The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial

BACKGROUND: The Swiss health ministry launched a national quality program ‘QualiCCare’ in 2011 to improve health care for patients with COPD. The aim of this study is to determine whether participation in the COPD quality initiative (‘QualiCCare’) improves adherence to recommended clinical processes and shows impact on patients’ COPD care and on the impact of COPD on a person's life. METHODS: CAROL is a cluster-randomized controlled trial with randomization on the general practioner (GP) level. Thirty GPs will be randomly assigned to equally sized intervention group or control group. Each GP will approach consecutively and regardless of the reason for the current consultation, patients aged 45 years or older, with a smoking history of ≥ ten pack-years (PY). Patients with confirmed (by spirometric evaluation) COPD will be included in the study. GPs in the intervention group will receive ‘QualiCCare’ education, which addresses knowledge, decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence-based key elements. In the control group, no educational intervention will be applied and COPD patients will be treated as usual. The study period is one year. The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD: smoking cessation counseling, influenza vaccination, motivation for physical activity, appropriate pharmacotherapy, patient education and collaborative care. Given a power of 90% and a significance level alpha of 5%, 15 GPs recruiting eight patients each will be necessary in both study arms. With an assumed dropout rate of 20%, 288 patients will need to be included. DISCUSSION: It is important to develop and implement interventions that add value to COPD care considering quality and efficiency. Care pathways modifying the knowledge and behavior of physicians have the potential for improving care by transferring knowledge to clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01921556