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

COPD Clinical Trial

— CAROL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01921556
• Other study ID #: CAROL
• Status: Active, not recruiting
• Phase: N/A
• First received: July 30, 2013
• Last updated: June 17, 2016
• Start date: September 2013
• Est. completion date: October 2017

Study information

• Verified date: June 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: October 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Switzerland	Institute of General Practice, University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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	No
Secondary	Quality of life	We use the COPD Assessment Test (CAT). The CAT provides clinicians and patients with a reliable measure of overall COPD-related health status for the assessment and long-term follow-up of individual patients. The CAT is a validated short and simple patient-completed questionnaire that has been developed for use in routine clinical practice to measure the health status and grading the impact of COPD on patients' life. The CAT has very similar discriminative properties to the much more complex SGRQ (St. Georges Respiratory Questionnaire), and is available in different languages. It compromises 8 simple questions, 8 items on a scale 0-5 with a total scoring range of 0-40. CAT score <10 low impact, 10-20 medium impact >30 very high impact of COPD on patients life	one year	No