Communication Strategies for COVID-19 and Flu Vaccination Rates

Recruiting in Palo Alto (17 mi)

Overseen by Lila J. Rutten, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Under 19, Not empaneled

No Placebo Group

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. ^{1 2 3 4 5}

Is the communication strategy for increasing COVID-19 and flu vaccination rates safe for humans?

The research does not provide specific safety data for communication strategies like Clinician communication or Patient letter, but it does highlight the importance of effective communication in addressing vaccine hesitancy and ensuring vaccine safety awareness. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Research Team

Lila J. Rutten, PhD

Principal Investigator

Mayo Clinic

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 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.

Participant Groups

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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

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

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Impact of COVID-19 on Patient Experience Within a Midwest Hospital System: A Case Study. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

The Readability of Outpatient Plastic Surgery Clinic Letters: Are We Adhering to Plain English Writing Standards? [2021]

4. England pubmed.ncbi.nlm.nih.gov

Outcomes of Physicians' Communication Goals During Patient Interactions. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Enhancing Physician's Toolkit: Integrating Storytelling in Medical Practice. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Data Mining Pipeline for COVID-19 Vaccine Safety Analysis Using a Large Electronic Health Record. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

How to communicate with vaccine-hesitant parents. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Transparency and the Food and Drug Administration--a quantitative study. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? [2018]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Netherlands pubmed.ncbi.nlm.nih.gov

A meta-analysis of influenza vaccination following correspondence: Considerations for COVID-19. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Communicating with Patients about COVID-19 Vaccination: A Qualitative Study on Vaccinators in Tuscany Region, Italy. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Increased influenza vaccination of healthcare workers at a pediatric cancer hospital: results of a comprehensive influenza vaccination campaign. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Primary Care Clinicians as COVID-19 Vaccine Ambassadors. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Influenza Vaccination Quality Improvement as a Model for COVID-19 Prophylaxis. [2021]