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Introduction: Case management (CM) is among the most studied effective models of integrated care for people with complex needs. The goal of this study is to scale up and assess CM in primary healthcare for people with complex needs., Methods and Analysis: The research questions are: (1) which mechanisms contribute to the successful scale-up of CM for people with complex needs in primary healthcare?; (2) how do contextual factors within primary healthcare organisations contribute to these mechanisms? and (3) what are the relationships between the actors, contextual factors, mechanisms and outcomes when scaling-up CM for people with complex needs in primary healthcare? We will conduct a mixed methods Canadian interprovincial project in Quebec, New-Brunswick and Nova Scotia. It will include a scale-up phase and an evaluation phase. At inception, a scale-up committee will be formed in each province to oversee the scale-up phase. We will assess scale-up using a realist evaluation guided by the RAMESES checklist to develop an initial programme theory on CM scale-up. Then we will test and refine the programme theory using a mixed-methods multiple case study with 10 cases, each case being the scalable unit of the intervention in a region. Each primary care clinic within the case will recruit 30 adult patients with complex needs who frequently use healthcare services. Qualitative data will be used to identify contexts, mechanisms and certain outcomes for developing context-mechanism-outcome configurations. Quantitative data will be used to describe patient characteristics and measure scale-up outcomes., Ethics and Dissemination: Ethics approval was obtained. Engaging researchers, decision-makers, clinicians and patient partners on the study Steering Committee will foster knowledge mobilisation and impact. The dissemination plan will be developed with the Steering Committee with messages and dissemination methods targeted for each audience., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Context: Aging and increasing comorbidities in the population are leading to more complex care for patients and primary healthcare providers. Community organizations (COs) may play a role in the services offered to support patients with chronic diseases (PCDs) but there are currently no clear guidelines to support primary healthcare providers in linking patients to COs., Objectives: The aim of this study was to describe the role of primary healthcare providers regarding linking PCDs to COs by: (1) describing linking activities; and (2) identifying the main facilitators and barriers associated with these activities., Methods: This scoping review was based on the Arksey and O'Malley method, completed by Levac, Colquhoun, and O'Brien. Related keywords were used in 7 databases to search relevant studies. After the initial screening, 135 full texts were assessed for eligibility by 2 reviewers using inclusion/exclusion criteria. Empirical studies describing activities performed by primary healthcare providers in linking PCDs to COs or describing facilitators or barriers to linking activities were included. Studies describing activities linking to other services than COs or located in emergency departments were excluded., Results: In total, 28 studies were included. Information reported in the studies was classified into 8 main linking activities: capacity development, patient identification, assessment, information, planning, referral, follow-up, and collaboration. Facilitators and barriers to these activities were related to intrapersonal characteristics of providers and patients, professional practice, work environment, relationships, and external influences. Healthcare providers' involvement was often adapted according to their field of practice., Conclusion: This scoping review details the role of primary healthcare providers when linking PCDs to COs in a collaborative and interdisciplinary context, which can be adapted to clinical practice by providers, experts, or stakeholders to support improvement in chronic care management., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Case management (CM) is recognized to improve care integration and outcomes of people with complex needs who frequently use healthcare services, but challenges remain regarding interaction between primary care clinics and hospitals. This study aimed to implement and evaluate an integrated CM program for this population where nurses in primary care clinics worked with a hospital case manager., Methods: A multiple embedded case study was conducted in the Saguenay-Lac-Saint-Jean region (Québec, Canada), in four dyads including a clinic and a hospital. Mixed data collection included, at baseline and 6 months, interviews and focus groups with stakeholders, patient questionnaires (patient experience of integrated care and self-management), and emergency department (ED) visits in the previous 6 months., Results: Integrated CM implementation was optimal when all stakeholders provided collective leadership, and were supportive of the program, particularly the physicians. The 6-month program enabled the observation of positive qualitative outcomes in most clinic-hospital dyads where implementation occurred. Full implementation was associated with improved care integration., Discussion and Conclusion: Integrated CM between primary care clinics and hospitals is a promising innovation to improve care integration for people with complex needs who frequently use healthcare services. Collective leadership and physicians' buy-in to integrated CM are important to foster the implementation., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023. Published by Elsevier B.V.)

Background: Multimorbidity is a complex health situation that requires interventions tailored to patient needs; the outcomes of such interventions are difficult to evaluate. The purpose of this study was to describe the outcomes of patient-centred interventions for people with multimorbidity from the patients' and healthcare providers' perspectives., Methods: This study followed a qualitative descriptive design. Nine patients with multimorbidity and 18 healthcare professionals (nurses, general practitioners, nutritionists, and physical and respiratory therapists), participating in a multimorbidity-adapted intervention in primary care were recruited. Data were collected using semi-structured interviews with 12 open-ended questions. Triangulation of disciplines among interviewers, research team debriefing, data saturation assessment and iterative data collection and analysis ensured a rigorous research process., Results: Outcome constructs described by participants covered a wide range of themes and were grouped into seven outcome domains: Health Management, Physical Health, Functional Status, Psychosocial Health, Health-related Behaviours, General Health and Health Services. The description of constructs by stakeholders provides valuable insight on how outcomes are experienced and worded by patients., Conclusion: Participants described a wide range of outcome constructs, which were relevant to and observable by patients and were in line with the clinical reality. The description provides a portrait of multimorbidity-adapted intervention outcomes that are significant for the selection and development of clinical research outcome measures.

The objective was to report on issues related to patients with complex care needs and recommendations identified by 160 key participants at a summit in Quebec City about better integration of primary health care services for patients with chronic diseases and complex care needs. A descriptive qualitative approach was used. While focus groups were led by a facilitator, a rapporteur noted highlights and a research team member took independent notes. All notes were analyzed by using a thematic analysis according to an inductive method. Seven issues were identified, leading to the formulation of recommendations: (1) valuing the experience of the patient; (2) early detecting of a non-homogeneous patient population; (3) defining interprofessional collaboration based on patient needs; (4) conciliating services provided by clinical settings according to a registered clientele-based logic with the population-based logic; (5) working with the community sector; (6) aligning patient-oriented research values with existing challenges to primary care integration; and (7) promoting resource allocation consistent with targeted recommendations. The summit highlighted the importance of engaging all stakeholders in improvement of integrated care for patients with complex care needs. The resulting recommendations target shared priorities towards better health, social, and community-based services integration for these patients.

Background: Frequent users of healthcare services are often categorised as 'heavy-cost patients'. In the recent years, many jurisdictions have attempted to implement different public policies to optimise the use of health services by frequent users. However, throughout this process, little attention has been paid to their experience as patients., Objective: To thematically synthesise qualitative studies that explore the experience of frequent users of primary care and emergency department services., Design: Qualitative systematic review and thematic synthesis., Setting: Primary care and emergency department., Participants: Frequent users of primary care and emergency department services., Methods: A qualitative systematic review was conducted using three online databases (MEDLINE with full text, CINAHL with full text and PsycINFO). This search was combined to an extensive manual search of reference lists and related citations. A thematic synthesis was performed to develop descriptive themes and analytical constructs., Study Selection: Twelve studies were included. All included studies met the following inclusion criteria: qualitative design; published in English; discussed frequent users' experiences from their own perspectives and users' experiences occurred in primary care and/or emergency departments., Results: The predominant aspects of frequent users' experiences were: (1) the experience of being ill and (2) the healthcare experience. The experience of being ill encompassed four central themes: physical limitations, mental suffering, impact on relationships and the role of self-management. The healthcare experience embraced the experience of accessing healthcare and the global experience of receiving care., Conclusion: This synthesis sheds light on potential changes to healthcare delivery in order to improve frequent users' experiences: individualised care plans or case management interventions to support self-management of symptoms and reduce psychological distress; and giving greater importance on the patient-providers relationship as a central facet of healthcare delivery. This synthesis also highlights future research directions that would benefit frequent users., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Case management (CM) in a primary care setting is a promising approach to integrating and improving healthcare services and outcomes for patients with chronic conditions and complex care needs who frequently use healthcare services. Despite evidence supporting CM and interest in implementing it in Canada, little is known about how to do this. This research aims to identify the barriers and facilitators to the implementation of a CM intervention in different primary care contexts (objective 1) and to explain the influence of the clinical context on the degree of implementation (objective 2) and on the outcomes of the intervention (objective 3)., Methods and Analysis: A multiple-case embedded mixed-methods study will be conducted on CM implemented in ten primary care clinics across five Canadian provinces. Each clinic will represent a subunit of analysis, detailed through a case history. Cases will be compared and contrasted using multiple analytical approaches. Qualitative data (objectives 1 and 2) from individual semistructured interviews (n=130), focus group discussions (n=20) and participant observation of each clinic (36 hours) will be compared and integrated with quantitative (objective 3) clinical data on services use (n=300) and patient questionnaires (n=300). An evaluation of intervention fidelity will be integrated into the data analysis., Ethics and Dissemination: This project received approval from the CIUSSS de l'Estrie - CHUS Research Ethic Board (project number MP-31-2019-2830). Results will provide the opportunity to refine the CM intervention and to facilitate effective evaluation, replication and scale-up. This research provides knowledge on how to resp ond to the needs of individuals with chronic conditions and complex care needs in a cost-effective way that improves patient-reported outcomes and healthcare use, while ensuring care team well-being. Dissemination of results is planned and executed based on the needs of various stakeholders involved in the research., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Case management (CM) is a promising intervention for frequent users of health care services. Our research question was how and under what circumstances does CM in primary care work to improve outcomes among frequent users with chronic conditions?, Methods: We conducted a realist synthesis, searching MEDLINE, CINAHL, Embase, and PsycINFO (1996 to September 2017) for articles meeting the following criteria: (1) population: adult frequent users with chronic disease, (2) intervention: CM in a primary care setting with a postintervention evaluation, and (3) primary outcomes: integration of services, health care system use, cost, and patient outcome measures. Academic and gray literature were evaluated for relevance and robustness. Independent reviewers extracted data to identify context, mechanism, and outcome (CMO) configurations. Analysis of CMO configurations allowed for the modification of an initial program theory toward a refined program theory., Results: Of the 9,295 records retrieved, 21 peer-reviewed articles and an additional 89 documents were retained. We evaluated 19 CM interventions and identified 11 CMO configurations. The development of a trusting relationship fostering patient and clinician engagement in the CM intervention was recurrent in many CMO configurations., Conclusion: Our refined program theory proposes that in the context of easy access to an experienced and trusted case manager who provides comprehensive care while maintaining positive interactions with patients, the development of this relationship fosters the engagement of both individuals and yields positive outcomes when the following mechanisms are triggered: patients and clinicians feel supported, respected, accepted, engaged, and committed; and patients feel less anxious, more secure, and empowered to self-manage., (© 2020 Annals of Family Medicine, Inc.)

Purpose: Case management (CM) interventions are effective for frequent users of health care services, but little is known about which intervention characteristics lead to positive outcomes. We sought to identify characteristics of CM that yield positive outcomes among frequent users with chronic disease in primary care., Methods: For this systematic review of both quantitative and qualitative studies, we searched MEDLINE, CINAHL, Embase, and PsycINFO (1996 to September 2017) and included articles meeting the following criteria: (1)population: adult frequent users with chronic disease, (2)intervention: CM in a primary care setting with a postintervention evaluation, and (3)primary outcomes: integration of services, health care system use, cost, and patient outcome measures. Independent reviewers screened abstracts, read full texts, appraised methodologic quality (Mixed Methods Appraisal Tool), and extracted data from the included studies. Sufficient and necessary CM intervention characteristics were identified using configurational comparative methods., Results: Of the 10,687 records retrieved, 20 studies were included; 17 quantitative, 2 qualitative, and 1 mixed methods study. Analyses revealed that it is necessary to identify patients most likely to benefit from a CM intervention for CM to produce positive outcomes. High-intensity intervention or the presence of a multidisciplinary/interorganizational care plan was also associated with positive outcomes., Conclusions: Policy makers and clinicians should focus on their case-finding processes because this is the essential characteristic of CM effectiveness. In addition, value should be placed on high-intensity CM interventions and developing care plans with multiple types of care providers to help improve patient outcomes., (© 2019 Annals of Family Medicine, Inc.)

Objective: To identify the mechanisms associated with success and failure of chronic disease prevention and management (CDPM) programs, as well as their key contexts., Design: Realist synthesis., Setting: Six primary care CDPM programs funded between 2011 and 2013 in Quebec., Participants: Patients, health providers, program leaders, and other stakeholders involved in CDPM programs., Methods: A collaborative research process was implemented, involving representatives from the executive and advisory committees: researchers, health care providers, decision makers, and patients and families. Leaders were asked to provide all documents related to their programs to the research team. The documents were selected depending on their relevance and rigour. The thematic analysis of each program consisted of identifying the outcomes and mechanisms, as well as the specific contexts associated with these outcomes. Results for each program were validated by its leader before synthesizing the results of all programs together., Main Findings: A total of 108 documents (eg, grant applications, scientific reports) were collected from the programs. Positive and negative outcomes were observed at the patient, health care provider, and health care system levels. Four main mechanism categories were associated with outcomes: patient-centred interdisciplinary care; self-management support and a motivational approach; professional support; and care coordination and relationships with partners. The main contextual factors that influenced the successes of these mechanisms were related to patients (multimorbidity, involvement of family caregivers), to health care providers (professional training, culture of interprofessional collaboration, mobilization of family physician), and to health care organizations (coordination between services, history of collaboration between partners, funding)., Conclusion: This study confirms the essential role of patient-centred interdisciplinary care; self-management support and a motivational approach; professional support; and care coordination and relationships with partners when caring for patients with chronic diseases. It constitutes a relevant contribution for stakeholders involved in primary care transformation and should be used to inform the sustainability and scaling up of CDPM programs., (Copyright© the College of Family Physicians of Canada.)

Background: The PR1MaC study was conducted to evaluate the integration of Chronic Disease Prevention and Management services into primary care practices and was reported effective. The aim of this study was to further explore the effects of the PR1MaC intervention on patients and their family., Methods: We conducted a qualitative study embedded in a randomized controlled trial. The trial was implemented in eight primary health care practices in the Saguenay region, Quebec, Canada. The interdisciplinary patient-centred team-based intervention included self-management support and a motivational approach. We conducted focus groups and semi-directed individual interviews with patients, family members and healthcare professionals., Results: Perceived positive effects can be grouped into six major themes: awareness, improved knowledge, improved motivation and empowerment, adoption of healthy behaviours, improvement of health status and improvement of quality of life. On the negative side, some participants reported lack of sustainability of newly acquired benefits in the months following the intervention., Conclusions: Integrating chronic disease prevention and management services into primary care settings had impacts on patients and their family members. These findings are consistent with findings that were reported in the quantitative study. Further studies should address longterm sustainabilility in terms of benefits for the patients., Trial Registration: ClinicalTrials.gov, no.: NCT01319656 .

Introduction: Significant evidence in the literature supports case management (CM) as an effective intervention to improve care for patients with complex healthcare needs. However, there is still little evidence about the facilitators and barriers to CM implementation in primary care setting. The three specific objectives of this study are to: (1) identify the facilitators and barriers of CM implementation in primary care clinics across Canada; (2) explain and understand the relationships between the actors, contextual factors, mechanisms and outcomes of the CM intervention; (3) identify the next steps towards CM spread in primary care across Canada., Methods and Analysis: We will conduct a multiple-case embedded mixed methods study. CM will be implemented in 10 primary care clinics in five Canadian provinces. Three different units of analysis will be embedded to obtain an in-depth understanding of each case: the healthcare system (macro level), the CM intervention in the clinics (meso level) and the individual/patient (micro level). For each objective, the following strategy will be performed: (1) an implementation analysis, (2) a realist evaluation and (3) consensus building among stakeholders using the Technique for Research of Information by Animation of a Group of Experts method., Ethics and Dissemination: This study, which received ethics approval, will provide innovative knowledge about facilitators and barriers to implementation of CM in different primary care jurisdictions and will explain how and why different mechanisms operate in different contexts to generate different outcomes among frequent users. Consensual and prioritised statements about next steps for spread of CM in primary care from the perspectives of all stakeholders will be provided. Our results will offer context-sensitive explanations that can better inform local practices and policies and contribute to improve the health of patients with complex healthcare needs who frequently use healthcare services. Ultimately, this will increase the performance of healthcare systems and specifically mitigate ineffective use and costs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Family Medicine Groups (FMGs) are the most recently developed primary care organizations in Quebec (Canada). Nurses within FMGs play a central role for patients with chronic diseases (CD). However, this complex role and the nursing activities related to this role vary across FMGs. Inadequate knowledge of nursing activities limits the implementation of exemplary nursing practices. This study aimed to describe FMG nursing activities with patients with CD and to describe the facilitators and barriers to these activities. A multiple-case study was performed with ten nurses practicing among patients with CD in FMGs. Five data sources were used to provide an in-depth description of nursing activities and the facilitators and barriers to the development of these activities. After qualitative data analysis, findings show that nursing activities are clustered into five domains: Global assessment of the patient, Care management, Health promotion, Nurse-physician collaboration, and Planning services for patients with CD. Activities vary depending on contextual factors identified in each case. This multiple-case study provides a clear description of nursing activities with patients with CD. There is a need for improved nursing activities and expertise in domains of activities that are less present in FMGs, such as case management and interprofessional collaboration., (© 2018 John Wiley & Sons Ltd.)

Purpose: Nurses are identified as a key provider in the management of patients in primary care. The objective of this study was to evaluate patients' experience of care in primary care as it pertained to the nursing role. The aim was to test the hypothesis that, in primary health care organizations (PHCOs) where patients are systematically followed by a nurse, and where nursing competencies are therefore optimally used, patients' experience of care is better., Method: Based on a cross-sectional analysis combining organizational and experience of care surveys, we built 2 groups of PHCOs. The first group of PHCOs reported having a nurse who systematically followed patients. The second group had a nurse who performed a variety of activities but did not systematically follow patients. Five indicators of care were constructed based on patient questionnaires. Bivariate and multivariate linear mixed models with random intercepts and with patients nested within were used to analyze the experience of care indicators in both groups., Results: Bivariate analyses revealed a better patient experience of care in PHCOs where a nurse systematically followed patients than in those where a nurse performed other activities. In multivariate analyses that included adjustment variables related to PHCOs and patients, the accessibility indicator was found to be higher., Conclusion: Results indicated that systematic follow-up of patients by nurses improved patients' experience of care in terms of accessibility. Using nurses' scope of practice to its full potential is a promising avenue for enhancing both patients' experience of care and health services efficiency.

Background: Cancer is now viewed as a chronic disease, presenting challenges to follow-up and survivorship care. Models to shift from haphazard, suboptimal and fragmented episodes of care to an integrated cancer care continuum must be developed, tested and implemented. Numerous studies demonstrate improved care when follow-up is assured by both oncology and primary care providers rather than either group alone. However, there is little data on the roles assumed by specialized oncology teams and primary care providers and the extent to which they work together. This study aims to develop, pilot test and measure outcomes of an innovative risk-based coordinated cancer care model for patients transitioning from specialized oncology teams to primary care providers., Methods/design: This multiple case study using a sequential mixed-methods design rests on a theory-driven realist evaluation approach to understand how transitions might be improved. The cases are two health regions in Quebec, Canada, defined by their geographic territory. Each case includes a Cancer Centre and three Family Medicine Groups selected based on differences in their determining characteristics. Qualitative data will be collected from document review (scientific journal, grey literature, local documentation), semi-directed interviews with key informants, and observation of care coordination practices. Qualitative data will be supplemented with a survey to measure the outcome of the coordinated model among providers (scope of practice, collaboration, relational coordination, leadership) and patients diagnosed with breast, colorectal or prostate cancer (access to care, patient-centredness, communication, self-care, survivorship profile, quality of life). Results from descriptive and regression analyses will be triangulated with thematic analysis of qualitative data. Qualitative, quantitative, and mixed methods data will be interpreted within and across cases in order to identify context-mechanism associations that explain outcomes., Discussion: The study will provide empirical data on a risk-based coordinated model of cancer care to guide actions at different levels in the health system. This in-depth multiple case study using a realist approach considers both the need for context-specific intervention research and the imperative to address research gaps regarding coordinated models of cancer care.

Background: Although health literacy and quality of life are important concepts in health care, the link between them is unclear, especially for a population of frequent users of health care services with chronic diseases. Low health literacy is a common problem that has been linked to several negative health outcomes. Quality of life is an important health outcome in patient-centered care. Frequent users of health care services are a vulnerable population that deserves attention due to high costs and negative outcomes such as lower quality of life and higher mortality. The objective of this study was to examine the relationship between health literacy and the physical and mental components of quality of life among frequent users of health care services with chronic diseases., Methods: This study presents the cross-sectional analysis of data collected through the V1SAGES project, a randomized controlled trial on the effectiveness of a case management intervention in primary care in Quebec, Canada. Participants (n = 247) were frequent users of health care services presenting at least one chronic condition. Health literacy was measured by the Newest Vital Sign (NVS), and the physical and mental components of quality of life were evaluated by the Short Form Health Survey Version 2 (SF-12v2). The association between health literacy (independent variable) and the physical and mental components of quality of life was examined using biserial correlation., Results: No association was found between health literacy and quality of life (physical component: r = 0.108, ρ = 0.11; mental component: r = 0.147, ρ = 0.15)., Conclusion: This study suggests that there is no relationship between health literacy and the physical and mental components of quality of life among frequent users of health care services., Trial Registration: NCT01719991 . Registered October 25, 2012.

Introduction : in collaboration with family physician, primary care nurses can play a key role for persons with chronic diseases (CD). However, these activities vary from one practice to another. Context : the absence of evidence hinders our understanding of the issues related to the improvement of nursing practices in primary care organizations. Objective : to describe the primary care nurse’s activities for persons with CD and elements influencing those activities. Design : systematic literature review. Method : MEDLINE, CINHAL and SCOPUS electronic databases were reviewed. Key words : « primary health care », « primary nursing » and « chronic disease ». Results : eighteen studies were included in the review. Nurses activities can be clustered in four domain of activities : 1) Global assessment of the person with CD, 2) Care management, 3) Health Promotion and 4) Nurse-Physician Collaboration. Elements influencing nurses’ activities can be related to the setting of care, to nurse or to the person with CD. Discussion : nurses’ activities in primary care are understudied. Activities such as case management and interprofessional collaboration are lacking. Conclusion : descriptive studies are needed to describe in-depth nurses’ activities in primary settings for persons with CD.

Purpose: Although case management (CM) is increasingly being implemented to address the complex needs of vulnerable clienteles, few studies have examined the patient experience of CM. This study aimed to examine the experience of patients and their family members with care integration as part of a primary care CM intervention. Patients in the study were frequent users of health care services who had chronic diseases., Methods: A descriptive, qualitative approach was conducted involving 25 patients and 8 of their family members. Data were collected through in-depth interviews of the patients and 2 focus groups of family members and were analyzed thematically., Results: While some participants did not fully understand the CM intervention and a few believed that it involved too many appointments, the CM nurses were patients' preferred contact with primary care. The nurses actively involved the patients in developing and carrying out their individualized services plans (ISPs) with other health care partners. Patients felt that their needs were taken into consideration, especially regarding access to the health care system. The case manager facilitated access to information as well as communication and coordination among health care and community partners. This improved communication comforted the patients and nurtured a relationship of trust. Participants were actively involved in decision-making. Their ISPs helped them know where they were going and improved transitions between services., Conclusions: The experience of patients and family members was overall very positive regarding care integration. They reported improved access, communication, coordination, and involvement in decision-making as well as better health care transitions., (© 2015 Annals of Family Medicine, Inc.)

Background: The Health Education Impact Questionnaire (heiQ) allows for the evaluation of the effects of education interventions provided to patients with chronic diseases. This study describes the process for the cross-cultural adaptation and validation of the heiQ into French (heiQ-Fv)., Methods: We undertook a systematic translation process followed by a validation study based on the secondary analysis of cross-sectional data from a longitudinal study. Participants in the validation study were adult patients from primary care clinics in Quebec, Canada, with one or more of the following diseases: diabetes, asthma, chronic obstructive pulmonary disease, cardiovascular disease; or one or more risk factors for these diseases. Main outcomes of the study were the French version of the heiQ-Fv and the validation analyses that included internal consistency, test-retest reliability, confirmatory factor analysis (CFA) and concomitant validity., Results: The validation analysis was conducted on results from 332 participants. Cronbach's alphas (internal consistency) for seven domains of the heiQ-Fv varied from 0.80 to 0.89; one domain scored 0.69. The test-retest analysis (n = 50) yielded intra-class correlation coefficients from 0.66 to 0.86. The CFA of the eight heiQ domains with the hypothesis of no correlation between the domains yielded a model that did not exhibit acceptable fit values. A model with the hypothesis of all domains correlated exhibited acceptable fit values (scaled chi-square = 1210.15, degrees of freedom = 712, p < 0.001; CFI = 0.98; RMSEA = 0.06; SRMR = 0.065). Results show a moderate correlation (concomitant validity) between five domains of the heiQ-Fv and the Self-Efficacy for Managing Chronic Diseases. We also found a moderate to strong correlation between the Emotional Wellbeing domain of the heiQ and the Kessler Psychological Distress Scale (K6) (r = 0.61; 95 % CI: 0.52 -0.69, p < 0.01)., Conclusions: The heiQ was translated into French using a rigorous translation process; the French-language version showed good psychometric properties. Health professionals and researchers in primary care settings may use the heiQ-FV to evaluate the impact of educational programs on patients with chronic diseases.

Background: The increasing number of patients with chronic diseases represents a challenge for health care systems. The Chronic Care Model suggests a multi-component remodelling of chronic disease services to improve patient outcomes. To meet the complex and ongoing needs of patients, chronic disease prevention and management (CDPM) has been advocated as a key feature of primary care producing better outcomes, greater effectiveness and improved access to services compared to other sectors. The objective of this study is to evaluate the adaptation and implementation of an intervention involving the integration of chronic disease prevention and management (CDPM) services into primary health care., Methods/design: The implementation of the intervention will be evaluated using descriptive qualitative methods to collect data from various stakeholders (decision-makers, primary care professionals, CDPM professionals and patients) before, during and after the implementation. The evaluation of the effects will be based on a combination of experimental designs: a randomized trial using a delayed intervention arm (n = 326), a before-and-after design with repeated measures (n = 163), and a quasi-experimental design using a comparative cohort (n = 326). This evaluation will utilize self-report questionnaires measuring self-efficacy, empowerment, comorbidity, health behaviour, functional health status, quality of life, psychological well-being, patient characteristics and co-interventions. The study will take place in eight primary care practices of the Saguenay region of Quebec (Canada). To be included, patients will have to be referred by their primary care provider and present at least one of the following conditions (or their risk factors): diabetes, cardiovascular diseases, chronic obstructive pulmonary disease, asthma. Patients presenting serious cognitive problems will be excluded., Discussion: In the short-term, improved patient self-efficacy and empowerment are expected. In the mid-term, we expect to observe an improvement in health behaviour, functional health status, quality of life and psychological well-being. At the organizational level, the project should lead to coordinated service delivery, improved patient follow-up mechanisms and enhanced interprofessional collaboration. Integration of CDPM services at the point of care in primary care practices is a promising innovation in care delivery that needs to be thoroughly evaluated., Trial Registration: ClinicalTrials.gov Identifier: NCT01319656.

Background: Chronic diseases represent a major challenge for health care and social services. A number of people with chronic diseases require more services due to characteristics that increase their vulnerability. Given the burden of increasingly vulnerable patients on primary care, a pragmatic intervention in four Family Medicine Groups (primary care practices in Quebec, Canada) has been proposed for individuals with chronic diseases (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain) who are frequent users of hospital services. The intervention combines case management by a nurse with group support meetings encouraging self-management based on the Stanford Chronic Disease Self-Management Program. The goals of this study are to: (1) analyze the implementation of the intervention in the participating practices in order to determine how the various contexts have influenced the implementation and the observed effects; (2) evaluate the proximal (self-efficacy, self-management, health habits, activation and psychological distress) and intermediate (empowerment, quality of life and health care use) effects of the intervention on patients; (3) conduct an economic analysis of the efficiency and cost-effectiveness of the intervention., Methods/design: The analysis of the implementation will be conducted using realistic evaluation and participatory approaches within four categories of stakeholders (Family Medicine Group and health centre management, Family Medicine Group practitioners, patients and their families, health centre or community partners). The data will be obtained through individual and group interviews, project documentation reviews and by documenting the intervention. Evaluation of the effects on patients will be based on a pragmatic randomized before-after experimental design with a delayed intervention control group (six months). Economic analysis will include cost-effectiveness and cost-benefit analysis., Discussion: The integration of a case management intervention delivered by nurses and self-management group support into primary care practices has the potential to positively impact patient empowerment and quality of life and hopefully reduce the burden on health care. Decision-makers, managers and health care professionals will be aware of the factors to consider in promoting the implementation of this intervention into other primary care practices in the region and elsewhere., Trial Registration: NCT01719991.

Background: More and more people suffer from concomitant chronic physical diseases and common mental disorders, calling for integrated self-management support in primary care. However, self-management support of chronic physical diseases and common mental disorders is not clearly operationalized by guidelines and is still conducted in silos by primary care nurses, especially in favour of chronic diseases. This study aims to better understand primary care nurses' experience of integrated self-management support for people with physical chronic diseases and common mental disorders. Methods: An interpretive descriptive qualitative approach was conducted with 23 primary care nurses from family medicine groups in Quebec (Canada). They were selected through purposive and snowball sampling methods to participate in an individual interview. Data were analysed using an iterative inductive and deductive analysis (Rainbow Model of Integrated Care and the Practical Reviews in Self-Management Support (PRISMS) taxonomy). Results: Nurses' experience of integrated self-management support for people with CD and CMD was structured around: (1) elements of the approach; (2) clinical integration through prevention and health promotion; and (3) operationalization of integrated self-management support. Several elements deemed essential to integrated self-management support were identified. Nurses offered integrated self-management support through prevention of risk factors and promotion of a healthy lifestyle for physical chronic diseases and common mental disorders. Nurses' self-management support activities included education, action plans, monitoring, and many practical, psychological, and social support strategies. A model of integrated self-management support for primary care nursing is proposed to better understand its clinical integration. Conclusion: This study presents clinical integration of self-management support and activities for people with physical chronic diseases and common mental disorders in primary care settings. Understanding integrated self-management support will help implement future interventions. [ABSTRACT FROM AUTHOR]

Introduction: Growing evidence supports patient engagement (PE) in health implementation research to improve the quality, relevance and uptake of research. However, more guidance is needed to plan and operationalize PE before and throughout the research process. The aim of the study was to develop a logic model illustrating the causal links between context, resources, activities, outcomes and impact of PE in an implementation research programme. Methods: The Patient Engagement in Health Implementation Research Logic Model (hereafter the Logic Model) was developed using a descriptive qualitative design with a participatory approach, in the context of the PriCARE programme. This programme aims to implement and evaluate case management for individuals who frequently use healthcare services in primary care clinics across five Canadian provinces. Participant observation of team meetings was performed by all team members involved in the programme and in‐depth interviews were conducted by two external research assistants with team members (n = 22). A deductive thematic analysis using components of logic models as coding categories was conducted. Data were pooled in the first version of the Logic Model, which was refined in research team meetings with patient partners. The final version was validated by all team members. Results: The Logic Model highlights the importance of integrating PE into the project before its commencement, with appropriate support in terms of funding and time allocation. The governance structure and leadership of both principal investigators and patient partners have significant effects on PE activities and outcomes. As an empirical and standardized illustration that facilitates a shared understanding, the Logic Model provides guidance for maximizing the impact of patient partnership in various contexts for research, patients, providers and health care. Conclusion: The Logic Model will help academic researchers, decision makers and patient partners plan, operationalize, and assess PE in implementation research for optimal outcomes. Patient or Public Contribution: Patient partners from the PriCARE research programme contributed to developing the research objectives and designing, developing and validating data collection tools, producing data, developing and validating the Logic Model and reviewing the manuscript. [ABSTRACT FROM AUTHOR]

Introduction: Despite nurses' substantial role in care coordination, few education programs exist to better support them in this role. Identification of a set of core care coordination activities across heterogeneous care coordination programs would facilitate the development of a standard of practice. We sought to examine care coordination activities across two care coordination programs in Family Medicine Groups in Quebec, and their relationship to the program design. Methods: We performed a comparative case study of two care coordination programs in primary care targeting frequent users of healthcare services and people with Alzheimer's disease and related disorders. Data collection included documents and semi-structured interviews with key informants. Results: Several activities were common to both programs, such as patient identification; assessment, development of an individualized service plan; and linking patients and caregivers with professionals and services. However, their components were different due to the impact of the integrated care program design, policy environment, and the target patient populations' complex needs. Discussion: The homogeneity or heterogeneity of patients' complex needs shapes their care trajectory and the intensity of their care coordination needs. As the complexity of these needs grows, so does the necessity to build the care coordinators' capacity for integrated care. [ABSTRACT FROM AUTHOR]

Background: Studies have highlighted common challenges and barriers to patient engagement in research, but most were based on patient partners' or academic researchers' experiences. A better understanding of how both groups differentially experience their partnership could help identify strategies to improve collaboration in patient engagement research. Aim: This study aimed to describe and compare patient partners' and academic researchers' experiences in patient engagement research. Methods: Based on a participatory approach, a descriptive qualitative study was conducted with patient partners and academic researchers who are involved in the PriCARE research programme in primary health care to examine their experience of patient engagement. Individual semi‐structured interviews with patient partners (n = 7) and academic researchers (n = 15) were conducted. Academic researchers' interview verbatims, deidentified patient partners' summaries of their interviews and summaries of meetings with patient partners were analysed using inductive thematic analysis in collaboration with patient partners. Results: Patient partners and academic researchers' experiences with patient engagement are captured within four themes: (1) evolving relationships; (2) creating an environment that fosters patient engagement; (3) striking a balance; and (4) impact and value of patient engagement. Evolving relationships refers to how partnerships grew and improved over time with an acceptance of tensions and willingness to move beyond them, two‐way communication and leadership of key team members. Creating an environment that fosters patient engagement requires appropriate structural support, such as clear descriptions of patient partner roles; adequate training for all team members; institutional guidance on patient engagement; regular and appropriate translation services; and financial assistance. For patient partners and academic researchers, striking a balance referred to the challenge of reconciling patient partners' interests and established research practices. Finally, both groups recognized the value and positive impact of patient engagement in the programme in terms of improving the relevance of research and the applicability of results. While patient partners and academic researchers identified similar challenges and strategies, their experiences of patient engagement differed according to their own backgrounds, motives and expectations. Conclusion: Both patient partners and academic researchers highlighted the importance of finding a balance between providing structure or guidelines for patient engagement, while allowing for flexibility along the way. Patient or Public Contribution: Patient partners from the PriCARE research programme were involved in the following aspects of the current study: (1) development of the research objectives; (2) planning of the research design; (3) development and validation of data collection tools (i.e., interview guides); (4) production of data (i.e., acted as interviewees); (5) validation of data analysis tools (code book); (6) analysis of qualitative data; and (7) drafting of the manuscript and contributing to other knowledge translation activities, such as conference presentations and the creation of a short animated video. [ABSTRACT FROM AUTHOR]

Aim: To map integrated and non-integrated self-management support interventions provided by primary care nurses to persons with chronic diseases and common mental disorders and describe their characteristics. Design: A scoping review. Data sources: In April 2020, we conducted searches in several databases (Academic Research Complete, AMED, CINAHL, ERIC, MEDLINE, PsycINFO, Scopus, Emcare, HealthSTAR, Proquest Central) using self-management support, nurse, primary care and their related terms. Of the resulting 4241 articles, 30 were included into the analysis. Review methods: We used the Rainbow Model of Integrated Care to identify integrated self-management interventions and to analyze the data and the PRISMS taxonomy for the description of interventions. Study selection and data synthesis were performed by the team. Self-management support interventions were considered integrated if they were consistent with the Rainbow model's definition of clinical integration and person-focused care. Results: The 30 selected articles related to 10 self-management support interventions. Among these, five interventions were considered integrated. The delivery of the interventions showed variability. Strategies used were education, problem-solving therapies, action planning, and goal setting. Integrated self-management support intervention characteristics were nurse-person relationship, engagement, and biopsychosocial approach. A framework for integrated self-management was proposed. The main characteristics of the non-integrated self-management support were disease-specific approach, protocol-driven, and lack of adaptability. Conclusion: Our review synthesizes integrated and non-integrated self-management support interventions and their characteristics. We propose recommendations to improve its clinical integration. However, further theoretical clarification and qualitative research are needed. Implication for nursing: Self-management support is an important activity for primary care nurses and persons with chronic diseases and common mental disorders, who are increasingly present in primary care, and require an integrated approach. Impact: This review addresses the paucity of details surrounding integrated self-management support for persons with chronic diseases and common mental disorders and provides a framework to better describe its characteristics. The findings could be used to design future research and improve the clinical integration of this activity by nurses. [ABSTRACT FROM AUTHOR]

The case study design is particularly useful for implementation analysis of complex health care innovations in primary care that can be influenced by the context of dynamic environments. Case studies may be combined with participatory approaches where academics conduct joint research with nonacademic stakeholders, to foster translation of findings results into practice. The aim of this article is to clarify epistemological and methodological considerations of case studies with a participatory approach. It also aims to propose best practice recommendations when using this case study approach. We distinguish between the participatory case study with full co-construction and co-governance, and the case study with a participatory approach whereby stakeholders are consulted in certain phases of the research. We then compare the epistemological posture of 3 prominent case study methodologists, Yin, Stake, and Merriam, to present the epistemological posture of case studies with a participatory approach. The relevance, applications, and procedures of a case study with a participatory approach methodology are illustrated through a concrete example of a primary care research program (PriCARE). We propose 12 steps for designing and conducting a case study with a participatory approach that may help guide researchers in the implementation analysis of complex health care innovations in primary care. [ABSTRACT FROM AUTHOR]

Background: Multimorbidity challenges the health‐care system and requires innovative approaches. In 2015, a 4‐month patient‐centred interdisciplinary pragmatic intervention was implemented in primary care with the aim of supporting self‐management for patients with multimorbidity. Objective: To explore the perceptions and experiences of health‐care professionals, patients and their caregivers with a 4‐month patient‐centred interdisciplinary pragmatic intervention in primary care. Design: A descriptive, qualitative study using semi‐structured interviews was conducted. Setting and participants: A purposive sample of 30 participants was recruited from seven family medicine groups including patients, caregivers and health‐care professionals (HCPs). Interviews were analysed using Thorne's interpretive description approach. Results: Findings were grouped into the benefits and challenges of participating in the intervention. The programme allowed patients to adopt realistic and adapted objectives; to customize interventions to the patient's reality; and to help patients gain confidence, improve their knowledge, skills and motivation to manage their condition. Interprofessional collaboration eased the exchange of information via team meetings and electronic medical records. Challenges were related to collaboration, communication, coordination of work and integration of newly relocated HCPs mainly due to part‐time assignments and staff turnover. HCPs part‐time schedules limited their availability and hindered patients' follow‐up. Discussion and conclusion: This intervention was useful and rewarding from the HCPs, patients and caregivers' perspective. However, to ensure the success of this complex interdisciplinary intervention, implementers and managers should anticipate organizational barriers such as availability and time management of relocated HCPs. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to evaluate the effects of the V1SAGES case management intervention (Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support) for frequent users of health care services with chronic disease and complex care needs on psychological distress and patient activation.Methods: We used a 2-phase sequential mixed methods design. The first phase was a pragmatic randomized controlled trial with intention-to-treat analysis that measured the effects of the intervention compared with usual care on psychological distress and patient activation before and after 6 months. The second phase had a qualitative descriptive design and entailed thematic analysis of in-depth interviews (25 patients, 6 case management nurses, 9 health managers) and focus groups (8 patients' spouses, 21 family physicians) to understand stakeholders' perceived effects of the intervention on patients.Results: A total of 247 patients were randomized into the intervention group (n = 126) or the control group (n = 121). Compared with usual care, the intervention reduced psychological distress (odds ratio = 0.43; 95% CI, 0.19-0.95, P = .04), but did not have any significant effect on patient activation (P = .43). Qualitative results suggested that patients and their spouses benefitted from the case management intervention, gaining a sense of security, and stakeholders noted better patient self-management of health.Conclusions: Together, our study's quantitative and qualitative results suggest that case management reduces psychological distress, making patients and caregivers feel more secure, whereas impact on self-management is unclear. Case management is a promising avenue to improve outcomes among frequent users of health care with complex needs. [ABSTRACT FROM AUTHOR]

Background Although chronic disease management interventions for persons with multimorbidity are offered in primary healthcare, a strong evidence base supporting such interventions is still lacking. Part of this problem is due to the heterogeneity in the use of outcome measures in multimorbidity intervention research. Objectives This review aims to describe and map outcome measurement in chronic disease management intervention research for people with multimorbidity. Design A scoping review of multiple chronic disease management intervention studies published between January 1996 and July 2017. Data sources Search of the academic literature was undertaken in the MEDLINE, CINAHL and PsycINFO electronic databases. Results Twenty-two studies were identified, 56 outcomes were reported, grouped into 18 categories and six emergent domains of outcomes: General health, Psychosocial, Disease management, Health-related behaviours, Functional and Health services. Quality of life, health-related behaviors and self-efficacy were the most reported outcome categories, while patient satisfaction, communication with providers and adverse outcomes were rarely reported. Conclusions The mapping and description brought to light the large heterogeneity of outcome categories and measures. The organization proposed in this paper could contribute to improved outcome selection for research, care and policy and lead to the creation of adapted patient-related outcome measures. [ABSTRACT FROM AUTHOR]

Background: Nurses in primary care organizations play a central role for patients with chronic disease. Lack of clarity in role description may be associated with underutilization of nurse competencies that could benefit the growing population of patients with chronic disease. Objective: The purpose of the research was to describe nursing activities in primary care settings with patients with chronic disease. Methods: A Web-based survey was sent to nurses practicing in Family Medicine Groups in the Canadian Province of Québec. Participants rated the frequency with which they carried out nursing activities in five domains: (a) global assessment, (b) care and case management, (c) health promotion, (d) nurse--physician collaboration, and (e) planning services for patients with chronic disease. Findings were summarized with descriptive statistics (means, standard deviations, and ranges). Results: The survey was completed by 266 of the 322 nurses who received the survey (82.6%). Activities in the health promotion and global assessment of the patient domains were carried out most frequently. Planning services for patients with chronic disease were least frequently performed. Discussion: This study provides a broad description of nursing activities with patients with chronic disease in primary care. The findings provide a baseline for clinicians and researchers to document and improve nursing activities for optimal practice for patients with chronic disease. [ABSTRACT FROM AUTHOR]

Aims and objectives To describe nursing activities in primary care with patients affected by physical chronic disease and common mental disorders. Background Patients in primary care who are affected by physical chronic disease and common mental disorders such as anxiety and depression require care and follow-up based on their physical and mental health condition. Primary care nurses are increasingly expected to contribute to the care and follow-up of this growing clientele. However, little is known about the actual activities carried out by primary care nurses in providing this service in the Province of Quebec (Canada). Methods A qualitative descriptive study was conducted. Data were obtained through semistructured individual interviews with 13 nurses practising among patients with physical chronic disease in seven Family Medicine Groups in Quebec (Canada). Results Participants described five activity domains: assessment of physical and mental health condition, care planning, interprofessional collaboration, therapeutic relationship and health promotion. Conclusion The full potential of primary care nurses is not always exploited, and some activities could be improved. Evidence for including nurses in collaborative care for patients affected by physical chronic disease and common mental disorders has been shown but is not fully implemented in Family Medicine Groups. Future research should emphasise collaboration among mental health professionals, primary care nurses and family physicians in the care of patients with physical chronic disease and common mental disorders. Relevance to clinical practice Primary care nurses would benefit from gaining more knowledge about common mental disorders and from identifying the resources they need to contribute to managing them in an interdisciplinary team. [ABSTRACT FROM AUTHOR]

Background: Large amount of evidence supports the contribution of the Stanford Chronic Disease Self-Management Program (CDSMP) to a global chronic disease management strategy. However, many studies have suggested further exploring of the factors influencing acceptance and completion of participants in this program.Objective: This study aimed to describe and examine factors associated with acceptance and completion rates of the CDSMP among frequent users of health care services, and to highlight the experience of patients and peer leaders who facilitated the program.Methods: A descriptive design with mixed sequential data was used. Acceptance and completion rates were calculated and their relationship with patient characteristics was examined in regression analysis (n = 167). Interviews were conducted among patients who accepted (n = 11) and refused (n = 13) to participate and with the program coordinator. Focus groups were held with the seven peer leaders who facilitated the program. Data were analysed using thematic analysis.Results: Of the 167 patients invited, 60 (36%) accepted to participate in the program. Group format was the most frequent reason to decline the invitation to participate. Twenty-eight participants (47%) completed the program. Participants who dropped out during the program raised different reasons such as poor health and too much heterogeneity among participants. Factors such as location, schedule, content, group composition and facilitation were considered as important elements contributing to the success of the program.Conclusion: The CDSMP could therefore be considered as a self-management support option for this vulnerable clientele, while taking measures to avoid too much heterogeneity among participants to improve completion rates. [ABSTRACT FROM AUTHOR]

Introduction In recent years, several projects and innovations have been carried out in primary healthcare level, in Quebec, to reduce fragmentation and improve healthcare delivery through better coordination of services for patients with complex needs. These projects were all based in family medicine clinics yet presented significant structural and content variations across clinics. Moreover, when several care coordination projects were conducted in one clinic, they included a different list of care coordination components, carried out by the same care coordinators. In this study we aim to examine similarities and divergences in terms of design, policy environment and components across care coordination projects and how these similarities or divergences are related to patients' complex needs. Methods A comparative case study was conducted using a purposive sampling of two projects, the V1SAGES project (case management targeting frequent users of healthcare services), and the Quebec Alzheimer Plan (QAP). Data collection included a documentary analysis and five semi-structured interviews with key researchers involved in the implementation of the ""cases"". The Integrated Care Case Study Descriptive Template was used as a framework. Within and cross-case analysis were performed. Results In terms of design and policy environment, both projects include a shared governance model that facilitated innovations. Patients were involved in different phases of both projects. The PAQ is a more mature project. It was lunched earlier, was intended to be scaled up at a national, had more allocated funds and a solid change management support which also impacted the staffing model and training. Common coordination activities include identifying eligible patients and assessing their needs jointly with the physician, interdisciplinary follow-up, communicating with other professionals and services and facilitating transitions. Indeed, the presence and use of referral processes varied between settings. VISAGES care coordination activities are more oriented towards linking patients and family with health and social care professionals while those of QAP focus on early diagnosis and follow up. Discussions Characteristics of patients' complex needs have a major impact on design, implementation and delivery of care coordination projects. Indeed, the homogeneity of PAQ target group population shaped the patient care trajectory as based on disease management and care while also considering social needs. In parallel, the heterogeneity of VISAGES target patient population required a case management approach where less emphasis is placed on disease and more on integrating health and social care services. A single care trajectory based on disease would not be relevant nor feasible. This main difference had an impact on the clinical tools that were developed, staff training and care coordination activities. Conclusions Care coordination projects targeting patients with complex needs may vary in terms of design and components. However, they share a commonality in that they tend to adjust to the varying homogeneity of needs. Lessons learned The scale-up of every care coordination project necessitates an effective change management support. Limitations Data collection could have included observations or interviews with healthcare professionals; however, the pandemic impeded their availability. Suggestions for future research Future research should address patient's experience of care coordination. [ABSTRACT FROM AUTHOR]

Background: Frequent users of healthcare services are a vulnerable population that deserves attention due to high costs and negative outcomes such as lower quality of life and higher mortality. Healthcare systems should offer interventions tailored to their needs and to their level of health literacy, including strategies to promote activation. The relationship between health literacy and patient activation remains to be explored. The aim of this study was to examine the association between health literacy and patient activation in a population of frequent users of healthcare services with chronic diseases. Methods: Cross-sectional data were collected (before randomization) through a clinical trial evaluating a case management intervention in primary care. Participants (n = 247) were recruited from the list of frequent users of 4 Family Medicine Groups (FMG) in the Saguenay-Lac-St-Jean region of Québec (Canada). They completed questionnaires by self-report during an encounter with a research assistant: (1) the Newest Vital Sign (NVS) to evaluate health literacy (independent variable); and (2) the Patient Activation Measure-13 (PAM-13) to evaluate patient activation (dependent variable). The relationship between health literacy and activation was examined using biserial correlations. Results: No association was found between health literacy (independent variable) and patient activation (rb = 0.075, ρ = 0.07) for this population of frequent users of healthcare services. Conclusions: This study suggests that there is no relationship between health literacy and patient activation among frequent users of healthcare services. Trial registration: NCT01719991. Registered October 25, 2012. [ABSTRACT FROM AUTHOR]