize-through the experience of vaccinators-the challenges faced during COVID-19 vaccination consultations and the communication strategies adopted. A qualitative study was conducted on COVID-19 vaccinators in Tuscany, Italy. Face-to-face interviews were conducted and examined by thematic analysis. In total, 30 vaccinators were interviewed. Four main themes emerged. The first highlighted distinct profiles of users' attitudes toward COVID-19 vaccination. Barriers and promoters of vaccine uptake emerged in the second theme: concerns over the vaccine, excessive exposure to information, and a lack of clear guidance from institutions were the main factors behind hesitancy. The third theme highlighted users' information-seeking behaviors; vaccinators observed that users ideologically opposed to the vaccine (IOV) unconsciously seek information that confirms their theories. The last theme comprised communication strategies for dealing with hesitancy. Empathy, first-hand examples, transparency, and tailored communication style appear to be effective in building vaccine trust. Lastly, the impossibility of developing a decision-making partnership with IOVs was noticed. These findings may help to better characterize public attitudes toward COVID-19 vaccination and highlight key communication principles and strategies to foster vaccine confidence.
Increased influenza vaccination of healthcare workers at a pediatric cancer hospital: results of a comprehensive influenza vaccination campaign. [2018]A comprehensive influenza vaccination campaign improved vaccination rates among healthcare workers with direct patient care responsibilities from 45% during the 2003-2004 influenza season to 80% during the 2004-2005 season. A strategy of weekly feedback to unvaccinated employees was the most important factor in enhancing the rate of vaccination acceptance and was particularly effective among the nursing staff.
Primary Care Clinicians as COVID-19 Vaccine Ambassadors. [2022]The development of highly efficacious COVID-19 vaccines has brought a feeling of hope to many in the US (United States) and across the globe. However, it is estimated that approximately one-third of the US and international population are hesitant to receive the COVID-19 vaccine. For most Western countries with the economic means to purchase sufficient vaccine for their citizens, the medical community now has the opportunity to lead the vaccination communication campaign. Because frontline clinicians were the first to be vaccinated in the United States (US), they are uniquely positioned to be the most trusted source of vaccine information. Primary care clinicians, more than other groups of clinicians, scientists, government officials, media, etc. have the greatest chance for instilling confidence about the vaccine to their patients, including the most vulnerable and the most distrusting. They are considered credible and trustworthy allies for their patients in the US, however, clinicians receive little to no formal training in communication related to controversial topics, such as vaccine hesitancy. With the increasing worry about highly transmissible COVID-19 viral mutations and possible related vaccine resistance, it becomes even more critical to accelerate vaccination efforts across every community. Educating primary care clinicians regarding the importance of talking to their patients regarding their COVID-19 vaccination plans is essential.
Influenza Vaccination Quality Improvement as a Model for COVID-19 Prophylaxis. [2021]Many comparisons have been made on the effect and impact of COVID-19 on influenza pandemics of history. Therefore, it is reasonable to infer that the strategies utilized by healthcare providers to improve influenza vaccination rates can similarly be applied to the administration of a COVID-19 vaccine. The purpose of this study was to determine the rationale of low influenza vaccination rates in an urban allergy clinic and how to improve patient education and knowledge regarding the importance of influenza vaccination. A three-year comparison of interventions is presented as well as its application to future COVID-19 vaccinations.