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

NCT ID: NCT01921556

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-10-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

QualiCCare education

"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.

Group Type: ACTIVE_COMPARATOR

active comparator, QualiCCare education

Intervention Type: BEHAVIORAL

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.

usual care

The practices randomized to the control group apply care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas J. Rosemann, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Institute of General Practice

Locations

Institute of General Practice, University of Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 24670200 (View on PubMed)

Other Identifiers

CAROL

Identifier Type: -

Identifier Source: org_study_id