Clinical trial NCT01921556: The Improving Care in Chronic Obstructive Lung Disease Study A Cluster Randomized 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 216
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* Males and females = 45yrs of age and
* Smoker or ex-smoker (with at least 10 PY) and
* Obstruction in spirometry FEV1/FVC\< 0.7

Exclusion criteria:

* No obstruction in spirometry (FEV1/FVC \> 0.7) or
* Patients with history of asthma or hay fever or
* Other concomitant pulmonary disease or
* Patients with malignancies of any other system and/or other severe disease with an estimated life expectancy of less than six months or
* Insufficient German language skills or
* Patients who contact the practice for emergencies only or as a substitute practice

Primary outcomes:
measure: "Quality of care process"
timeFrame: one year
Secondary outcomes:
measure: Quality of life
timeFrame: one year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Institute of General Practice, University of Zurich
Study officials:
affiliation: University Hospital Zurich, Institute of General Practice
name: Thomas J. Rosemann, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steurer-Stey C, Markun S, Lana KD, Frei A, Held U, Wensing M, Rosemann T. 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. Trials. 2014 Mar 27;15:96. doi: 10.1186/1745-6215-15-96.