Improvement in COPD Elderly Patients Health: Study Protocol

February 21, 2023 updated by: Medical University of Lodz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 90-153
        • Medical University of Lodz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Usual care.
Other: Intervention 1
COPD management checklist will be delivered at the beginning of the study.
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.
Other: Intervention 2
COPD management checklist will be delivered at the beginning of the study and repeated after 6 months.
Other: Intervention 2
The same checklist will be delivered at the beginning of the study and repeated after 6 months.

What is the study measuring?

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.
Time Frame: 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.
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.
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Collaborators

National Science Centre, Poland

Investigators

  • Principal Investigator: Maciek Godycki-Cwirko, Prof., Centre for Family and Community Medicine, Medical Univeristy of Lodz, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/21/B/NZ7/02052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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