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

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ClinicalTrials.gov Identifier: NCT01921556
Recruitment Status : Unknown
Verified June 2016 by University of Zurich.
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2013
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.


Condition or disease Intervention/treatment Phase
COPD Behavioral: active comparator, QualiCCare education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Study Start Date : September 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
Active Comparator: 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.
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.

No Intervention: usual care
The practices randomized to the control group apply care as usual



Primary Outcome Measures :
  1. "Quality of care process" [ Time Frame: one year ]
    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


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: one year ]
    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



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921556


Locations
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Switzerland
Institute of General Practice, University of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Thomas J. Rosemann, Prof MD University Hospital Zurich, Institute of General Practice

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01921556     History of Changes
Other Study ID Numbers: CAROL
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases