Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial
BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7642 (Published 28 November 2012) Cite this as: BMJ 2012;345:e7642
- Erik W M A Bischoff, general practitioner1,
- Reinier Akkermans, biostatistician1,
- Jean Bourbeau, respiratory physician and epidemiologist2,
- Chris van Weel, professor of general practice1,
- Jan H Vercoulen, medical psychologist34,
- Tjard R J Schermer, epidemiologist1
- 1Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, P O Box 9101, 6500 HB Nijmegen, Netherlands
- 2Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre, Montreal, Canada
- 3Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre
- 4Department of Medical Psychology, Radboud University Nijmegen Medical Centre
- Correspondence to: E Bischoff E.Bischoff{at}elg.umcn.nl
- Accepted 23 October 2012
Abstract
Objective To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients’ management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice.
Design 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial.
Setting 15 general practices in the eastern part of the Netherlands.
Participants Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded.
Interventions A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients’ own initiative).
Outcome measures The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients’ management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale.
Results 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58).
Conclusions Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group.
Trial registration Clinical trials NCT00128765.
Footnotes
We acknowledge the contribution of Ellen Erren, respiratory nurse at the Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, the Netherlands, who supervised the training for the practice nurses and coached them thereafter. We are grateful to all study personnel of each participating general practice and to all participating patients for their dedication in this study.
Contributors: EWMAB, JHV, CvW, and TRJS participated in the original design of the study. EWMAB, JHV, and TRJS supervised the collection of data. EWMAB, RA, and TRJS did the statistical analyses. EWMAB led the writing of the report, which was co-led by JB and TRJS and assisted by all other authors. All authors had full access to all of the study data, assisted in the interpretation of the data, and have seen and approved the final version of the report. EWMAB is the guarantor.
Funding: This study was funded by the Netherlands Organisation for Health Research and Development (ZonMw) and Partners in Care Solutions for COPD (PICASSO). The funding sources had no role in the design, conduct, or reporting of the study.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no authors received any support from any company for the submitted work; no authors have any relationship with any company that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study was approved by the Medical Ethics Committee of the Radboud University Nijmegen Medical Centre (number 2004/249). All patients gave written informed consent.
Data sharing: Technical appendix, statistical code, and dataset are available from the corresponding author.
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