Is integrated disease management of COPD effective? Results of the RECODE cluster randomized controlled trial in real world patients

Objective and Methods We conducted a 24-month,two-group,cluster randomized controlled trial to evaluate the effects of IDM in COPD patients compared to usual care. Intervention practices received a training on implementing IDM, including spirometry, assessment of disease burden, exacerbation management, motivational interviewing, physiotherapeutic reactivation and smoking cessation. The primary outcome was difference in Clinical COPD Questionnaire(CCQ) at 12 months. Secondary outcomes were quality of life(SF-36, EQ-5D), MRC dypnoea, exacerbation-related outcomes, self-management(SMAS), physical activity(IPAQ) and level of care integration(PACIC). Results Of a total of 1086 patients from 40 clusters, we randomly assigned 554 to the IDM group and 532 to the usual care group. There was no difference between both groups on the CCQ at 12 months(MD -0.01;95% CI -0.1-0.08;p=0.8). We found no differences on secondary outcomes between both groups, except for the PACIC follow-up/coordination domain(indicating improvement in integrated care) and proportion of physical active patients. Exacerbation rates(moderate and severe) and hospitalization days between both groups did not differ. Conclusion Although we found improvement in the level of care integration, we found no additional clinical and quality of life benefits of an IDM approach in primary care compared to usual care. Contradictory findings with earlier positive studies could be explained by differences between interventions(intensity, provider-targeted),study populations(low degree of illness, less motivated) or suboptimal implementation in an already well-developed Dutch healthcare system.