Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— TICD-COPDOfficial title:
Tailored Implementation for Chronic Diseases.
Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem,
which is strongly related to smoking. Despite publication of guidelines on the prevention
and treatment of COPD, not all COPD patients receive the best available healthcare.
Investigators developed a tailored implementation strategy for improving primary care
physicians' adherence to COPD management guidelines. The primary aim of the presented trial
is to evaluate the effects of this strategy on physician's performance. The secondary aim is
to examine the validity of the tailoring of implementation interventions.
Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1
year will increase among participants assigned to the intervention group in comparison to
those assigned to the control group?
Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540
patients with diagnosed COPD will be included from 18 general practices in Poland. A
tailored implementation program will be offered to general practitioners. Participating
physicians in the intervention practices (n=18) will receive training to provide brief
anti-smoking counselling. An additional form containing COPD severity scale will be inserted
into patient's medical records. The checklist with key information about the disease and its
management while consulting a patient with COPD will be provided to practitioners.
Investigators will provide practices with training inhaler devices for general practitioners
(GPs) to teach patients in correct use of each device and to note this education/training in
patient's medical records. The control practices will provide usual care.
Discussion: The results of this trial will be directly applicable to primary care in Poland
and add to the growing body of evidence on interventions to improve chronic illness care.
Status | Completed |
Enrollment | 540 |
Est. completion date | February 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients with diagnosed COPD via the medical records with code J44 Exclusion Criteria: - terminal illness - cognitive impairments |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Lodz | Lodz |
Lead Sponsor | Collaborator |
---|---|
Medical Universtity of Lodz |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adherence to the selected guidelines by GPs in primary care settings. | The percentage of GPs adhering to the selected guidelines in primary care settings. | 1 year | No |
Primary | The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. | Brief anti-smoking counseling will be provided for GPs. | 1 year | No |
Secondary | Health outcomes in patients' medical records. | Investigators will review COPD patients' medical records to measure health outcomes such as smoking status change, quantity of and adherence to medication, change in modified Medical Research Council (mMRC) scale and number of exacerbations in the past and over the study period. Also, investigators will consider utilization of the Chronic Respiratory Questionnaire (CRQ). |
1 year | No |
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