COPD Clinical Trial
Official title:
The Improving Care in Chronic Obstructive Lung Disease Study: CAROL Improving Processes of Care and Quality of Life of COPD Patients in Primary Care: A Cluster Randomized Trial
Background The Swiss health ministry launched a national quality program "QualiCCare" in
2011 to improve healthcare 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 quality of life in patients with COPD.
The care in obstructive lung disease study (CAROL) is a cluster-randomized controlled trial
with randomization on the practice level. Thirty practices will be randomly assigned to
equally sized intervention group or control group.
Each General Practioner (GP) of a practice will approach consecutively and regardless the
reason for the current encounter, COPD patients diagnosed by spirometric evaluation (FEV1/
FVC < 0.70), aged 45 years older, with a smoking history of = 10 pack-years (PY). 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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