Primary Care Integrated Management of chronic obstructive pulmonary disease (PRIM-COPD): study protocol for a cluster-randomised controlled trial.

INTRODUCTION

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, with China bearing a particularly high burden. Major gaps persist in early diagnosis, guideline-based treatment and long-term disease management, especially in primary care. This study aims to evaluate the efficacy and feasibility of the National Essential Public Health Services (NEPHS) COPD management approach and to generate evidence to inform the optimisation of national COPD care standards.

METHODS AND ANALYSIS: The Primary Care Integrated Management (PRIM) trial is a prospective, multicentre, cluster-randomised controlled study conducted in seven pilot regions in China, with primary healthcare institutions as the unit of randomisation. Participants are adults aged ≥35 years with spirometry-confirmed COPD, recruited either through screening or from existing patient databases. Institutions will be randomised in a 1:1 ratio to the intervention (PRIM) or usual care arms using a computer-generated allocation sequence, stratified by urban-rural location. The intervention comprises quarterly general practitioner (GP)-led follow-ups, health education and disease management according to pilot NEPHS COPD guidelines, supported by a three-tier oversight structure involving the National Center for Respiratory Medicine, leading tertiary hospitals and primary healthcare institutions. Co-primary outcomes are the annual number of acute exacerbations and health-related quality of life (European Quality of Life-5 Dimensions and 5 Levels). Secondary outcomes include smoking status, health status assessed by the COPD Assessment Test (CAT), dyspnoea score and GP knowledge. Analyses will follow the intention-to-treat principle, using multivariable regression models adjusted for clustering and prespecified baseline covariates. Cost-effectiveness analyses of the PRIM intervention in the Chinese population are also planned.

ETHICS AND DISSEMINATION: Ethics approval has been granted by China-Japan Friendship Hospital (approval number 2024-KY-163).

TRIAL REGISTRATION NUMBER: NCT06573580.