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

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          Abstract

          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.

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          Most cited references28

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          Development and validation of the Patient Assessment of Chronic Illness Care (PACIC).

          There is a need for a brief, validated patient self-report instrument to assess the extent to which patients with chronic illness receive care that aligns with the Chronic Care Model-measuring care that is patient-centered, proactive, planned and includes collaborative goal setting; problem-solving and follow-up support. A total of 283 adults reporting one or more chronic illness from a large integrated health care delivery system were studied. Participants completed the 20-item Patient Assessment of Chronic Illness Care (PACIC) as well as measures of demographic factors, a patient activation scale, and subscales from a primary care assessment instrument so that we could evaluate measurement performance, construct, and concurrent validity of the PACIC. The PACIC consists of 5 scales and an overall summary score, each having good internal consistency for brief scales. As predicted, the PACIC was only slightly correlated with age and gender, and unrelated to education. Contrary to prediction, it was only slightly correlated (r = 0.13) with number of chronic conditions. The PACIC demonstrated moderate test-retest reliability (r = 0.58 during the course of 3 months) and was correlated moderately, as predicted (r = 0.32-0.60, median = 0.50, P < 0.001) to measures of primary care and patient activation. The PACIC appears to be a practical instrument that is reliable and has face, construct, and concurrent validity. The resulting questionnaire is in the public domain, and recommendations for its use in research and quality improvement are outlined.
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            Consort 2010 statement: extension to cluster randomised trials.

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              St. George's Respiratory Questionnaire: MCID.

              The SGRQ is a disease-specific measure of health status for use in COPD. A number of methods have been used for estimating its minimum clinically important difference (MCID). These include both expert and patient preference-based estimates. Anchor-based methods have also been used. The calculated MCID from those studies was consistently around 4 units, regardless of assessment method. By contrast, the MCID calculated using distribution-based methods varied across studies and permitted no consistent estimate. All measurements of clinical significance contain sample and measurement error. They also require value judgements, if not about the calculation of the MCID itself then about the anchors used to estimate it. Under these circumstances, greater weight should be placed upon the overall body of evidence for an MCID, rather than one single method. For that reason, estimates of MCID should be used as indicative values. Methods of analysing clinical trial results should reflect this, and use appropriate statistical tests for comparison with the MCID. Treatments for COPD that produced an improvement in SGRQ of the order of 4 units in clinical trials have subsequently found wide acceptance once in clinical practice, so it seems reasonable to expect any new treatment proposed for COPD to produce an advantage over placebo that is not significantly inferior to a 4-unit difference.
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                Author and article information

                Contributors
                Role: PhD candidate
                Role: PhD candidate
                Role: professor of general practice
                Role: professor of general practice
                Role: PhD candidate
                Role: professor of biostatistics
                Role: ICT developer
                Role: associate professor
                Role: professor of economic evaluations of innovative healthcare for chronic diseases
                Role: associate professor
                Journal
                BMJ
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2014
                10 September 2014
                : 349
                : g5392
                Affiliations
                [1 ]Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, Netherlands
                [2 ]Institute for Medical Technology Assessment, Erasmus University, 3000 DR Rotterdam, Netherlands
                [3 ]Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, 6500 HB Nijmegen, Netherlands
                [4 ]Department of Medical Statistics and Bioinformatics, Leiden University Medical Centre
                [5 ]Stichting Zorgdraad Foundation, 6862 XN Oosterbeek, Netherlands
                [6 ]Department of Medical Decision Making, Leiden University Medical Centre
                Author notes
                Correspondence to: A L Kruis  a.l.kruis@ 123456lumc.nl
                Article
                krua019774
                10.1136/bmj.g5392
                4160285
                25209620
                9c52cffd-bf1a-424c-9859-daffc142767a
                © Kruis et al 2014

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

                History
                : 19 August 2014
                Categories
                Research

                Medicine
                Medicine

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