The Mental Health and Wellbeing of Unpaid Caregivers: An Intersectionality-Informed Mixed Methods Study
Principal Investigators: Parry M, Beleno R (Lived Experience Representative), Nissim R, Peter E.
Co-Investigators: Baiden D, Baxter P, Betini R, Bjørnnes AK, Burnside H, Gaetano D (Lived Experience Representative), Hemani S, McCarthy J, Nickerson N (Lived Experience Representative), Norris C, Nylén-Eriksen M, Pilote L, & Warkentin K (Lived Experience Representative). Collaborators and Partners: Brennenstuhl S, Ontario Caregiver Organization, Council for Agencies Serving South Asians (CASSA), Ye Hong Centre for Geriatric Care, Canadian Cancer Society, Mohammed S, Canadian Black Policy Network, Mental Health Commission of Canada, Caregivers Nova Scotia, Wu W.
Funding: Canadian Institutes of Health Research Project Grant: Fall 2021 and Spring 2022 – Patient Oriented Research Priority Announcement
Background: Unpaid caregiving is a public health issue of increasing importance in Canada. Almost one-third of Canadians provide unpaid personal, psychological, physical, social and financial care to someone with a long-term health condition, a disability, or with increased needs due to aging. It is absolutely essential to understand the unpaid caregiver experiences of racial and ethnic minority populations in Canada. One out of five people in Canada is born elsewhere; the 3 largest visible ethnic groups are South Asians, Chinese and Blacks – representing 60% of the Canadian racial and ethnic populations.
Objective: To describe the intersections of race and ethnicity, sex, age, and gender in the assessment of the health and wellbeing in unpaid caregivers across Canada.
Methods: This study uses a cross-sectional survey design. A sample of unpaid caregivers over 18 years of age will be recruited. For our study, an unpaid caregiver is defined as a person who provides care services to an adult greater than 18 years of age in need of care in the home without financial compensation. Services can include assistance with transportation, meal preparation and clean-up, house cleaning and maintenance, laundry, personal care, and managing finances. Exclusions include caregivers who are paid with money to deliver care (e.g., nurse, personal support worker, physician, etc.). Unpaid caregivers will be recruited through established methods (e.g., email listservs, newsletters etc.) used by our collaborators (e.g., Church of Pentecost, Pentecost International Worship Centre, Council for Agencies Serving South Asians (CASSA), Yee Hong Centre for Geriatric Care, and partner organizations (e.g., Mental Health Commission of Canada, Ontario Caregiver Organization, Caregivers Nova Scotia, and the Canadian Black Policy Network). Our target number of surveys is 525. We will ensure a diverse sample and continue our recruitment until we have achieved a target of 315 respondents from racial and ethnic populations (i.e., 60% South Asian, Chinese, Black). Social media and a study webpage will also be used for recruitment. Our partners with lived experience (caregivers) will form an Engagement Advisory Committee and they will participate in the development of videos for the study webpage. Interested participants will be directed to the study webpage to learn more about the study.
The Mental Health and Wellbeing of Unpaid Caregivers in Canada: Advancing Intersectionality for Health Equity in Priority Communities
Principal Investigators: M. Parry, E. Peter
Co-Investigators: Abejirinde I, Baiden D, Baxter P, Betini R, Bjoernnes AK, Dev R, Hemani S, Nissim R, Norris C, Pham Q, Pilote L, Singh L, Wright V. Collaborators: Chow C (Yee Hong Centre for Geriatric Care), Hassan S (CASSA), Mohammed S, Seth G, Shou S, Tunji-Ajayi L (SCAGO), Wu W.
Funding: CIHR Project Grant Fall 2024 and Spring 2025 Competition, Sex and Gender in Health Research Priority Announcement
About: This study will include a sample of 20 to 40 unpaid caregivers who completed the Phase 2a survey. These caregivers will be invited to participate in our qualitative interviews. This will include caregivers with fair/poor wellbeing (as determined by their Phase 2a survey) and good/excellent wellbeing, including a representative sample related to race and ethnicity and those with diverse gender identities.
Objectives: To explore caregiving experiences and to examine the broader contexts of fair/poor and good/excellent wellbeing in unpaid caregivers.This will inform questions to better explain caregiver wellbeing across the intersections of race and ethnicity, sex, age, and gender
The Mental Health and Wellbeing of Unpaid Caregivers in Canada: An Intersectionality-Informed Study
Principal Investigators: M. Parry/University of Toronto
Funding: Petro-Canada CareMakers Foundation (Philanthropic)
About: We will conduct semi-structured interviews and a consensus meeting with key stakeholders to provide new insights and suggest innovative solutions (i.e., tools/resources, policies) aimed to alleviate the systematic challenges faced by unpaid/family caregivers across Canada. We anticipate both short-term (end-of-grant) and long-term Knowledge Translation and Exchange (KTE) activities to be identified at the consensus meeting. Short-term KTE activities will be outputs of this 1-year funded grant application and the identified long-term KTE activities will inform a future grant application.
Objectives: To explore caregiving experiences and to examine the broader contexts of fair/poor and good/excellent wellbeing in unpaid caregivers.This will inform questions to better explain caregiver wellbeing across the intersections of race and ethnicity, sex, age, and gender.
CROWNING US: Cardiovascular Risk AcrOss the Lifespan with WomeN, INtersex, Gender Diverse and other Under-Served People in Canada
Principal Investigators: M. Parry (NPA), K.A. Mullen (Co-PI)
Co-Investigators: Abejirinde I, Allana S, Baiden D, Colella T, Goodenough C, Haagaard A, Jaffer S, Mallory R, Monaghan J, Robert H, Wright V.
Funding: CIHR Planning and Dissemination Grant
About: The post-2015 development agenda of the United Nations sets targets for 17 Sustainable Development Goals (SDG, 2015-2030). Within these goals is a focus on physical and mental health and wellbeing, extending healthy life expectancy for all, including access to quality health care and the primordial and primary prevention of non-communicable diseases, including cardiovascular disease. This project specifically focuses on Sustainable Development Goal #17 – Partnerships. We will recruit across all three key life stages (early life, reproductive years, and post-menopause) to address existing cardiovascular disease risk knowledge gaps through theory-driven research conducted with women, intersex, gender diverse and other under-served people living in Canada.
Objectives: The five objectives of this project are to: 1) accelerate sex- and gender-specific cardiovascular risk knowledge (i.e., knowledge dissemination), 2) increase regional and national community/PWLLE partnerships, 3) create a greater readiness for community/PWLLE collaboration, 4) foster new and strengthened partnerships that are equitable, diverse, and inclusive, and 5) prioritize cardiovascular risk research priorities identified by women, intersex, gender diverse and under-served people across Canada (i.e., knowledge generation).
Multigenerational Caregiving at Home for a Relative with Dementia amidst COVID-19: A Qualitative Multiple Case Study of the New Immigrant South Asian Experience
Principal Investigators: P. Baxter (NPA), M. Parry, M.Savundranayagam
Co-Investigators: Bhatti I, Bindra J, Chagani J, Dobbins M, Gaetano D, Gupta J, Hemani S, Hussain M, Innes A, Jack S, Krishnapillai A, Udod S. Collaborators: Mohammed S, Bangladeshi-Canadian Community Services (BCS), Council of Agencies Serving South Asians (CASSA), Ontario Caregiver Organization (OCO), National Initiative for the Care of the Elderly (NICE), Family Councils Ontario (FCO), Alzheimer Society of Toronto, McMaster Institute for Research on Aging (MIRA), South Asian Women’s Centre (SAWC).
Funding: Canadian Institutes of Health Research Project Grant: Spring 2023
About: Our rapid integrated mixed methods review revealed no studies conducted in Canada related to new immigrant South Asian multigenerational family caregiving of a relative with dementia (RwD) before or during COVID-19. Others have recognized a gap in the literature on the unique challenges faced by South Asian caregivers living in Canada and note the importance of acquiring knowledge to understand how to support this group in a culturally relevant manner to promote positive outcomes.
Objectives: There are three main study objectives: 1) understand how and why caregiving experiences within multigenerational South Asian families originating from Pakistan, Bangladesh, India, or Sri Lanka are impacted by COVID-19, 2) understand how and why the intersections of ethnicity, gender (identities, roles, relations, institutionalized), age, religion, and culture influence the experience of caring for a RwD, and 3) understand how structural, personal, and relational processes changed during COVID-19 and how and why these changes influenced multigenerational family caregiving for a RwD.
Understanding how to Promote Post-Pandemic Recovery in South Asian Women Caregivers of Older Adults Living in Multigenerational Households: A Mixed Methods Approach to Identifying Needs and Gaps in Social and Health Services
Principal Investigators: P. Baxter (NPA), M. Parry, M.Savundranayagam
Co-Investigators: Innes A, Willetts G. Collaborators: Mohammed S, Council of Agencies Serving South Asians (CASSA), Family Councils Ontario (FCO), Alzheimer Society of Toronto, Asian Women’s Centre (SAWC), Hussain M, Moni T, Chowdhury F, Raina P.
Funding: New Frontiers in Research Fund – Special Call 2023
About: In 2018, it was estimated that 7.8 million Canadians contributed 5.7 billion hours of unpaid care to family members, friends, and neighbours with long-term health problems, disabilities, or functional limitations. Prior to the COVID-19 pandemic, it was well understood that without access to appropriate social and community supports, unpaid caregivers would experience lower life satisfaction, more daily stress, and worse self-reported mental health. The COVID-19 pandemic has complicated the practice of unpaid caregiving by introducing and enforcing public health measures intended to slow the spread of viral infection (e.g., social distancing). In Canada, there is limited information on the pandemic-related impacts on SA caregivers. The information that is available has tended to focus on rates of COVID-19 infection in the SA community more generally, as well as related morbidity and mortality. Within the Greater Toronto Area specifically, which is among the five top metropolitan areas in Canada with a high proportion of South Asia people (12% of the total population), people from the South Asian community were 5 to 10 times more likely to acquire a COVID-19 infection and twice as likely to die from the infection than White people. Importantly however, prior to the pandemic, SA communities were described as one of the most vulnerable populations in Canada, with evidence indicating they had faced significant barriers to receiving social and healthcare services needed to care for older adults requiring assistance.
Objectives: There are five study objectives: 1) use a novel approach (combining a transformative research paradigm and elements of the RE-AIM framework) to conduct a needs assessment intended to identify the social and healthcare needs of unpaid SA women caregivers of an older adult living with a chronic condition in multigenerational homes in the GTA, 2) use an interdisciplinary approach as a catalyst to examine how equity and sustainability can be achieved for unpaid women SA caregivers by addressing high-priority caregiving needs and determining what culturally relevant high-risk, high-reward interventions can be implemented on a wide scale, 3) gain trust by engaging and empowering unpaid SA women caregivers of older adults by giving them a voice in developing/changing the health care system to better meet their needs and so that future research interventions can be successfully implemented nationally and transnationally, 4) co-create at least one high-priority intervention and identify measures of effectiveness and impact, and establish an implementation and evaluation prototype, and 5) develop partnerships within the SA community in preparation for future research initiatives to promote well-being for unpaid SA women caregivers of older adults.
A Conversational Health Chatbot, Bringing Compassion to a Tailored Digital Health Intervention for Women with Heart Disease
Principal Investigator: M. Parry
Supervisor: E. Peter
Mentors: Nicole Nickerson, Vincenza Spiteri DeBonis, Donna Hart, Lise Owens, Joe Cafazzo, Mustafa Al-Durra
Funding: AMS Healthcare (2022)
About: This AMS Healthcare Fellowship in Compassion and Artificial Intelligence aims to advance the development of an existing tool (a chatbot for supporting women with heart disease in managing their symptoms and health-related decision-making) by making it more personal and emotionally intelligent. The team includes experts in compassionate care, digital health, and cloud solutions as well as women with lived experience providing support as mentors.
Objectives: Specific objectives are to: 1) conduct a rapid review of the literature to determine how Chatbots and simulated conversations have been used to improve health outcomes for patients with CVD and identify associated compassion attributes, strengths/limitations, opportunities and risks, 2) present findings from the rapid review at a series of consultation workshops, and 3) produce chatbot attributes that demonstrate compassionate care for women with heart disease.
Training Platform in Diabetes, Obesity and Cardiometabolic Health
Principal Investigators: Tchernof A (NPA), Ball G, Blondin D, Brunt K, Colquhoun H, Doucette C, Forhan M, McGavock J, Parry M, Creaton R, Sénéchal M, Wei X, Wing SS. (Arland- put initials first for consistency)
Co-investigators: Bélanger M, Carpentier A, Estall J, Kastner M, Kuk J, Lewis G, Mason R, Morrison K, Nagpal S, Patton I, Steinberg G, Twells L, Verchere B. Collaborator: Fantus G, Visekruna S.
Trainee: Burnside, H.
Funding: CIHR Training Grant: Health Research Training Platform
About: Canada is fortunate to have many highly productive research teams, networks and
institutions, tackling a range of research gaps in the prevention and treatment of diabetes,
obesity and cardiometabolic complications, in some cases alongside patient and community
partners. These teams have come together to jointly create Canada’s largest health research
training platform in the area of obesity and diabetes to date. This platform will provide unique
opportunities for trainees at all levels and early career investigators across the country to benefit from broad programs and the unique strengths of each regional entity. Obesity, diabetes and cardiometabolic conditions are interconnected diseases that are best understood through complementary approaches ranging from basic sciences to public health, from molecules to communities. Providing future researchers with a perspective broader than their specific field of expertise will improve health outcomes, reduce the burden on healthcare systems, and improve the lived experience of those affected across their lifespan.
Objectives: The platform’s overarching aims are: 1) to optimize access to individual training and mentoring trajectories, professional development, and experiential learning for a diverse population
of trainees and ECIs, leading to favorable research career outcomes in the areas of interest; and
2) to harness the strengths of regional research teams to create Canada’s largest integrated, transdisciplinary training and mentoring asset in these fields.
Peer Support Interventions for Women with Cardiovascular Disease: An Evidence Map
Principal Investigators: M. Parry, K.A. Mullen
Co-Investigators: Adreak N, Colella T, Dancey S, El Ali S, Goodenough C (Lived Experience Representative), Hay J, Johnston A, Kapur D, Liblik K, Liu S, Noble M, Robert H (Lived Experience Representative), Tang N, Visintini S.
Funding: Canadian Institutes of Health Research Project Grant: Fall 2021 and Spring 2022 – Patient Oriented Research Priority Announcement
Background and Objective: We are using the Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework, SPOR Patient Engagement Framework and the Individual and the Individual and Family Self-Management Theory to describe peer support interventions used for women with cardiovascular disease (heart disease, stroke, heart failure). We have a strong team of patients as partners in research, trainees, early/new investigators, decision-makers, and have expertise in screening and review methodologies, patient engagement and patient-oriented research (POR), sex and gender science, peer support, cardiovascular disease in women, and knowledge transfer and exchange.
Methods: The main purpose of performing a broad map of the literature (i.e., evidence map) is to identify the range of research and identify gaps and future research needs. An evidence map is broad and it is generally the first step in conducting a systematic review. We will follow the same six steps utilized in performing our previous broad map of the literature: 1) identify the scope of the evidence map, 2) define key variables, 3) establish a comprehensive search strategy, 4) identify clear eligibility criteria, 5) systematically retrieve, screen and classify the evidence, and 6) report the findings in an evidence map.
Her Heart Matters: Uncovering the Cardiac Pain Experiences of Women with Disabilities through Patient Journal Mapping
Principal Investigators: M. Parry, AK. Bjørnnes
Co-Investigators: H. Clarke, L. Cooper, D. Hart, C. Lalloo, J. McFetridge-Durdle, M. McGillion, C. Norris, L. Pilote, J. Price, J. Stinson, J. Watt-Watson
Funding: Women’s Xchange
Background and Objective: Globally, women have greater cardiovascular morbidity and mortality compared to men, and women with physical disabilities have 6.6 times higher odds of coronary artery disease and 5.9 times higher odds of having cardiac pain/cardiac symptoms compared to women without disabilities. There is limited evidence describing the cardiac pain experiences in women with disabilities. We are partnering with the Network of Women with Disabilities (NOW), the Canadian Council of Disabilities (CCD) and the DisAbled Women’s Network (DAWN) of Canada to learn how to improve decision-making, access and quality of care for women who have disabilities and cardiac pain/cardiac symptoms through patient journey mapping.
Methods:This project will utilize a qualitative collaborative approach that engages women over 40 years living with a mobility disability (e.g., paraplegia, quadriplegia, osteoarthritis, etc.) and cardiac pain/cardiac symptoms, health care providers, researchers, and healthcare human factors designers. The project will include three phases informed by Boyd’s six steps for healthcare co-design: Phase 1 Discover – explore cardiac pain experiences through semi-structured interviews, Phase 2 Develop – create patient journey prototypes using interdisciplinary focus groups, and Phase 3 Disseminate.
Development and Usability Testing of at heart: An Integrated Smartphone and Web-Based Intervention for Women with Cardiac Pain and Cardiac Symptoms
Principal Investigators: M. Parry, H. Clarke
Co-Investigators: AK. Bjørnnes, J. Cafazzo, L. Cooper, A. Dhukai, P. Harvey, J. Katz, C. Lalloo, M. Leegaard, F. Légaré, J. McFetridge-Durdle, M. McGillion, C. Norris, R. Patterson, L. Pilote, L. Pink, J. Price, J. Stinson, JC. Victor, J. Watt-Watson
Collaborators: C. Auld, C. Faubert, D. Park, M. Park, B. Rickard, V. Spiteri DeBonis
Funding: Canadian Institutes of Health Research (CIHR) Project Grant
Background and Objective: More women die of coronary artery disease (CAD) than cancer, chronic lower respiratory disease, Alzheimer’s disease, and accidents combined. Coronary artery disease is also the leading cause of death of women across all ages, and recent data show an increase in CAD incidence and deaths in women younger than 55 years of age. Women with CAD have cardiac pain and other symptoms that differ from that of men. The overall goal of this program of research is to develop and systematically evaluate an integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce cardiac pain/cardiac symptoms and increase health-related quality of life in women with heart disease.
Methods: This study uses a mixed methods strategy used for the development of the at heart content/core feature set (Phase 2A), usability testing (Phase 2B) and evaluation with a pilot randomized controlled trial (RCT) (Phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop at heart. The Phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (Phase 4, future work). Patient partners have been actively involved in setting the at heart research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life.
On behalf of the investigating team, Monica accepted the 2021 Canadian Women’s Heart Health Summit Best Poster Presentation Award for her poster, “The Development and Evaluation of at heart”. The poster can be viewed here: https://bit.ly/3G4IimT
Family Carers and COVID-19: A Rapid Integrated Mixed Methods Systematic Review
Principal Investigators: M. Parry, AK. Bjørnnes
Co-Investigators: N. Nickerson, K. Warkentin, H. Burnside, S. Hemani, C. Norris, E. Peter, L. Pilote,
Collaborators: S. Mohammed, M. Nylen-Eriksen, A. Coupal (The Ontario Caregiver Organization)
Funding: Canadian Institutes of Health Research (CIHR) Operating Grant
Background and Objective: Family caregivers provide unpaid personal, psychological, physical, social and financial care. They provide unpaid care and are the backbone of the healthcare system; 28% of Canadians are current caregivers and 46% will be caregivers at some point in their lives. Over one-half (54%) of caregivers are women between the ages of 45 and 65 years. By 2035, the annual unpaid caregiver contribution to the Canadian health care system is estimated to be $128 billion. Caregivers perform duties with little protective equipment, balancing work with added caregiving responsibilities. In addition, when loved ones are admitted to hospital for treatment, caregivers are separated from their family member, when comfort and care is needed most. The overall goal of this rapid integrated mixed-methods systematic review is to determine what is known about the mental health and wellbeing of family caregivers during communicable disease outbreaks, such as COVID-19.
Methods: This study builds on previous experience and expertise in knowledge synthesis using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education. The firs tstep in the EPPI review process involves a broad mapping exercise to retrieve, screen and classify the published and unpublished evidence. The second step in the EPPI review process is to present and discuss the results of our broad mapping and screening exercise with our collaborators and investigators. The third step in the EPPI process is to conduct two-rapid parallel COVID-19 systematic syntheses. The first parallel syntheses is focused on bimonthly (i.e., every two months) systematic searches of the published/unpublished literature. The second parallel synthesis is focused on a systematic review of the grey literature. Both parallel syntheses will help us determine: 1) the mental health and wellbeing of family caregivers across ethnicities, ages, and sex/gender, and 2) national and international resources, knowledge translation approaches, practices and platforms used to improve the mental health and wellbeing of family/unpaid caregivers during COVID-19.
Building Capacity for Patient-Oriented Research (POR) in Clinical Trials, TranSlaTing the Evidence into Practice, Policy and Outcomes: The POR STEPP Digital Health Project in Ontario
Principal Investigator: M. Parry, A. Najam (Patient Partner)
Co-Investigators: T. Ceroni (Patient Partner), S. Hemani, AK. Bjørnnes, A. Ellis, I. Gilron, M. Park (Patient Partner), D. Richards, K. Toupin-April, D. Wells (Patient Partner)
Collaborator: S. Marlin (Clinical Trials Ontario-CTO)
Funding: Ontario SPOR Support Unit EMPOWER Digital Award
Background and Objectives: We used the Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework, partnered with CTO to build Patient and Investigator Decision Aids (https://www.ctontario.ca/patients-public/resources-for-engaging-patients/decision-aids-for-patient-partner-engagement-with-clinical-trials/). These decision aids will make a significant contribution to Canada’s strategy for patient-oriented research (POR) and will support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system. Patients are the heart of the POR strategy; our patient partners have been actively engaged and will continue to partner and co-lead this digital health project. This project is guided by the IDEAS (Integrate, Design, Assess and Share) framework and toolkit and the World Health Organization’s (WHO) framework for disseminating and scaling up innovations. The aims of this project is to: 1) engage multi-stakeholders and develop a knowledge translation and scaling-up strategy for wider effects and reach, 2) build relationships and translate knowledge about patient and investigator decision aids using multiple information and activity streams, 3) push our patient and investigator decision aids to those who could use them provincially, and 4) integrate end-users to translate knowledge to increase impact through policy briefs, public forums, conference presentations, open-access publication, and social media.
Methods: We will engage multi-stakeholders in workshops to disseminate POR and decision aid knowledge and ideate creative dissemination and scaling-up strategies. POR and decision aid training workshops will be delivered by the Co-PI (Parry) or Co-I (Richards) and a patient partner co-investigator (Najam/Wells) to interested patients, investigators, decision-makers, health charity and patient organizations. Knowledge obtained through this award will inform strategies for scaling up the POR STEPP Digital Health Project nationally and internationally. We will assess the attributes that determine scalability and identify needed actions using our ‘hot-line’ notes and a brief semi-structured interview guide based on the WHO. Results will be disseminated through policy briefs, public forums, conference presentations, open-access publications, and social media.
Patient Engagement Partnerships in Clinical Trials (PEP-CT): Systematic Development and Testing of Patient Partner and Researcher Decision Aids
Principal Investigators: M. Parry, T. Ceroni
Co-Investigators: H. Ansari, AK. Bjørnnes, H. Burnside, S. Cavallo, A. Day, S. Ellis, D. Feldman, I. Gilron, A. Najam, M. Park, D. Richards, K. Toupin-April, D. Wells
Collaborator: S. Marlin (Clinical Trials Ontario)
Funding: Canadian Institutes of Health Research (CIHR) Project Grant
Background and Objectives: Building capacity to improve the uptake of sex/gender and strengthen research partnerships in clinical trials requires training and support. Our innovative web-based open-access patient partner and investigator decision aids will transform knowledge and help build capacity for sex/gender uptake and patient-oriented research in Canada. We have included enablers of decision aid utilization, including online delivery, organizational endorsement, and utilization of a strong implementation and dissemination plan. We have also integrated POR principles and practices by engaging patient partners across all phases of our program of research. Patient partners have: 1) identified research priorities/search terms, 2) developed grant proposals, 3) designed decision aids, 4) collected/analyzed data, and 5) disseminated results through conference presentation and publication. The overall goal of this 2-year project is to refine, translate and evaluate two decision aids (patient and investigator) designed in Phase 1A (CIHR-funded) and Phase 1B (Ontario SPOR Support Unit [OSSU]-funded) to improve sex/gender uptake and patient engagement partnerships in clinical trials (PEP-CT).
Methods: Refinement and evaluation of the decision aids to improve patient partnerships in clinical trials is guided by the International Patient Decision Aid Standards, User-Centered Design and the Ottawa Decision-Support Framework. Funding from the Ontario SPOR Support Unit allowed us to brainstorm and disseminate our web-based open-access patient and investigator decision aids in Ontario. Relevant feedback from that phase of the project will be incorporated into further decision aid refinements and then each will be translated to French, refined though iterative cycles of usability testing (alpha testing) with end-users (patients and investigators), and evaluated using a pragmatic pre/post-pilot study (beta [field] testing). Results of the pragmatic pre/post-pilot study of bilingual decision aids will establish the extent to which each decision aid is feasible in terms of implementation (acceptability, engagement and fidelity). We have followed rigorous processes to evaluate all relevant quality criteria for decision-making processes. Field/beta testing will enable us to finalize, disseminate and evaluate adoption of these open-access web-based innovations.