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Challenges exist for the management of diabetes care in First Nations populations. RADAR (Reorganizing the Approach to Diabetes through the Application of Registries) is a culturally appropriate, innovative care model that incorporates a disease registry and electronic health record for local care provision with remote coordination, tailored for First Nations people. This study assessed the effectiveness of RADAR on patient outcomes and diabetes care organization in participating communities in Alberta, Canada. It revealed significant improvements in outcomes after 2 years, with 91% of patients achieving a primary combined end point of a 10% improvement in or persistence at target for A1C, systolic blood pressure, and/or LDL cholesterol. Qualitative assessment showed that diabetes care organization also improved. These multimethod findings support tailored diabetes care practices in First Nations populations. [ABSTRACT FROM AUTHOR]

Background: First Nations (FN) people of Canada experience health, social, and systemic inequities due to colonization. Consequently, COVID-19 has placed further mental health stress on people related to personal finances, employment security and worry over infection, resulting in exacerbated effects of unresolved past medical and physical traumas. This study aims to understand the experiences related to mental health in an Alberta FN community during the early stages of the pandemic. Methods: In partnership with FN leadership, the study implemented an online cross-sectional survey. Adults from a large FN community in Alberta, Canada, were asked to complete a survey, including two mental health-related screening questionnaires: (1) Generalized Anxiety Disorder-2 item; and (2) Patient Health Questionnaire-2 item. In addition, respondents could provide responses to open-ended questions about their experiences. Results: Among 106 respondents, 95 (89.6%) finished the survey; 18% of adults screened positive for depressive symptoms (score of 3 or greater) and reported difficulty following public health advice for using hand sanitizer, maintaining social distancing, or self-isolating. 21% of adults screened positive for symptoms of anxiety (score of 3 or greater) and reported difficulty maintaining social distance, self-isolating, obtaining food and clothing, or meeting other basic living requirements. Conclusions: FN communities may be disproportionately affected by COVID-19, and may experience exacerbated symptoms of anxiety, depression and overall poor mental health and well-being. Additional supports and services, including for mental health, should be considered for FN in the context of COVID-19 public health measures. Highlights: The COVID-19 pandemic has brought upon increased stress and accompanying symptoms of anxiety and depression for a First Nations community in Alberta. Studies, such as this one, that characterize the influence of the COVID-19 pandemic on mental health among First Nations people, are urgently needed because of increasing demands on healthcare systems due to the pandemic and potential delays in the care of patients living with pre-existing mental health conditions. There is an opportunity to capitalize on First Nations people's experiences of post-traumatic growth proactively supporting/maintaining their well-being and possibly the development of community-based mental health interventions and supports. [ABSTRACT FROM AUTHOR]

Background: Diabetes care remains suboptimal in First Nations populations. Innovative and culturally relevant approaches are needed to promote systematic and proactive organization of diabetes care for people living with diabetes on-reserve in Canada. The RADAR model is one strategy to improve care: an integrated disease registry paired with an electronic health record for local community healthcare providers with remote care coordination. We qualitatively assessed adoption and implementation of RADAR in First Nations communities in Alberta to inform its potential spread in the province.Methods: We used the RE-AIM framework to evaluate adoption and implementation of RADAR in 6 First Nations communities. Using purposeful sampling, we recruited local healthcare providers and remote care coordinators involved in delivering RADAR to participate in telephone or in-person interviews at 6- and 24-months post-implementation. Interviews were digitally recorded, transcribed, and verified for accuracy. Data was analyzed using content analysis and managed using ATLAS.ti 8.Results: In total, we conducted 21 semi-structured interviews (6 at 6-months; 15 at 24-months) with 11 participants. Participants included 3 care coordinators and 8 local healthcare providers, including registered nurses, licensed practical nurses, and registered dietitians. We found that adoption of RADAR was influenced by leadership as well as appropriateness, acceptability, and perceived value of the model. In addition, we found that implementation of RADAR was variable across communities regardless of implementation supports and appropriate community-specific adaptations.Conclusions: The variable adoption and implementation of RADAR has implications for how likely it will achieve its anticipated outcomes. RADAR is well positioned for spread through continued appropriate community-based adaptations and by expanding the existing implementation supports, including dedicated human resources to support the delivery of RADAR and the provision of levels of RADAR based on existing or developed capacity among local HCPs.Trial Registration: Not applicable to this qualitative assessment.  ISRCTN14359671 . [ABSTRACT FROM AUTHOR]

Background: Primary care reforms should be supported by high-quality evidence across the entire life cycle of research. Front-line healthcare providers play an increasing role in implementation research. We recently evaluated two interventions for people with type 2 diabetes (T2D) in partnership with four Primary Care Networks (PCNs) in Alberta, Canada. Here, we report healthcare professionals perspectives on participating in primary care implementation research.Methods: Guided by the RE-AIM framework, we collected qualitative data before, during, and after both interventions. We conducted 34 in-person or telephone interviews with 17 individual PCN professionals. We used content analysis to identify emerging codes and concepts.Results: Two major themes emerged from the data. First, healthcare managers were eager to conduct implementation research in a primary care setting. Second, regardless of willingness to conduct research, there were challenges to implementing experimental study designs for both interventions. PCN professionals presumed the interventions were better than usual care, expressed role conflict, and reported administrative burdens related to research participation. Perceptions of patient vulnerability and an obligation to intervene exacerbated these issues.Conclusions: Healthcare professionals with limited practical research experience might not foresee the challenges in implementing experimental study designs in primary care settings to generate high-quality evidence. These issues are intensified when healthcare professionals perceive target patient populations as vulnerable and in need of intervention based on the presenting illness. Possible solutions include further research training, involving healthcare professionals in study design development, and using non-clinical staff to conduct research activities, particularly among acutely unwell patient populations. [ABSTRACT FROM AUTHOR]

Abstract: Background: The normalization thesis refers to processes whereby stigmatized individuals, groups, and activities are accommodated into everyday social life. This study explored the utility of normalization for understanding the social accommodation of HCV among street-involved injection drug users (IDUs) in a Canadian city. Methods: In-depth semi-structured interviews (1–4hr) were conducted with 61 drug injectors recruited through a harm reduction program and user networks in Edmonton''s inner city. Analyses and results: An inductive approach characterized common and unique themes across participants, using a combination of phenomenological and thematic analyses and the constant comparative method. Most respondents readily participated in a normalized discourse about HCV, wherein ‘everybody''s got it’, transmission is unavoidable, and that being HCV+ – while being less serious than HIV – is a defining characteristic of ID use. However, results indicated that participation in normalized HCV discourse was situational, strategic, and at times, contradictory with respect to (a) coping with HCV diagnosis and progression, (b) negotiating riskier or safer injection practices, and (c) disclosing serostatus to others. Conclusions: While normalization is useful for understanding the internalization of a medico-epidemiologic concept (‘HCV status’) into this user population, systematic description of coping and risk management practices relative to IDUs’ acceptance or rejection of normalized expectations of HCV is important for developing tailored harm reduction programs and policies. [Copyright &y& Elsevier]

The purpose of this qualitative study was to explore working men's perspectives about sleep health and the intersecting influences of gender and work, describing participant's views on current and potential programming and organizational support to promote sleep health. Twenty men employed in male-dominated industries in the north-central region of Alberta, Canada, participated in 4 consultation group discussions addressing motivators, facilitators and barriers to sleep health. Participants reported sleeping an average of 6.36 (SD ±1.1) hours per night, and the majority worked more than 40 hours per week. Data were analyzed using an inductive approach. The findings provided important insights. In normalizing sleep deprivation and prioritizing the need to "just keep going" on six or less hours of sleep, the men subscribed to masculine ideals related to workplace perseverance, stamina and resilience. Workplace cultures and practices were implicated including normative dimensions of overtime and high productivity and output, amid masculine cultures constraining emotions and conversations about sleep, the sum of which muted avenues for discussing, let alone promoting sleep. Challenges to good sleep were primarily constructed around time constraints, and worry about meeting work and home responsibilities. Men's preferences for workplace support included providing and incentivizing the use of sleep health resources, designing work for sleep health (e.g., shift schedules, overtime policies) and getting advice from experienced coworkers and experts external to the workplace organization. These findings hold potential for informing future gender-sensitive programming and organizational practices to support sleep health among working men. [ABSTRACT FROM AUTHOR]

Background: Decision aids can help patients set realistic expectations. In this study, we explored alternative presentations to visualise patient-reported outcomes (EQ-5D-5L) data within an online, individualized patient decision aid for total knee arthroplasty (TKA) that, in part, generates individualized comparisons based on age, sex and body mass index, to enhance usability prior to implementation into routine clinical practice. Methods: We used data visualization techniques to modify the presentation of EQ-5D-5L outcomes data within the decision aid. The EQ-5D-5L data was divided into two parts allowing patients to compare themselves to similar individuals (1) pre-surgery and (2) 1-year post-surgery. We created 2 versions for each part and sought patient feedback on comprehension, usefulness, and visual appeal. Patients from an urban orthopedic clinic were recruited and their ratings and comments were recorded using a researcher-administered checklist. Data were managed using Microsoft Excel, R version 3.6.1 and ATLAS.ti V8 and analyzed using descriptive statistics and directed content analysis. Results: A total of 24 and 25 patients participated in Parts 1 and 2, respectively. Overall, there was a slight preference for Version 1 in Part 1 (58.3%) and Version 2 in Part 2 (64%). Most participants demonstrated adequate comprehension for all versions (range 50–72%) and commented that the instructions were clear. While 50–60% of participants rated the content as useful, including knowing the possible outcomes of surgery, some participants found the information interesting only, were unsure how to use the information, or did not find it useful because they had already decided on a treatment. Participants rated visual appeal for all versions favorably but suggested improvements for readability, mainly larger font and image sizes and enhanced contrast between elements. Conclusions: Based on the results, we will produce an enhanced presentation of EQ-5D-5L data within the decision aid. These improvements, along with further usability testing of the entire decision aid, will be made before implementation of the decision aid in routine clinical practice. Our results on patients' perspectives on the presentation of EQ-5D-5L data to support decision making for TKA treatments contributes to the knowledge on EQ-5D-5L applications within healthcare systems for clinical care. [ABSTRACT FROM AUTHOR]

Background: Type-2 diabetes rates in First Nations communities are 3-5 times higher than the general Canadian population, resulting in a high burden of disease, complications and comorbidity. Limited community nursing capacity, isolated environments and a lack of electronic health records (EHR)/registries lead to a reactive, disorganized approach to diabetes care for many First Nations people. The Reorganizing the Approach to Diabetes through the Application of Registries (RADAR) project was developed in alignments with federal calls for innovative, culturally relevant, community-specific programs for people with type-2 diabetes developed and delivered in partnership with target communities.Methods: RADAR applies both an integrated diabetes EHR/registry system (CARE platform) and centralized care coordinator (CC) service that will support local healthcare. The CC will work with local healthcare workers to support patient and community health needs (using the CARE platform) and build capacity in best practices for type-2 diabetes management. A modified stepped wedge controlled trial design will be used to evaluate the model. During the baseline phase, the CC will work with local healthcare workers to identify patients with type-2 diabetes and register them into the CARE platform, but not make any management recommendations. During the intervention phase, the CC will work with local healthcare workers to proactively manage patients with type-2 diabetes, including monitoring and recall of patients, relaying clinical information and coordinating care, facilitated through the shared use of the CARE platform. The RE-AIM framework will provide a comprehensive assessment of the model. The primary outcome measure will be a 10% improvement in any one of A1c, BP, or cholesterol over the baseline values. Secondary endpoints will address other diabetes care indicators including: the proportion of clinical measures completed in accordance with guidelines (e.g., foot and eye examination, receipt of vaccinations, smoking cessation counseling); the number of patients registered in CARE; and the proportion of patients linked to a health services provider. The cost-effectiveness of RADAR specific to these communities will be assessed. Concurrent qualitative assessments will provide contextual information, such as the quality/usability of the CARE platform and the impact/satisfaction with the model.Discussion: RADAR combines innovative technology with personalized support to deliver organized diabetes care in remote First Nations communities in Alberta. By improving the ability of First Nations to systematically identify and track diabetes patients and share information seamlessly an overall improvement in the quality of clinical care of First Nations people living with type-2 diabetes on reserve is anticipated.Trial Registration: ISRCTN study ID ISRCTN14359671 , retrospectively registered October 7, 2016. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials are considered the "gold standard" for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention "on" or control "off " groups in time series dependent sequential clusters. Methods: We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design. Results and discussion: The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers' perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process. Conclusions: Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials are considered the “gold standard” for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention “on” or control “off ” groups in time series dependent sequential clusters. Methods: We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design. Results and discussion: The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers’ perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process. Conclusions: Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Depressive symptoms are common and, when coexisting with diabetes, worsen outcomes and increase health care costs. We evaluated a nurse case-manager-based collaborative primary care team model to improve depressive symptoms in diabetic patients. RESEARCH DESIGN AND METHODS: We conducted a controlled implementation trial in four nonmetropolitan primary care networks. Eligible patients had type 2 diabetes and screened positive for depressive symptoms, based on a Patient Health Questionnaire (PHQ) score of >=10. Patients were allocated using an 'on-off' monthly time series. Intervention consisted of case-managers working 1:1 with patients to deliver individualized care. The main outcome was improvement in PHQ scores at 12 months. A concurrent cohort of 71 comparable patients was used as nonscreened usual care control subjects. RESULTS: Of 1,924 patients screened, 476 (25%) had a PHQ score >10. Of these, 95 were allocated to intervention and 62 to active control. There were no baseline differences between groups: mean age was 57.8 years, 55% were women, and the mean PHQ score was 14.5 (SD 3.7). Intervention patients had greater 12-month improvements in PHQ (7.3 [SD 5.6]) compared with active-control subjects (5.2 [SD 5.7], P = 0.015). Recovery of depressive symptoms (i.e., PHQ reduced by 50%) was greater among intervention patients (61% vs. 44%, P = 0.03). Compared with trial patients, nonscreened control subjects had significantly less improvement at 12 months in the PHQ score (3.2 [SD 4.9]) and lower rates of recovery (24%, P < 0.05 for both). CONCLUSIONS: In patients with type 2 diabetes who screened positive for depressive symptoms, collaborative care improved depressive symptoms, but physician notification and follow-up was also a clinically effective initial strategy compared with usual care. [ABSTRACT FROM AUTHOR]

OBJECTIVE Depressive symptoms are common and, when coexisting with diabetes, worsen outcomes and increase health care costs. We evaluated a nurse case-manager-based collaborative primary care team model to improve depressive symptoms in diabetic patients. RESEARCH DESIGN AND METHODS We conducted a controlled implementation trial in four nonmetropolitan primary care networks. Eligible patients had type 2 diabetes and screened positive for depressive symptoms, based on a Patient Health Questionnaire (PHQ) score of S10. Patients were allocated using an "on-off" monthly time series. Intervention consisted of case-managers working 1:1 with patients to deliver individualized care. The main outcome was improvement in PHQ scores at 12 months. A concurrent cohort of 71 comparable patients was used as nonscreened usual care control subjects. RESULTS Of 1,924 patients screened, 476 (25%) had a PHQ score >10. Of these, 95 were allocated to intervention and 62 to active control. There were no baseline differences between groups: mean age was 57.8 years, 55% were women, and the mean PHQ score was 14.5 (SD 3.7). Intervention patients had greater 12-month improvements in PHQ (7.3 [SD 5.6]) compared with active-control subjects (5.2 [SD 5.7], P = 0.015). Recovery of depressive symptoms (i.e., PHQ reduced by 50%) was greater among intervention patients (61% vs. 44%, P = 0.03). Compared with trial patients, nonscreened control subjects had significantly less improvement at 12 months in the PHQ score (3.2 [SD 4.9]) and lower rates of recovery (24%, P < 0.05 for both). CONCLUSIONS In patients with type 2 diabetes who screened positive for depressive symptoms, collaborative care improved depressive symptoms, but physician notification and follow-up was also a clinically effective initial strategy compared with usual care. [ABSTRACT FROM AUTHOR]

Background: When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting. Methods/design: We initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1) improving depressive symptoms, 2) improving blood glucose, blood pressure and cholesterol, and 3) improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled "on-off" trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol). Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all measured outcomes. Direct costing of all intervention components and measurement of all health care utilization using linked administrative databases will be used to determine the cost-effectiveness of the intervention relative to usual care. Discussion: Our comprehensive evaluation will generate evidence to reliability, effectiveness and sustainability of this collaborative care model for patients with chronic diseases and depression. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials are considered the "gold standard" for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention "on" or control "off " groups in time series dependent sequential clusters.Methods: We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design.Results and Discussion: The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers' perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process.Conclusions: Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial.Trial Registration: Health Eating and Active Living with Diabetes: ClinicalTrials.gov identifier: NCT00991380. Date registered: 7 October 2009. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Clintrials.gov Identifier: NCT01328639 Date registered: 30 March 2011. [ABSTRACT FROM AUTHOR]

Background: While strong and consistent evidence supports the role of lifestyle modification in the prevention and management of type 2 diabetes (T2DM), the best strategies for program implementation to support lifestyle modification within primary care remain to be determined. The objective of the study is to evaluate the implementation of an evidence-based self- management program for patients with T2DM within a newly established primary care network (PCN) environment. Method: Using a non-randomized design, participants (total N = 110 per group) will be consecutively allocated in bi-monthly blocks to either a 6-month self-management program lead by an Exercise Specialist or to usual care. Our primary outcome is self-reported physical activity and pedometer steps. Discussion: The present study will assess whether a diabetes self-management program lead by an Exercise Specialist provided within a newly emerging model of primary care and linked to available community-based resources, can lead to positive changes in self-management behaviours for adults with T2DM. Ultimately, our work will serve as a platform upon which an emerging model of primary care can incorporate effective and efficient chronic disease management practices that are sustainable through partnerships with local community partners. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT00991380 [ABSTRACT FROM AUTHOR]