Overview

This trial is active, not recruiting.

Condition copd
Treatment active comparator, qualiccare education
Sponsor University of Zurich
Start date September 2013
End date January 2017
Trial size 216 participants
Trial identifier NCT01921556, CAROL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
"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.
active comparator, qualiccare education
Physicians randomized into the intervention group get a "QualiCCare" 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.
(No Intervention)
The practices randomized to the control group apply care as usual

Primary Outcomes

Measure
"Quality of care process"
time frame: one year

Secondary Outcomes

Measure
Quality of life
time frame: one year

Eligibility Criteria

Male or female participants from 45 years up to 85 years old.

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

Additional Information

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
Principal investigator Thomas J. Rosemann, Prof MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Zurich.