NCT02213809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
822

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

4.2 years

First QC Date

August 8, 2014

Last Update Submit

January 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later.

    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.

    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 Outcomes (2)

  • Difference i patients' assessment of Lung Information Needs Questionnaire (LINQ) before the intervention and 18 months later.

    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.

    1-2 months before the intervention and 18 months after the intervention

Study Arms (2)

Case method education in COPD

EXPERIMENTAL

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

Traditional education in COPD

ACTIVE COMPARATOR

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

Interventions

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.

Case method 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.

Traditional education in COPD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family Medicine, NVS, Karolinska Institutet

Huddinge, 141 83, Sweden

Location

Related Publications (3)

  • Sandelowsky H, Krakau I, Modin S, Stallberg B, Nager A. Primary care patients with mild or stable chronic obstructive pulmonary disease need more support in disease management: a secondary analysis of a cluster randomized controlled trial. Scand J Prim Health Care. 2023 Dec;41(4):495-504. doi: 10.1080/02813432.2023.2280039. Epub 2023 Nov 29.

  • Sandelowsky H, Krakau I, Modin S, Stallberg B, Johansson SE, Nager A. Effectiveness of traditional lectures and case methods in Swedish general practitioners' continuing medical education about COPD: a cluster randomised controlled trial. BMJ Open. 2018 Aug 10;8(8):e021982. doi: 10.1136/bmjopen-2018-021982.

  • Sandelowsky H, Krakau I, Modin S, Stallberg B, Nager A. Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial. Trials. 2017 Apr 27;18(1):197. doi: 10.1186/s13063-017-1889-4.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Nager, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR
  • Hanna Sandelowsky, MD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer and general practitioner

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 12, 2014

Study Start

October 16, 2014

Primary Completion

December 12, 2018

Study Completion

December 12, 2018

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations