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Case Method Education on COPD to General Practitioners (PRIMAIR)

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ClinicalTrials.gov Identifier: NCT02213809
Recruitment Status : Unknown
Verified November 2017 by Anna Nager, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2014
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Dalarna County Council, Sweden
Information provided by (Responsible Party):
Anna Nager, Karolinska Institutet

Brief Summary:

Background:

COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most patients with COPD are discovered and treated in primary health care. Co-morbidity with heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most important factor for decelerating the progress of COPD. In addition, medication and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown poor quality of primary health care provided to patients with COPD.

As general practitioners often deal with multiple medical problems and patients' motivation when diagnosing and treating COPD we hypothesize that case method education (see description under "intervention") in COPD has better effect than traditional education (see description under "intervention").This study aims to examine the effect of case method education on (1) learning in COPD among general practitioners and on (2) health in their patients with COPD.

Method:

Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs) in COPD for their general practitioners. The educations will be held during two times (two hours each) within a time range of three months, covering examination and treatment of patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as well as questions about medication, exacerbations and other chronic diseases. The questionnaire will be sent to the patients 1-2 months before the education and 18 months after the education. Differences in assessments in the questionnaire before and after the education will be compared between the patients listed at the PHCCs that have received case method education vs. traditional education. In addition, general practitioners (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12 months after the education, covering the learning outcomes in order to study differences in learning between the two intervention groups.


Condition or disease Intervention/treatment Phase
COPD Behavioral: Case method education in COPD Behavioral: Traditional education in COPD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Case Method Education to General Practitioners on Their Knowledge on COPD and on the Health of Their Patients With COPD
Actual Study Start Date : October 16, 2014
Estimated Primary Completion Date : December 12, 2018
Estimated Study Completion Date : December 12, 2018

Arm Intervention/treatment
Experimental: Case method education in COPD
Two hours of case method education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers. The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education.
Behavioral: Case method education in COPD
In case method a rich narrative describing of a real-life situation (teaching case) is presented, in which the learning group must make a decision or solve a problem. The teaching case provide information, but neither analysis nor conclusions. The analytical work of explaining the relationships among events in the case, identifying options, evaluating choices and predicting the effects of actions is the work done by students during the discussion.

Active Comparator: Traditional education in COPD
Two hours of traditional education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers.The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education.
Behavioral: Traditional education in COPD
Traditional education in this study means that the teacher mainly speaks to the group. Although short cases may be used for illustration, the main focus is not that the group shall solve problems from a narrative case.




Primary Outcome Measures :
  1. Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later. [ Time Frame: 1-2 months before the intervention and 18 months after the intervention ]
    The CCQ measures health status in patients with COPD and consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). All scores range from 0 to 6; (0 = no impairment).

  2. Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education. [ Time Frame: Immediately before the intervention and 12 months later. ]
    The questionnaire covers examination and treatment of COPD and includes multiple choice questions as well as questions about attitudes that will be answered in free text.


Secondary Outcome Measures :
  1. Difference i patients' assessment of Lung Information Needs Questionnaire (LINQ) before the intervention and 18 months later. [ Time Frame: 1-2 months before the intervention and 18 months after the intervention ]
    LINQ measures patients perceptions about COPD and what information about COPD patients think that they have percieved from health care personnel.

  2. Difference in patients' assessment of COPD Assessment Test (CAT) before the intervention and 18 months later. [ Time Frame: 1-2 months before the intervention and 18 months after the intervention ]
    The COPD Assessment Test (CAT) measures the impact of COPD on a person's life.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary Health Care Centers (PHCC): >10.000 patients listed. >70% permanent employed general practitioners
  • Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008.

Exclusion Criteria:

  • None

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): NCT02213809


Locations
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Sweden
Department of Family Medicine, NVS, Karolinska Institutet
Huddinge, Sweden, 141 83
Sponsors and Collaborators
Karolinska Institutet
Dalarna County Council, Sweden
Investigators
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Principal Investigator: Anna Nager, PhD Karolinska Institutet
Study Director: Hanna Sandelowsky, MD Karolinska Institutet