The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes.</p> <p>Methods</p> <p>An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups.</p> <p>Discussion</p> <p>The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work.</p> <p>Trial Registration number</p> <p><b>NCT00962468</b></p

Inhalatietherapie

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Education and discharge management in home oxygen therapy

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Clinical pathway for acute COPD exacerbations reduces hospital stay and readmission rate

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Inhospital management of COPD exacerbations: a systematic review of the literature with regard to adherence to international guidelines

Rationale Chronic obstructive pulmonary disease (COPD) exacerbations are a leading cause of hospitalization. Suboptimal inhospital management is expected to lead to more frequent exacerbations and recurrent hospital admission, and is associated with increased mortality. Aims To explore inhospital management of COPD and to compare the results with recommendations from international guidelines. Methods A literature search was carried out for relevant articles published 2000-2009 in the databases Medline, Cochrane Library, Cumulative Index for Nursing and Allied Health Literature and Invert. In addition, the reference lists of the selected articles were examined. Main inclusion criteria were as follows: COPD, exacerbation, hospitalization, description of inpatient management, and clinical trials. Assessment and treatment strategies in different studies were analysed and compared with American Thoracic Society-European Respiratory Society and Global Initiative for Chronic Obstructive Lung Disease guidelines. Outcomes were analysed. Results Seven eligible studies were selected. Non-pharmacological treatment was infrequently explored. When compared with international guidelines, diagnostic assessment and therapy were suboptimal, especially non-pharmacological treatment. Respiratory physicians were more likely to perform recommended interventions than non-respiratory physicians. Conclusions Adherence to international guidelines is low for inhospital management of COPD exacerbations, especially in terms of non-pharmacological treatment. Further investigation is recommended to explore strategies like care pathways that improve performance of recommended interventions.status: publishe

Impact of a care pathway for exacerbation of chronic obstructive pulmonary disease: a cluster randomized controlled trial

Management of patients hospitalised with COPD exacerbations involves a wide range of diagnostic, pharmacological, and non-pharmacological processes. In addition, coordination of the multidisciplinary care process is complex. Implementation of care pathways has become very popular for improving care processes and optimising outcomes. However, until now it remains unclear whether care pathways actually work and which active components are responsible for their effect. In this PhD dissertation research, we examined the impact of a care pathway for COPD exacerbations on care processes and clinical outcomes by developing new methodology and analysing interim data of an international cluster Randomized Controlled Trial (cRCT).Firstly, a systematic review was conducted to explore the level of adherence of actual care to internationally acknowledged COPD guidelines. The findings showed that quality of care for these patients was very suboptimal, especially for non-pharmacological management. However, measured indicators were very discordant among previously published studies, and compliance to non-pharmacological processes was scarcely assessed, implying that further research on process adherence is needed.Secondly, a systematic literature review sought to identify all studies that had examined the development, implementation, and characteristics of existing COPD care pathways, and that had evaluated their impact on care processes, clinical outcomes, and team functioning. Only four studies with a quasi-experimental design were found. The studies described positive effects on diagnostic and non-pharmacological processes; though because of limited reporting of statistics, divergent measurements, and evaluation of a care pathway by means of a historical control group, the internal validity of the results was questionable. Therefore, confident conclusions on the impact of COPD care pathways based on these studies could not be drawn.Thirdly, in order to rate content validity of process and outcome indicators, an international Delphi study was conducted with a Delphi panel composed of 35 panelists from 15 countries. Among the panellists were 19 medical doctors, 8 nurses, and 8 physiotherapists. Consensus by at least 75% of panelists that an indicator is relevant for follow-up was reached for 26 of 72 evaluated process indicators (36.1%) and for 10 of 21 outcome indicators (47.6%).Fourthly, a new eight-step method was developed for designing the clinical content of an evidence-based care pathway. Applying this method resulted in a set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators, which were piloted and approved by nine multidisciplinary teams. These findings indicate that the sets of key interventions and indicators are appropriate for the standardisation and follow-up of in-hospital management of COPD exacerbations. Furthermore, the eight-step method can also help teams in shaping the clinical content of their future care pathways for other patient populations.Fifthly,the European Quality of Care Pathways study was launched in four countries (Belgium, Ireland, Italy, and Portugal). This is a cRCT aiming to study the impact of care pathways for COPD exacerbations on care processes and clinical outcomes. A second aim was to study why and under what circumstances care pathways work, but this research question was not included in this PhD dissertation. In total, 65 hospitals were randomised, with 33 hospitals assigned to the experimental group in which a care pathway is implemented, and 32 hospitals assigned to a control group in which usual care is provided. The experiment is a complex intervention comprising three active components: (i) feedback on actual performance based on a clinical audit before care pathway implementation, (ii) integration of a set of evidence-based key interventions, and (iii) training on care pathway development and implementation based on the PDSA cycle. The measurements, including follow-up of 24 process and 15 outcome indicators, were conducted in both groups and results were compared to see if care pathway implementation leads to better results.The EQCP study in Belgium is one year ahead of the other countries (Ireland, Italy, and Portugal) and is also considered to be a pilot test. Because of timing and feasibility of the PhD, only the results of the Belgian EQCP study are included in the results section of this dissertation. Final results based on the data of all four countries are expected to be analysed in autumn 2013, and will be disseminated by the EQCP study group via publications and conference proceedings in 2013 and 2014. The preliminary results of the Belgian EQCP study strongly suggest that care pathways lead to improved care processes, as an increase in performance levels of 10 to 50% were found. These results also show that care pathways have the potential to improve clinical outcomes. However, the Belgian sample size is small, and consequently statistical power is limited. Not surprisingly, then, only scarce significant results were found, leading to provisional conclusions at this time. Significant conclusions on the effectiveness of care pathways can only be drawn based on the results of the total sample of the four involved countries. However, according to clinical practice guidelines, the criterion is that all process indicators must meet 100% performance, regardless of patient characteristics. Consequently, the results on the process indicators, in this case better performance levels of up to 50% in the care pathway group, may not be may not be considered to be coincidental results arising from chance variation in small samples. Finally, a process evaluation on the implementation level of the set of evidence-based key interventions was conducted in the seven experimental hospitals in the Belgium EQCP study. Although study coordinators and team members reported that the care activities were highly implemented, these implementation levels did not correspond with the results on process indicators after implementation, as a considerable number of indicators were still suboptimally performed. These findings suggest that the teams may have overestimated their own implementation level, and consequently additional measures like interviews and direct observation may be needed to provide more objective information on the implementation process. However, this implementation analyses give teams insight into discrepancies between highly reported implementation levels and subtoptimal performance of the implemented processes. Consequently, these analyses may sensitise the teams that further actions for improvement are necessary. Secondly, these analyses will provide important insights for other teams planning to implement the care pathway intervention, especially with regard to possible improvement actions and potential barriers for implementation. The EQCP study will be continued in Ireland, Italy, and Portugal, and the same protocol will be used, including the same intervention and the same measurements. Preliminary results from these countries show that adherence to guidelines is comparable with the Belgian data, implying that considerable room for improvement exists also in these countries. Although performance levels improved in the care pathway group, half of the indicators remained suboptimally performed, indicating that the complex intervention was adopted but not integrated into daily practice. As a consequence, a Belgian clinical working group on in-hospital management of COPD exacerbations will be initiated. The aims of this group will be (i) to further improve in-hospital care for COPD patients experiencing exacerbations, and (ii) to assess and enhance sustainability of results. Therefore, a Continous Quality Improvement (CQI) approach will be used. Important additional focus will be put on team training, patient involvement, and organisational context. Future research on care pathways should focus on reorganisation of chronic care in order to deal with the current challenges of rising chronic disease, ageing population, and the inevitable shift from hospital-centred medicine to home care and self-management. An integrated care pathway that bridges primary care and hospitals, and allows multidisciplinary teams to interact with active patients and communities, facilitated by information technology (IT), can encounter the current defragmented implementation of the Chronic Care Model and has an enormous potential for optimising chronic patient care and improving outcomes like hospital admissions and quality of life. In conclusion, the results of this dissertation strongly suggest that care pathways lead to improved care processes and have potential to optimise clinical outcomes. Nevertheless, to further improve the care process and to enhance sustainability, continuous quality improvement will be needed.status: publishe

An International Study of Adherence to Guidelines for Patients Hospitalised with a COPD Exacerbation

Guideline adherence rates for the treatment of chronic obstructive pulmonary disease (COPD) exacerbation are low. The aim of this study is to perform an importance-performance analysis as an approach for prioritisation of interventions by linking guidelines adherence rates to expert consensus rates for the in-hospital management of COPD exacerbation. We illustrate the relevance of such approach by describing variation in guideline adherence across indicators and hospitals. A secondary data analysis of patients with an acute COPD exacerbation admitted to Belgian, Italian and Portuguese hospitals was performed. Twenty-one process indicators were used to describe adherence to guidelines from patient record reviews. Expert consensus on the importance for follow-up of these 21 indicators was derived from a previous Delphi study. Three of the twenty-one indicators had high level of expert consensus and a high level of adherence. Eleven of the twenty-one indicators had high level of expert consensus but a low level of adherence. For none of the 378 patients included in this study were all process indicators adhered to, patients received 41.0% of the recommended care on average, and only 34.1% of the patients received 50% or more of the care they should receive. There was also a large variation within and between hospitals regarding the care received. This study confirms the findings of previous studies, indicating that COPD exacerbations are largely undertreated. Importance-performance analysis provides a decision-making tool for prioritising indicators. All hospitals in this study would benefit from having in place a quality framework for systematic follow-up of these indicators

Smoking cessation during hospital stay: nursing acton and answers

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An International Study of Adherence to Guidelines for Patients Hospitalised with a COPD Exacerbation

Guideline adherence rates for the treatment of chronic obstructive pulmonary disease (COPD) exacerbation are low. The aim of this study is to perform an importance-performance analysis as an approach for prioritisation of interventions by linking guidelines adherence rates to expert consensus rates for the in-hospital management of COPD exacerbation. We illustrate the relevance of such approach by describing variation in guideline adherence across indicators and hospitals. A secondary data analysis of patients with an acute COPD exacerbation admitted to Belgian, Italian and Portuguese hospitals was performed. Twenty-one process indicators were used to describe adherence to guidelines from patient record reviews. Expert consensus on the importance for follow-up of these 21 indicators was derived from a previous Delphi study. Three of the twenty-one indicators had high level of expert consensus and a high level of adherence. Eleven of the twenty-one indicators had high level of expert consensus but a low level of adherence. For none of the 378 patients included in this study were all process indicators adhered to, patients received 41.0% of the recommended care on average, and only 34.1% of the patients received 50% or more of the care they should receive. There was also a large variation within and between hospitals regarding the care received. This study confirms the findings of previous studies, indicating that COPD exacerbations are largely undertreated. Importance-performance analysis provides a decision-making tool for prioritising indicators. All hospitals in this study would benefit from having in place a quality framework for systematic follow-up of these indicators.peerreview_statement: The publishing and review policy for this title is described in its Aims & Scope. aims_and_scope_url: http://www.tandfonline.com/action/journalInformation?show=aimsScope&journalCode=icop20status: publishe