RECODE, cluster Randomized clinical trial on Effectiveness of integrated COPD management in primary carE.|
|- candidate number||7896|
|- NTR Number||NTR2268|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mrt-2010|
|- Secondary IDs||20513 / 171002203 ; LUMC projectnr / ZonMW projectnr |
|- Public Title||RECODE, cluster Randomized clinical trial on Effectiveness of integrated COPD management in primary carE.|
|- Scientific Title||RECODE, cluster Randomized clinical trial on Effectiveness of integrated COPD management in primary carE.|
|- hypothesis||An ICT-supported, integrated, multidisciplinary treatment of COPD in primary care compared to usual care in primary care practices will improve the quality of life of COPD patients at an acceptable level of cost-effectiveness.|
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Quality of life, Cost-effectiveness , General practice|
|- Inclusion criteria||Primary care patients with COPD (FEV1/FVC<0.7) according to GOLD and NHG-classification.|
|- Exclusion criteria||Terminally ill patients and expected non-compliance according to GP. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||31-dec-2013|
|- Target number of participants||1080|
|- Interventions||The intervention in 20 Dutch primary care practices consists of a multidisciplinary (general practitioners, physician assistants and physiotherapists) course in which efficient task delegation, specific referral, and development of feasible treatment plans and practice plans are emphasized. Active promotion of self-management, incorporated feedback on specific parts of disease management, application of clinically relevant indicators of quality of care and structurally deploying a chronic care-optimalization model are all part of the implementation package, which is supported by a flexible web-based application. This highly integrated information can be accessed according to authorisation status, leading to the unique combination of reactivating self management and multidisciplinary COPD-care.
The control group of 20 Dutch primary care practices will continue usual care according to current guidelines, and will not be offered group training, self management support, clinical feedback or bench-mark information.
|- Primary outcome||The primary outcome of the study is the difference in health status of the participants in the intervention group versus the usual care group after 12 months, as measured with the Clinical COPD Questionnaire (CCQ).|
|- Secondary outcome||1. Disease-specific quality of life (SGRQ);|
2. Dyspnoea (MRC dyspnoea scale);
3. Quality of life (SF-36, EQ-5D);
4. Self-management (SMAS);
5. Daily activities (IPAQ);
6. Patients' experiences with health care (PACIC);
7. Smoking behaviour (packyears, guided cessation attempts);
8. Medication use (inhaled corticosteroids and bronchodilators);
9. Health care usage;
10. Exacerbations (oral prednisolone and/or antibiotic courses);
11. Hospital admissions or specialist visits;
12. Absence of work;
13. Primary care providersí experience with health care (ACIC)
|- Timepoints||1. Baseline;|
2. 6, 9, 12, 18 and 24 months of follow up.
Primary endpoint at 12 months follow up.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.L. Kruis|
|- CONTACT for SCIENTIFIC QUERIES||Dr. N.H. Chavannes|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Achmea|
|- Publications||Hoogendoorn M, van Wetering CR, Schols AM et al. Is INTERdisciplinary COMmunity-based COPD management (INTERCOM) cost-effective? Eur Respir J 2010; 35(1):79-87. |
Chavannes NH, Grijsen M, van den Akker M et al. Integrated disease management improves one-year quality of life in primary care COPD patients: a controlled clinical trial. Prim Care Respir J 2009; 18(3):171-176.
Kruis AL, Chavannes NH. Potential benefits of integrated COPD management in primary care. Monaldi Arch Chest Dis 2010; 73:3, 130-134.
Kruis AL, van Adrichem J, Erkelens MR, Scheepers H, in ít Veen H, Muris JWM, Chavannes NH. Sustained effects of integrated COPD management on health status and exercise capacity in primary care patients. Int J Chron Obstruct Pulmon Dis. 2010; 5, 407-413.
|- Brief summary||Introduction:|
COPD is a worldwide growing healthcare problem, which will be the third leading cause of death by 2020. COPD also constitutes an important financial burden that confronts health care providers with increasing treatment capacity shortages. The most effective treatment of COPD is pulmonary rehabilitation, of which elements can be implemented successfully in primary care setting. Favorable long-term effects on quality of life have been demonstrated, but wide introduction in the Dutch primary care setting still needs further justification in the form of a proper (cost-) effectiveness analysis.
RECODE aims to assess the (cost) effectiveness of an ICT-supported, integrated, multidisciplinary two-year treatment of COPD in primary care as compared to usual care.
Two-group cluster-randomized design in which a multidisciplinary course and support of implementation will be randomized per (local) cluster of primary care teams, after baseline measurements have taken place.
Primary care COPD patients (FEV1/FVC<0.7) according to GOLD and NHG-classification.
A multidisciplinary (GPs, physician assistants and physiotherapists) course in which efficient task delegation, specific referral, and development of feasible treatment plans and practice plans are emphasized. Active promotion of self-management, incorporated feedback on specific parts of disease management, application of clinically relevant indicators of quality of care and structurally deploying a chronic care-optimalization model are all part of the implementation package, which is supported by a flexible web-based application.
Primary: The difference in functional status of the participants in the intervention group versus the usual care group after 12 months, as measured with the Clinical COPD Questionnaire(CCQ).
Secondary : Disease-specific quality of life (SGRQ), dyspnoea (MRC dyspnoea scale), Quality of life (SF-36, EQ-5D), self-management (SMAS), Daily activities (IPAQ), Patients experiences with health care (PACIC), smoking behaviour (packyears, guided cessation attempts), medication use (inhaled corticosteroids and bronchodilators), health care usage, exacerbations (oral prednisolone and/or antibiotic courses), hospital admissions or specialist visits, absence of work, primary care providersí experience with health care (ACIC).
1080 patients, 2 yrs follow up (primary endpoint 1 yr).
Economic evaluation will include the program costs, costs of implementation strategies and all other downstream costs of COPD-related care. Costs of productivity loss due to absence from paid work will be included. Incremental costs will be compared to differences in QALYs.
|- Main changes (audit trail)|
|- RECORD||31-mrt-2010 - 25-jul-2011|
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