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

NCT01921556 | Unknown

• 1 other identifier: CAROL
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• "Quality of care process"

  Difference in "quality of care process" (total increase in performed measures/fulfilled indicators) will be assessed after one year between COPD patients in the intervention and control group as reported by the patient

  one year

Secondary Outcomes (1)

• Quality of life

  one year

Study Arms (2)

QualiCCare education

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.

Behavioral: active comparator, QualiCCare education

usual care

NO INTERVENTION

The practices randomized to the control group apply care as usual

Interventions

active comparator, QualiCCare education 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.

QualiCCare education

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Institute of General Practice, University of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 24670200 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas J. Rosemann, Prof MD

  University Hospital Zurich, Institute of General Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 13, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 20, 2016

Record last verified: 2016-06

Locations

CH (1)