Exploring characteristics of COPD patients with clinical improvement after integrated disease management or usual care: post-hoc analysis of the RECODE study.

BACKGROUND: The cluster randomized controlled trial on (cost-)effectiveness of integrated chronic obstructive pulmonary disease (COPD) management in primary care (RECODE) showed that integrated disease management (IDM) in primary care had no effect on quality of life (QOL) in COPD patients compared with usual care (guideline-supported non-programmatic care). It is possible that only a subset of COPD patients in primary care benefit from IDM. We therefore examined which patients benefit from IDM, and whether patient characteristics predict clinical improvement over time. METHOD: Post-hoc analyses of the RECODE trial among 1086 COPD patients. Logistic regression analyses were performed with baseline characteristics as predictors to examine determinants of improvement in QOL, defined as a minimal decline in Clinical COPD Questionnaire (CCQ) of 0.4 points after 12 and 24 months of IDM. We also performed moderation analyses to examine whether predictors of clinical improvement differed between IDM and usual care. RESULTS: Regardless of treatment type, more severe dyspnea (MRC) was the most important predictor of clinically improved QOL at 12 and 24 months, suggesting that these patients have most room for improvement. Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months). CONCLUSIONS: More severe dyspnea is a key predictor of improved QOL in COPD patients over time. More research is needed to replicate patient characteristics associated with clinical improvement with IDM, such that IDM programs can be offered to patients that benefit the most, and can potentially be adjusted to meet the needs of other patient groups as well. TRIAL REGISTRATION: Netherlands Trial Register, NTR2268. Registered 31 March 2010.

Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial.

BACKGROUND AND AIMS: The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients. METHODS: Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 ± 0.9 years) with moderate airflow obstruction (FEV1 55.1 ± 2.2% predicted) and impaired exercise capacity (Wmax 63.5 ± 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included. RESULTS: After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Δ1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p < 0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Δ1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Δ-1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months; only amotivation towards healthy eating yielded a significant between-group difference (Δ1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750. CONCLUSIONS: Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden.

Defining good health and care from the perspective of persons with multimorbidity: results from a qualitative study of focus groups in eight European countries.

OBJECTIVES: The prevalence of multimorbidity is increasing in many Western countries. Persons with multimorbidity often experience a lack of alignment in the care that multiple health and social care organisations provide. As a response, integrated care programmes are appearing. It is a challenge to evaluate these and to choose appropriate outcome measures. Focus groups were held with persons with multimorbidity in eight European countries to better understand what good health and a good care process mean to them and to identify what they find most important in each. METHODS: In 2016, eight focus groups were organised with persons with multimorbidity in: Austria, Croatia, Germany, Hungary, the Netherlands, Norway, Spain and the UK (total n=58). Each focus group followed the same two-part procedure: (1) defining (A) good health and well-being and (B) a good care process, and (2) group discussion on prioritising the most important concepts derived from part one and from a list extracted from the literature. Inductive and deductive analyses were done. RESULTS: Overall, the participants in all focus groups concentrated more on the care process than on health. Persons with multimorbidity defined good health as being able to conduct and plan normal daily activities, having meaningful social relationships and accepting the current situation. Absence of shame, fear and/or stigma, being able to enjoy life and overall psychological well-being were also important facets of good health. Being approached holistically by care professionals was said to be vital to a good care process. Continuity of care and trusting professionals were also described as important. Across countries, little variation in health definitions were found, but variation in defining a good care process was seen. CONCLUSION: A variety of health outcomes that entail well-being, social and psychological facets and especially experience with care outcomes should be included when evaluating integrated care programmes for persons with multimorbidity.

Relevant models and elements of integrated care for multi-morbidity: Results of a scoping review.

BACKGROUND: In order to provide adequate care for the growing group of persons with multi-morbidity, innovative integrated care programmes are appearing. The aims of the current scoping review were to i) identify relevant models and elements of integrated care for multi-morbidity and ii) to subsequently identify which of these models and elements are applied in integrated care programmes for multi-morbidity. METHODS: A scoping review was conducted in the following scientific databases: Cochrane, Embase, PubMed, PsycInfo, Scopus, Sociological Abstracts, Social Services Abstracts, and Web of Science. A search strategy encompassing a) models, elements and programmes, b) integrated care, and c) multi-morbidity was used to identify both models and elements (aim 1) and implemented programmes of integrated care for multi-morbidity (aim 2). Data extraction was done by two independent reviewers. Besides general information on publications (e.g. publication year, geographical region, study design, and target group), data was extracted on models and elements that publications refer to, as well as which models and elements are applied in recently implemented programmes in the EU and US. RESULTS: In the review 11,641 articles were identified. After title and abstract screening, 272 articles remained. Full text screening resulted in the inclusion of 92 articles on models and elements, and 50 articles on programmes, of which 16 were unique programmes in the EU (n=11) and US (n=5). Wagner's Chronic Care Model (CCM) and the Guided Care Model (GCM) were most often referred to (CCM n=31; GCM n=6); the majority of the other models found were only referred to once (aim 1). Both the CCM and GCM focus on integrated care in general and do not explicitly focus on multi-morbidity. Identified elements of integrated care were clustered according to the WHO health system building blocks. Most elements pertained to 'service delivery'. Across all components, the five elements referred to most often are person-centred care, holistic or needs assessment, integration and coordination of care services and/or professionals, collaboration, and self-management (aim 1). Most (n=10) of the 16 identified implemented programmes for multi-morbidity referred to the CCM (aim 2). Of all identified programmes, the elements most often included were self-management, comprehensive assessment, interdisciplinary care or collaboration, person-centred care and electronic information system (aim 2). CONCLUSION: Most models and elements found in the literature focus on integrated care in general and do not explicitly focus on multi-morbidity. In line with this, most programmes identified in the literature build on the CCM. A comprehensive framework that better accounts for the complexities resulting from multi-morbidity is needed.

The SELFIE framework for integrated care for multi-morbidity: Development and description.

BACKGROUND: The rise of multi-morbidity constitutes a serious challenge in health and social care organisation that requires a shift from disease- towards person-centred integrated care. The aim of the current study was to develop a conceptual framework that can aid the development, implementation, description, and evaluation of integrated care programmes for multi-morbidity. METHODS: A scoping review and expert discussions were used to identify and structure concepts for integrated care for multi-morbidity. A search of scientific and grey literature was conducted. DISCUSSION: meetings were organised within the SELFIE research project with representatives of five stakeholder groups (5Ps): patients, partners, professionals, payers, and policy makers. RESULTS: In the scientific literature 11,641 publications were identified, 92 were included for data extraction. A draft framework was constructed that was adapted after discussion with SELFIE partners from 8 EU countries and 5P representatives. The core of the framework is the holistic understanding of the person with multi-morbidity in his or her environment. Around the core, concepts were grouped into adapted WHO components of health systems: service delivery, leadership & governance, workforce, financing, technologies & medical products, and information & research. Within each component micro, meso, and macro levels are distinguished. CONCLUSION: The framework structures relevant concepts in integrated care for multi-morbidity and can be applied by different stakeholders to guide development, implementation, description, and evaluation.

Systematic Review and Quality Appraisal of Cost-Effectiveness Analyses of Pharmacologic Maintenance Treatment for Chronic Obstructive Pulmonary Disease: Methodological Considerations and Recommendations.

BACKGROUND: Worldwide, chronic obstructive pulmonary disease (COPD) is a highly prevalent chronic lung disease with considerable clinical and socioeconomic impact. Pharmacologic maintenance drugs (such as bronchodilators and inhaled corticosteroids) play an important role in the treatment of COPD. The cost effectiveness of these treatments has been frequently assessed, but studies to date have largely neglected the impact of treatment sequence and the exact stage of disease in which the drugs are used in real life. OBJECTIVE: We aimed to systematically review recently published articles that reported the cost effectiveness of COPD maintenance treatments, with a focus on key findings, quality and methodological issues. METHODS: We performed a systematic literature search in Embase, PubMed, the UK NHS Economic Evaluation Database (NHS-EED) and EURONHEED (European Network of Health Economics Evaluation Databases) and included all relevant articles published between 2011 and 2015 in either Dutch, English or German. Main study characteristics, methods and outcomes were extracted and critically assessed. The Quality of Health Economic Studies (QHES) instrument was used as basis for quality assessment, but additional items were also addressed. RESULTS: The search identified 18 recent pharmacoeconomic analyses of COPD maintenance treatments. Papers reported the cost effectiveness of long-acting muscarinic antagonist (LAMA) monotherapy (n = 6), phosphodiesterase (PDE)-4 inhibitors (n = 4), long-acting beta agonist/inhaled corticosteroid (LABA/ICS) combinations (n = 4), LABA monotherapy (n = 2) and LABA/LAMA combinations (n = 2). All but two studies were funded by the manufacturer, and all studies indicated favourable cost effectiveness; however, the number of quality-adjusted life-years (QALYs) gained was small. Less than half of the studies reported a COPD-specific outcome in addition to a generic outcome (mostly QALYs). Exacerbation and mortality rates were found to be the main drivers of cost effectiveness. According to the QHES, the quality of the studies was generally sufficient, but additional assessment revealed that most studies poorly represented the cost effectiveness of real-life medication use. CONCLUSIONS: The majority of studies showed that pharmacologic COPD maintenance treatment is cost effective, but most studies poorly reflected real-life drug use. Consistent and COPD-specific methodology is recommended.

Impact of financial agreements in European chronic care on health care expenditure growth.

Various types of financial agreements have been implemented in Europe to reduce health care expenditure by stimulating integrated chronic care. This study used difference-in-differences (DID) models to estimate differences in health care expenditure trends before and after the introduction of a financial agreement between 9 intervention countries and 16 control countries. Intervention countries included countries with pay-for-coordination (PFC), pay-for-performance (PFP), and/or all inclusive agreements (bundled and global payment) for integrated chronic care. OECD and WHO data from 1996 to 2013 was used. The results from the main DID models showed that the annual growth of outpatient expenditure was decreased in countries with PFC (by 21.28 US$ per capita) and in countries with all-inclusive agreements (by 216.60 US$ per capita). The growth of hospital and administrative expenditure was decreased in countries with PFP by 64.50 US$ per capita and 5.74 US$ per capita, respectively. When modelling impact as a non-linear function of time during the total 4-year period after implementation, PFP decreased the growth of hospital and administrative expenditure and all-inclusive agreements reduced the growth of outpatient expenditure. Financial agreements are potentially powerful tools to stimulate integrated care and influence health care expenditure growth. A blended payment scheme that combines elements of PFC, PFP, and all-inclusive payments is likely to provide the strongest financial incentives to control health care expenditure growth.

Cost-effectiveness of integrated COPD care: the RECODE cluster randomised trial.

OBJECTIVES: To investigate the cost-effectiveness of a chronic obstructive pulmonary disease (COPD) disease management (COPD-DM) programme in primary care, called RECODE, compared to usual care. DESIGN: A 2-year cluster-randomised controlled trial. SETTING: 40 general practices in the western part of the Netherlands. PARTICIPANTS: 1086 patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. INTERVENTIONS: A multidisciplinary team of caregivers was trained in motivational interviewing, setting up individual care plans, exacerbation management, implementing clinical guidelines and redesigning the care process. In addition, clinical decision-making was supported by feedback reports provided by an ICT programme. MAIN OUTCOME MEASURES: We investigated the impact on health outcomes (quality-adjusted life years (QALYs), Clinical COPD Questionnaire, St. George's Respiratory Questionnaire and exacerbations) and costs (healthcare and societal perspective). RESULTS: The intervention costs were €324 per patient. Excluding these costs, the intervention group had €584 (95% CI €86 to €1046) higher healthcare costs than did the usual care group and €645 (95% CI €28 to €1190) higher costs from the societal perspective. Health outcomes were similar in both groups, except for 0.04 (95% CI -0.07 to -0.01) less QALYs in the intervention group. CONCLUSIONS: This integrated care programme for patients with COPD that mainly included professionally directed interventions was not cost-effective in primary care. TRIAL REGISTRATION NUMBER: Netherlands Trial Register NTR2268.

Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.

OBJECTIVE: To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. DESIGN: 24 month, multicentre, pragmatic cluster randomised controlled trial SETTING: 40 general practices in the western part of the Netherlands PARTICIPANTS: Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. INTERVENTION: General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). MAIN OUTCOME MEASURES: The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. RESULTS: Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow-up/coordination" (indicating improved integration of care) and proportion of physically active patients. Exacerbation rates as well as number of days in hospital did not differ between groups. After 24 months, no differences were seen in outcomes, except for the PACIC follow-up/coordination domain. CONCLUSION: In this pragmatic study, an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care, except improved level of integrated care and a self reported higher degree of daily activities. The contradictory findings to earlier positive studies could be explained by differences between interventions (provider versus patient targeted), selective reporting of positive trials, or little room for improvement in the already well developed Dutch healthcare system. TRIAL REGISTRATION: Netherlands Trial Register NTR2268.

Integrated disease management interventions for patients with chronic obstructive pulmonary disease.

BACKGROUND: In people with chronic obstructive pulmonary disease (COPD) there is considerable variation in symptoms, limitations and well-being, which often complicates medical care. To improve quality of life (QoL) and exercise tolerance, while reducing the number of exacerbations, a multidisciplinary program including different elements of care is needed. OBJECTIVES: To evaluate the effects of integrated disease management (IDM) programs or interventions in people with COPD on health-related QoL, exercise tolerance and number of exacerbations. SEARCH METHODS: We searched the Cochrane Airways Group Register of trials, CENTRAL, MEDLINE, EMBASE and CINAHL for potentially eligible studies (last searched 12 April 2012). SELECTION CRITERIA: Randomized controlled trials evaluating IDM programs for COPD compared with controls were included. Included interventions consisted of multidisciplinary (two or more health care providers) and multi-treatment (two or more components) IDM programs with a duration of at least three months. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data; if required, we contacted authors for additional data. We performed meta-analyses using random-effects modeling. We carried out sensitivity analysis for allocation concealment, blinding of outcome assessment, study design and intention-to-treat analysis. MAIN RESULTS: A total of 26 trials involving 2997 people were included, with a follow-up ranging from 3 to 24 months. Studies were conducted in 11 different countries. The mean age of the included participants was 68 years, 68% were male and the mean forced expiratory volume in one second (FEV1)% predicted value was 44.3% (range 28% to 66%). Participants were treated in all types of healthcare settings: primary (n = 8), secondary (n = 12), tertiary care (n = 1), and in both primary and secondary care (n = 5). Overall, the studies were of high to moderate methodological quality.Compared with controls, IDM showed a statistically and clinically significant improvement in disease-specific QoL on all domains of the Chronic Respiratory Questionnaire after 12 months: dyspnea (mean difference (MD) 1.02; 95% confidence interval (CI) 0.67 to 1.36); fatigue (MD 0.82; 95% CI 0.46 to 1.17); emotional (MD 0.61; 95% CI 0.26 to 0.95) and mastery (MD 0.75; 95% CI 0.38 to 1.12). The St. George's Respiratory Questionnaire (SGRQ) for QoL reached the clinically relevant difference of four units only for the impact domain (MD -4.04; 95% CI -5.96 to -2.11, P < 0.0001). IDM showed a significantly improved disease-specific QoL on the activity domain of the SGRQ: MD -2.70 (95% CI -4.84 to -0.55, P = 0.01). There was no significant difference on the symptom domain of the SGRQ: MD -2.39 (95% CI -5.31 to 0.53, P = 0.11). According to the GRADE approach, quality of evidence on the SGRQ was scored as high quality, and on the CRQ as moderate quality evidence. Participants treated with an IDM program had a clinically relevant improvement in six-minute walking distance of 43.86 meters compared with controls after 12 months (95% CI 21.83 to 65.89; P < 0.001, moderate quality). There was a reduction in the number of participants with one or more hospital admissions over three to 12 months from 27 per 100 participants in the control group to 20 (95% CI 15 to 27) per 100 participants in the IDM group (OR 0.68; 95% CI 0.47 to 0.99, P = 0.04; number needed to treat = 15). Hospitalization days were significantly lower in the IDM group compared with controls after 12 months (MD -3.78 days; 95% CI -5.90 to -1.67, P < 0.001). Admissions and hospital days were graded as high quality evidence. No adverse effects were reported in the intervention group. No difference between groups was found on mortality (OR 0.96; 95%CI 0.52 to 1.74). There was insufficient evidence to refute or confirm the long term effectiveness of IDM. AUTHORS' CONCLUSIONS: In these COPD participants, IDM not only improved disease-specific QoL and exercise capacity, but also reduced hospital admissions and hospital days per person.

Exploring payment schemes used to promote integrated chronic care in Europe.

The rising burden of chronic conditions has led several European countries to reform healthcare payment schemes. This paper aimed to explore the adoption and success of payment schemes that promote integration of chronic care in European countries. A literature review was used to identify European countries that employed pay-for-coordination (PFC), pay-for-performance (PFP), and bundled payment schemes. Existing evidence from the literature was supplemented with fifteen interviews with chronic care experts in these countries to obtain detailed information regarding the payment schemes, facilitators and barriers to their implementation, and their perceived success. Austria, France, England, the Netherlands, and Germany have implemented payment schemes that were specifically designed to promote the integration of chronic care. Prominent factors facilitating implementation included stakeholder cooperation, adequate financial incentives for stakeholders, and flexible task allocation among different care provider disciplines. Common barriers to implementation included misaligned incentives across stakeholders and gaming. The implemented payment schemes targeted different stakeholders (e.g. individual caregivers, multidisciplinary organizations of caregivers, regions, insurers) in different countries depending on the structure and financing of each health care system. All payment reforms appeared to have changed the structure of chronic care delivery. PFC, as it was implemented in Austria, France and Germany, was perceived to be the most successful in increasing collaboration within and across healthcare sectors, whereas PFP, as it was implemented in England and France, was perceived most successful in improving other indicators of the quality of the care process. Interviewees stated that the impact of the payment reforms on healthcare expenditures remained questionable. The success of a payment scheme depends on the details of the specific implementation in a particular country, but a combination of the schemes may overcome the barriers of each individual scheme.

RECODE: design and baseline results of a cluster randomized trial on cost-effectiveness of integrated COPD management in primary care.

BACKGROUND: Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated disease management (IDM) programs on quality of care and health status of COPD patients in primary care, representing a much larger group of COPD patients. Therefore, the RECODE trial assesses the long-term clinical and cost-effectiveness of IDM in primary care. METHODS/DESIGN: RECODE is a cluster randomized trial with two years of follow-up, during which 40 clusters of primary care teams (including 1086 COPD patients) are randomized to IDM or usual care. The intervention started with a 2-day multidisciplinary course in which healthcare providers are trained as a team in essential components of effective COPD IDM in primary care. During the course, the team redesigns the care process and defines responsibilities of different caregivers. They are trained in how to use feedback on process and outcome data to guide implement guideline-driven integrated healthcare. Practice-tailored feedback reports are provided at baseline, and at 6 and 12 months. The team learns the details of an ICT program that supports recording of process and outcome measures. Afterwards, the team designs a time-contingent individual practice plan, agreeing on steps to be taken in order to integrate a COPD IDM program into daily practice. After 6 and 12 months, there is a refresher course for all teams simultaneously to enable them to learn from each other's experience. Health status of patients at 12 months is the primary outcome, measured by the Clinical COPD Questionnaire (CCQ). Secondary outcomes include effects on quality of care, disease-specific and generic health-related quality of life, COPD exacerbations, dyspnea, costs of healthcare utilization, and productivity loss. DISCUSSION: This article presents the protocol and baseline results of the RECODE trial. This study will allow to evaluate whether IDM implemented in primary care can positively influence quality of life and quality of care in mild to moderate COPD patients, thereby making the benefits of multidisciplinary rehabilitation applicable to a substantial part of the COPD population. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2268.