Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention
Phase: NA
Conditions: Heart Failure, Mental Health, Stress, Anxiety, Depression
Sponsor: Bruyère Health Research Institute.

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Integrating Mental Health into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility 
Study of the FRAME Intervention 
NCT #: 
 
 
Principal/Qualified Investigator:  Krystal Kehoe MacLeod 
Contact Details: kmacleod@bruyere.org 
 
 
Study Sponsor: Brain-Heart Interconnectome 
Contact Details: ICC-BHI@uottawa.ca. 
Study Funder: Canada First Research Excellent Fund (CFREF) 
Contact Details: ICC-BHI@uottawa.ca. 
 
                                                       Protocol Version: October 1, 2025 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
STUDY COLLABORATORS/CO-INVESTIGATORS:  
Name:  Vivian Welch 
Title/Position:  Research Scientist 
Department/Institution:  Bruyere Health Research Institute  
Email Address:  VWelch@bruyere.org  
 
PROTOCOL SIGNATURE PAGE 
I assume full responsibility for the scientific and ethical conduct of the study at my research site as described in this 
Protocol and supporting documentation (e.g. BREB), and agree to conduct this study in compliance with the Tri-Council 
Policy Statement 2: Ethical Conduct for Research Involving Humans; the International Conference on Harmonization – 
Good Clinical Practice: Consolidated Guideline; the provisions of the Personal Health Information Protection Act 2004, 
and the Food and Drug Act of Health Canada and its applicable regulations, and any other relevant regulations or 
guidelines endorsed by Bruyère Health, and the Bruyère Health Research Institute. I certify that all researchers and other 
personnel involved in this study at this institution are appropriately qualified and experienced or will undergo 
appropriate training and supervision to fulfill their role in this study.  
☒  By checking here, I certify that I meet the requirements of a “Qualified Investigator” as defined by Health Canada.        
 Initial here: KKM 
 
Principal Investigator Name (printed): Krystal Kehoe MacLeod 
 
Principal Investigator Signature:  
 
1. STUDY SUMMARY INFORMATION (this section is intended to be brief and succinct) 

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Study Title 
Integrating Mental Health into Heart Failure Care: A Hybrid Type 1 
Pretest-Posttest Feasibility Study of the FRAME Intervention 
Study Design (RCT, blinding, placebo, 
qualitative, etc.) 
This is a Hybrid Type 1 effectiveness-implementation design using 
a pretest–post-test mixed-methods design. The study evaluates the 
preliminary effectiveness of the FRAME intervention while 
concurrently assessing implementation processes across different 
healthcare settings within our pilot test sites. Quantitative data will 
be collected through patient surveys at two-time points (baseline 
and 6-month follow-up). Qualitative data will be collected through 
process mapping workshops with the site staff (e.g., site champion, 
care providers and administrative staff) either virtually or in-person 
following interview questions (see Appendix B) and optional semi-
structured interviews with patients and caregivers. An interview 
guide will be developed in a later stage and will be submitted to the 
REB for review and approval prior to implementation, no 
randomization or blinding will be used. 
Expected duration of Study 
September 2025- December 2026 
List all study locations/centres 
1. Seaway Valley Community Health Centre 
2. Winchester District Memorial Hospital 
3. Centre de santé communautaire de l'Estrie 
4. Orleans Cardiopulmonary Group  
5. Carrefour santé Aline-Chrétien Health Hub Orleans 
6. Équipe de sante familiale communautaire de l’Est d’Ottawa 
7. United Counties Prescott and Russell Community 
Paramedicine Program   
8. Cornwall Community Paramedicine Program 
9. Montfort Hospital Emergency Department 
10. University of Ottawa Heart Institute – Heart Function Clinic 
Expected number of participants 
Primary care settings (n = 5): Total estimated pool = 1,000 patients. 
Cardiac clinics (n = 3): Total estimated pool = 8,320 patients. 
Cardiac rehabilitation programs (n = 3): Total estimated pool = 300-
600 patients. 
Emergency departments (n = 2):  Total estimated pool = 240–480 
patients 
Study Objectives 
Primary Outcome Objectives 

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• 
Increase patient engagement in mental health 
conversations (with providers or loved ones) 
• 
Improve help-seeking behaviours, confidence in initiating 
mental health discussions, and awareness of mental health 
resources 
Process Evaluation Objectives 
• 
Identify implementation barriers and facilitators 
• 
Explore changes in clinical workflows related to mental 
health integration 
Methodology 
 
 
This study will use a pretest–posttest, mixed-methods design 
embedded within a Hybrid Type 1 implementation-effectiveness 
framework. Quantitative data will be collected via patient surveys 
administered at baseline and 6 months post-intervention to assess 
changes in mental health awareness, confidence, and help-seeking 
behaviours.The study will be conducted across 8–12 healthcare 
settings in Ontario, with procedures adapted to each site’s 
operational context. 
Quantitative Methods: 
 Surveys will be administered to patients before and after the 
intervention via QR code posters linking to the tool website, 
referrals from healthcare providers, and telephone/email recruitment 
methods to eligible patients from the patient roster in the site (only 
applicable for sites with a patient roster). Primary and secondary 
outcome measures will assess: 
• 
Frequency of mental health conversations 
• 
Engagement in help-seeking behaviours 
• 
Confidence discussing mental health 
• 
Awareness of mental health resources and supports in their 
community 
See Appendix A for surveys 
Qualitative and Implementation Methods: 

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• 
2-hour process mapping workshops with site staff pre- and 
post-implementation is a research method to visualize how 
a current clinical workflow works.  Process mapping and 
evaluation workshops will be audio-recorded (with verbal 
and written consent) and focus on how mental health 
conversations are currently integrated into patient care 
and how FRAME was used during the intervention. These 
recordings will help identify facilitators and barriers to 
implementation. See Appendix B for the process mapping 
interview questions.  
• 
Interviews: Semi-structured inThis will be used as a 
comparison for pre- and post-intervention. The workshops 
with be audio-recorded and transcribed using PlayWrite. 
• 
30-minute virtual  monthly check-ins led by the research 
team with site champion and with site staff (if they wish to 
attend) during implementation phase to assess 
troubleshooting, facilitators and barriers of intervention. 
• 
Semi-structured interviews with a subset of patient and 
caregivers (n=12=15) post-intervention to explore their 
experiences with FRAME and its perceived impact (see 
Appendix B for interview guides). Note that interview 
guides are currently under development and will be 
submitted to the REB for review and approval prior to use.  
• 
Tool uptake tracking through QR code scans and digital 
metrics (e.g., website trafficking)  
Primary Endpoint: Change in the proportion of patients who report 
having mental health conversations with a healthcare provider or 
loved one in the past 6 months.  
Secondary Endpoints: (1) Change in patient engagement in mental 
health help-seeking behaviours. (2) Change in confidence in 
initiating mental health discussions with a healthcare provider or a 
loved one. (3)  
Inclusion and Exclusion Criteria 
Inclusion Criteria 
Patients (surveys and/or interviews): 
1. Documented diagnosis with heart failure or on specific 
heart-failure related medications (used in the Emergency 
Department settings only). See section 5.1 for the 
medication list.  
2. Receiving care at a participating pilot site 

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3. Resides in Ontario or Quebec 
4. Must be able to speak, read and understand English or 
French 
5. Willing and able to provide informed consent and contact 
information for the administration of the follow-up survey 
(6 months post), for interviews (after the outcome survey) 
and compensation. 
Caregivers (interviews): 
1. A caregiver of a patient with heart failure  
2. Must be able to speak and understand English or French 
3. Willing and able to provide informed consent to participate 
in the interview  
4. Willing to provide contact information for compensation of 
the interview. 
Healthcare Providers / Administrative Staff: 
1. Currently employed at a participating pilot site 
2. Directly involved in patient care or clinic workflow 
3. Willing and able to participate in process mapping 
workshops 
4. Site champion willing to participate in monthly check-ins 
during the intervention phase 
Exclusion Criteria 
• 
Patients unable to provide informed consent (e.g., due to 
cognitive impairment or significant language barriers 
without available translated support) 
• 
Patients with no access to the internet as the tool is a web-
based intervention  
Study Intervention 
The Heart x Mental Health FRAME (Foundation, Recognition, 
Awareness, Management and Engagement) tool is a multi-
component, co-designed web tool created in collaboration with 
patient partners, caregivers, healthcare providers, Archipel Ontario 
Health Team and Great River Ontario Health Team. It is designed to 
improve recognition, awareness, management and support for 
mental health in patients with heart failure. There are three different 
versions: one for healthcare providers, one for caregivers and one 
for patients (see Appendix C-E). 
The intervention includes: 

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2. BACKGROUND AND RATIONALE  
 
Many mental health conditions and cardiovascular diseases, such as heart failure, share common mechanisms 
and can jointly contribute to poor health outcomes for patients (1). Individuals with heart failure are more likely 
• 
Educational material about heart failure and mental health 
• 
Conversational support to help facilitate discussions about 
mental health 
• 
Self-management activity maps (e.g., tips about nutrition 
and exercise)  
• 
Asset maps (i.e., displaying available resources in the 
community) 
• 
The provider-facing discussion tool to help initiate 
conversations about mental health and guide referrals or 
supports. 
FRAME was developed through a co-design process informed by 
the lived experiences of community partners and is intended to be 
adaptable to different healthcare environments. The intervention is 
low-burden and aims to normalize conversations about mental 
health in cardiac care settings. 
Study Summary or Abstract 
 
 
Heart failure is a high-risk, chronic condition that impacts patients' 
mental health. Approximately 50% of heart failure patients 
experience comorbid mental health conditions, such as stress, 
depression and anxiety, which affect their day-to-day lives. Despite 
this interconnection, the integration of mental health awareness and 
support into cardiac care remains limited. To address this gap, the 
FRAME (Foundation, Recognition, Awareness, Management, 
Engagement) intervention was co-designed by researchers, 
healthcare providers, health system decisionmakers, and patient 
partners. This pilot study evaluates the feasibility of implementing 
the FRAME intervention in pilot clinical sites within two health 
regions in Ontario, Canada, including team-based family medicine 
clinics, cardiac rehabilitation/specialist clinics, and emergency 
departments. Utilizing a pretest–posttest hybrid 1 model 
intervention design, this study evaluates process indicators and 
patient-focused outcomes through surveys and semi-structured 
qualitative interviews. Findings from this study will inform a future 
large scale cohort study and scalable integration of the FRAME tool 
into existing cardiac care pathways to enhance mental health 
awareness and support among heart failure patients. 

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than others to experience symptoms of depression, anxiety, or stress, which are factors that can further 
exacerbate cardiovascular disease progression (1,2). Despite growing evidence of this relationship, treatment for 
brain-heart interconnected conditions remains fragmented. Distinct treatment pathways for mental health and 
cardiac conditions result in care gaps and reinforce silos both within the health system and between health and 
community care sectors. Knowledge about brain-heart interconnections has yet to be meaningfully integrated 
into care directives or health system reform initiatives aimed at addressing interconnected conditions. 
Previous Work and the FRAME Intervention 
Year 1 (April 2024 to March 2025) and the beginning of Year 2 of this project focused on understanding 
community needs and priorities and identifying care gaps. This was followed by the co-design of an 
intervention to address those needs in Eastern Ontario, in partnership with community research members and 
two Ontario Health Teams, Archipel and Great River. We triangulated data from (a) asset mapping, (b) 
consultations with patients, caregivers, clinicians and community service providers, (c) a rapid scoping review, 
and (d) collaborative co-design sessions. During this phase, we also built and strengthened relationships with 
decision makers at Ontario Health and the Ministry of Health, executives in Ontario Health Teams and 
Indigenous community leaders and advisors. 
The intervention is called FRAME, which stands for Foundation, Recognition, Awareness, Management and 
Engagement. Our intervention targets heart failure patients who are experiencing or at risk of mental health 
challenges, as well as their caregivers and care providers. It is designed to improve awareness of the 
connections between brain and heart health and to increase understanding of the services and resources 
available in the community. It is structured across three audiences: provider facing, caregiver facing, and patient 
facing (See Appendix C, D, E). The intervention supports the development of knowledge about the connection 
between heart and mental health, promotes early recognition of emotional distress, and provides practical steps 
to encourage discussion about mental health, the adoption of self-management approaches and the use of 
community-based resources. 
Heart Failure x Mental Health FRAME Intervention: 
• Foundation helps build understanding of the link between mental and heart health 
• Recognition supports early identification of emotional challenges 
• Awareness addresses the impact of heart failure on mood, identity, relationships and daily functioning 
• Management equips individuals with self-management strategies for both mental and cardiac health 
• Engagement connects patients and caregivers to community resources and promotes proactive care 
 
FRAME is both an educational and action-oriented intervention that aims to increase confidence and capacity 
among patients, caregivers and providers to recognize and respond to the mental health needs of individuals 
living with heart failure. 
Rationale 

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To address interconnected brain and heart health issues, we are applying a Participatory Action Research 
approach (3,4). This ensures our research is community-led and action-oriented, with the goal of developing and 
evaluating interventions that support improved care for patients, caregivers, providers and decision makers. In 
collaboration with two Ontario Health Teams, Great River and Archipel, we will pilot and evaluate the FRAME 
intervention in three care settings: primary care, cardiology and emergency departments. These care settings 
represent the three most common touchpoints with the health care system for patients with heart failure – at 
their primary care provider, at the cardiologist, and at the emergency department 
Pilot testing the intervention is a critical step to determine its feasibility, acceptability and potential for 
integration into real-world care settings. While the intervention was co-designed with local interest-holders and 
tailored to address known service gaps, it is essential to assess how it functions in practice. Following a Hybrid 
Type 1 implementation-effectiveness design (5,6) we will explore and evaluate how the FRAME intervention is 
received by patients, caregivers and providers, identify barriers to implementation, and refine tools and 
materials before broader scale-up.  
Our proposed work also aligns with the Ministry of Health’s healthcare reform priorities (7).  Pillar Two 
emphasizes the need to improve access to timely care, especially for individuals with chronic illnesses. 
Supporting heart failure patients with mental health concerns by improving their awareness of available services 
and self-management options (such as exercise, nutrition, and social activation) can help ensure they have the 
knowledge and information (including cost, language, cultural fit and wait times) to make informed decisions 
about care within their communities. This study seeks to support communities in strengthening their existing 
care delivery systems to better address the overlapping needs of brain and heart health, specifically in the 
context of heart failure and mental health. 
 
Context 
 
The FRAME intervention will be pilot tested in 8 to 12 care settings, evenly distributed across two Ontario 
Health Team regions located in Eastern Ontario: Great River Ontario Health Team and the Archipel Ontario 
Health Team. These settings represent a mix of primary care, cardiac rehabilitation and specialization clinics, 
emergency services and community paramedic services where individuals with heart failure typically receive 
care. 
 The study will involve collecting data from three groups: 
• Adult patients (40 years and older) who have a diagnosis of heart failure or are on a heart-failure-
related medications (this will be at the emergency department only, see section 5.1 for medication list), 
and who are receiving care at one of the pilot sites. 
• Care providers (e.g., clinicians, nurses, allied health professionals, paramedics) who serve our target 
patient population in one of the pilot sites.  
• Caregivers who provide support for people with heart failure.  

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Participants must be able to provide informed consent and speak either English or French. 
Setting Name 
Setting Type (Primary, Cardiac, 
Emergency) 
Great River Ontario Health Team 
Seaway Valley Community Health Centre 
  
Primary Care 
Cardiac Rehabilitation Program 
Cornwall Community Paramedic Program 
  
Primary Care 
Centre de santé communautaire de l'Estrie  
Primary Care 
Cardiac Rehabilitation Program 
Winchester District Memorial Hospital  
  
Cardiac Imaging 
Emergency Department 
Archipel Ontario Health Team 
Équipe de sante familiale communautaire de l’Est 
d’Ottawa  
  
Primary Care 
United Counties Prescott and Russell Community 
Paramedicine Program 
Primary Care 
Orleans Cardiopulmonary Group   
  
Cardiac Clinic 
Carrefour santé Aline-Chrétien Health Hub 
Orleans  
  
Cardiac Rehabilitation Program 
Montfort Hospital 
Emergency Care 
Known and Potential Risks and Benefits  
While the intervention poses minimal risk, participants may experience emotional or psychological discomfort when 
discussing mental health. Benefits include increased mental health literacy and improved patient-provider communication 
around psychosocial concerns. 
 
3. STUDY OBJECTIVES AND PURPOSE 
 
The outcome evaluation will focus on three core outcomes: 

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1. Frequency of Mental Health Conversations (primary) 
This outcome measures if patients with heart failure report having a discussion about mental health after being 
introduced to FRAME. 
2. Engagement in Health Seeking Behaviours (secondary) 
This outcome evaluates whether participants (patients) report accessing mental health-related support, following 
the FRAME intervention. Supports may include formal resources (e.g., referrals to psychological services), 
informal or community-based support (e.g., peer groups, faith-based programs), and self-management strategies 
(e.g., mindfulness, exercise, online tools).  
3. Confidence in Engaging in Mental Health Conversations (secondary) 
This outcome assesses perceived knowledge of the interconnection between mental health and heart failure 
through self-reported confidence in initiating mental health discussions. 
 
The process evaluation will focus on understanding how FRAME is implemented across our selected test sites and 
identifying contextual factors that influence its feasibility, acceptability and integration into heart failure care. Guided 
by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework (8–10), the process 
evaluation will observe the following areas:  
1. Integration of FRAME into Clinical Workflows 
This area will observe how the intervention is incorporated into everyday clinical processes. We will evaluate this 
through pre- and post-implementation 2-hour process mapping workshops with site staff such as care providers, 
administrators (11) This will help us assess how mental health conversations are or are not being addressed in clinical 
workflows, and how these processes changes following the FRAME intervention.  
2. Barriers and Facilitators to Implementation 
Throughout the intervention phase, site champions will provide feedback to the research team during 30-minute 
monthly check-in meetings. The purpose of the meetings will be to discuss troubleshooting, workflow compatibility, 
patient engagement. Other site staff (e.g., care providers or administrative staff) will be more than welcome to join the 
meetings as well to provide additional insights.  
3. Engagement with FRAME  
Digital analytics and passive data collection (e.g., number of QR code scans) will be used to monitor how often and 
where the patient and caregiver resources are access. This will provide an estimate of how much reach and visibility 
the intervention is receiving within each setting.  
4. STUDY DESIGN & METHODOLOGY 
4.1   Endpoints 
This study will assess both outcome and process endpoints to evaluate the impact and implementation of the FRAME 
intervention across pilot healthcare sites.  
• 
Primary Endpoint: Change in the frequency of mental health conversations. 
This will be self-reported by patients with heart failure before and after the exposure to the FRAME intervention. 
This will be measured by a self-reported survey questions asking whether the participant has discussed their 
mental health with a healthcare provider in the past 6 months.  

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The time points for this endpoint will be compared between pre-intervention (intake survey) and post-intervention 
(6-month follow-up survey). (see Appendix A for surveys) 
• 
Secondary Endpoints:  
There are three secondary endpoints that will measure changes in broader behavioural and attitudinal 
outcomes. All secondary outcomes will be self-reported through two timepoints: an intake survey 
(baseline) and an outcome survey administered approximately six months later. 
 
1. Change in mental health help-seeking behavior (e.g., accessing community-based supports or self- 
management activities).  
This will be self-reported by patients on the survey that will capture the use of self-management or community-
based mental health supports. The outcome survey will repeat these questions to identify changes over time. The 
timepoint for this would be pre- and post-intervention.  
2. Change in patient confidence to discuss mental health 
This will be self-reported by patients on the survey items assessing confidence levels in initiating mental health 
discussions either with a healthcare provider or a loved one (e.g., caregiver, friend, etc...). The time point would 
be pre- and post-intervention.  
3. Change in awareness of where to find mental health information or support. 
This will be self-reported by patients assessing perceived knowledge of where and how to access mental health 
information and supports. This timepoint would be pre- and post-intervention.  
All of these outcomes will also be questioned in the interviews, should the patients/caregivers wish to participate 
(see Appendix B for the interview guides). 
Process Evaluation Endpoints: 
1. Integration of FRAME Into Clinical Workflows  
Measurement: Pre- and post-intervention recorded virtual or in-person 2-hour process mapping workshops with site staff 
to assess changes in mental health care pathways in heart failure care.  
2. Implementation Barriers and Facilitators  
Measurement: Monthly 30-minute recorded check-ins with site champions and staff to document implementation 
challenges, and successes.  
3. Patient Engagement with FRAME 
Measurement: Quantitative metrics with number of QR code scans and webpage visits to assess usage of patient-facing 
resources.  
 
4.2   Study Design 
This study will use a Hybrid Type 1 effectiveness- implementation design, which is well-suited to for evaluating 
interventions in real-world healthcare settings where both clinical outcomes and implementation processes are focus areas. 
This design evaluates the effectiveness of an intervention while also collecting formative data to understand it’s 

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implementation context, where we determine its feasibility, acceptability, barriers and facilitators to uptake to support 
future trials (12). These implementation science hybrid designs are increasingly used in health services research to 
improve the transition of evidence-based practices into routine care. 
The primary aim of Hybrid Type 1 would be to determine whether an intervention is effective in improving targeted 
outcomes. In this case, our primary and secondary outcomes for patients with heart failure. The secondary aim is to 
explore the conditions that influence its successful implementation and to determine what adaptation are needed to 
enhance integration in future and larger-scale trials adaptations (12). This approach showcases recommendations from 
implementation science to evaluate what works from whom and under what circumstances (5,13,14). This design also 
prioritizes testing the delivery of outcomes of an intervention while also gathering formative data on implementation 
processes.   
The FRAME intervention was co-designed with patient partners, caregivers, healthcare providers and researchers. It has a 
strong foundation in evidence, however, it has not yet been implemented or evaluated in clinical settings. This study will 
assess the preliminary effectiveness of FRAME on patient-reported mental health conversations, help-seeking behaviours 
and confidence in discussing mental health and the “implementability” of the tool, including how it is adopted and 
integrated into clinical workflows across three healthcare settings: primary care, cardiac care and emergency departments. 
To guide implementation evaluation, our study will apply the RE-AIM framework (Reach, Effectiveness, Adoption, 
Implementation, Maintenance), which is a widely used implementation science model that supports comprehensive 
assessments of outcomes. 
A mixed-methods approach will be used to collect and analyze both quantitative and qualitative data from patients, 
caregivers and site staff. This would include: 
• 
Pre- and post-implementation surveys for patients 
• 
Implementation tracking (e.g., the number of QR codes scanned, site champion check-ins) 
• 
Pre- and post-implementation process mapping workshops with site staff to visualize changes in clinical 
workflows related to mental health integration 
The decision to use a Hybrid Type 1 model was based on a reflection analysis after 10 years of effective-implementation 
hybrid studies had a guide of four questions to consider when selecting a hybrid study type (15). For example, one of the 
questions asks about how much the research team knows about implementation determinants for the intervention and 
suggests that if we do not know much, consider a type 1 design. After the consideration of similar questions, the hybrid 
type 1 design was the most appropriate, as it will allow us to assess the preliminary effectiveness of the tool in improving 
mental health awareness and support while identifying implementation facilitators, barriers, and contextual considerations 
across our pilot test sites to assist us refine the tool for future scalability. See Figure 1 for a visual overview of how the 
hybrid model has been adapted and operationalized for this study, with a timeline specification. 
 

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Figure 1. Adaptation of a Hybrid Type 1 Effectiveness-Implementation Design for the Heart Failure x Mental 
Health FRAME Intervention Feasibility Study. This figure illustrates how the FRAME intervention will be integrated 
using the Hybrid Type 1 design with timelines across different clinical pilot test sites, specifying the activities that occur 
per month and the implementation phase. 
   
4.3   Study Measures 
 
This study uses a Hybrid Type 1 effectiveness–implementation design to evaluate both patient-centred outcomes and 
implementation processes related to the FRAME intervention. Given the non-randomized nature of this feasibility study, 
efforts to reduce bias will include standardized data collection tools across all sites, training of research staff, use of 
validated survey items, and structured analytic approaches. No blinding or randomization will be used due to the 
exploratory nature of this study. 
1. Outcome Evaluation 
The outcome evaluation will assess the preliminary effectiveness of the FRAME intervention using patient-reported 
outcome measures. The focus is on evaluating changes in awareness, confidence, and engagement with mental health 
supports following exposure to the FRAME tool. 

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Primary Outcome Measure: Frequency of Mental Health Conversations 
• 
Description: This outcome will be measuring patient behaviour change in the form of an increased number of 
mental health conversations after using the intervention. 
• 
Participants: Patients with a documented diagnosis of heart failure or on heart-failure related medications.  
Timing: Pre-intervention (baseline) and 6 months post-intervention 
Secondary Outcome Measures:  
(1) Engagement in Health-Seeking Behaviours 
• 
Description: This outcome will be measuring health-seeking behaviours in the form of whether they have 
accessed or know where to access mental health supports (e.g., community-based support) or information (e.g., 
self-management activities) 
• 
Participants: Same as primary outcome 
Timing: Same as primary outcome 
(2) Confidence in Engaging in Mental Health Conversations 
• 
Description: This outcome will be measuring patient confidence in the form of initiating or participating in 
conversations about their mental health with a healthcare provider or loved one.  
• 
Participants: Same as primary outcome 
Timing: Same as primary outcome 
 
Measures and Data Collection: 
• 
Intake survey (baseline): Self-administered questionnaires via RedCAP assessing the above outcomes.  
• 
Outcome survey (post-intervention): Follow-up questionnaire with the same questions above in RedCAP to 
assess changes in the same domains 6 months after the intervention. The end of the survey will also include an 
invitation for an interview.  
• 
Survey Questions : The questions were adapted from validated tools such as the Mental Health Literacy Scale 
(16) , Opening Minds Stigma Scale (17), and the General Self-Efficacy Scale (18).  
• 
Semi-structured interviews (optional for patients and their caregivers): 20-30-minute interviews with a 
subsample of survey respondents' post-intervention to explore their experiences with FRAME resources and its 
influence on mental health engagement. We anticipate recruiting approximately n=12-15 patient participants for 
interviews, but will continue until data saturation is reached, defined as the point when no new themes are 
emerging (19). The final number may vary based on the diversity of participant experiences, and additional 
interviews may be conducted if needed to ensure broad representation. 
See Appendix A for the surveys 
Data Consolidation and Analysis: 
Survey Data: 
All survey responses will be self-administered by participants using REDCap and automatically stored on its secure 
server. Data will be exported for analysis using either SPSS or R. Descriptive statistics will be used to summarize 
demographic characteristics and baseline outcome measures. 

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To evaluate the primary endpoint and three secondary endpoints, we will conduct paired t-tests (or non-parametric 
equivalents if assumptions are not met) to examine within-subject changes between baseline and six-month follow-up. As 
multiple comparisons will be performed across related outcomes, we will control the overall family-wise error rate using 
the Holm-Bonferroni method (20). This approach ensures that statistical significance is not overstated due to the number 
of related hypothesis tests conducted. A p-value threshold adjusted via Holm-Bonferroni will be applied to determine 
significance across the four outcomes (one primary and three secondaries). 
Interview Data: 
Interviews will be audio-recorded or video-recorded (if conducted on Microsoft Teams) with participants' verbal and 
written consent. Interviews conducted virtually will be recorded through Microsoft Teams or by phone, and in-person 
interviews may use an encrypted recording device or PlayWrite. Recordings will be transcribed verbatim. Transcripts will 
be imported into MAXQDA 2022 for qualitative analysis. An inductive thematic analysis will be conducted following 
Braun and Clarke’s six-phase approach(21), allowing themes to emerge from the data. Qualitative rigour will be 
supported using Lincoln and Guba’s trustworthiness criteria (credibility, dependability, confirmability, and transferability) 
(22). 
2. Process Evaluation 
The process evaluation assesses how the FRAME intervention was implemented, its perceived feasibility, acceptability, 
and fit within each clinical context. It includes provider/staff perspectives.  
Participants: Care providers, administrative staff, and site champions 
Timing: Pre-intervention (baseline), during implementation, and post-intervention 
Measures and Data Collection: 
• 
Process Mapping Workshops (pre/post): Two-hour facilitated in-person or virtual workshops with care 
providers and staff to visualize clinical workflows and how/when mental health is addressed. A baseline process 
map will be developed and revisited post-implementation to identify changes. A secondary process map will be 
developed to visually represent the changes in workflow and practices before and after the intervention. Process 
Mapping workshops will be audio-recorded (with verbal and written consent), transcribed using PlayWright or 
Microsoft Teams transcription, and analyzed thematically using MAXQDA.  Process mapping workshop 
recordings will inform the construction of visual process maps for each site pre- and post-intervention. Coding 
will follow an inductive approach to identify patterns in mental health within the specific clinic setting following 
Braun & Clarke’s framework. 
• 
Implementation monitoring: QR code usage and web traffic analytics for FRAME materials. Site champions 
will also provide monthly feedback during 30-minute check-ins for barriers, facilitators and any troubleshooting.  
 
Data Consolidation and Analysis: 
All data collected during process mapping workshops and monthly site champion check-ins will be audio-recorded with 
verbal and written consent and transcribed using PlayWright or Microsoft Teams transcription. These transcripts will be 
imported into MAXQDA 2022 for analysis. A deductive analysis approach will be used, guided by the RE-AIM 

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framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) (10). Transcripts will be coded according 
to predefined categories that reflect RE-AIM domains, allowing the research team to systematically assess how FRAME 
was implemented, adopted by staff, and maintained across different care settings. 
Pre- and post-intervention process maps will be constructed for each site and visually compared to identify changes in 
workflow, conversation points, and mental health-related practices. A fidelity checklist will also be developed and used to 
document and monitor consistency in the implementation of FRAME activities across all participating sites (23). This 
checklist will be updated throughout the implementation period based on data from the monthly site check-ins and QR 
code and survey usage. Since this is a pre-post implementation study without randomization, there will be no allocation 
concealment or blinding. However, the accumulation of different data sources will enhance the validity of findings. 
 
 
4.4   Drug/Device Trial Description (for Health Canada regulated and non-regulated clinical      
  trials) 
N/A   
 
4.5   Study Duration 
The study will run from September 2025 to December 2026, with the following phases: 
Baseline / Pre-Implementation Phase (September to January 2026)  
Each participating site will begin with a baseline data collection phase to understand how mental health is currently 
discussed, integrated and addressed within each care setting. This phase will also gather input directly from patients to 
assess current experiences and needs. 
Data Collection 
Process Mapping:  As an initial step, each site will take part in a process mapping activity to examine how mental health 
is currently addressed within clinical workflows. Process mapping is a structured method used to visually represent and 
analyze the steps involved in healthcare delivery (24). It helps teams identify where, when and how mental health is, or is 
not, being addressed, and highlights opportunities for improvement. Benefits include improved understanding of local 
systems, identification of service gaps or redundancies, and the development of a shared perspective among team 
members. Care providers and administrative staff from each setting (n = 2-5) will be invited to attend a two-hour 
workshop to complete the process mapping activity collaboratively and then be sent the final process map to review and 
provide feedback. This session will be recorded for future reference to make the process map. See Appendix B for the 
interview guide. 
Intake Survey:  To capture patient perspectives on mental health in the context of heart failure care, a brief pre-intake 
survey will be made available (Appendix A). QR codes linking to the survey will be posted in each setting (see Appendix 
F), and providers who are willing will be invited to share the survey link with their patients by email or in person. The 
survey will assess patients’ current mental health experiences, awareness of resources and any unmet needs. Patient name, 

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phone number and email will be collected to facilitate contact for the outcome survey after the pilot test period. Patients 
who complete the intake survey will receive early access to the FRAME intervention before it is fully advertised and 
publicly available during the implementation phase in January 2026.  
Implementation Phase (January–July 2026): 
Following baseline activities, each site will begin the implementation of the FRAME intervention, with training, site-
specific adaptations and a six-month pilot period. This phase will focus on integrating the intervention into routine care 
practices through provider engagement. For providers, training will cover how to use the informational and discussion 
support tool (Appendix C). With providers and administrative staff, we will discuss and decide how to advertise the 
patient and caregiver-facing components of the FRAME intervention. Booklets and posters will be distributed to support 
both provider and patient engagement. 
January – Training and Rollout Preparation 
Training will be tailored to the needs and preferences of each site. A planning discussion will take place with site leads to 
determine preferred training modalities (e.g., in-person sessions, virtual modules, printed materials) during the pre-
implementation phase. For providers, training will cover how to use the informational and discussion support tool 
(Appendix C). With providers and administrative staff, we will discuss and decide how to advertise the patient and 
caregiver-facing components of the FRAME intervention. Booklets and posters will be distributed to support both 
provider and patient engagement. 
February to July – Pilot Testing the FRAME Intervention 
The intervention will be implemented over six months at all participating sites. QR codes and posters will be displayed to 
connect patients with FRAME materials and support tools. Care providers will be encouraged to share FRAME resources 
during routine care interactions and begin initiating mental health conversations using the tool provided. Each site will 
identify a “site champion” to support internal coordination and communication. Monthly 30-minute virtual check-ins will 
be held with each site champion to monitor progress, troubleshoot challenges, and share insights across sites. These 
check-ins will be open to other site team members who wish to attend. All sessions will be recorded and transcribed to 
support the process evaluation. 
Data Collection 
Intervention Uptake Monitoring:  Engagement with the intervention will be tracked by monitoring QR code usage and 
web traffic to patient- and caregiver-facing FRAME resources. 
Implementation Feedback: Site champions will provide updates during monthly check-ins, including reflections on 
implementation progress, provider engagement, patient responses and any barriers or facilitators encountered.  
Post-implementation and Evaluation (August–December 2026):  
Following the six-month pilot period, the intervention will be evaluated using the RE-AIM framework (Reach, 
Effectiveness, Adoption, Implementation, Maintenance) to assess its impact on mental health discussion and engagement 
within each care setting. Evaluation activities will vary between patients and site staff (care providers and administrative 
staff). 

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Data Collection 
Patient Evaluation:  
Outcome Survey: To assess behaviour, change and engagement with mental health following exposure to the FRAME 
intervention, patients who completed the pre-intake survey will be invited to complete a follow-up survey six months after 
being exposed to the FRAME intervention. The research team will contact eligible patients by email to complete the 
outcome survey and attach the outcome survey poster (Appendix G). In addition, participating care providers may support 
recruitment by reaching out to patients who interacted with the FRAME intervention during the implementation phase. 
The follow-up survey will explore changes in awareness, comfort discussing mental health, and uptake of self-
management strategies or resources (Appendix A). 
Interviews: At the end of the outcome survey, patients will be invited to indicate whether they are interested in 
participating in a 20-30-minute interview with the research team. Those who express interest will be contacted by a 
member of the research team to schedule the interview by phone or email (this will be indicated by patient's preference on 
the survey). Interviews will be semi-structured and conducted either by phone or via Microsoft Teams, depending on the 
participant’s preference. We anticipate recruiting approximately n=12-15 patient participants for interviews, but will 
continue until data saturation is reached, defined as the point when no new themes are emerging (19). The final number 
may vary based on the diversity of participant experiences, and additional interviews may be conducted if needed to 
ensure broad representation. 
A formal interview guide will not be developed at this stage. Instead, interviews will be designed to explore emerging 
trends from the intake and outcome survey data. This flexible, responsive approach will allow the research team to probe 
more deeply into trends or complexity shown in the collected quantitative survey data. This ensures that qualitative data 
collected from the interview enriches the interpretation of the quantitative survey results. An REB amendment will be 
submitted beforehand with the attached interview guide.  
Care Provider and Site Staff Evaluation Workshop: To evaluate implementation outcomes and provider experiences, 
we will conduct a two-hour evaluation workshop with approximately n=2-5 staff members per site. Participants may 
include care providers, site champions, and administrative staff involved in implementation. Interviews will explore 
whether the provider-facing FRAME tool was useful and relevant, how it was integrated into the workflow, and whether it 
contributed to increased discussion and engagement around mental health in the context of heart failure care. The initial 
process map created during the pre-intervention phase will be revisited during the post-implementation period to facilitate 
discussion about how mental health care pathways have changed as a result of the intervention. A secondary process map 
will be developed to visually represent the changes in workflow and practices before and after the intervention. This 
updated map will be shared with each pilot site as a resource to support ongoing maintenance of the changes beyond the 
pilot period. No long-term follow-up is planned post-pilot and evaluation phase.  
Caregivers Interviews: Caregivers will be recruited through two pathways during the pilot phase. First, when scheduling 
interviews with patients, the research team will ask whether the patient has a caregiver who may be interested in 
participating in an interview. They participate either independently or as part of a dyadic interview, depending on the 
preferences of the patient and caregiver. Second, caregivers who interact with the caregiver-focused webpage on the 
FRAME site will see a pop-up invitation offering the opportunity to share their contact information if they are interested 
in being interviewed. 

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Caregivers who express interest will be contacted by the research team to schedule a 15- to 20-minute interview, 
conducted by phone, in person, or via Microsoft Teams, based on their preference. The interviews will follow a grounded 
theory approach (25) and begin with two open-ended prompts (Appendix B), allowing themes to emerge naturally. This 
approach is intended to create space for caregivers to share their experiences in their own words. 
4.6   Study Stopping Rules/Termination 
As this study poses minimal risk to participants, stopping rules are limited to practical and ethical concerns. The study or a 
portion of it will be discontinued if: 
 
For intake and outcome survey: 
• 
Participants can close the browser if they change the mind about participating and if after filling out survey. 
Participants may also click on the withdrawal button at the bottom of the survey. 
• 
Ethical concerns arise during the study that warrant a temporary pause or complete stop, as determined by the 
principal investigator and/or Research Ethics Board. 
• 
Participants may withdraw at any time without consequence, and incomplete survey data will be excluded from 
analysis if the participant requests removal. 
For interviews:  
• 
Participants may withdraw from the study at any time during the interview without consequence. Incomplete 
interviews will be excluded from the analysis if the participant requests removal.  
4.7   Drug or Investigational Product Accountability Procedures      
N/A          
4.8    Randomization and Blinding 
    N/A  
            
4.9    Data Records 
N/A 
 
 
 
5. SELECTION AND WITHDRAWAL OF STUDY PARTICIPANTS 
 
5.1   Inclusion Criteria 
Inclusion Criteria: 
Patients (Surveys and Optional Interviews)  
1. Patients with a formal diagnosis of heart failure 
2. Patients on the following list of medications (26): 
• 
Angiotensin receptor-neprilysin inhibitors (ARNI), called sacubitril-valsartan  
• 
Angiotensin converting enzyme inhibitors (ACEi), called “prils”  
• 
Angiotensin-receptor blockers (ARBs), called “sartans” 
• 
Beta-blockers, called “lols” 

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• 
Mineralocorticoid receptor receptor antagonists (MRAs) 
• 
Sodium-glucose co-transporter-2 (SGLT2) inhibitors, called “flozins” 
 
3. Receiving care at one of the participating pilot test sites or if they found their way to the tool website 
4. Willing and able to provide informed consent and name, email address and phone number for follow-up contact 
(for survey and interview) 
 
Caregivers (Optional interviews):  
1. Caregivers who support adult(s) with heart failure.  
Healthcare Providers and Site Staff 
1. Healthcare provider (e.g., physician, nurses, allied health professionals, pharmacists, community paramedics) 
currently working at one of the participating pilot test sites  
2. Involved in care or coordination of care for patients with heart failure (e.g., administration, executive staff) 
3. Willing to participate in pre- and post-intervention process mapping workshops  
 
5.2   Exclusion Criteria  
Patients  
1. Inability to provide informed consent (e.g., due to cognitive impairment or language barriers without translated 
support) 
2. Participants that do not have access to the internet will not be able to use the web-tool.  
 
Healthcare Providers 
1. Providers that are not involved in the care of heart failure patients  
         
5.3   Reasons for a Participant Being Withdrawn, or Withdrawing, from the Study 
Participants may be withdrawn or choose to withdraw from the study for the following reasons: 
• 
The participant withdraws consent at any time. 
• 
The participant is no longer reachable (i.e., lost to follow-up). 
• 
The participant is non-compliant with the study procedures (e.g., does not complete the survey despite reminders). 
• 
The participant no longer meets the inclusion criteria (e.g., if they move out of the participating care setting). 
• 
A protocol violation occurs that necessitates the removal of the participant. 
• 
The participant passes away during the course of the study. 
Participant Replacement: 
Participants who withdraw will not be replaced. Data will be analyzed only from completed surveys and interviews. 
Withdrawal Process: 
If a participant chooses to withdraw, no further data will be collected. Any previously collected data will be retained and 
de-identified unless the participant requests that their data be removed, in which case all identifiable data will be deleted. 

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The participant must contact the principal investigator by email within two weeks from their submission of the survey 
and/or interview in this case and will be written on the consent form.  
5.4   Study Stopping/Termination Rules 
  The study may be suspended or terminated early for any of the following reasons: 
• 
It becomes clear that the study will not reach its primary outcome or recruitment targets. 
• 
Unanticipated risks to participants arise (e.g., participants experience distress at a level that outweighs the 
minimal risk profile of the study). 
• 
Persistent non-compliance with the protocol by study sites or staff. 
• 
Infrastructure issues (e.g., loss of site partners, withdrawal of funding, or changes in Ontario Health Team 
capacity to participate). 
• 
Pandemic restrictions or similar external events affect the feasibility or safety of continuing the study. 
           
6. STUDY MEASURES AND PARTICIPATION 
 
6.1  Treatment of Participants for Drug/Device Trials  
N/A          
6.2  Treatment of Participants for all other Studies  
Participants will not receive any drug or physical treatment. Study procedures involve: 
• 
Patients complete surveys at two time points (baseline and 6-months post-intervention). This survey will take 
about 10-15 minutes to complete. 
• 
Optional 30-minute semi-structured interviews with a subsample of patients and caregivers who indicate on the 
outcome survey they wish to participate.  
• 
Clinic staff at participating pilot sites will participate in two 2-hour process mapping workshops (pre- and post-
intervention) 
There are no restrictions to food, drink, medications or physical activity for participation in the study. 
 6.3 Monitoring Participant Compliance  
Compliance monitoring will be minimal due to the nature of the study: 
• 
Surveys: Completion will be monitored through the survey platform for both the intake and outcome surveys. 
Email reminders can be sent to patients who did not complete the survey but started it via the automated system 
sent from the platform. No follow-up is required after the survey unless the participant expresses interest in 
having an interview. An e-gift card will be sent via email after the completion of the intake survey and after the 
outcome survey.  
• 
Interviews: Scheduled based on participant availability and confirmed by the research team; no follow-up is 
required after the interview is completed, other than providing the compensation via email.  
• 
No diaries, bloodwork, or physiological measures are required. 
Participants are considered compliant if they complete the survey or attend the interview after consent. There are no long-
term participation requirements beyond the post-intervention period. 
7. ASSESSMENT OF EFFICACY 

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Primary and secondary outcomes will be assessed using pre- and post-intervention surveys administered to patients during 
the following timeframes: 
Assessment Methods: 
Baseline / Pre-Implementation Phase (September to December 2025) 
Survey Data: All patient intake survey data will be collected via REDCap, a secure, web-based platform. Surveys will 
capture demographics, current mental health engagement, awareness of services, and confidence in discussing mental 
health. Data will be exported into SPSS or R for analysis. Descriptive statistics will be used to summarize participant 
characteristics and baseline responses across sites. These baseline measures will serve as a reference point for comparison 
with follow-up responses after the intervention. 
Process Mapping Workshops: Workshops will be audio-recorded with verbal  consent and transcribed using Microsoft 
Teams or PlayWrite. Transcripts will be imported into MAXQDA 2022. A deductive analysis will be conducted using the 
RE-AIM framework, with codes organized by implementation domains (e.g., Reach, Adoption, Implementation). The 
findings from the workshop will also inform the construction of baseline visual process maps for each site. These maps 
will help document existing mental health pathways and serve as a comparison point for post-implementation changes. 
  
Implementation Phase (January to July 2026) 
Implementation Monitoring: Intervention uptake will be tracked using analytics such as QR code scans and web traffic 
for FRAME resources. A fidelity checklist will be created to document which components of the FRAME intervention 
were implemented at each site, including training completion, distribution of materials, and resource sharing. Monthly 
check-ins with site champions will be recorded and transcribed. Feedback from these sessions will be coded using the RE-
AIM framework to assess implementation progress, emerging barriers, and facilitators. Feedback from providers and site 
champions during monthly check-ins will be used to monitor real-time implementation trends. These discussions will be 
deductively coded using the RE-AIM framework and used to update the fidelity checklist and track variation in 
intervention delivery across settings. 
  
Post-Implementation and Evaluation Phase (August to December 2026) 
Survey Data (Outcome Survey): 
 Patients who completed the intake survey will be invited to complete a follow-up survey six months after FRAME 
exposure. Data will again be collected in REDCap. Paired t-tests (or non-parametric equivalents, such as the Wilcoxon 
signed-rank test) will be conducted to examine changes in: 
• 
Frequency of mental health discussions 
• 
Engagement in mental health-related supports 
• 
Confidence in discussing mental health with providers 
 

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Regression models may also be applied to explore the association between intervention exposure and outcomes, adjusting 
for demographic or site-level differences. 
Patient Interviews: Approximately n=12–15 patient interviews will be conducted, with flexibility to continue until data 
saturation is reached. Interviews will be recorded, transcribed, and thematically analyzed in MAXQDA 2022 using Braun 
& Clarke’s six-phase method. This inductive analysis will explore patient experiences with the FRAME intervention, 
including its usefulness and impact on behavior. Interview content will also help contextualize survey findings. Rigor will 
be supported using Lincoln & Guba’s criteria for trustworthiness (credibility, dependability, confirmability, and 
transferability). 
Caregiver Interviews: Caregivers will be recruited through patients or directly from the FRAME website. They will 
participate in 15–20-minute interviews, individually or as part of a dyad. Interviews will follow a grounded theory 
approach, starting with two open-ended prompts (Appendix B) to allow themes to emerge naturally. Transcripts will be 
analyzed inductively in MAXQDA to build theory about caregiver experiences, challenges, and support needs in relation 
to heart failure and mental health. 
Provider and Staff Evaluation Workshops: Follow-up workshops with 2–5 staff per site will revisit the original process 
maps created during the pre-implementation phase. Post-implementation process maps will be developed collaboratively 
during the session to visualize changes in workflow. These recordings will be transcribed and analyzed deductively using 
the RE-AIM framework, and maps will be compared to assess workflow improvements or gaps. These final process maps 
will be left with each site to support sustainability beyond the pilot period. 
 
8. POTENTIAL BENEFITS, RISKS AND SAFETY 
 
8.1  Potential Benefits 
Patients having access to the tool may indirectly benefit from increased attention to mental health in their heart failure care 
journey. No guaranteed direct benefit is offered to participants. Participants could: 
• 
Gain awareness about the connection between heart health and mental health 
• 
Learn about resources available in the community and have access to guides that will help they self-manage their 
heart failure and mental well-being. 
• 
Feel empowered to engage in conversations about mental health with their healthcare providers. 
8.2  Risks 
• 
Emotional or psychological discomfort when reflecting on personal mental health due to the sensitive nature of 
the topic.  
• 
Confidentiality breach: minimal risk due to the use of identifiable contact information  
Mitigation Strategies: 

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• 
A list of free and accessible mental health resources will be provided to all participants in the consent form and 
before interviews begin. 
• 
Participants may skip any survey and interview questions they do not wish to answer. 
• 
Interviews will be scheduled at participants’ convenience, and they can pause or end the interview at any time. 
• 
Participants will be reminded they can withdraw without any consequence. 
• 
Personal information of participants will be stored securely in RedCAP and Bruyere Health Research Institute 
SharePoint.  
• 
All identifiable information will be de-identified prior to analysis.  
These risks and mitigation strategies will be outlined clearly in the informed consent form (ICF).     
 8.3  Safety 
As this study does not involve a medical or therapeutic intervention, serious adverse events are unlikely. However, some 
adverse events may occur:  
• 
Any Adverse Events, such as participant distress during interviews, will be documented and discussed with the 
principal investigator. 
• 
No Adverse Drug Reactions are applicable. 
 
9. RECRUITMENT 
 
Sample Size Pool and Recruitment Estimates 
Based on preliminary discussions with participating pilot sites, we estimate a total recruitment pool of approximately 
7,060 to 7,300 patients across the 8–12 participating care settings during the six-month intervention period. Estimates are 
stratified by setting type, accounting for site volume, focus of care, and potential overlap: 
• 
Primary care settings (n = 5): Each site is expected to see approximately 200 eligible patients over six months, 
based on weekly estimates provided by participating providers. Total estimated pool = 1,000 patients. 
• 
Cardiac clinics (n = 3): From two of our community sites, we expected to see approximately 2,160 unique patients 
over six months, given the high focus on heart failure. We expect the pool from the University of Ottawa Heart 
Institute site to be bigger, approximately 4,000 unique patients. Total estimated pool = 8,320 patients. 
• 
Cardiac rehabilitation programs (n = 3): While these programs may include repeat visits, each site is expected to 
have approximately 100-200 unique patients over the course of six months. Total estimated pool = 3,00-600 
patients. 
• 
Emergency departments (n = 2): Each site is estimated to contribute 120–240 eligible patients over six months, 
depending on volume and fluctuations. Total estimated pool = 240–480 patients. 
Overall, this results in a projected recruitment pool of approximately 10,100 to 10,400 eligible patients, with 
minimal anticipated overlap across care settings. Some overlap may occur with emergency department visits. 
Sample size estimates were calculated based on a paired t-test design, which reflects the study’s pre-post structure, 
comparing patient-reported outcomes before and after exposure to the FRAME intervention. To control for the increased 

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risk of Type I error due to multiple hypothesis tests (one primary and three secondary outcomes), a Bonferroni correction 
was applied. This adjusted the significance level (alpha) from 0.05 to 0.0125 per test. A desired statistical power of 0.80 
was used to ensure adequate sensitivity to detect meaningful change.  
• 
Small effect (Cohen’s d = 0.1): 1,118 participants pre and post 
• 
Small-to-moderate effect (Cohen’s d = 0.15): 499 participants pre and post 
• 
Moderate effect (Cohen’s d = 0.2): 282 participants pre and post 
The actual effect size to use will be guided by the expected impact of the intervention based on similar prior studies and 
the minimal clinically important difference for the outcomes being assessed. Given the total projected recruitment pool of 
10,100 to 10,400 eligible patients, we anticipate that it will be feasible to meet sample size requirements for detecting 
even small-to-moderate changes 
Sample size was calculated using a paired t-test model to compare pre- and post-intervention survey scores. We applied 
a Bonferroni correction for four outcome measures (one primary and three secondary), adjusting alpha to 0.0125. A 
power of 0.80 was selected. 
Estimated minimum sample sizes: 
• 
Small effect (Cohen’s d = 0.1): 1,118 participants 
• 
Small-to-moderate effect (Cohen’s d = 0.15): 499 participants 
• 
Moderate effect (Cohen’s d = 0.2): 282 participants 
Given a projected total eligible patient population of 10,100–10,400 across participating sites during the study period, 
we anticipate being able to recruit the sample needed to detect even small-to-moderate effects. 
Breakdown of anticipated research participants: 
• 
Patients: Up to 1,200 for pre-post surveys; all will be invited for follow-up interviews but only 12-15 interviews 
will be conducted. 
• 
Caregivers: Estimated 10–20, based on patient consent and availability; only those who express interest will be 
invited for interviews. 
• 
Healthcare providers/clinic staff: Up to 80 participants total (~6–10 per site), depending on site size. These 
individuals will take part in the process mapping workshops, training sessions, monthly check-ins, and the 
evaluation workshop. They will be recruited based on initial meetings with site staff.  
Recruitment of patients will stop once target pre-post survey completion is achieved (n = ~500–1,200) and 
interviews are completed (n=~12-5).  The research team has sufficient staff support to meet the demands of the 6-
month data collection period. 
 
 

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Recruitment Methods: 
1. Patient Recruitment 
Survey Recruitment  
Eligible patients will be recruited to complete the intake and outcome surveys (Appendix A) through the following 
methods: 
• 
Clinic-Based Posters with QR Codes: Posters will be displayed in high-traffic areas within each participating 
site (e.g., waiting rooms, exam rooms, reception desks). Each poster will include a QR code that links directly to 
the intake or outcome survey (Appendix F and G), depending on the pilot phase and the survey will be hosted on 
REDCap.  
• 
Email and Phone Outreach: Participating site staff will identify eligible patients and contact them via email or 
phone to introduce the study. If a patient expresses interest, the intake survey will be shared by either the site staff 
or the research team. This email will include a secure link to the intake survey as well as access to the FRAME 
tool after completion of the survey. See Appendix H for all recruitment texts.  
• 
During the Intervention Phase: Care providers will share the FRAME tool directly with patients during routine 
clinical interactions. As part of this interaction, patients will be informed about the study and asked if they 
consent to be contacted later by the research team for the outcome survey. If patients agree, their contact 
information will be collected at that point and sent to the research team. 
• 
Outcome Survey Distribution: At the time of completing the intake survey, patients will be asked to provide 
their name, email, and/or phone number so they can be contacted to complete the outcome survey. This will be 
clearly explained at the end of the intake survey. Six months after a patient has completed the intake survey and 
received the FRAME tool, the research team will reach out via the contact information provided to invite them to 
complete the outcome (post-intervention) survey. Follow-up will be conducted through email and/or phone, based 
on the patient’s stated preference. 
• 
Patient Website Pop-Up: Patients accessing the online FRAME tool will receive a pop-up message inviting them 
to participate in the outcome survey.  
• Social media recruitment: Study posters and survey links will be shared via social media platforms and 
communication channels managed by Brain-Heart Interconnectome, our Ontario Health Teams, and 
their communication channels. This includes posts on platforms such as Instagram, Facebook as well as 
promotion through newsletters and community-facing websites to increase visibility and engagement 
with eligible patients. 
Interview Recruitment 
At the end of the outcome survey, patients will be asked if they are interested in participating in a 20–30-minute follow-up 
interview. The research team will reach out to those who express to schedule the interview. Interviews will be conducted 
by phone or Microsoft Teams based on participant preference. Participants who complete the interview will receive a $25 
Amazon gift card. 
2. Caregiver Recruitment 
Caregivers will be recruited through two pathways.  
• 
Patient Referral (Dyadic or Individual Participation): When scheduling patient interviews, the research team 
will ask whether the patient has a caregiver who might also be interested in participating. If so, the caregiver may 
participate independently or as part of a dyadic interview, depending on their preference. 

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• 
Caregiver Website Pop-Up: A pop-up invitation will appear when caregivers access the caregiver-facing 
FRAME resource website. Those interested in participating will be invited to share their contact information. The 
research team will follow up to schedule a 15–20-minute interview via phone, Microsoft Teams, or in person. 
Caregivers who participate in interviews will receive a $25 gift card. 
• 
Social media recruitment: Study posters and survey links will be shared via social media platforms and 
communication channels managed by Brain-Heart Interconnectome, our Ontario Health Teams, and 
their communication channels. This includes posts on platforms such as Instagram, Facebook as well as 
promotion through newsletters and community-facing websites to increase visibility and engagement 
with eligible patients. 
3. Healthcare providers and administration staff 
Site Champion Selection: 
Each site will nominate one staff member to act as a site champion, responsible for coordinating local activities and 
participating in monthly check-in meetings with the research team. Site champions will be identified during early planning 
discussions with each clinic.  
Process Mapping and Evaluation Workshops: 
All participating sites will identify relevant care providers and administrative staff to take part in the process mapping 
workshops. Recruitment will occur through direct discussion with site leads during the planning phase to identify 
appropriate staff (e.g., clinician, nurses, social workers, receptionists, clinic managers) who are actively involved in 
patient care and/or clinic workflows. 
• 
Pre-Implementation (Process Mapping Workshops): A two-hour workshop will be scheduled at each site with 
invited staff to map out the current workflow for addressing mental health in heart failure care. 
• 
Post-Implementation (Evaluation Workshop): Following the intervention period, the same or additional staff 
will be invited to participate in a second workshop to review how workflows have changed and to provide 
feedback on the intervention. 
4. Site Compensation 
Each participating site will receive financial compensation to support the time and resources required to implement and 
evaluate the FRAME intervention. This funding is intended to offset the operational costs associated with participating in 
the pilot and will include support for: 
• 
Training time for care providers and staff involved in implementing the FRAME tool. 
• 
Attendance at workshops, including the baseline process mapping and post-implementation evaluation sessions. 
• 
Remuneration for site champions, who will lead local coordination and attend monthly check-ins. 
• 
Funds for printing and distributing posters and FRAME-related patient materials. 
• 
Hourly remuneration for staff time spent supporting recruitment, such as emailing or calling eligible patients to 
invite participation in the survey. 
Care providers will not receive compensation for using the provider-facing FRAME tool as part of routine care. 
Compensation is limited to time spent in training or other research-specific activities. See budget attachment for a detail 
description.  
10.  CONSENT AND SCREENING 

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Consent Procedures: 
• 
Survey participants will review an informed consent via RedCAP before continuing the survey for both the intake 
and outcome surveys (see Appendix I and J) 
• 
Interview participants will provide verbal and written consent before the interview by phone/Microsoft Teams 
(see Appendix K and L). 
• 
Participants will receive a digital copy of the consent form. 
• 
Workshop/monthly-check in participants will review a written consent form and provide verbal consent before 
each session occurs.  
• 
There are no screening procedures beyond confirming participants’ eligibility (see Appendix A, questions 5-6 in 
primary care/cardiac rehabilitation/cardiac specialist and questions 5-7 in the Emergency Department for 
screening eligibility)  
Time commitment: 
Surveys: ~10-15 minutes 
Process Mapping Focus Groups: 4 hours (2 hours pre-implementation and 2 hours post-implementation) 
Reoccurring Team Meetings with Sites during the implementation phase: 30-minute monthly check-ins.  
Substitute decision-makers: 
Not applicable. All participants must be capable of consenting. 
 
10.1  Ongoing Consent/Assent 
• 
Ongoing verbal confirmation of consent will be obtained at the start of each interview. 
• 
Participants will be reminded that they can stop at any time without penalty. 
• 
For surveys, participants may stop at any point and skip questions as they choose. 
              
11.  SPECIMEN COLLECTION, STORAGE AND ANALYSIS  
N/A 
 
 
 
 
 
 
 

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                                                                                  Visit the REB Website: https://www.bruyere.org/en/researchethicsboard 
 
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