Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.

BACKGROUND: The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited. OBJECTIVE: This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. METHODS: A structured literature search was developed and deployed in 4 electronic databases-MEDLINE, IEEE Xplore, Scopus, and Web of Science-for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis. RESULTS: In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33%) and participants' perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. CONCLUSIONS: There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.

Identifying and adapting interventions to reduce documentation burden and improve nurses' efficiency in using electronic health record systems (The IDEA Study): protocol for a mixed methods study.

BACKGROUND: Although EHR systems have become a critical part of clinical care, nurses are experiencing a growing burden due to documentation requirements, taking time away from other important clinical activities. There is a need to address the inefficiencies and challenges that nurses face when documenting in and using EHRs. The objective of this study is to engage nurses in generating ideas on how organizations can support and optimize nurses' experiences with their EHR systems, thereby improving efficiency and reducing EHR-related burden. This work will ensure the identified solutions are grounded in nurses' perspectives and experiences and will address their specific EHR-related needs. METHODS: This mixed methods study will consist of three phases. Phase 1 will evaluate the accuracy of the EHR system's analytics platform in capturing how nurses utilize the system in real-time for tasks such as documentation, chart review, and medication reconciliation. Phase 2 consists of a retrospective analysis of the nursing-specific analytics platform and focus groups with nurses to understand and contextualize their usage patterns. These focus groups will also be used to identify areas for improvement in the utilization of the EHR. Phase 3 will include focus groups with nurses to generate and adapt potential interventions to address the areas for improvement and assess the perceived relevance, feasibility, and impact of the potential interventions. DISCUSSION: This work will generate insights on addressing nurses' EHR-related burden and burnout. By understanding and contextualizing inefficiencies and current practices, opportunities to improve EHR systems for nursing professional practice will be identified. The study findings will inform the co-design and implementation of interventions that will support adoption and impact. Future work will include the evaluation of the developed interventions, and research on scaling and disseminating the interventions for use in different organizations, EHR systems, and jurisdictions in Canada.

Meaningful Digital Consent in Canada: Recommendations from Pan-Canadian Consent Management Workshops.

The digital health landscape is rapidly evolving with regard to how society accesses and interacts with digital information and technologies. With a largely commercial marketplace, there are growing concerns that users are not fully informed about how their data are used. Canadian privacy legislation is currently undergoing modernization to improve the transparency of commercial information handling practices through the introduction of meaningful consent. This paper reports on workshops held across Canada, exploring the implications of meaningful consent in a digital health context. Recommendations focus on measures to promote transparency, improve digital literacy and foster public trust in digital health innovations.

Ready or Not: Key Insights to Enabling Adolescents' Access to Their Personal Health Information.

Granting minors with online access to their personal health information (PHI) is a complex policy and implementation issue, requiring a balance of rapid changes in adolescent maturity and autonomy, adolescent need for privacy and confidentiality and care responsibilities of custodians and providers. There are currently no standard legislation or policies that enable access; however, most implementations use the age of majority or the mature minor doctrine as an approach - each with its own limitations. This paper highlights key legislative and implementation insights for organizations seeking to enable adolescents with online access to their PHI, calling for leadership to address this issue.

Development of a Resource Guide to Support the Engagement of Mental Health Providers and Patients With Digital Health Tools: Multimethod Study.

BACKGROUND: As mental illness continues to affect 1 in 5 individuals, and the need for support has increased during the COVID-19 pandemic, the promise of digital mental health tools remains largely unrealized due to a lack of uptake by patients and providers. Currently, most efforts on supporting the uptake of digital mental health tools remain fragmented across organizations and geography. There is a critical need to synthesize these efforts in order to provide a coordinated strategy of supporting the adoption of digital mental health tools. OBJECTIVE: The specific aim of this project is to develop a web-based resource document to support the engagement of mental health providers and patients in the use of digital mental health tools. METHODS: The web-based resource was developed using a multimethod approach. A grey literature review was conducted in 2019 to identify relevant toolkits that are available in the public domain. This was supplemented with an environmental scan where individuals with expertise in the development, acquisition, implementation, and evaluation of digital mental health tools were invited to contribute additional tools or documents not identified in the grey literature search. An engagement workshop was held with stakeholders to explore how the resource document should be developed and delivered. These findings were collectively used to develop the final iteration of the resource document. RESULTS: Based on a gray literature review and environmental scan with 27 experts, 25 resources were identified and included in the resource guide. These resources were developed for patients and providers by organizations from 5 countries. An engagement workshop was held with 14 stakeholders, and barriers related to cultural sensitivity, sustainability, and accessibility of the toolkit were identified. The final iteration of the resource document was developed by the research team using findings from the gray literature review, environmental scan, and engagement workshop. The contents of the 45-page resource guide are directed at mental health care providers, administrators, and patients (inclusive of families and caregivers). CONCLUSIONS: The use of a multimethod approach led to the development of a resource guide that builds on existing evidence on digital mental health tools and was co-designed with stakeholders and end-users. The resource guide is now publicly available online for free and is being promoted through digital health and mental health websites. Future work should explore how this document can be integrated into clinical care delivery and pathways.

Implementation of a Clinical, Patient-Level Dashboard at a Mental Health Hospital: Lessons Learned from Two Pilot Clinics.

The Centre for Addiction and Mental Health has implemented mechanisms to standardize routine data collection with the vision of a Learning Health System. To improve clinical decision-making and patient outcomes, a clinical dashboard was implemented to provide a real-time visualization of data from patient self-assessments and other physical and mental health indicators. This case report shares early findings of dashboard implementation to understand user uptake and improve fidelity of the technology and processes that need to support adoption. Moreover, these findings will inform the strategy and development of a hospital-wide scalable dashboard that will span across clinical areas and leverage artificial intelligence to continuously improve patient outcomes and equitable care delivery.

A holistic approach to integrating patient, family, and lived experience voices in the development of the BrainHealth Databank: a digital learning health system to enable artificial intelligence in the clinic.

Artificial intelligence, machine learning, and digital health innovations have tremendous potential to advance patient-centred, data-driven mental healthcare. To enable the clinical application of such innovations, the Krembil Centre for Neuroinformatics at the Centre for Addiction and Mental Health, Canada's largest mental health hospital, embarked on a journey to co-create a digital learning health system called the BrainHealth Databank (BHDB). Working with clinicians, scientists, and administrators alongside patients, families, and persons with lived experience (PFLE), this hospital-wide team has adopted a systems approach that integrates clinical and research data and practices to improve care and accelerate research. PFLE engagement was intentional and initiated at the conception stage of the BHDB to help ensure the initiative would achieve its goal of understanding the community's needs while improving patient care and experience. The BHDB team implemented an evolving, dynamic strategy to support continuous and active PFLE engagement in all aspects of the BHDB that has and will continue to impact patients and families directly. We describe PFLE consultation, co-design, and partnership in various BHDB activities and projects. In all three examples, we discuss the factors contributing to successful PFLE engagement, share lessons learned, and highlight areas for growth and improvement. By sharing how the BHDB navigated and fostered PFLE engagement, we hope to motivate and inspire the health informatics community to collectively chart their paths in PFLE engagement to support advancements in digital health and artificial intelligence.

Identifying Implementation Strategies to Enhance the Uptake of OpenNotes in Mental Health Settings: A Study Protocol.

Numerous benefits have been shown when OpenNotes functionality is present in a patient portal. Despite the benefits, many mental health providers have demonstrated concern with regards to sharing their clinical documentation with their patients electronically. This poster will describe a mixed-methods study protocol that aims to address the concerns of mental health providers by co-producing and contextualizing resources to support the uptake of OpenNotes by mental health providers in the Canadian context.

Race and Racialization in Mental Health Research and Implications for Developing and Evaluating Machine Learning Models: A Rapid Review.

Machine learning models are often trained on sociodemographic features to predict mental health outcomes. Biases in the collection of race-related data can limit the development of useful and fair models. To assess the current state of this data in mental health research, we conducted a rapid review guided by Critical Race Theory. Findings reveal limitations in the measurement and reporting of race and ethnicity, potentially leading to models that amplify health inequities.

Canadian perspectives of digital mental health supports: Findings from a national survey conducted during the COVID-19 pandemic.

Objectives: The impact of the COVID-19 pandemic on population mental health has highlighted the potential for digital mental health to support the needs of those requiring care. This study sought to understand the digital mental health experiences and priorities of Canadians affected by mental health conditions (i.e. seekers, patients, and care partners). Methods: A national cross-sectional electronic survey of Canadians was administered through a market research firm's survey panel. Seekers, patients, and care partners were asked about their digital mental health experiences (e.g. uptake, barriers to access) and priorities. Survey responses were summarized using descriptive statistics. Results: Overall, 1003 participants completed the survey. 70.2% of participants routinely use digital mental health supports to support themselves or those they care for; however, only 28.6% of participants are satisfied with the available digital mental health supports. Most participants (73.3%) have encountered some barriers when accessing digital mental health supports. Awareness of digital mental health supports was a top barrier identified by participants. The top digital mental health priorities consisted of digital mental health curation, navigation, and a digital mental health passport. Conclusions: Most participants use digital mental health supports for themselves or others, however, many are unaware of digital mental health supports available. Efforts to improve navigating access to digital and in-person mental health services are seen as a top priority, highlighting the need to enable seekers, patients, and care partners to find the appropriate support and make decisions on how to best improve their mental health.

Planning for the Future of Digital Mental Health in Canada: Priorities of Canadians Affected by Mental Health Conditions.

Digital mental health tools have the potential to support people affected by mental health conditions. A pan-Canadian survey was conducted to understand the current and future digital health needs. The results show that Canadians prioritized tools that support them in navigating the physical and digital mental healthcare systems and that are integrated into their care.

Supporting the use of patient portals in mental health settings: a scoping review.

With the increased use of patient portals in acute and chronic care settings as a strategy to support patient care and improve patient-centric care, there is still little known about the impact of patient portals in mental health contexts. The purposes of this review were to: 1) identify the critical success factors for successful patient portal implementation and adoption among end-users that could be utilized in a mental health setting; 2) uncover what we know about existing mental health portals and their effectiveness for end-users; and 3) determine what indicators are being used to evaluate existing patient portals for end-users that may be applied in a mental health context. This scoping review was conducted through a search of six electronic databases including Medline, EMBASE, PsycINFO, and CINAHL for articles published between 2007 and 2021. A total of 31 articles were included in the review. Critical success factors of patient portal implementation included those related to education, usefulness, usability, culture, and resources. Only two patient portals had articles published related to their effectiveness for end-users (one in Canada and the other in the United States). More than 100 measures of process (n = 73) and outcome (n = 59) indicators were extracted from the studies and mapped to the Benefits Evaluation Framework. Patient portals carry great potential to improve patient care, but more attention needs to be given to ensure they are being evaluated through the development and implementation phases with the end-users in mind. Further understanding of process indicators relating to use are essential for long-term patient adoption of portals to obtain their potential benefits.

"I think it's something that we should lean in to": The use of OpenNotes in Canadian psychiatric care contexts by clinicians.

Background: OpenNotes is the concept of patients having access to their health records and clinical notes in a digital form. In psychiatric settings, clinicians often feel uncomfortable with this concept, and require support during implementation. Objective: This study utilizes an implementation science lens to explore clinicians' perceptions about using OpenNotes in Canadian psychiatric care contexts. The findings are intended to inform the co-design of implementation strategies to support the implementation of OpenNotes in Canadian contexts. Method: This qualitative descriptive study employed semi-structured interviews which were completed among health professionals of varying disciplines working in direct care psychiatric roles. Data analysis consisted of a qualitative directed content analysis using themes outlined from an international Delphi study of mental health clinicians and experts. Ethical approval was obtained from the Centre for Addiction and Mental Health and the University of Toronto. Results: In total, 23 clinicians from psychiatric settings participated in the interviews. Many of the themes outlined within the Delphi study were voiced. Benefits included enhancements to patient recall, and empowerment, improvements to care quality, strengthened relational effects and effects on professional autonomy and efficiencies. Despite the anticipated benefits of OpenNotes, identified challenges pertained to clarity surrounding exemption policies, training on patient facing notes, managing disagreements, and educating patients on reading clinical notes. Conclusion: Many benefits and challenges were identified for adopting OpenNotes in Canadian psychiatric settings. Future work should focus on applying implementation frameworks to develop interventions that address the identified challenges.

Foundations for Meaningful Consent in Canada's Digital Health Ecosystem: Retrospective Study.

BACKGROUND: Canadians are increasingly gaining web-based access to digital health services, and they expect to access their data from these services through a central patient access channel. Implementing data sharing between these services will require patient trust that is fostered through meaningful consent and consent management. Understanding user consent requirements and information needs is necessary for developing a trustworthy and transparent consent management system. OBJECTIVE: The objective of this study is to explore consent management preferences and information needs to support meaningful consent. METHODS: A secondary analysis of a national survey was conducted using a retrospective descriptive study design. The 2019 cross-sectional survey used a series of vignettes and consent scenarios to explore Canadians' privacy perspectives and preferences regarding consent management. Nonparametric tests and logistic regression analyses were conducted to identify the differences and associations between various factors. RESULTS: Of the 1017 total responses, 716 (70.4%) participants self-identified as potential users. Of the potential users, almost all (672/716, 93.8%) felt that the ability to control their data was important, whereas some (385/716, 53.8%) believed that an all or none control at the data source level was adequate. Most potential users preferred new data sources to be accessible by health care providers (546/716, 76.3%) and delegated parties (389/716, 54.3%) by default. Prior digital health use was associated with greater odds of granting default access when compared with no prior use, with the greatest odds of granting default access to digital health service providers (odds ratio 2.17, 95% CI 1.36-3.46). From a list of 9 information elements found in consent forms, potential users selected an average of 5.64 (SD 2.68) and 5.54 (SD 2.85) items to feel informed in consenting to data access by care partners and commercial digital health service providers, respectively. There was no significant difference in the number of items selected between the 2 scenarios (P>.05); however, there were significant differences (P<.05) in information types that were selected between the scenarios. CONCLUSIONS: A majority of survey participants reported that they would register and use a patient access channel and believed that the ability to control data access was important, especially as it pertains to access by those outside their care. These findings suggest that a broad all or none approach based on data source may be accepted; however, approximately one-fifth of potential users were unable to decide. Although vignettes were used to introduce the questions, this study showed that more context is required for potential users to make informed consent decisions. Understanding their information needs will be critical, as these needs vary with the use case, highlighting the importance of prioritizing and tailoring information to enable meaningful consent.

Patient and Family Engagement Approaches for Digital Health Initiatives: Protocol for a Case Study.

BACKGROUND: Digital health initiatives such as patient portals, virtual care platforms, and smartphone-based apps are being implemented at a rapid pace in health care organizations worldwide. This is often done to improve access beyond traditional in-person care and enhance care quality. Recent studies have indicated that better outcomes of using these initiatives and technologies may be achieved when patients and their family members are engaged in all aspects of planning, implementation, use, and evaluation. However, little guidance exists for how health care administrators can achieve effective engagement in digital health initiatives specifically. OBJECTIVE: The objective of this study is to document processes related to planning and implementing patient and family engagement (PFE) in digital health initiatives. This information will be used to develop tangible resources (eg, a field guide) that other organizations can use to implement PFE approaches for digital health initiatives in their organizations. METHODS: A previously developed multidimensional conceptual framework for PFE in health and health care contexts will be used to guide this work. To understand the intricacies involved in using PFE approaches in digital health strategies, a case study will be conducted. More specifically, this work will employ an embedded single-case design with PFE in digital health initiatives at a large Canadian mental health and addictions teaching hospital. Multiple digital health projects being undertaken at the study site will be explored to better understand where the PFE is intended to support the design, implementation, and operation of the digital health platform or technology. These projects will form the individual units of analysis. Data collection will involve field notes and artifact collection by a participant observer and interviews with the various digital health project teams. Data analysis will include a content and thematic analysis, triangulation of the findings, and a chronological mapping of data to a PFE process. RESULTS: Funding for this work was provided by the Canadian Institutes of Health Research (CIHR), via a Health System Impact Fellowship. As of August 2020, digital health projects that will form the case study units have been identified, and the participant observer has started to embed themselves into these projects. Although the development and collection of field notes and artifacts, respectively, have begun, interviews have not been conducted. The study is expected to conclude in September 2021. Once this study is complete, the development of a field guide and resources to support the uptake of PFE strategies in digital health will begin. CONCLUSIONS: By better understanding the processes involved in PFE in digital health projects, guidance can be provided to relevant stakeholders and organizations about how to do this work in an effective manner. It is then anticipated that with the increasing use of PFE approaches, there may be improved uptake, experience, and outcomes associated with using digital health technologies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/24274.

Sharing Clinical Notes in a Canadian Mental Health Setting: Recommendations from Applying the Consolidated Framework for Intervention Research.

During the COVID-19 pandemic, the OpenNotes movement presents an optimal solution for virtual engagement through the sharing of clinical notes within mental health care settings. Therefore, we conducted interviews to discover how mental health clinicians interact with patients using OpenNotes. We integrated The Consolidated Framework for Intervention Research to establish implementation recommendations. As both challenges and opportunities were identified, future research should address challenges to foster patient and clinician engagement in sharing clinical notes.

The eHealth Trust Model: A Patient Privacy Research Framework.

Patient privacy concerns are often cited as a barrier to health information exchange (HIE) implementations; however, the current understanding of patient perspective is limited due to a fragmented approach to patient privacy research. The limited evidence suggests that the patient privacy perspective is context-dependent and may involve benefit-risk tradeoffs. A standardized approach to the contextual factors would allow for more consistent assessment, providing a better understanding or explanation of the contextual factors influencing the patient privacy perspective and their attitudes towards HIE. This paper describes the development of the eHealth Trust Model-an evidence-based theory-grounded conceptual framework intended to guide future patient privacy research.

Patient Privacy Perspectives on Health Information Exchange in a Mental Health Context: Qualitative Study.

BACKGROUND: The privacy of patients with mental health conditions is prominent in health information exchange (HIE) discussions, given that their potentially sensitive personal health information (PHI) may be electronically shared for various health care purposes. Currently, the patient privacy perspective in the mental health context is not well understood because of the paucity of in-depth patient privacy research; however, the evidence suggests that patient privacy perspectives are more nuanced than what has been assumed in the academic and health care community. OBJECTIVE: This study aimed to generate an understanding on how patients with mental health conditions feel about privacy in the context of HIE in Canada. This study also sought to identify the factors underpinning their privacy perspectives and explored how their perspectives influenced their attitudes toward HIE. METHODS: Semistructured interviews were conducted with patients at a Canadian academic hospital for addictions and mental health. Guided by the Antecedent-Privacy Concern-Outcome macro-model, interview transcripts underwent deductive and inductive thematic analyses. RESULTS: We interviewed 14 participants. Their privacy concerns varied, depending on the participant's privacy experiences and health care perceptions. Media reports of privacy breaches and hackers had little impact on participants' privacy concerns because of a fatalistic belief that privacy breaches are a reality in the digital age. Rather, direct observations and experiences with the mistreatment of PHI in health care settings caused concern. Decisions to trust others with PHI depended on past experiences with the individual (or institution) and health care needs. Participants had little knowledge of patient privacy rights and legislation but were willing to participate in HIE because of perceived individual and societal benefits. CONCLUSIONS: This study introduces evidence that patients with mental health conditions would support HIE. Participants were pragmatic, supporting HIE because they wanted the best care possible. They also understood that their PHI was critical in supporting the single-payer Canadian health care system. Participant health care experiences informed their privacy perspectives, trust, and PHI sharing attitudes-all accentuating the importance of the patient experience in building trust in HIE. Their lack of knowledge about patient rights and PHI uses highlights the degree of trust they have in the health care system to protect their privacy. These findings suggest that the patient privacy discourse should extend beyond the oft-cited barrier of patient privacy concerns to include discussions about building trust, communicating the benefits of HIE, and improving patient experiences. Although our findings are in the Canadian context, this study highlights the importance of engaging patients in privacy policy discussions, regardless of jurisdiction, to ensure their nuanced perspectives are reflected in policy decisions on their PHI.

Understanding the patient privacy perspective on health information exchange: A systematic review.

BACKGROUND: Health information exchange (HIE), the ability for health information technology (HIT) to share patient data, can improve the efficiency and effectiveness of healthcare; however, this ability may cause patient concern about their ability to control who can access their health records (i.e., privacy). These concerns may affect a patient's candor in their therapeutic patient-provider relationships, thereby undermining their care. While patient privacy concerns are often cited as a barrier to HIT implementation, the patient privacy perspective is not well understood. The purpose of this systematic review is to provide an in-depth exploration of the patient privacy perspective toward HIE, its antecedents, and its outcomes. MATERIALS AND METHODS: A systematic review was conducted on seven health sciences and interdisciplinary databases. Empirical studies that assessed the patient perception of privacy in context of interoperable HIT were included. All included articles were independently screened, extracted, and analyzed by two reviewers. The results were extracted and categorized based on the dimensions outlined in the Antecedent Privacy Concern Outcomes macro-model (APCO). RESULTS: Of the 1713 unique citations, 59 articles met the inclusion criteria which consisted of 39 (66.1%) quantitative studies, 15 (25.4%) qualitative studies, and 5 (8.5%) mixed methods studies. Fourteen articles (23.7%) were specifically focused on understanding privacy. The patient privacy perspective was operationalized in different ways, with privacy concern being the most common measure (25.4%). The percentage of participants expressing privacy concern ranged from 15% to 74%, depending on the study. Perceived quality of care was associated with lower privacy concerns. Privacy concerns were associated with privacy protective behaviours; however, the perceived benefit of HIE may mitigate the effects of privacy concern. CONCLUSION: Using the APCO as a guide, this review found that the patient privacy perspective is dynamic, complex, and still not well understood. There may be an oversimplification of the patient privacy perspective and its impact given the paucity of privacy-focused research. The evidence suggests patient perceptions of healthcare and the value of HIE are important factors in mitigating privacy concerns and its effects. More in-depth privacy studies are required to further illuminate the nuances of the patient perspective and provide policy-makers with greater insights on the privacy barrier.