Communication Strategies for COVID-19 and Flu Vaccination Rates

Overseen By Lila J Rutten, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 19, Not empaneled

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the number of adults vaccinated against COVID-19 and the flu. It will test two methods: sending patients a letter with strong vaccination recommendations and reminders, and emailing clinicians monthly to encourage patient vaccinations during visits. The trial will compare vaccine rates in clinics using both methods versus those that do not. Adults receiving primary care at one of eight Mayo Clinic locations who have not been vaccinated for COVID-19 or flu might be suitable candidates. As an unphased trial, this study allows participants to contribute to improving public health strategies for increasing vaccination rates.

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 prior data suggests that these communication strategies are safe and effective?

Research has shown that clear communication from doctors can significantly increase vaccine uptake. One study emphasized that a strong recommendation from doctors persuaded more people to get vaccinated against COVID-19. This study also found that messages about protecting others were particularly effective.

Both the COVID-19 and flu vaccines have undergone thorough testing. They are widely used and recommended for adults, indicating they are generally well-tolerated with known safety profiles. Most side effects, such as sore arms or mild fevers, are minor and temporary.

The strategies tested in this trial, such as sending letters and emails, aim to improve communication. They pose no safety risks themselves but focus on encouraging people to receive these already safe vaccines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial's approach to boosting COVID-19 and flu vaccination rates because it focuses on enhancing communication strategies, which is a shift from traditional methods like vaccine reminders or public service announcements. Unlike standard practices, this study uses a combination of personalized patient letters and clinician email prompts to encourage stronger vaccine recommendations. This dual communication strategy aims to create a more persuasive and personalized dialogue between healthcare providers and patients, potentially leading to higher vaccination uptake. By focusing on communication rather than just the vaccines themselves, this trial could uncover new ways to improve public health outcomes.

What evidence suggests that this trial's communication strategies could be effective for increasing COVID-19 and flu vaccination rates?

This trial will evaluate the effectiveness of communication strategies on vaccination rates. Research has shown that sending just one written message can increase flu vaccination rates by 16% compared to no outreach. In this trial, one group will receive both a patient letter and clinician communication to encourage vaccination. Effective communication from doctors and nurses leads to better health outcomes for patients. Studies have also shown that flu vaccines reduce the risk of serious illness by 40% to 60% on average. Simple reminders, such as electronic nudges, have increased vaccination rates. Together, these methods help more people get vaccinated against the flu and COVID-19. ^{2 6 7 8 9}

Who Is on the Research Team?

Lila J. Rutten, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Clinician communication
• Patient letter

Trial Overview The 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.

How Is the Trial Designed?

Group I: Patient letter and clinician communication Experimental Treatment 1 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 intervention Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

ModernaTX, Inc.

Industry Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

A study analyzing 100 pre-Covid and 58 peri-Covid plastic surgery clinic letters found that the readability levels were too high for the general population, with median U.S. grade scores ranging from 9 to 13.2, indicating that many patients may struggle to understand the information provided.

Despite an increase in direct-to-patient communication from 8% to 28% during the Covid-19 pandemic, there was no significant improvement in the readability of these letters, suggesting a need for better standardization and awareness of readability in patient correspondence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Readability of Outpatient Plastic Surgery Clinic Letters: Are We Adhering to Plain English Writing Standards? Drury, DJ., Kaur, A., Dobbs, T., et al.[2021]

Traditional methods of communicating medical information, especially regarding COVID-19, are becoming less effective, highlighting the need for alternative communication methods like podcasts and social media.

Using storytelling techniques in medical communication can enhance the physician-patient relationship, leading to increased patient satisfaction and compliance with treatment, while also helping physicians better understand their patients' concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Physician's Toolkit: Integrating Storytelling in Medical Practice. Ghosh, AK., Joshi, S.[2021]

Effective patient-clinician communication significantly influences health outcomes, as evidenced by extensive research over the past 75 years, highlighting its importance in medical practice.

Key communication skills, such as agenda-setting and ensuring patient understanding, not only improve treatment efficacy but also enhance patient satisfaction and reduce the likelihood of legal issues following adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The secret of the care of the patient is in knowing and applying the evidence about effective clinical communication. Frankel, RM., Sherman, HB.[2016]

A novel data mining pipeline was used to analyze a large dataset of 553,682 individuals to compare adverse events between COVID-19 and influenza vaccines, revealing that the COVID-19 vaccine has a similar rate of adverse events as the influenza vaccine.

The study identified 20 potential COVID-19 vaccine-related adverse events that warrant further investigation, highlighting the importance of ongoing monitoring for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data Mining Pipeline for COVID-19 Vaccine Safety Analysis Using a Large Electronic Health Record. Huang, Y., Li, X., Dongarwar, D., et al.[2023]

A comprehensive influenza vaccination campaign significantly increased vaccination rates among healthcare workers from 45% in the 2003-2004 season to 80% in the 2004-2005 season.

Providing weekly feedback to unvaccinated employees was the key strategy that boosted vaccination acceptance, especially among nursing staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased influenza vaccination of healthcare workers at a pediatric cancer hospital: results of a comprehensive influenza vaccination campaign. McCullers, JA., Speck, KM., Williams, BF., et al.[2018]

A qualitative study involving 30 COVID-19 vaccinators in Tuscany identified key barriers to vaccine uptake, including concerns about the vaccine, overwhelming information, and unclear guidance from health authorities, which contributed to vaccine hesitancy.

Effective communication strategies to build trust in vaccines included using empathy, sharing personal experiences, being transparent, and adapting communication styles to individual needs, although it was noted that engaging with those ideologically opposed to the vaccine was particularly challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating with Patients about COVID-19 Vaccination: A Qualitative Study on Vaccinators in Tuscany Region, Italy. Alderotti, G., Corvo, MF., Buscemi, P., et al.[2023]

A study comparing patient perceptions of provider communication during COVID and non-COVID diagnoses revealed shared themes, such as inconsistent communication and variable education, but also highlighted significant differences in care quality and timeliness, particularly for COVID patients.

COVID patients reported feelings of provider gratitude and consistent education, yet experienced challenges with the quality of care and timeliness, indicating that the pandemic has notably impacted patient-provider relationships and overall satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of COVID-19 on Patient Experience Within a Midwest Hospital System: A Case Study. Drapeaux, A., Jenson, JA., Fustino, N.[2021]

In two studies analyzing physician-patient interactions, the goal of reducing patient distress was consistently linked to improved outcomes, suggesting its importance in communication during healthcare visits.

While all five communication goals (providing information, reducing distress, increasing patient satisfaction, increasing adherence, and encouraging hope) showed positive relationships with outcomes, prioritizing distress reduction may lead to particularly beneficial results for both patients and physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Physicians' Communication Goals During Patient Interactions. Hua, J., Howell, JL., Sweeny, K., et al.[2021]

A systematic review of 28 randomized controlled trials found that sending a single written message to individuals significantly increased influenza vaccine uptake by 16% compared to no contact, indicating that direct communication can effectively encourage vaccination.

The effectiveness of this intervention was consistent across various types of correspondence, age groups, and locations, suggesting it could be a valuable strategy for public health authorities to enhance vaccination rates for both influenza and potentially COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of influenza vaccination following correspondence: Considerations for COVID-19. Murphy, RP., Taaffe, C., Ahern, E., et al.[2022]

Approximately one-third of the population in the US and globally is hesitant to receive the COVID-19 vaccine, highlighting a significant barrier to achieving widespread vaccination.

Primary care clinicians are seen as the most trusted sources of vaccine information and play a crucial role in addressing vaccine hesitancy, yet they often lack formal training in effective communication strategies for discussing controversial topics like vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Clinicians as COVID-19 Vaccine Ambassadors. Katzman, JG., Katzman, JW.[2022]

A quality improvement initiative at an allergy clinic in New York City significantly increased influenza vaccination rates from 9.25-13.60% to 91.34% by addressing vaccine hesitancy and improving patient education.

The study highlights the importance of implementing standardized protocols and shared decision-making to enhance vaccination rates, which can be applied to future COVID-19 vaccination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influenza Vaccination Quality Improvement as a Model for COVID-19 Prophylaxis. Chin, J., Zhou, Y., Chen, CL., et al.[2021]

Despite high vaccination rates in the U.S., 85% of healthcare providers encounter vaccine refusal from parents each year, highlighting the need for effective communication strategies.

Healthcare providers can significantly influence vaccine-hesitant parents by engaging in open dialogues, addressing concerns, and sharing personal stories about vaccine-preventable diseases to reinforce the importance of immunization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to communicate with vaccine-hesitant parents. Healy, CM., Pickering, LK.[2022]

A survey of 433 physicians and 1,000 American adults revealed a significant disagreement on the timing of medical safety communications, with physicians generally opposing early signal postings while the public favored them.

Over 25% of the public indicated they would stop taking their medication if they found it listed on the FDA's Adverse Event Reporting System, highlighting the need for better communication strategies that consider public perception and understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transparency and the Food and Drug Administration--a quantitative study. Lofstedt, R., Bouder, F., Chakraborty, S.[2013]

A survey of U.S. healthcare providers revealed that while 71% were aware of the Vaccine Adverse Event Reporting System (VAERS), only 17% of those who identified adverse events following immunization (AEFI) actually reported them, indicating a significant gap in reporting practices.

Factors such as unfamiliarity with the reporting process and the type of medical practice (internal medicine vs. pediatrics) were associated with lower reporting rates, suggesting that targeted educational interventions could enhance vaccine safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? McNeil, MM., Li, R., Pickering, S., et al.[2018]

Healthcare professionals are ethically and legally required to report any suspected adverse events from vaccinations to national agencies like the Vaccine Adverse Event Reporting System (VAERS), which helps monitor vaccine safety.

Data from VAERS and other reporting systems indicate that the rates of adverse events from approved SARS-CoV-2 vaccines are very low, supporting the safety of these vaccines and suggesting that this monitoring approach could be useful for future vaccines against other zoonotic infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: What Can be Learned from National and International Vaccine Adverse Event Reporting Systems During the COVID-19 Pandemic? Parums, DV.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8592234/

A meta-analysis of influenza vaccination following ... A formal meta-analysis shows that sending a single written message increased influenza vaccine uptake by 16%, relative to the no contact comparator group.

2. withpower.com withpower.com/trial/phase-covid-19-9-2024-d754b?condition=flu&ageList=65&overallStatus=Recruiting&hasNoPlacebo=false

Communication Strategies for COVID-19 and Flu ... Research shows that effective clinician communication, including setting communication goals and reducing patient distress, leads to better patient outcomes and ...

3. publichealthcollaborative.org publichealthcollaborative.org/communication-tools/communicating-about-flu-and-covid-19-vaccination-in-2025-26/

Communicating About Flu and COVID-19 Vaccination in ... Seasonal flu vaccine effectiveness studies show that flu vaccination, on average, reduces the risk of serious illness by 40% to 60%. Vaccines ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2824956

Electronic Nudges to Increase Influenza Vaccination in ... This randomized clinical trial evaluates whether behaviorally informed electronically delivered letter-based nudges could increase influenza ...

5. jmir.org jmir.org/2022/10/e38710/

Influence of Digital Intervention Messaging on Influenza ... The vaccination rate was 13 percentage points higher among participants who completed all 6 intervention messages versus none, and at least 2 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9523946/

Impact of a physician recommendation on COVID-19 ... An explicit recommendation and “protect others” message appear to be important elements of a physician recommendation for COVID-19 vaccination.

7. cdn.who.int cdn.who.int/media/docs/default-source/covid-19-vaccines-safety-surveillance-manual/training-slides_covid-19_vs_communication.pdf

COVID-19 vaccine safety communication To empower people to make evidence-informed choices about COVID-19 vaccination. Encourage trust in health authorities and those delivering the vaccine.

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/142817/cdc_142817_DS1.pdf

Building Confidence in COVID-19 Vaccines Among Your ... Talk about your personal decision and experience in getting a COVID-19 vaccine and your experience treating COVID-19 patients. Enabling them to get back to ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05244356

Health Communication to Influence COVID-19 Vaccination ... Message content describing a risky choice frame that compares the incidence rates of blood clots occurring with COVID-19 vaccination versus contracting COVID- ...