The Improving Care in Chronic Obstructive Lung Disease Study A Cluster Randomized Trial (CAROL)

University of Zurich (UZH)

Status: Unknown

Conditions: COPD

Treatments: Behavioral: active comparator, QualiCCare education

Study type: Interventional

Funder types: Other

Identifiers

NCT01921556

CAROL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

QualiCCare education

Active Comparator group

Description:

"QualiCCare"education is a training workshop designed to educate professionals on the guidelines but also and particularly governing professional behavior by feedback, reminders and pathways that help to change their attitudes and care behavior. Based on behavioral and learning theory, QualiCCare intervention not only tries to increase knowledge but also internal motivation and decision making by stimuli and resources and by written instruments that guide evidence based decision support.

Treatment:

Behavioral: active comparator, QualiCCare education

usual care

No Intervention group

Description:

The practices randomized to the control group apply care as usual