Using Exploratory Trials to Identify Relevant Contexts and Mechanisms in Complex Electronic Health Interventions: Evaluating the Electronic Patient-Reported Outcome Tool.

BACKGROUND: Designing appropriate studies for evaluating complex interventions, such as electronic health solutions to support integrated care, remains a methodological challenge. With the many moving parts of complex interventions, it is not always clear how program activities are connected to anticipated and unanticipated outcomes. Exploratory trials can be used to uncover determinants (or mechanisms) to inform content theory that underpins complex interventions before designing a full evaluation plan. OBJECTIVE: A multimethod exploratory trial of the electronic patient-reported outcome (ePRO) tool was conducted to uncover contexts, processes and outcome variables, and the mechanisms that link these variables before full-scale evaluation. ePRO is a mobile app and portal designed to support goal-oriented care in interdisciplinary primary health care practices (clinical-level integration). This paper offers evaluation findings and methodological insight on how to use exploratory trial data to identify relevant context, process, and outcome variables, as well as central (necessary to achieving outcomes) versus peripheral (less critical and potentially context dependent) mechanisms at play. METHODS: The 4-month trial was conducted in 2 primary health care practices in Toronto, Canada. The patients were randomized into control and intervention groups and compared pre and post on quality of life and activation outcome measures. Semistructured interviews were conducted with providers and patients in the intervention group. Narrative analysis was used to uncover dominant mechanisms that inform the intervention's content theory (how context and process variables are linked to outcomes). RESULTS: Overall, 7 providers, 1 administrator, and 16 patients (7-control, 9-intervention) participated in the study. This study uncovered many complex and nuanced context, process, and outcome variables at play in the intervention. Narrative analysis of patient and provider interviews revealed dominant story lines that help to tease apart central and peripheral mechanisms driving the intervention. Provider and patient story lines centered around fitting the new intervention into everyday work and life of patients and providers and meaningfulness of the intervention. These themes were moderated by patient-provider relationships going into and throughout the intervention, their comfort with technology, and the research process. CONCLUSIONS: Identifying dominant story lines using narrative analysis helps to identify the most relevant context and process variables likely to influence study outcomes. Normalization process theory emerges as a useful theory to uncover underlying mechanisms because of its emphasis on the social production and normalization of technological, processual, and social aspects of work; all found to be critical to our intervention. The number of complex, overlapping influencing variables suggests that complex interventions such as ePRO require us to pay careful attention to central versus peripheral mechanisms that will influence study outcomes. The narrative methods presented here are shown to be useful in uncovering these mechanisms and help to guide subsequent larger evaluation studies.

mHealth Tools for the Self-Management of Patients With Multimorbidity in Primary Care Settings: Pilot Study to Explore User Experience.

BACKGROUND: Given the complex and evolving needs of individuals with multimorbidity, the adoption of mHealth tools to support self-management efforts is increasingly being explored, particularly in primary care settings. The electronic patient-reported outcomes (ePRO) tool was codeveloped with patients and providers in an interdisciplinary primary care team in Toronto, Canada, to help facilitate self-management in community-dwelling adults with multiple chronic conditions. OBJECTIVE: The objective of study is to explore the experience and expectations of patients with multimorbidity and their providers around the use of the ePRO tool in supporting self-management efforts. METHODS: We conducted a 4-week pilot study of the ePRO tool. Patients' and providers' experiences and expectations were explored through focus groups that were conducted at the end of the study. In addition, thematic analyses were used to assess the shared and contrasting perspectives of patients and providers on the role of the ePRO tool in facilitating self-management. Coded data were then mapped onto the Individual and Family Self-Management Theory using the framework method. RESULTS: In this pilot study, 12 patients and 6 providers participated. Both patients and providers emphasized the need for a more explicit recognition of self-management context, including greater customizability of content to better adapt to the complexity and fluidity of self-management in this particular patient population. Patients and providers highlighted gaps in the extent to which the tool enables self-management processes, including how limited progress toward self-management goals and the absence of direct provider engagement through the ePRO tool inhibited patients from meeting their self-management goals. Providers highlighted proximal outcomes based on their experience of the tool and specifically, they indicated that the tool offered valuable insights into the broader patient context, which helps to inform the self-management approach and activities they recommend to patients, whereas patients recognized the tool's potential in helping to improve access to different providers in a team-based primary care setting. CONCLUSIONS: This study identifies a more explicit recognition of the contextual factors that influence patients' ability to self-manage and greater adaptability to accommodate patient complexity and provider workflow as next steps in refining the ePRO tool to better support self-management efforts in primary care ahead of its application in a full-scale randomized pragmatic trial.

Addressing the Evidence Gap in Stroke Rehabilitation for Complex Patients: A Preliminary Research Agenda.

Evidence suggests that a stroke occurs in isolation (no comorbid conditions) in less than 6% of patients. Multimorbidity, compounded by psychosocial issues, makes treatment and recovery for stroke increasingly complex. Recent research and health policy documents called for a better understanding of the needs of this patient population, and for the development and testing of models of care that meet their needs. A research agenda specific to complexity is required. The primary objective of the think tank was to identify and prioritize research questions that meet the information needs of stakeholders, and to develop a research agenda specific to stroke rehabilitation and patient complexity. A modified Delphi and World Café approach underpinned the think tank meeting, approaches well recognized to foster interaction, dialogue, and collaboration between stakeholders. Forty-three researchers, clinicians, and policymakers attended a 2-day meeting. Initial question-generating activities resulted in 120 potential research questions. Sixteen high-priority research questions were identified, focusing on predetermined complexity characteristics-multimorbidity, social determinants, patient characteristics, social supports, and system factors. The final questions are presented as a prioritized research framework. An emergent result of this activity is the development of a complexity and stroke rehabilitation research network. The research agenda reflects topics of importance to stakeholders working with stroke patients with increasingly complex care needs. This robust process resulted in a preliminary research agenda that could provide policymakers with the evidence needed to make improvements toward better-organized services, better coordination between settings, improved patient outcomes, and lower system costs.

Community Care for People with Complex Care Needs: Bridging the Gap between Health and Social Care.

INTRODUCTION: A growing number of people are living with complex care needs characterized by multimorbidity, mental health challenges and social deprivation. Required is the integration of health and social care, beyond traditional health care services to address social determinants. This study investigates key care components to support complex patients and their families in the community. METHODS: Expert panel focus groups with 24 care providers, working in health and social care sectors across Toronto, Ontario, Canada were conducted. Patient vignettes illustrating significant health and social care needs were presented to participants. The vignettes prompted discussions on i) how best to meet complex care needs in the community and ii) the barriers to delivering care to this population. RESULTS: Categories to support care needs of complex patients and their families included i) relationships as the foundation for care, ii) desired processes and structures of care, and iii) barriers and workarounds for desired care. DISCUSSION AND CONCLUSIONS: Meeting the needs of the population who require health and social care requires time to develop authentic relationships, broadening the membership of the care team, communicating across sectors, co-locating health and social care, and addressing the barriers that prevent providers from engaging in these required practices.

The Electronic Patient Reported Outcome Tool: Testing Usability and Feasibility of a Mobile App and Portal to Support Care for Patients With Complex Chronic Disease and Disability in Primary Care Settings.

BACKGROUND: People experiencing complex chronic disease and disability (CCDD) face some of the greatest challenges of any patient population. Primary care providers find it difficult to manage multiple discordant conditions and symptoms and often complex social challenges experienced by these patients. The electronic Patient Reported Outcome (ePRO) tool is designed to overcome some of these challenges by supporting goal-oriented primary care delivery. Using the tool, patients and providers collaboratively develop health care goals on a portal linked to a mobile device to help patients and providers track progress between visits. OBJECTIVES: This study tested the usability and feasibility of adopting the ePRO tool into a single interdisciplinary primary health care practice in Toronto, Canada. The Fit between Individuals, Fask, and Technology (FITT) framework was used to guide our assessment and explore whether the ePRO tool is: (1) feasible for adoption in interdisciplinary primary health care practices and (2) usable from both the patient and provider perspectives. This usability pilot is part of a broader user-centered design development strategy. METHODS: A 4-week pilot study was conducted in which patients and providers used the ePRO tool to develop health-related goals, which patients then monitored using a mobile device. Patients and providers collaboratively set goals using the system during an initial visit and had at least 1 follow-up visit at the end of the pilot to discuss progress. Focus groups and interviews were conducted with patients and providers to capture usability and feasibility measures. Data from the ePRO system were extracted to provide information regarding tool usage. RESULTS: Six providers and 11 patients participated in the study; 3 patients dropped out mainly owing to health issues. The remaining 8 patients completed 210 monitoring protocols, equal to over 1300 questions, with patients often answering questions daily. Providers and patients accessed the portal on an average of 10 and 1.5 times, respectively. Users found the system easy to use, some patients reporting that the tool helped in their ability to self-manage, catalyzed a sense of responsibility over their care, and improved patient-centered care delivery. Some providers found that the tool helped focus conversations on goal setting. However, the tool did not fit well with provider workflows, monitoring questions were not adequately tailored to individual patient needs, and daily reporting became tedious and time-consuming for patients. CONCLUSIONS: Although our study suggests relatively low usability and feasibility of the ePRO tool, we are encouraged by the early impact on patient outcomes and generally positive responses from both user groups regarding the potential of the tool to improve care for patients with CCDD. As is consistent with our user-centered design development approach, we have modified the tool based on user feedback, and are now testing the redeveloped tool through an exploratory trial.