Telehealth Education for Vaccine Hesitancy

Overseen By Sara Al-Dahir, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Xavier University of Louisiana.

Disqualifiers: Completed COVID-19 vaccine, Allergy, Immunosuppressive conditions, Congestive heart failure, Cardiac arrhythmia

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

Compensation: Varies

Number of Visits: 3

360 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a 24-30 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run telehealth education focused on wellness and vaccination. Individuals will be randomized to either a wellness only model focusing on nutrition, diabetes and hypertension or a wellness model with a vaccination education component. All participants will complete individual and group based interventions. Individuals will be recruited from industries with high risk for COVID-19 and other respiratory illness infection, such as health workers, teachers aides and the food industry. We are recruiting individuals who identify as African-American, Hispanic, come from a semi-rural/rural community or have additional social determinants of health that indicate social vulnerability. The primary outcome is COVID-19 vaccine completion. The secondary outcome is influenza vaccine completion.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education about vaccines and wellness, so it's unlikely that you would need to change your medication routine.

What data supports the effectiveness of the treatment Telehealth Education for Vaccine Hesitancy?

Research shows that telehealth and internet-based education programs can improve health outcomes and user satisfaction in various clinical settings. These programs have been effective in increasing patient engagement and improving practices, suggesting potential benefits for addressing vaccine hesitancy through telehealth education. ^{1 2 3 4 5}

How does the Telehealth Education for Vaccine Hesitancy treatment differ from other treatments for vaccine hesitancy?

This treatment is unique because it uses telehealth (remote healthcare services) to provide education and support, which can be more accessible and convenient for patients compared to traditional in-person interventions. It combines wellness education with specific vaccination information, potentially addressing both general health concerns and specific vaccine hesitancy in a comprehensive manner. ^{6 7 8 9 10}

Research Team

Sara Al-Dahir, PhD

Principal Investigator

Xavier University of Louisiana.

Klaus Heyer, PhD

Principal Investigator

Nunez Community College

Eligibility Criteria

This trial is for adults aged 18-55 working in high-risk industries like healthcare, education, and food service. Participants should have incomplete COVID-19 or flu vaccinations, speak English, and be able to use telehealth tech. Those with severe allergies to vaccines, certain heart conditions, immunosuppressive diseases, or who've completed their COVID-19 vaccine series can't join.

Inclusion Criteria

Able to use Telehealth technology via tablet, cell phone, or computer

I am between 18 and 55 years old.

Able to speak English

Exclusion Criteria

I have been diagnosed with congestive heart failure.

I have been diagnosed with an irregular heartbeat.

Individuals with documented allergy or reaction to COVID-19 or influenza vaccine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive telehealth interventions focusing on wellness, with one arm also receiving vaccination education and counseling

24-30 months

Minimum of 3 individual visits and group informational visits

Follow-up

Participants are monitored for vaccine completion and changes in vaccine hesitancy

1 year

Treatment Details

Interventions

• Telehealth: Wellness and Vaccination
• TeleHealth: Wellness Only

Trial Overview The study tests a telehealth program run by clinical pharmacists focusing on wellness and vaccination education. Participants will either learn about general wellness or wellness plus vaccination over a period of up to 30 months through individual and group sessions. The goal is to see if this increases vaccine completion rates among at-risk workers.

Participant Groups

Group I: Telehealth Arm: Wellness with Vaccine Education Experimental Treatment 1 Intervention

Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. In addition, they will complete education and counseling on vaccination. All educations will be completed one-on-one as well as small group.

Group II: Telehealth Arm: Wellness Only Active Control 1 Intervention

Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. All educations will be completed one-on-one as well as small group.

Who Is Running the Clinical Trial?

Xavier University of Louisiana.

Lead Sponsor

Trials

9

Recruited

2,700+

Findings from Research

Professionally facilitated Internet-based health programs can moderately improve health outcomes and user satisfaction for certain clinical populations, indicating their potential effectiveness.

However, there is a need for a stronger evidence base to support the broader implementation of these eHealth applications in patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based patient education and support interventions: a review of evaluation studies and directions for future research. Nguyen, HQ., Carrieri-Kohlman, V., Rankin, SH., et al.[2022]

A systematic review of 52 studies on ECHO and ECHO-like tele-education models found that while providers reported increased satisfaction, knowledge, and clinical confidence, the overall quality of evidence was low due to reliance on self-reports and surveys.

For patient-related outcomes, evidence suggested some effectiveness in improving care for conditions like hepatitis C and type 2 diabetes, but most studies were non-randomized and retrospective, highlighting the need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Project ECHO Models of Medical Tele-Education: a Systematic Review. McBain, RK., Sousa, JL., Rose, AJ., et al.[2021]

The Project ECHO model has effectively expanded access to specialized cancer care over the past 10 years, with a review of 25 studies showing widespread participation and improved learning among healthcare providers.

Nearly half of the studies indicated that ECHO programs led to changes in provider practices, particularly in areas like HCV vaccination and palliative care, suggesting the model's potential to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project ECHO for Cancer Care: a Scoping Review of Provider Outcome Evaluations. Arora, S., Brakey, HR., Jones, JL., et al.[2023]

Caregivers who participated in a 6-week telehealth wellness program reported feeling more prepared for their caregiving roles, highlighting the importance of self-maintenance strategies and the normalization of their experiences through group support.

Despite some challenges with technology, participants found the telehealth format beneficial for learning and building relationships, suggesting that telehealth can effectively increase access to health promotion programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver Perceptions of a Telehealth Wellness Program. Serwe, KM., Hersch, GI., Pickens, ND., et al.[2018]

The eHealth intervention was delivered with high fidelity, with 93% of participants receiving initial training and 98.45% of expected follow-ups conducted, indicating strong program adherence.

Despite high engagement from 40.4% of users over 12 months, increased usage did not lead to significant improvements in clinical outcomes or lifestyle changes, suggesting that simply using the intervention more frequently does not guarantee better health results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. Coorey, G., Peiris, D., Scaria, A., et al.[2021]

Vaccine hesitancy is recognized by the World Health Organization as a major global health threat, necessitating effective strategies to address it.

The AIMS approach (Announce, Inquire, Mirror, and Secure) is a training method for healthcare professionals that aims to improve communication with hesitant patients, fostering trust and potentially increasing vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AIMS approach: regulating receptivity in patient-provider vaccine conversations. Parrish-Sprowl, J., Thomson, A., Johnson, RD., et al.[2023]

A survey of pharmacists in Alaska identified unmet training needs related to vaccine hesitancy, which is crucial for improving vaccine confidence and increasing vaccination rates.

An expert panel developed a tailored training program for pharmacy professionals, emphasizing adult-learning strategies and real-world examples to effectively address vaccine hesitancy among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pandemic response in Alaska: Preparing pharmacists to lead vaccination efforts. Robinson, R., Young, A., Wagner, R., et al.[2023]

A quality improvement project involving 70 participants successfully identified vaccine hesitancy (VH) using the Parent Attitudes about Childhood Vaccines survey, leading to targeted interventions.

After the intervention, 81.8% of participants who were initially hesitant about vaccines no longer showed hesitancy, indicating that routine screening and targeted interventions can significantly improve vaccine compliance (p = .004).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine Hesitancy in Rural Pediatric Primary Care. Mical, R., Martin-Velez, J., Blackstone, T., et al.[2021]

An educational intervention at Wright-Patterson Air Force Base successfully reduced COVID-19 vaccine hesitancy among 500 participants, with 36% of initially hesitant individuals becoming receptive to vaccination after the seminar.

Trust in healthcare providers significantly influenced the change in vaccine intent, highlighting that building trust can be crucial in addressing vaccine hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Education Intervention on COVID-19 Vaccine Hesitancy in a Military Base Population. Li, PC., Theis, SR., Kelly, D., et al.[2022]

Vaccine hesitancy (VH) is characterized by a delay in acceptance or outright refusal of vaccines, even when vaccination services are readily available.

Understanding the factors contributing to vaccine hesitancy is crucial for improving vaccination rates and public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mass Immunization and Vaccine Hesitancy in Children and Their Families: A Long and Winding Road Ahead to Address without a Second Thought. Gori, D., Montalti, M., Guaraldi, F.[2021]

References

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

Internet-based patient education and support interventions: a review of evaluation studies and directions for future research. [2022]

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

Impact of Project ECHO Models of Medical Tele-Education: a Systematic Review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Project ECHO for Cancer Care: a Scoping Review of Provider Outcome Evaluations. [2023]

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

Caregiver Perceptions of a Telehealth Wellness Program. [2018]

5. Canada pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The AIMS approach: regulating receptivity in patient-provider vaccine conversations. [2023]

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

Pandemic response in Alaska: Preparing pharmacists to lead vaccination efforts. [2023]

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

Vaccine Hesitancy in Rural Pediatric Primary Care. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Impact of an Education Intervention on COVID-19 Vaccine Hesitancy in a Military Base Population. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Mass Immunization and Vaccine Hesitancy in Children and Their Families: A Long and Winding Road Ahead to Address without a Second Thought. [2021]