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Open Access Study protocol

RECODE: Design and baseline results of a cluster randomized trial on cost-effectiveness of integrated COPD management in primary care

Annemarije L Kruis1*, Melinde RS Boland2, Catharina H Schoonvelde1, Willem JJ Assendelft13, Maureen PMH Rutten-van Mölken2, Jacobijn Gussekloo1, Apostolos Tsiachristas2 and Niels H Chavannes1

Author Affiliations

1 Dept of Public Health and Primary Care, Leiden University Medical Centre, P.O. Box 9600, Leiden, RC, 2300, The Netherlands

2 Institute for Medical Technology Assessment, Erasmus University, PO Box 1738, Rotterdam, DR, 3000, the Netherlands

3 Dept of Primary and Community Care, Radboud University Nijmegen Medical Center, PO Box 9101, Nijmegen, HB, 6500, the Netherlands

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BMC Pulmonary Medicine 2013, 13:17  doi:10.1186/1471-2466-13-17

Published: 23 March 2013

Abstract

Background

Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated disease management (IDM) programs on quality of care and health status of COPD patients in primary care, representing a much larger group of COPD patients. Therefore, the RECODE trial assesses the long-term clinical and cost-effectiveness of IDM in primary care.

Methods/design

RECODE is a cluster randomized trial with two years of follow-up, during which 40 clusters of primary care teams (including 1086 COPD patients) are randomized to IDM or usual care. The intervention started with a 2-day multidisciplinary course in which healthcare providers are trained as a team in essential components of effective COPD IDM in primary care. During the course, the team redesigns the care process and defines responsibilities of different caregivers. They are trained in how to use feedback on process and outcome data to guide implement guideline-driven integrated healthcare. Practice-tailored feedback reports are provided at baseline, and at 6 and 12 months. The team learns the details of an ICT program that supports recording of process and outcome measures. Afterwards, the team designs a time-contingent individual practice plan, agreeing on steps to be taken in order to integrate a COPD IDM program into daily practice. After 6 and 12 months, there is a refresher course for all teams simultaneously to enable them to learn from each other’s experience. Health status of patients at 12 months is the primary outcome, measured by the Clinical COPD Questionnaire (CCQ). Secondary outcomes include effects on quality of care, disease-specific and generic health-related quality of life, COPD exacerbations, dyspnea, costs of healthcare utilization, and productivity loss.

Discussion

This article presents the protocol and baseline results of the RECODE trial. This study will allow to evaluate whether IDM implemented in primary care can positively influence quality of life and quality of care in mild to moderate COPD patients, thereby making the benefits of multidisciplinary rehabilitation applicable to a substantial part of the COPD population.

Trial registration

Netherlands Trial Register (NTR): NTR2268

Keywords:
COPD; Disease management; Primary care; Cost-effectiveness; Integrated care