RESEARCH
thebmj.com • Respiratory medicine updates from BMJ http://www.bmj.com/specialties/respiratory-medicine
Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial Annemarije L Kruis,1 Melinde R S Boland,2 Willem J J Assendelft,1 3 Jacobijn Gussekloo,1 Apostolos Tsiachristas,2 Theo Stijnen,4 Coert Blom,5 Jacob K Sont,6 Maureen P H M Rutten-van Mölken,2 Niels H Chavannes1 ЖЖEDITORIAL by Bourbeau 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 Correspondence to: A L Kruis [email protected] Cite this as: BMJ 2014;349:g5392 doi: 10.1136/bmj.g5392
This is a summary of a paper that was published on thebmj.com as BMJ 2014;349:g5392
STUDY QUESTION Is integrated disease management for patients with chronic obstructive pulmonary disease (COPD) in primary care effective in improving patient related outcomes? SUMMARY ANSWER This pragmatic study found no additional benefit of an integrated disease management approach delivered in primary care compared with usual care, except an improved level of integrated care and a self reported higher degree of daily activities. WHAT IS KNOWN AND WHAT THIS PAPER ADDS In a Cochrane systematic review, integrated disease management programmes for COPD showed clinically relevant effects on quality of life and exercise tolerance and reductions in admissions and hospital days. This large study in Dutch primary care could not replicate these effects.
Design This was a 24 month, multicentre, pragmatic cluster randomised controlled trial with general practices as the unit of randomisation. Participants and setting We included patients with a diagnosis of COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria for patients were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Primary outcome(s) The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire.
Main results and the role of chance We found no difference between groups on the Clinical COPD Questionnaire at 12 months (mean difference −0.01, 95% confidence interval −0.1 to 0.08; P=0.8). After 12 months, we found no differences in secondary outcomes between groups, except for the Patient Assessment Chronic Illness Care 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. Harms No harms were reported. Bias, confounding, and other reasons for caution Blinding of participants and clinicians for this type of intervention was impossible. In an attempt to minimise bias, blinded research nurses collected the data and patients were instructed not to talk about their type of intervention. After 24 months, dropout rates were low, but selectively higher in patients with worse baseline scores. This raises questions about generalisability. However, after correction for baseline scores, we saw no evidence for health benefits of the intervention at all, indicating that dropout is unlikely to have biased the result. Generalisability to other populations In our pragmatic trial, owing to our limited number of exclusion criteria, only 11% of all registered primary care COPD patients were not eligible to participate. Therefore, the results of this study are generalisable to other primary care COPD patients.
Clinical outcomes: within and between group differences at 12 months, corrected for age, sex, baseline score, and MRC score >2. Values are means (95% CIs) unless stated otherwise Outcome
Intervention (n=554; 20 clusters)
Usual care (n=532; 20 clusters)
Mean difference (95% CI)
P value
CCQ total score SGRQ total score MRC dyspnoea score EQ-5D IPAQ—high/moderate (%) PACIC—total score Current smokers (%) Days in hospital Moderate exacerbations (rate) Severe exacerbations (rate)
–0.03 (–0.09 to 0.03) –0.40 (–1.46 to 0.65) 0.23 (0.14 to 0.33) –0.04 (–0.06 to –0.02) 12.4 –0.02 ( –0.11 to 0.08) 48.6 10.5 (7.6 to 13.3) 0.58 (0.45 to 0.75) 0.13 (0.08 to 0.21)
0.03 (–0.03 to 0.09) 0.33 (–0.78 to 1.43) 0.19 (0.09 to 0.29) –0.01 (–0.03 to 0.01) 7.8 –0.08 (–0.18 to 0.02) 51.7 10.7 (7.4 to 14.0) 0.48 (0.37 to 0.62) 0.10 (0.06 to 0.18)
–0.01 (–0.1 to 0.08) –0.73 (–2.25 to 0.78) 0.04 (–0.09 to 0.18) –0.03 (–0.06 to 0) 4.6 0.06 (–0.06 to 0.19) 3.1 0.2 (–4.3 to 4.3) 1.22 (0.97 to 1.54)* 1.20 (0.78 to 1.84)*
0.80 0.34 0.52 0.07 2. *Means rate ratio.
the bmj | 27 September 2014
11
Copyright of BMJ: British Medical Journal is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
thebmj.com • Respiratory medicine updates from BMJ http://www.bmj.com/specialties/respiratory-medicine
Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial Annemarije L Kruis,1 Melinde R S Boland,2 Willem J J Assendelft,1 3 Jacobijn Gussekloo,1 Apostolos Tsiachristas,2 Theo Stijnen,4 Coert Blom,5 Jacob K Sont,6 Maureen P H M Rutten-van Mölken,2 Niels H Chavannes1 ЖЖEDITORIAL by Bourbeau 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 Correspondence to: A L Kruis [email protected] Cite this as: BMJ 2014;349:g5392 doi: 10.1136/bmj.g5392
This is a summary of a paper that was published on thebmj.com as BMJ 2014;349:g5392
STUDY QUESTION Is integrated disease management for patients with chronic obstructive pulmonary disease (COPD) in primary care effective in improving patient related outcomes? SUMMARY ANSWER This pragmatic study found no additional benefit of an integrated disease management approach delivered in primary care compared with usual care, except an improved level of integrated care and a self reported higher degree of daily activities. WHAT IS KNOWN AND WHAT THIS PAPER ADDS In a Cochrane systematic review, integrated disease management programmes for COPD showed clinically relevant effects on quality of life and exercise tolerance and reductions in admissions and hospital days. This large study in Dutch primary care could not replicate these effects.
Design This was a 24 month, multicentre, pragmatic cluster randomised controlled trial with general practices as the unit of randomisation. Participants and setting We included patients with a diagnosis of COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria for patients were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Primary outcome(s) The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire.
Main results and the role of chance We found no difference between groups on the Clinical COPD Questionnaire at 12 months (mean difference −0.01, 95% confidence interval −0.1 to 0.08; P=0.8). After 12 months, we found no differences in secondary outcomes between groups, except for the Patient Assessment Chronic Illness Care 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. Harms No harms were reported. Bias, confounding, and other reasons for caution Blinding of participants and clinicians for this type of intervention was impossible. In an attempt to minimise bias, blinded research nurses collected the data and patients were instructed not to talk about their type of intervention. After 24 months, dropout rates were low, but selectively higher in patients with worse baseline scores. This raises questions about generalisability. However, after correction for baseline scores, we saw no evidence for health benefits of the intervention at all, indicating that dropout is unlikely to have biased the result. Generalisability to other populations In our pragmatic trial, owing to our limited number of exclusion criteria, only 11% of all registered primary care COPD patients were not eligible to participate. Therefore, the results of this study are generalisable to other primary care COPD patients.
Clinical outcomes: within and between group differences at 12 months, corrected for age, sex, baseline score, and MRC score >2. Values are means (95% CIs) unless stated otherwise Outcome
Intervention (n=554; 20 clusters)
Usual care (n=532; 20 clusters)
Mean difference (95% CI)
P value
CCQ total score SGRQ total score MRC dyspnoea score EQ-5D IPAQ—high/moderate (%) PACIC—total score Current smokers (%) Days in hospital Moderate exacerbations (rate) Severe exacerbations (rate)
–0.03 (–0.09 to 0.03) –0.40 (–1.46 to 0.65) 0.23 (0.14 to 0.33) –0.04 (–0.06 to –0.02) 12.4 –0.02 ( –0.11 to 0.08) 48.6 10.5 (7.6 to 13.3) 0.58 (0.45 to 0.75) 0.13 (0.08 to 0.21)
0.03 (–0.03 to 0.09) 0.33 (–0.78 to 1.43) 0.19 (0.09 to 0.29) –0.01 (–0.03 to 0.01) 7.8 –0.08 (–0.18 to 0.02) 51.7 10.7 (7.4 to 14.0) 0.48 (0.37 to 0.62) 0.10 (0.06 to 0.18)
–0.01 (–0.1 to 0.08) –0.73 (–2.25 to 0.78) 0.04 (–0.09 to 0.18) –0.03 (–0.06 to 0) 4.6 0.06 (–0.06 to 0.19) 3.1 0.2 (–4.3 to 4.3) 1.22 (0.97 to 1.54)* 1.20 (0.78 to 1.84)*
0.80 0.34 0.52 0.07 2. *Means rate ratio.
the bmj | 27 September 2014
11
Copyright of BMJ: British Medical Journal is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
