Improvement in COPD Elderly Patients Health: Study Protocol

Study Overview
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Brief Summary
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Guidelines development, their implementation and the physicians' adherence may have an impact on the occurrence of Chronic Obstructive Pulmonary Disease (COPD) exacerbations and patient's quality of life. We have developed an educational program based on a checklist to assist general practitioners in managing COPD patients. The results of this trial based on electronic health records from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist, will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care and patient's quality of life.

Detailed Description
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This study is the three-arm cluster controlled randomized trial (CRT) with the patients nested within practices. The effectiveness of Checklist in reduction of COPD exacerbations health outcomes in COPD patients after 2 interventions will be evaluated and compared to that of usual care. The results of this trial will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care.

Official Title
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Checklist Based Method for Improvement of COPD Care in Elderly in General Practice: Cluster Randomized Controlled Trial Using Electronic Health Records

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: Intervention 1
* Other: Intervention 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: aged 65 years and older with diagnosis of COPD registered as J-44 (ICD-10). Centres: Primary Health Care Centers (PHCC) with at least 46 COPD patients listed. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Usual care. | |
| Other: Intervention 1<br>COPD management checklist will be delivered at the beginning of the study. | Other: Intervention 1<br>* Checklist will be delivered at the beginning of the study. The educational intervention program will consist of a checklist that provides family physicians with COPD management for the elderly.<br>|
| Other: Intervention 2<br>COPD management checklist will be delivered at the beginning of the study and repeated after 6 months. | Other: Intervention 2<br>* The same checklist will be delivered at the beginning of the study and repeated after 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control. | Variables from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist will be used to assess hospitalization of elderly patients with the J-44 code as a main reason for admission after 1 year. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of deaths, or specific short and long acting drugs prescribed in intervention arms vs. control and the effect of the educational intervention. | Variables from BIG DATA databases, electronic health records (EHR) associated with checklist will be used to assess patients' health outcomes. The effect of the educational intervention will be evaluated using logistic 2-level regression analysis. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), elderly, exacerbation of COPD, prevalence, checklist, randomized controlled trial, electronic health records