Patient Perspectives on a Pilot Virtual Follow-up Program After Hypertensive Disorders of Pregnancy: A Qualitative Study.

Background: Hypertensive disorders of pregnancy (HDPs) are a risk factor for future cardiovascular disease; therefore, follow-up and implementation of early interventions is recommended. We performed a qualitative study to assess the feasibility and user response to a mobile-health tool and virtual consultation aimed at educating people with an HDP on future cardiovascular risk, and at better understanding patients' priorities for postpartum care. Methods: Participants with a history of an HDP in the past 5 years had access to an online educational tool and participated in a virtual consultation to discuss their cardiovascular risks after experiencing an HDP. Participants were invited to a focus group to obtain feedback on their postpartum experience and the Her-HEART program. Results: A total of 20 female participants were enrolled in the study between January 2020 and February 2021. Of these, 16 participants took part in 1 of 5 focus groups. Participants reported a lack of awareness of future cardiovascular disease risks prior to participating in the program, and identified barriers to counselling, including traumatic birth experiences, inappropriate timing, and competing priorities. Participants reported that the virtual Her-HEART program was an effective avenue to provide counselling on long-term cardiovascular risks. They highlighted the importance of coordinated care pathways and mental health support in postpartum follow-up programs. Conclusion: We have shown the feasibility of providing an educational website and virtual consultation to facilitate counselling in people affected by HDPs. Our results shed light on patient-reported priorities related to the content and delivery of postpartum counselling after an HDP.

Contexte: Les troubles hypertensifs de la grossesse (THG) représentent un facteur de risque de maladies cardiovasculaires. Il est donc recommandé d'assurer un suivi et d'intervenir de façon précoce. Nous avons réalisé une étude qualitative pour évaluer la faisabilité et la réaction des utilisatrices à un outil de santé mobile et à une consultation virtuelle visant à informer les personnes atteintes d'un THG à propos de leur risque cardiovasculaire et à mieux comprendre leurs priorités en matière de soins post-partum. Méthodologie: Les participantes ayant présenté un THG au cours des cinq dernières années ont eu accès à un outil éducatif en ligne et ont participé à une consultation virtuelle pour discuter de leur risque cardiovasculaire. Elles ont été invitées à un groupe de discussion afin d'obtenir des commentaires sur leur expérience post-partum et sur le programme Her-HEART. Résultats: Au total, 20 participantes ont été sélectionnées entre janvier 2020 et février 2021. Parmi elles, 16 ont pris part à l'un des cinq groupes de discussion. Les participantes ont déclaré qu'elles connaissaient mal leur risque de maladies cardiovasculaires avant de participer au programme et ont fait état d'obstacles les faisant hésiter à consulter, notamment des expériences traumatisantes à l'accouchement, le manque de temps et des priorités conflictuelles. Les participants ont déclaré que le programme virtuel Her-HEART était un moyen efficace de fournir des conseils sur les risques cardiovasculaires à long terme. Elles ont souligné l'importance d'une trajectoire de soins coordonnée et d'un soutien psychologique dans les programmes de suivi post-partum. Conclusion: Nous avons démontré la pertinence d'un site Web éducatif et d'une consultation virtuelle pour faciliter l'accompagnement des patientes atteintes d'un THG. Les résultats mettent également en lumière les priorités des patientes ayant présenté un tel trouble en ce qui concerne les modalités d'un accompagnement post-partum.

Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial.

BACKGROUND: There is a paucity of controlled clinical trial data based on research with Indigenous peoples. A lack of data specific to Indigenous peoples means that new therapeutic methods, such as those involving electronic health (eHealth), will be extrapolated to these groups based on research with other populations. Rigorous, ethical research can be undertaken in collaboration with Indigenous communities but requires careful attention to culturally safe research practices. Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research. To be effective, researchers must first gain an in-depth understanding of Indigenous determinants of health, including the harmful consequences of colonialism. Second, researchers need to learn how colonialism affects the research process. The challenge then for eHealth researchers is to braid Indigenous ethical values with the requirements of good research methodologies into a culturally safe research protocol. OBJECTIVE: A recent systematic review showed that Indigenous peoples are underrepresented in randomized controlled trials (RCTs), primarily due to a lack of attention to providing space for Indigenous perspectives within the study frameworks of RCTs. Given the lack of guidelines for conducting RCTs with Indigenous communities, we conducted an analysis of our large evaluation data set collected in the Diagnosing Hypertension-Engaging Action and Management in Getting Lower Blood Pressure in Indigenous Peoples and Low- and Middle- Income Countries (DREAM-GLOBAL) trial over a period of five years. Our goal is to identify wise practices for culturally safe, collaborative eHealth and RCT research with Indigenous communities. METHODS: We thematically analyzed survey responses and qualitative interview/focus group data that we collected over five years in six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL. We established themes that reflect culturally safe approaches to research and then developed wise practices for culturally safe research in pragmatic eHealth research. RESULTS: Based on our analysis, successful eHealth research in collaboration with Indigenous communities requires a focus on cultural safety that includes: (1) building a respectful relationship; (2) maintaining a respectful relationship; (3) good communication and support for the local team during the RCT; (4) commitment to co-designing the innovation; (5) supporting task shifting with the local team; and (6) reflecting on our mistakes and lessons learned or areas for improvement that support learning and cultural safety. CONCLUSIONS: Based on evaluation data collected in the DREAM-GLOBAL RCT, we found that there are important cultural safety considerations in Indigenous eHealth research. Building on the perspectives of Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities. TRIAL REGISTRATION: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226.

Enhancing Indigenous health research capacity in northern Ontario through distributed community engaged medical education at NOSM: A qualitative evaluation of the community engagement through research pilot program.

BACKGROUND: The Community Engagement Through Research (CETR) program matches Indigenous communities interested in exploring their own health research questions with NOSM learners seeking experience in health services research, supervised by faculty experienced in community-based participatory research. METHODS: Qualitative research was conducted using key informant interviews to examine outcomes of the matching of medical students with Indigenous distributed medical education (DME) communities in NOSM's distributed curriculum, in particular improvements for capacity for Indigenous health research in Northern Ontario. RESULTS: Interviews showed that community-centred research was appreciated by community, students and faculty and the social accountability aspect was acknowledged. Students and community members found meaning in the immediate applicability of the research to real community problems and felt inspired by it. The challenges that were identified were mainly related to time and resource constraints, including providing sufficient research training for learners, and the time period required for research ethics board approvals. CONCLUSIONS: The program successfully brought together communities interested in conducting their own health research, with medical students interested in learning about and conducting health research with Indigenous communities. It is therefore an example of successful community based participatory research supporting the social accountability mandate. Challenges are mainly administrative in nature. The program has the potential to be scalable and financially sustainable.

Does a one-day workshop improve clinical faculty's comfort and behaviour in practising and teaching evidence-based medicine? A Canadian mixed methods study.

OBJECTIVE: The purpose of this study was to determine the impact of a 1-day evidence-based medicine (EBM) workshop on physician attitudes and behaviours around teaching and practicing EBM. DESIGN: A mixed methods study using a before/after cohort. SETTING: A medical school delivering continuing professional development to 1250 clinical faculty over a large geographic area in Canada. PARTICIPANTS: 105 physician clinical faculty members. INTERVENTION: A 1-day workshop presented at 11 different sites over an 18-month period focusing on EBM skills for teaching and clinical practice. OUTCOME MEASURES: (1) A quantitative survey administered immediately before and after the workshop, and 3-6 months later, to assess the hypothesis that comfort with teaching and practising EBM can be improved.(2) A qualitative survey of the expectations for, and impact of the workshop on, participant behaviours and attitudes using a combination of pre, post and 3 to 6-month follow-up questionnaires, and telephone interviews completed 10-14 months after the workshop. RESULTS: Physician comfort with their EBM clinical skills improved on average by 0.93 points on a 5-point Likert scale, and comfort with EBM teaching skills by 0.97 points (p values 0.001). Most of this improvement was sustained 3-6 months later. Three to fourteen months after the workshop, half of responding participants reported that they were using the Population Intervention Comparator Outcome (PICO) methodology of question framing for teaching, clinical practice or both. CONCLUSIONS: Comfort in teaching and practicing EBM can be improved by a 1-day workshop, with most of this improvement sustained 3-6 months later. PICO question framing can be learnt at a 1-day workshop, and is associated with a self-reported change in clinical and teaching practice 3-14 months later. This represents both level 2 (attitudes) and level 3 (behaviours) change using the Kirkpatrick model of evaluation.

A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings.

BACKGROUND: To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. OBJECTIVE: Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension-Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. METHODS: Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. RESULTS: Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. CONCLUSIONS: Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. TRIAL REGISTRATION: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege).

Unpacking the Black Box: A Formative Research Approach to the Development of Theory-Driven, Evidence-Based, and Culturally Safe Text Messages in Mobile Health Interventions.

BACKGROUND: Mobile-cellular subscriptions have increased steadily over the past decade. The accessibility of SMS messages over existing mobile networks is high and has almost universal availability even on older and unsophisticated mobile phones and in geographic settings where wireless coverage is weak. There is intensive exploration of this inexpensive mobile telecommunication technology to improve health services and promote behavior change among vulnerable populations. However, a neglected area of research is the documentation and critical analysis of the formative research process required in the development and refinement of effective SMS messages. OBJECTIVE: The objective of this qualitative research study was to identify major factors that may impact on the effectiveness of evidence-based SMS messages designed to reduce health inequities in hypertension management in low resource settings, including Aboriginal populations in high-income countries and rural populations in low-income countries. Specifically, we were interested in uncovering the range of mediators that impact on appropriate message content transmission and, ultimately, on health behavior improvements in a range of these sociocultural settings. METHODS: Collaborative qualitative research with Canadian Aboriginal and Tanzanian participants was conducted to deconstruct the content and transmission of evidence-based health information contained in SMS messages in the context of an international research project designed to address health inequalities in hypertension, and to develop a grounded theory of the major factors that mediate the effectiveness of this communication. We also examined the interrelationship of these mediators with the three essential conditions of the behavior system of the Behavioral Change Wheel model (capability, opportunity, and motivation) and cultural safety. RESULTS: Four focus groups with a total of 45 participants were conducted. Our grounded theory research revealed how discrepancies develop between the evidence-based text message created by researchers and the message received by the recipient in mobile health interventions. These discrepancies were primarily generated by six mediators of meaning in SMS messages: (1) negative or non-affirming framing of advocacies, (2) fear- or stress-inducing content, (3) oppressive or authoritarian content, (4) incongruity with cultural and traditional practices, (5) disconnect with the reality of the social determinants of health and the diversity of cultures within a population, and (6) lack of clarity and/or practicality of content. These 6 mediators of meaning provide the basis for sound strategies for message development because they impact directly on the target populations' capability, opportunity, and motivation for behavior change. CONCLUSIONS: The quality of text messages impacts significantly on the effectiveness of a mobile health intervention. Our research underscores the urgent need for interventions to incorporate and evaluate the quality of SMS messages and to examine the mediators of meaning within each targeted cultural and demographic group. Reporting on this aspect of mobile health intervention research will allow researchers to move away from the current black box of SMS text message development, thus improving the transparency of the process as well as the quality of the outcomes.