Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
The overall objective of this study is to evaluate a collaborative self-management intervention in patients with moderate to severe COPD in a primary care population. To achieve this objective the investigators developed a diagnostic and treatment pathway for the management of COPD in primary care that is based on national guidelines and focused on patient self-management. .
Interventions
OTHERCase Management and Self-Management Education
A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician. Specific elements of evidence-based management are targetted for intervention. Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months. Telephone follow up will occur at a minimum at 6 and 9 months.
Sponsors
Pfizer
GlaxoSmithKline
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current or Ex-smokers * 40 years of age or over * Minimum 10 pack year smoking history * Post-bronchodilator FEV1 of 70% or less (4 puffs of Salbutamol) and Forced Expiratory Volume at 1sec to Forced Vital Capacity (FEV1/FVC) ratio 70% or less * A history of two exacerbations (involving treatment and/or visit to a health care practitioner) in the past 3 years OR 1 exacerbation in the past year * Provides informed consent
Exclusion criteria
* COPD exacerbation in the past 4 weeks * Diagnosis of asthma prior to the age of 40 years * Co-existing illness that could interfere with study results (ie. Congestive Heart Failure with exacerbation of symptoms) * Scheduled for COPD rehabilitation * A terminal illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD Assessment Test (CAT) | 1 Year | COPD related quality of life measure in primary care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Care Utilization for Emergency Department visits proportion and rate per year | 1 year | The proportion of subjects that utilized the Emergency for a COPD exacerbation |
| Health Care Utilization for Hospital Admission proportion and rate per year | 1 year | The proportion of subjects that were admitted to hospital for a COPD exacerbation An exacerbation is defined as an increase in or the onset of more than one respiratory symptom (cough, sputum, sputum purulence, wheezing, or dyspnea) lasting 3 days or more and requiring treatment with an antibiotic or a systemic corticosteroid. Respiratory status had to return to baseline for at least 72 hours before another exacerbation would be counted. |
| Severe Exacerbation proportion and rate per year | 1 year | The proportion of subjects experiencing one or more exacerbations in the study interval. An exacerbation diary will be completed for each event. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease control | 1 year | Disease control using the Clinical COPD questionnaire (CCQ) |
| Symptom Profile | 1 year | Change in Symptom profile (cough, wheeze, sputum production) |
| Quality of Life | 1 year | Improvement of Quality of Life using the CAT score(COPD Assessment Test) |
| Proportion of Patients on therapy appropriate to their stage of disease | 1 year | Evaluate medication prescribed related to stage of disease |
| Forced Expiratory Volume at 1sec (FEV1) % predicted | 1 year | FEV1 |
| Improvement in Knowledge of COPD and confidence in self-management | 1 year | Improvement in Bristol COPD Knowledge Questionnaire and patient self report |
| Process of Care | 1 year | Process of care: have written action plan, used action plan, advised to quit smoking, offered pharmacologic help with quitting, quit smoking, current packs/day, diagnosis confirmed by spirometry, vaccination rates, instructed on inhaler technique, vaccination rates |
| Dyspnea Improvement | 1 year | Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC). |
Countries
Canada
Outcome results
None listed