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Hospital-based chronic disease care model: protocol for an effectiveness and implementation evaluation.

ABSTRACT: INTRODUCTION:Novel and efficient healthcare approaches are needed to better serve increasingly older chronic disease patients. Many effective integrated chronic disease management strategies have emerged from the primary care sector. However, in many Asian and developing countries, primary care is underdeveloped, and patients prefer secondary-based services. The Integrated Generalist-led Hospital (IGH) care model is a new approach, which may be better suited for chronic disease patients in the local context. METHODS AND ANALYSIS:A hybrid type I study on the effectiveness and implementation of the IGH care model will be conducted. Implementation evaluation will be informed by the Consolidated Framework of Implementation Research (CFIR). Quantitative and qualitative data will be collected through in-depth interviews and focus group discussions with staff, a staff survey, patient interviews, clinical outcomes and cost data. Clinical outcomes include the length of stay, readmission, emergency room visit rate and mortality. Clinical outcomes will be summarised and compared with a propensity-matched 'usual care' group (derived from the general medicine ward(s) at a separate hospital). The Kaplan-Meier approach will be used to estimate time until death and time until first readmission (both within 30?days of discharge) and time until discharge. Multivariate regression models will be used to investigate the association between the care model and occurrence of readmission, emergency room visit and death, all within 30?days of discharge. Qualitative data will be analysed using a thematic analysis method. Qualitative and quantitative data will also be coded according to the five domains of the CFIR. ETHICS AND DISSEMINATION:This protocol was reviewed and approved by the National Healthcare Group Domain Specific Review Board (NHG DSRB 2019/00308). Results will be published in peer-reviewed scientific journals and conference presentations. Findings will also be discussed with key stakeholders through local dissemination events.

SUBMITTER: Sumner J

PROVIDER: S-EPMC7380726 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Hospital-based chronic disease care model: protocol for an effectiveness and implementation evaluation.

Sumner Jennifer J Phua Jason J Lim Yee Wei YW

BMJ open 20200722 7

<h4>Introduction</h4>Novel and efficient healthcare approaches are needed to better serve increasingly older chronic disease patients. Many effective integrated chronic disease management strategies have emerged from the primary care sector. However, in many Asian and developing countries, primary care is underdeveloped, and patients prefer secondary-based services. The Integrated Generalist-led Hospital (IGH) care model is a new approach, which may be better suited for chronic disease patients ...[more]

PMID: 32699165

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Project description:BackgroundThis study was a retrospective evaluation of an unsuccessfully implemented team-based, chronic disease management program, with an aim to understand more about implementation barriers. The program, the Chronic Disease Management Initiative (CDMI) was a new collaborative model of care for patients with COPD. It utilized customized health information and interactive tools, mainly smartphones, for ongoing disease management. The program's goal was to demonstrate that integrated team-based models of care could improve patient care, as well as reduce readmission rates and emergency department visits. The program planning for CDMI began in 2017, followed by the implementation and evaluation period in 2018. After a 10-month implementation period, the program was unable to enroll a sufficient number of patients to examine if there was an improvement in patient outcomes.MethodsA retrospective case-study design using multiple data sources was used to gather feedback from participants involved in CDMI. Data collection occurred throughout planning and implementation and continued into early 2019. Semi-structured interviews were conducted, and transcripts were analyzed using NVivo 10 software. This was followed by content analysis.ResultsAnalysis revealed four key themes as barriers to CDMI's implementation: 1) lack of a needs assessment with key stakeholders; 2) lack of buy-in from medical staff; 3) inadequate patient engagement and; 4) contextual barriers. Planners did not conduct a proper needs assessment, nor include patients in the study design. In addition, there was insufficient consideration for how CDMI should be integrated into the usual COPD care plan, leading to confusion in roles and responsibilities. Poor communication between the implementation team and healthcare providers implementing the program, led to a lack of buy-in and engagement.ConclusionThe key themes resonate with what is already known in the literature. This study supports the importance of using a theoretically grounded plan for implementation. Using a model only in the planning stages is insufficient even when an intervention is based on evidence to support higher quality care. It is imperative to consider practical and contextual factors of program implementation and their interactions. By detailing the 'failed implementation' of this intervention, we hope to share important lessons about the need to plan implementation processes early in program planning.

Project description:BackgroundOlder adults (> 65 years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home. Care transitions for this population are often poorly coordinated and fragmented, resulting in increased readmission rates, adverse medical events, decreased patient satisfaction and safety, and increased caregiver burden. There is a dearth of evidence on best practices in the provision of transitional care for older adults with MCC and depressive symptoms transitioning from hospital-to-home. This paper presents a protocol for a two-armed, multi-site pragmatic effectiveness-implementation trial of Community Assets Supporting Transitions (CAST), an evidence-informed nurse-led six-month intervention that supports older adults with MCC and depressive symptoms transitioning from hospital-to-home. The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.MethodsParticipants will be considered eligible if they are > 65 years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms. A total of 216 eligible and consenting participants will be randomly assigned to the control (usual care) or intervention (CAST) arm. The intervention consists of tailored care delivery comprising in-home visits, telephone follow-up and system navigation support. The primary measure of effectiveness is mental health functioning of the older adult participant. Secondary outcomes include changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months. Caregivers will be assessed for caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs. Descriptive and qualitative data from older adult and caregiver participants, and the nurse interventionists will be used to examine implementation of the intervention, how the intervention is adapted within each study region, and its potential for sustainability and scalability to other jurisdictions.DiscussionA nurse-led transitional care strategy may provide a feasible and effective means for improving health outcomes and patient/caregiver experience and reduce service use and costs in this vulnerable population.Trial registration# NCT03157999 . Registration Date: April 4, 2017.

Project description:Most research publications on Chronic Care Model (CCM) implementation originate from organizations or countries with a well-structured primary health care system. Information about efforts made in countries with a less well-organized primary health care system is scarce. In 2003, the Belgian National Institute for Health and Disability Insurance commissioned a pilot study to explore how care for type 2 diabetes patients could be organized in a more efficient way in the Belgian healthcare setting, a setting where the organisational framework for chronic care is mainly hospital-centered.Process evaluation of an action research project (2003-2007) guided by the CCM in a well-defined geographical area with 76,826 inhabitants and an estimated number of 2,300 type 2 diabetes patients. In consultation with the region a program for type 2 diabetes patients was developed. The degree of implementation of the CCM in the region was assessed using the Assessment of Chronic Illness Care survey (ACIC). A multimethod approach was used to evaluate the implementation process. The resulting data were triangulated in order to identify the main facilitators and barriers encountered during the implementation process.The overall ACIC score improved from 1.45 (limited support) at the start of the study to 5.5 (basic support) at the end of the study. The establishment of a local steering group and the appointment of a program manager were crucial steps in strengthening primary care. The willingness of a group of well-trained and motivated care providers to invest in quality improvement was an important facilitator. Important barriers were the complexity of the intervention, the lack of quality data, inadequate information technology support, the lack of commitment procedures and the uncertainty about sustainable funding.Guided by the CCM, this study highlights the opportunities and the bottlenecks for adapting chronic care delivery in a primary care system with limited structure. The study succeeded in achieving a considerable improvement of the overall support for diabetes patients but further improvement requires a shift towards system thinking among policy makers. Currently primary care providers lack the opportunities to take up full responsibility for chronic care.ClinicalTrials.gov Identifier: NCT00824499.

Project description:BACKGROUND:In Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary care systems and addressing the burden of multiple comorbidities. A growing body of literature supports the involvement of frontline providers, namely mid-level practitioners and community health workers, in chronic care management. Important operational questions remain, however, around the digital, training, and supervisory structures to support the implementation of effective, affordable, and equitable chronic care management programs. METHODS:A 12-month, population-level, type 2 hybrid effectiveness-implementation study will be conducted in rural Nepal to evaluate an integrated noncommunicable disease care management intervention within Nepal's new municipal governance structure. The intervention will leverage the government's planned roll-out of the World Health Organization's Package of Essential Noncommunicable Disease Interventions (WHO-PEN) program in four municipalities in Nepal, with a study population of 80,000. The intervention will leverage both the WHO-PEN and its cardiovascular disease-specific technical guidelines (HEARTS), and will include three evidence-based components: noncommunicable disease care provision using mid-level practitioners and community health workers; digital clinical decision support tools to ensure delivery of evidence-based care; and training and digitally supported supervision of mid-level practitioners to provide motivational interviewing for modifiable risk factor optimization, with a focus on medication adherence, and tobacco and alcohol use. The study will evaluate effectiveness using a pre-post design with stepped implementation. The primary outcomes will be disease-specific, "at-goal" metrics of chronic care management; secondary outcomes will include alcohol and tobacco consumption levels. DISCUSSION:This is the first population-level, hybrid effectiveness-implementation study of an integrated chronic care management intervention in Nepal. As low and middle-income countries plan for the Sustainable Development Goals and universal health coverage, the results of this pragmatic study will offer insights into policy and programmatic design for noncommunicable disease care management in the future. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04087369. Registered on 12 September 2019.

Project description:BackgroundAlthough guidelines recommend palliative care for patients with chronic obstructive pulmonary disease, there is little evidence for the effectiveness of palliative care interventions for this patient group specifically.AimTo describe the characteristics of palliative care interventions for patients with COPD and their informal caregivers and review the available evidence on effectiveness and implementation outcomes.DesignSystematic review and narrative synthesis (PROSPERO CRD42017079962).Data sourcesSeven databases were searched for articles reporting on multi-component palliative care interventions for study populations containing ⩾30% patients with COPD. Quantitative as well as qualitative and mixed-method studies were included. Intervention characteristics, effect outcomes, implementation outcomes and barriers and facilitators for successful implementation were extracted and synthesized qualitatively.ResultsThirty-one articles reporting on twenty unique interventions were included. Only four interventions (20%) were evaluated in an adequately powered controlled trial. Most interventions comprised of longitudinal palliative care, including care coordination and comprehensive needs assessments. Results on effectiveness were mixed and inconclusive. The feasibility level varied and was context-dependent. Acceptability of the interventions was high; having someone to call for support and education about breathlessness were most valued characteristics. Most frequently named barriers were uncertainty about the timing of referral due to the unpredictable disease trajectory (referrers), time availability (providers) and accessibility (patients).ConclusionLittle high-quality evidence is yet available on the effectiveness and implementation of palliative care interventions for patients with COPD. There is a need for well-conducted effectiveness studies and adequate process evaluations using standardized methodologies to create higher-level evidence and inform successful implementation.

Project description:If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented. The HiBalance program is systemically designed to target balance impairments in PD and has been shown effective at improving balance control and gait in a previous RCT. Study aims are to i) determine the effectiveness of the adapted HiBalance program on performance and self-rated outcomes such as balance control, gait and physical activity level ii) conduct a process evaluation of program implementation at the various clinics iii) determine barriers and facilitators to program implementation in these settings.This effectiveness-implementation type 1 hybrid study will use a non-randomized controlled design with consecutive inclusion of people with PD at multiple clinical sites. A mixed method approach will be used to collect clinical effectiveness data and process evaluation data which is both quantitative and qualitative in nature. The consolidated framework for implementation research (CFIR) will be used to guide the planning and collection of data concerning implementation barriers and facilitators. The HiBalance program will be provided by physical therapists as a part of standard rehabilitation care at the clinical sites, while the evaluation of the implementation process will be performed by the research group and funded by research grants.An effectiveness-implementation study design benefits patients by speeding up the process of translating findings from research settings to routine health care. Findings from this study will also be highly relevant for those working with neurological rehabilitation when faced with decisions concerning the translation of training programs from efficacy studies to everyday clinical practice.ClinicalTrials.gov march 2016, NCT02727478 .

Project description:Nearly all persons with dementia will experience neuropsychiatric symptoms (NPS) during the course of their disease. Clinicians and researchers emphasize the need for an evidence-informed standardized approach to managing NPS that integrates pharmacological and nonpharmacological treatments for real-world implementation. The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) represents such an approach and is a multicomponent intervention based on the theoretical framework of cognitive behavioural therapy.The trial is a 3-month cluster randomized trial conducted in 30 nursing homes including 168 participants with dementia and a high level of agitation. Each nursing home defined as a cluster will be randomized to receive either the TIME intervention (the intervention group) or a brief education-only intervention regarding dementia and NPS (the control group). TIME is a manual-based, multicomponent programme that includes a rigorous assessment, one or more case conferences and the treatment and evaluation of NPS. Patient-level measurements are taken at baseline (prior to randomization) and 8 and 12 weeks later. The primary outcome measure is the change in agitation, as defined by the Neuropsychiatric Inventory-Nursing Home Version, at 8 weeks from baseline. Secondary outcome measures include change in agitation at 12 weeks from baseline, and change from baseline at 8 and 12 weeks in other NPS, quality of life, and the use of psychotropic and analgesic medications. Mixed methods will be used to follow, measure and explore the implementation process and the effect of the intervention at the individual staff level and the organization level. Combining measurements of clinical effectiveness and implementation outcomes define this trial as an effectiveness-implementation hybrid trial.Measuring the implementation and effect of complex interventions aimed at reducing NPS in nursing homes is challenging. In this study protocol, we describe a multicomponent program, TIME, and discuss how an effectiveness-implementation cluster randomized hybrid trial can meet these challenges.ClinicalTrials.gov identifier NCT02655003 . Registered 6 January 2016.

Project description:IntroductionIn the COVID-19 environment of reduced patient interaction with the healthcare system, evidenced-based self-care of chronic disease is vital. We will evaluate the effect of an online chronic disease self-management programme (CDSMP) plus medication adherence tools on systolic blood pressure (SBP) (primary aim) and, seek to understand the barriers and facilitators to implementation of this modified CDSMP in faith-based organisations (FBOs) (secondary aim).MethodsWe will conduct an unblinded cluster randomised trial in FBOs throughout Barbados. Eligibility: Persons ages 35-70 years; a previous diagnosis of hypertension or currently on antihypertensive therapy and the occurrence of two or more blood pressure readings above 130 mm Hg (systolic) or 80 mm Hg (diastolic) on the day of recruitment. Persons not known to have hypertension but who have two or more blood pressure readings at or above 130 mm Hg (systolic) or 80 mm Hg (diastolic) on two recruitment days at least 1 week apart will also be eligible. The unit of randomisation is a church cluster which consists of 7-9 churches. We will perform block randomisation to assign 24 clusters to intervention or control. The intervention has three components: modified CDSMP workshops, distribution of medication pill boxes and use of social media (WhatsApp V.2.0) to encourage medication adherence. Controls will receive one didactic lecture only. We will determine the mean changes in SBP levels for the intervention group versus controls and compare differences in outcomes 6 months' post intervention using mixed effects regression models.Ethics and disseminationThis project has received ethical approval from the Institutional Review Board of the University of the West Indies in Barbados. Dissemination will use peer-reviewed publications, policy briefs to government and guidelines to leaders of FBOs. We aim to increase the proportion of patients with controlled hypertension and inform implementation of self-management programmes in small populations.Trail registration numberNCT04437966.

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Hospital-based chronic disease care model: protocol for an effectiveness and implementation evaluation.

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Hospital-based chronic disease care model: protocol for an effectiveness and implementation evaluation.

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