Case Method Education on COPD to General Practitioners (PRIMAIR)

January 11, 2023 updated by: Anna Nager, Karolinska Institutet

Effect of Case Method Education to General Practitioners on Their Knowledge on COPD and on the Health of Their Patients With COPD

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

822

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Huddinge, Sweden, 141 83
        • Department of Family Medicine, NVS, Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1-2 months before the intervention and 18 months after the intervention
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.
Immediately before the intervention and 12 months later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-2 months before the intervention and 18 months after the intervention
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.
1-2 months before the intervention and 18 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anna Nager, PhD, Karolinska Institutet
  • Study Director: Hanna Sandelowsky, MD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2014

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 10, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2013/232-31/5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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