Improvement in COPD Elderly Patients Health: Study Protocol

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301505
• Other study ID #: 2016/21/B/NZ7/02052
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2023
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2520
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Intervention 1
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.
• Intervention 2
The same checklist will be delivered at the beginning of the study and repeated after 6 months.

Locations

Country	Name	City	State
Poland	Medical University of Lodz	Lodz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lodz	National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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