Improvement in COPD Elderly Patients Health: Study Protocol

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: Intervention 1; Other: Intervention 2

• Registration Number: NCT04301505
• Lead Sponsor: Medical University of Lodz

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-02-18
• Study Start: 2020-03-01
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2520

Inclusion Criteria

1. Patients: aged 65 years and older with diagnosis of COPD registered as J-44 (ICD-10).
2. Centres: Primary Health Care Centers (PHCC) with at least 46 COPD patients listed.

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 1	Intervention 1	COPD management checklist will be delivered at the beginning of the study.
Intervention 2	Intervention 2	COPD management checklist will be delivered at the beginning of the study and repeated after 6 months.

Primary Outcome Measures

Name	Time	Method
The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control.	12 months	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.

Secondary Outcome Measures

Name	Time	Method
The proportion of deaths, or specific short and long acting drugs prescribed in intervention arms vs. control and the effect of the educational intervention.	12 months	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.

Trial Locations

Locations (1)

Medical University of Lodz; 🇵🇱 Lodz, Poland