Clinical trial NCT04301505: Improvement in COPD Elderly Patients Health: Study Protocol
Official title: Checklist Based Method for Improvement of COPD Care in Elderly in General Practice: Cluster Randomized Controlled Trial Using Electronic Health Records
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
elderly
exacerbation of COPD
prevalence
checklist
randomized controlled trial
electronic health records
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2020-03-10
Enrollment: 2520
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control.
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of deaths, or specific short and long acting drugs prescribed in intervention arms vs. control and the effect of the educational intervention.
timeFrame: 12 months
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University of Lodz
Study officials:
affiliation: Centre for Family and Community Medicine, Medical Univeristy of Lodz, Poland
name: Maciek Godycki-Cwirko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kowalczyk A, Zakowska I, Andrzejewska E, Kosiek K, Godycki-Cwirko M. A checklist-based method for improving COPD care for the elderly in general practice: study protocol for a cluster randomized controlled trial using electronic health records. Trials. 2021 Feb 25;22(1):161. doi: 10.1186/s13063-021-05103-0.