CONSENT FORM

ATTENTION: Please note we are currently in the testing phase of this project. In this phase, participation involves filling out the initial survey. You will not have access to the intervention or the follow-up survey.

Principal investigator: Dr. Giorgia Sulis, MD PhD
School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa
gsulis@uottawa.ca

Invitation to participate: You are invited to participate in the abovementioned research study conducted by Dr. Giorgia Sulis. This study is funded by the Canadian Immunization Research Network (CIRN).

Purpose of the study: The purpose of the study is to learn from people aged 65 or older about their experiences, attitudes, and beliefs about pneumococcal vaccines (pneumonia shot), as well as to assess their willingness to be vaccinated and actual vaccine uptake. We want to measure how participation in an intervention may change these outcomes. Your participation in the study is completely voluntary and you can refuse to participate or withdraw from the study at any time.

About the study: Pneumococcal disease is an infection caused by a type of bacteria called pneumococcus. This bacterium can cause infections in different parts of the body, including in the ear, sinuses, lung, blood, and in the lining of the brain and spinal cord. Preventing pneumococcal disease is a top public health priority in Canada and globally, not only to reduce serious infections caused by these bacteria but to also reduce resistance to antibiotics. People aged 65 years and older are at increased risk of hospitalization and death from pneumococcal disease, with significant health and economic costs associated with the disease. There are safe and effective vaccines available against pneumococcal disease, such as Prevnar13® and Pneumovax®. Our goal is to improve the knowledge, attitudes, willingness, and actual uptake of the pneumococcal vaccine among older adults who live at home, and who are at highest risk of severe outcomes associated with pneumococcal disease.

Participation: Your participation will consist of the following tasks. You will be assigned to either watch a short video and receive a reminder e-mail to get vaccinated or a reminder e-mail alone. The steps involved are 1) fill in a screening questionnaire to assess if you are eligible, 2) fill out the first web-based survey, 3) watch a web-based video (if assigned to the intervention group), 4) read an email with a reminder to be vaccinated (1 month later), 5) and fill in a follow-up survey (6 months later). If upon completion of one of the surveys, you express interest in being contacted by the research team, you might also be selected for a brief telephone interview to get more insights about your experience with pneumococcal vaccines and your participation in the study.

Accommodation to participate:

  • If you would like to participate but have difficulty completing the survey yourself, a caregiver can assist you.

Risks: There is minimal risk with participation in this study. If you feel discomfort or experience stress about certain topics being asked, you may decline to answer any question for any reason at any time.

Benefits: If the research improves pneumococcal vaccine uptake among older adults, this will reduce the risk of pneumococcal-related disease and help to curb the spread of antibiotic resistance, leading to a decrease in health-related and economic costs. By promoting vaccine literacy and confidence, our research will also help make progress towards the achievement of the pneumococcal vaccination coverage goal established by the Government of Canada for all adults aged 65 and older.

Confidentiality and privacy: Your name will not be recorded and the results from this study will not be linked to you. Any personal information you provide will be kept strictly confidential and we will abide by the federal, provincial, and local laws, rules and regulations that protect your confidentiality and privacy. In order to minimize the risk of security breaches and to help ensure your confidentiality, it is recommended that you use standard safety measures, such as signing out of your account, closing your browser, and locking your device when you are no longer using it/when you have completed the study.

Conservation of data: The data collected (electronic consent forms, the screening survey, the baseline and follow-up surveys, and the interview transcripts) will be stored in a secure database and will be only accessible to the study team. The data will be stored for a minimum of 5 years.

Voluntary participation: You are under no obligation to participate and if you choose to participate, you can withdraw from the study at any time and/or refuse to answer any questions, without suffering any negative consequences. If you choose to withdraw, all data gathered until the time of withdrawal will be removed from the dataset and not used in the study.

Contacts for study questions or problems: If you would like any further information regarding this research project or your participation in the study, you may contact Dr. Sulis’s team, at propel_study@uottawa.ca. The ethical components of the project were approved by the Health and Sciences and Science Research Ethics Board as study # H-09-23-9475 and complies with the Tri-Council Policy Statement for Research Involving Humans (TCPS2) and the Declaration of Helsinki. If you have any concerns about the ethical conduct of this study, you can contact the Office of Research Ethics and Integrity via email (ethics@uottawa.ca) or telephone (613-562-5387). It is recommended that you save a copy of this consent form for your records.

Please indicate if you consent to participate in the study:
I have read the Information and Consent Form. After considering the information provided, I consent to participate in this research project.

Initials:
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Date:

At the end of the study, with your consent, your responses to the survey may be made publicly available in a scientific repository, such as the uOttawa (University of Ottawa) Dataverse, through which researchers from around the world will have data for future research. Your email and other personal identifiers will not be deposited.

Please indicate if you consent to have your data deposited: