title: Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.
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.
  
  
  METHODS
  24 month, multicentre, pragmatic cluster randomised controlled trial
  
  
  METHODS
  40 general practices in the western part of the Netherlands
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands Trial Register NTR2268.
authors.affiliation: Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, Netherlands a.l.kruis@lumc.nl.
authors.forename: Annemarije L
authors.initials: AL
authors.lastname: Kruis
authors.affiliation: Institute for Medical Technology Assessment, Erasmus University, 3000 DR Rotterdam, Netherlands.
authors.forename: Melinde R S
authors.initials: MR
authors.lastname: Boland
authors.affiliation: Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, Netherlands Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, 6500 HB Nijmegen, Netherlands.
authors.forename: Willem J J
authors.initials: WJ
authors.lastname: Assendelft
authors.affiliation: Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, Netherlands.
authors.forename: Jacobijn
authors.initials: J
authors.lastname: Gussekloo
authors.affiliation: Institute for Medical Technology Assessment, Erasmus University, 3000 DR Rotterdam, Netherlands.
authors.forename: Apostolos
authors.initials: A
authors.lastname: Tsiachristas
authors.affiliation: Department of Medical Statistics and Bioinformatics, Leiden University Medical Centre.
authors.forename: Theo
authors.initials: T
authors.lastname: Stijnen
authors.affiliation: Stichting Zorgdraad Foundation, 6862 XN Oosterbeek, Netherlands.
authors.forename: Coert
authors.initials: C
authors.lastname: Blom
authors.affiliation: Department of Medical Decision Making, Leiden University Medical Centre.
authors.forename: Jacob K
authors.initials: JK
authors.lastname: Sont
authors.affiliation: Institute for Medical Technology Assessment, Erasmus University, 3000 DR Rotterdam, Netherlands.
authors.forename: Maureen P H M
authors.initials: MP
authors.lastname: Rutten-van Mölken
authors.affiliation: Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, Netherlands.
authors.forename: Niels H
authors.initials: NH
authors.lastname: Chavannes
mesh_terms: D000368:Aged; D016000:Cluster Analysis; D019033:Delivery of Health Care, Integrated / Q000592:standards*; D005260:Female; D058006:General Practice / Q000592:standards; D006801:Humans; D008297:Male; D009426:Netherlands; D029424:Pulmonary Disease, Chronic Obstructive / Q000628:therapy*; D016896:Treatment Outcome