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Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study.

ABSTRACT: BACKGROUND:The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15 to 20 years less than that for the population as a whole. Diabetes contributes significantly to this inequality, being 2 to 3 times more prevalent in people with SMI. Various risk factors have been implicated, including side effects of antipsychotic medication and unhealthy lifestyles, which often occur in the context of socioeconomic disadvantage and health care inequality. However, little is known about how these factors may interact to influence the risk of developing diabetes and poor diabetic outcomes, or how the organization and provision of health care may contribute. OBJECTIVE:This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with SMI. METHODS:This study will employ a concurrent mixed methods design combining the interrogation of electronic primary care health records from the Clinical Practice Research Datalink (CPRD GOLD) with qualitative interviews with adults with SMI and diabetes, their relatives and friends, and health care staff. The study has been funded for 2 years, from September 2017 to September 2019, and data collection has recently ended. RESULTS:CPRD and linked health data will be used to explore the association of sociodemographics, illness, and health care-related factors with both the development and outcomes of type 2 diabetes in people with SMI. Experiences of managing the comorbidity and accessing health care will be explored through qualitative interviews using topic guides informed by evidence synthesis and expert consultation. Findings from both datasets will be merged to develop a more comprehensive understanding of diabetes risks, interventions, and outcomes for people with SMI. Findings will be translated into recommendations for interventions and services using co-design workshops. CONCLUSIONS:Improving diabetes outcomes for people with SMI is a high-priority area nationally and globally. Understanding how risk factors combine to generate high prevalence of diabetes and poor diabetic outcomes for this population is a necessary first step in developing health care interventions to improve outcomes for people with diabetes and SMI. TRIAL REGISTRATION:ClinicalTrials.gov NCT03534921; https://clinicaltrials.gov/ct2/show/NCT03534921.

SUBMITTER: Bellass S

PROVIDER: S-EPMC6786849 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study.

Bellass Sue S Taylor Johanna J Han Lu L Prady Stephanie L SL Shiers David D Jacobs Rowena R Holt Richard Ian Gregory RIG Radford John J Gilbody Simon S Hewitt Catherine C Doran Tim T Alderson Sarah L SL Siddiqi Najma N

JMIR research protocols 20190906 9

<h4>Background</h4>The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15 to 20 years less than that for the population as a whole. Diabetes contributes significantly to this inequality, being 2 to 3 times more prevalent in people with SMI. Various risk factors have been implicated, including side effects of antipsychotic medication and unhealthy lifestyles, which often occur in the context of socioeconomic disadvantage and healt ...[more]

PMID: 31493324

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Project description:INTRODUCTION:Hospital redevelopment projects typically intend to improve hospital functioning and modernise the delivery of care. There is research support for the proposition that redevelopment along evidence-based design principles can lead to improved quality and safety. However, it is not clear how redevelopment influences the wider context of the hospital and its functioning. That is, beyond a limited examination of intended outcomes (eg, improved patient satisfaction), are there additional consequences (positive, negative or unintended) occurring within the hospital after the physical environment is changed? Is new always better? The primary purpose of this study is to explore the ripple effects of how hospital redevelopment may influence the organisation, staff and patients in both intended and unintended ways. METHODS AND ANALYSIS:We propose to conduct a longitudinal, mixed-methods, case study of a large metropolitan hospital in Australia. The study design consists of a series of measurements over time that are interrupted by the natural intervention of a hospital redevelopment. How hospital redevelopment influences the wider context of the hospital will be assessed in six domains: expectations and reflections of hospital redevelopment, organisational culture, staff interactions, staff well-being, efficiency of care delivery and patient experience. Methods of data collection include a hospital-wide staff survey, semistructured interviews, a network survey, a patient experience survey, analysis of routinely collected hospital data and observations. In addition to a hospital-level analysis, a total of four wards will be examined in-depth, with two acting as controls. Data will be analysed using thematic, statistical and network analyses, respectively, for the qualitative, quantitative and relational data. ETHICS AND DISSEMINATION:The study has been reviewed and approved by the relevant Ethics Committee in New South Wales, Australia. The results will be actively disseminated through peer-reviewed journals, conference presentations and in report format to the stakeholders.

Project description:IntroductionPeople with serious mental illness (SMI) have poor health outcomes, in part because of inequitable access to quality health services. Primary care is well suited to coordinate and manage care for this population; however, providers may feel ill-equipped to do so and patients may not have the support and resources required to coordinate their care. We lack a strong understanding of prevention and management of chronic disease in primary care among people with SMI as well as the context-specific barriers that exist at the patient, provider and system levels. This mixed methods study will answer three research questions: (1) How do primary care services received by people living with SMI differ from those received by the general population? (2) What are the experiences of people with SMI in accessing and receiving chronic disease prevention and management in primary care? (3) What are the experiences of primary care providers in caring for individuals with SMI?Methods and analysisWe will conduct a concurrent mixed methods study in Ontario and British Columbia, Canada, including quantitative analyses of linked administrative data and in-depth qualitative interviews with people living with SMI and primary care providers. By comparing across two provinces, each with varying degrees of mental health service investment and different primary care models, results will shed light on individual and system-level factors that facilitate or impede quality preventive and chronic disease care for people with SMI in the primary care setting.Ethics and disseminationThis study was approved by the University of Ottawa Research Ethics Board and partner institutions. An integrated knowledge translation approach brings together researchers, providers, policymakers, decision-makers, patient and caregiver partners and knowledge users. Working with this team, we will develop policy-relevant recommendations for improvements to primary care systems that will better support providers and reduce health inequities.

Project description:BackgroundObesity is common in individuals with severe mental illness (SMI), contributing to a significantly shortened lifespan when compared to the general population. Available weight loss treatments have attenuated efficacy in this population, underscoring the importance of prevention and early intervention.ObjectiveHere, we describe a type 1 hybrid study design for adapting and pilot-testing an existing mobile health intervention for obesity prevention in individuals with early SMI and Class I or early-stage obesity, defined as a BMI of 30-35.MethodsAn existing, evidence-based interactive obesity treatment approach using low-cost, semiautomated SMS text messaging was selected for adaptation. Community mental health clinics and Clubhouse settings in Eastern Missouri and South Florida were identified to participate. This study has the following 3 aims. First, using the Enhanced Framework for Reporting Adaptations and Modifications to Evidence-based interventions, contextual aspects of the clinical and digital treatment environments are identified for adaptation, considering 5 main stakeholder groups (clinical administrators, prescribing clinicians, case managers, nurses, and patients). Following a 2-week trial of unadapted SMS text messaging, Innovation Corps methods are used to discover needed intervention adaptations by stakeholder group and clinical setting. Second, adaptations to digital functionality and intervention content will be made based on themes identified in aim 1, followed by rapid usability testing with key stakeholders. A process for iterative treatment adaptation will be developed for making unplanned modifications during the aim 3 implementation pilot study. Individuals working in partner community mental health clinics and Clubhouse settings will be trained in intervention delivery. Third, in a randomized pilot and feasibility trial, adults with 5 years or less of treatment for an SMI diagnosis will be randomized 2:1 to 6 months of an adapted interactive obesity treatment approach or to an attentional control condition, followed by a 3-month extension phase of SMS text messages only. Changes in weight, BMI, and behavioral outcomes, as well as implementation challenges, will be evaluated at 6 and 9 months.ResultsInstitutional review board approval for aims 1 and 2 was granted on August 12, 2018, with 72 focus group participants enrolled; institutional review board approval for aim 3 was granted on May 6, 2020. To date, 52 participants have been enrolled in the study protocol.ConclusionsIn this type 1 hybrid study design, we apply an evidence-based treatment adaptation framework to plan, adapt, and feasibility test a mobile health intervention in real-world treatment settings. Resting at the intersection of community mental health treatment and physical health promotion, this study aims to advance the use of simple technology for obesity prevention in individuals with early-stage mental illness.Trial registrationClinicalTrials.gov NCT03980743; https://clinicaltrials.gov/ct2/show/NCT03980743.International registered report identifier (irrid)DERR1-10.2196/42114.

Project description:IntroductionA common problem low-income and middle-income countries face is the scarcity of community-based rehabilitation (CBR) resources and low service utilisation among persons with severe mental illness (SMI). Despite this problem, the factors and pathways followed influencing one's decision on service utilisation in China have not been fully comprehended. This study aims to develop a theory-based model that systematically describes the integrated decision-making process of mental health CBR utilisation among persons with SMI in China.Methods/designThis cross-sectional, mixed-methods study involves three main stages and is expected to last 3 years, from January 2018 to December 2020. In stage 1, the Social Exchange Theory is deployed as an analytical framework to comprehensively capture factors associated with tendency to use CBR services in China using semistructured interview methodology involving patients with SMI, their primary caregivers and CBR service providers. In stage 2, interpretive structural modelling will be applied to analyse the relationships between factors in different dimensions, at different levels and with different levels of impact. Stage 3 involves a multiregion survey among at least 300 family decision-makers (either the patient or their caregivers) in six communities in three cities to statistically validate the initial model derived in stage 2 using a further structural equation modelling.Ethics and disseminationEthical approval was granted by the Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (No 2017S319). All interviewees will be provided with written information about the study, and a signed consent will be retrieved prior to the interview. Rules on confidentiality and anonymity of data will be strictly followed. The findings of this study will be disseminated via international and domestic peer-reviewed journals, reports, conference presentations and symposium discussions. Reports will be submitted to the National Natural Science Foundation of China.

Project description:BackgroundParity of esteem means that end-of-life care for people with severe mental illness should be of equal quality to that experienced by all.AimTo synthesise international, English language, research and UK policy and guidance relating to the organisation, provision, and receipt of end-of-life care for people with severe mental illness.DesignA mixed methods systematic review was conducted following the Evidence for Policy and Practice Information and Co-ordinating Centre approach and informed by a stakeholder group. We employed thematic synthesis to bring together data from both qualitative and quantitative studies, and from non-research material. We assessed the strength of synthesised findings using the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approaches.Data sourcesTen electronic databases were searched from inception to December 2019, along with 62 organisational websites. Quality appraisal was conducted using Critical Appraisal Skills Programme checklists or other study design-specific alternatives as necessary.ResultsOf the 11,904 citations retrieved, 34 research publications were included plus 28 non-research items. The majority of research was of high or acceptable quality. An overarching synthesis including 52 summary statements, with assessments of confidence in the underpinning evidence, was produced using four themes: Structure of the system; Professional issues; Contexts of care; and Living with severe mental illness.ConclusionsImplications for services and practice reflect evidence in which there is a high degree of confidence. Partnership should be developed across the mental health and end-of-life systems, and ways found to support people to die where they choose. Staff caring for people with severe mental illness at the end-of-life need education, support and supervision. End-of-life care for people with severe mental illness requires a team approach, including advocacy. Proactive physical health care for people with severe mental illness is needed to tackle problems of delayed diagnosis.

Project description:IntroductionSevere mental illness (SMI) is associated with significant morbidity and mortality. People living with SMI often receive complex medication regimens. Optimising these regimens can be challenging. Non-adherence is common and addressing it requires a collaborative approach to decision making. MEDIATE uses a realist approach with extensive engagement with experts-by-experience to make sense of the complexities and identify potential solutions.Realist research is used to unpack and explain complexity using programme theory/theories that contain causal explanations of outcomes, expressed as context-mechanism-outcome-configurations. The programme theory/theories will enable MEDIATE to address its aim of understanding what works, for whom, in what circumstances, to optimise medication use with people living with SMI.Method and analysisMEDIATE will be conducted over six stages. In stage 1, we will collaborate with our service user/family carer lived experience group (LEG) and practitioner stakeholder group (SG), to determine the focus. In stage 2, we will develop initial programme theories for what needs to be done, by whom, how and why, and in what contexts to optimise medication use. In stage 3, we will develop and run searches to identify secondary data to refine our initial programme theories.Stage 4 involves selection and appraisal: documents will be screened by title, abstract/keywords and full text against inclusion and exclusion criteria. In stage 5, relevant data will extracted, recorded and coded. Data will be analysed using a realist logic with input from the LEG and SG. Finally, in stage 6, refined programme theories will be developed, identifying causal explanations for key outcomes and the strategies required to change contexts to trigger the key mechanisms that produce these outcomes.Ethics and disseminationPrimary data will not be collected, and therefore, ethical approval is not required. MEDIATE will be disseminated via publications, conferences and form the basis for future grant applications.Prospero registration numberCRD42021280980.

Project description:IntroductionMental illness stigma is associated with a range of negative consequences, such as reduced help-seeking for mental health problems. Since stigma affects individual, social, and structural aspects, multilevel interventions such as the Canadian programme The Working Mind have been proven to be the most effective. Given the solid evidence base for The Working Mind, it is our aim to implement and evaluate culturally adapted versions of the programme in German higher education, targeting students, employees and managers.Methods and analysisWe will evaluate the programme with regard to its effect on mental illness stigma, openness to mental health problems, willingness to seek help, and positive mental health outcomes. Further, we will investigate the programme's effectiveness dependent on gender and personal values, various mechanisms of change, and factors facilitating and hindering implementation. The study uses a sequential explanatory mixed-methods evaluation design (QUAN → qual) that consists of three steps: (1) quasi-experimental online survey with programme participants, (2) focus groups with programme participants, and (3) qualitative interviews with programme stakeholders. The quantitative data collected in step 1 will be analysed using 2×3 analysis of variances and a parallel multiple mediation analysis. The results will inform the qualitative data to be collected in steps 2 and 3, which will be analysed using qualitative content analysis.Ethics and disseminationThe study was approved by the local Ethics Committee (Ethics Committee of University Medicine Greifswald; BB 098/23). Participants have to provide written consent before taking part in a focus group or interview. As for the online survey, participants have to give their consent by agreeing to an online data protection form before they can start completing the survey. We will publish central results and the anonymised data in an Open Access Journal. Further, the statistical code will be included as a supplement to the paper(s) documenting the results of the study.Trial registration numberDRKS00033523.

Dataset Information

Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study.

Publications

Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study.

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