Educational Video + Reminder Email for Pneumonia Vaccination

(PROPEL Trial)

Overseen By Cassandra Laurie, MSc

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Ottawa

Disqualifiers: Nursing home resident, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

720 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely, as the trial focuses on educational interventions for vaccination.

What data supports the idea that Educational Video + Reminder Email for Pneumonia Vaccination is an effective treatment?

The available research shows that educational interventions, like videos and reminders, can significantly increase vaccination rates. For example, in a skilled nursing facility, a structured vaccination initiative increased vaccine uptake from 28% to 66%. Additionally, a study in a hospital setting found that educational programs combined with decision support tools improved vaccination assessment rates from 0% to 96%. These examples suggest that educational videos and reminder emails can effectively boost vaccination rates. ^{1 2 3 4 5}

What safety data exists for the educational video and reminder email for pneumonia vaccination?

The provided research primarily focuses on the safety of pneumococcal vaccines themselves, rather than the educational video or reminder email interventions. The studies discuss adverse events following pneumococcal vaccination, safety of the 13-valent pneumococcal conjugate vaccine, and general vaccine safety monitoring. However, there is no specific safety data available for the educational video or reminder email interventions related to pneumonia vaccination. ^{6 7 8 9 10}

Is the web-based educational video on pneumococcal vaccination a promising treatment?

Yes, the web-based educational video on pneumococcal vaccination is promising because it can help increase awareness and understanding of the vaccine, which is often lacking among patients. By educating people, it can encourage more individuals to get vaccinated, potentially improving vaccination rates. ^{1 3 5 11 12}

What is the purpose of this trial?

The goal of this trial is to compare the effect of a web-based educational video about pneumococcal vaccines and a reminder email to get vaccinated (intervention) with a reminder email alone (comparator) in adults aged 65 or older living in any Canadian province who reported not having received a pneumococcal vaccine. The main questions this trial aims to answer are: 1. does the educational intervention improve pneumococcal vaccine uptake, 2. does the educational intervention improve willingness to be vaccinated, 3. does the educational intervention improve knowledge of pneumococcal vaccination, 4. and does the educational intervention improve attitudes towards pneumococcal vaccines/vaccination? Eligible participants who provide electronic consent will: 1. fill out a web-based baseline survey, 2. receive access to the educational video (if assigned to the intervention group), 3. receive an email reminder to be vaccinated (both groups), 4. and fill in a web-based follow-up survey.

Research Team

Giorgia Sulis, PhD

Principal Investigator

School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa

Eligibility Criteria

This trial is for adults aged 65 or older living in Canada who haven't had a pneumococcal vaccine and can understand English or French. It's not for those living in nursing homes.

Inclusion Criteria

I can understand English and/or French.

I live at home, not in a nursing home.

I have not received a pneumococcal vaccine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants fill out a web-based baseline survey to assess knowledge, barriers, facilitators, and willingness to receive the pneumococcal vaccine

1 week

1 online survey

Intervention

Participants receive access to the educational video (if assigned to the intervention group) and an email reminder to be vaccinated

Immediate

Follow-up

Participants fill in a web-based follow-up survey to evaluate changes in vaccine knowledge, attitudes, willingness, and uptake

4-6 months

1 online survey

Treatment Details

Interventions

• Reminder email to be vaccinated
• Web-based educational video on pneumococcal vaccination

Trial Overview The study tests if a web-based educational video on pneumococcal vaccines plus an email reminder increases vaccine uptake compared to just the email reminder. Participants will fill out surveys before and after the intervention.

Participant Groups

Group I: Web-based educational video on pneumococcal vaccination and reminder email to be vaccinated Active Control 2 Interventions

Group II: Reminder email to be vaccinated Placebo Group 1 Intervention

Web-based educational video on pneumococcal vaccination is already approved in Canada for the following indications:

Approved in Canada as Web-based educational video on pneumococcal vaccination for:

• Education on pneumococcal vaccination for adults aged 65 or older

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Recruited

267,000+

Findings from Research

A closed-loop informatics approach was implemented in the Emergency Department over a 6-week period, resulting in an increase in pneumococcal vaccination rates for patients aged 65 and older from 49.8% to 54.9%.

Out of 572 candidate patients, 28 received the vaccine during their ED visit, highlighting the challenges in patient and physician acceptance despite the improved vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of a closed-loop, computerized reminder system for pneumococcal vaccination in the emergency department. Dexheimer, JW., Jones, I., Waitman, R., et al.[2019]

Pneumococcal vaccination significantly reduces pneumonia-related readmission rates and mortality in patients aged 65 and older, with a 35% reduction in pneumonia and all-cause mortality observed with appropriate vaccination.

A structured vaccination initiative at a skilled nursing facility successfully increased pneumococcal vaccine uptake from 28% to 66%, demonstrating that tailored, evidence-based interventions can effectively enhance vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Rates of Pneumococcal Vaccination in a Skilled Nursing Facility. Helms, J., Reinbeck, D.[2022]

The implementation of a computerized reminder for pneumococcal vaccination at hospital discharge significantly increased vaccination rates from 3.4% to 45% among eligible patients, demonstrating its effectiveness in improving vaccine uptake.

Certain patient characteristics influenced vaccination rates, with those diagnosed with alcoholism being more likely to receive the vaccine, while those with cancer and patients under hematology-oncology or cardiology specialists were less likely, indicating a need for targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A strategy to improve the utilization of pneumococcal vaccine. Clancy, CM., Gelfman, D., Poses, RM.[2019]

A stepwise educational and decision support program significantly improved pneumococcal vaccination assessment rates for hospitalized patients with community-acquired pneumonia, increasing from 0% to 96%.

For patients over 65 years, the vaccination assessment rates rose dramatically, demonstrating that targeted interventions can effectively enhance compliance with vaccination best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming barriers to pneumococcal vaccination in patients with pneumonia. Scheurer, DB., Cawley, PJ., Brown, SB., et al.[2018]

A culturally appropriate patient education videotape combined with a low-literacy brochure significantly increased pneumococcal vaccination rates among a predominantly black, elderly population in an inner-city public hospital, with patients being 3.5 times more likely to receive the vaccine compared to the control group.

The study, which involved 558 participants, found that the combination of the videotape and brochure was crucial for enhancing discussions with physicians about the vaccine, highlighting the importance of comprehensive educational materials rather than relying solely on audiovisual content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education strategies to improve pneumococcal vaccination rates: randomized trial. Thomas, DM., Ray, SM., Morton, FJ., et al.[2018]

Out of 39,933 adverse event reports, 5,718 (7.0%) were linked to pneumococcal vaccines, with the most common adverse events being fever in children after pneumococcal polysaccharide vaccines (PPSVs) and injection-site reactions in adults.

The study identified 13 new adverse event signals related to PPSVs, including four that were not listed on vaccine labels, highlighting the need for further research to validate these findings, especially in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signal Detection of Adverse Events Following Pneumococcal Vaccines from the Korea Adverse Event Reporting System Database, 2005-2016. Kim, KS., Oh, IS., Kim, HJ., et al.[2020]

A meta-analysis of safety data from 13 studies involving 4729 infants receiving the 13-valent pneumococcal conjugate vaccine (PCV13) and 2760 receiving the 7-valent vaccine (PCV7) showed that both vaccines had similar rates of local reactions and systemic events, indicating comparable safety profiles.

PCV13 demonstrated a favorable safety profile, with no clinically significant differences in adverse events compared to PCV7, which has over 10 years of clinical experience, suggesting that PCV13 is a safe option for routine immunization in infants and young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 13-valent pneumococcal conjugate vaccine in infants and children: meta-analysis of 13 clinical trials in 9 countries. Thompson, A., Gurtman, A., Patterson, S., et al.[2015]

Vaccine safety is rigorously monitored, with comprehensive systems in place to differentiate between adverse events that occur after vaccination and those caused by the vaccine itself.

The article highlights international vaccine withdrawals due to safety concerns and recent advancements in safety monitoring, emphasizing the commitment to ensuring vaccine safety and addressing vaccine hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine safety. Reid, S.[2020]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

The study found a significantly higher rate of adverse events following immunization (AEFI) in children aged 0-10 years in the Czech Republic, with a rate of 209 per 100,000 doses, compared to the official report of 34 per 100,000 doses.

Most AEFI were mild and non-serious, such as local redness and fever, typically occurring two days post-vaccination and lasting about four days, highlighting the need for better public education on reporting these events to improve vaccine safety and confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance study of adverse events following immunisation of children in the Czech Republic. Danova, J., Kocourkova, A., Celko, AM.[2022]

Physicians generally believe that the pneumococcal polysaccharide vaccine (PPV) is safe and effective, but they face challenges such as difficulty in determining patients' vaccination status and a lack of knowledge about re-vaccination, which hinder vaccination rates.

Patients often lack awareness of the PPV and many do not remember being informed or recommended to receive the vaccine by their doctors, contributing to low vaccination rates and racial disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult pneumococcal vaccination: a review of physician and patient barriers. Mieczkowski, TA., Wilson, SA.[2019]

An integrated information technology system in the emergency department (ED) increased pneumococcal vaccination rates from 38.8% to 45.4% among eligible patients aged 65 and older, demonstrating its effectiveness in a challenging healthcare setting.

Of the 2062 eligible patients, only 30.1% consented to vaccination, and despite physician prompts for 68.9% of these patients, 30.9% of physicians declined to order the vaccine, highlighting the need for improved clinician engagement in vaccination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized pneumococcal vaccination reminder system in the adult emergency department. Dexheimer, JW., Talbot, TR., Ye, F., et al.[2021]

References

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

Prospective evaluation of a closed-loop, computerized reminder system for pneumococcal vaccination in the emergency department. [2019]

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

Improving Rates of Pneumococcal Vaccination in a Skilled Nursing Facility. [2022]

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

A strategy to improve the utilization of pneumococcal vaccine. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Overcoming barriers to pneumococcal vaccination in patients with pneumonia. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Patient education strategies to improve pneumococcal vaccination rates: randomized trial. [2018]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Signal Detection of Adverse Events Following Pneumococcal Vaccines from the Korea Adverse Event Reporting System Database, 2005-2016. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of 13-valent pneumococcal conjugate vaccine in infants and children: meta-analysis of 13 clinical trials in 9 countries. [2015]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Vaccine safety. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Active surveillance study of adverse events following immunisation of children in the Czech Republic. [2022]

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

Adult pneumococcal vaccination: a review of physician and patient barriers. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A computerized pneumococcal vaccination reminder system in the adult emergency department. [2021]