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Clinical Trials/NCT01893476
NCT01893476
Completed
Not Applicable

Tailored Implementation for Chronic Diseases.

Medical University of Lodz1 site in 1 country540 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Medical University of Lodz
Enrollment
540
Locations
1
Primary Endpoint
The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.

Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?

Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.

Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem. Worldwide it has been ranked as the sixth leading cause of death for both genders. In 2020 COPD is projected to rank fifth worldwide in burden of disease. It is also projected to be the fourth leading cause of death worldwide by 2030 due to an increase in smoking rates and demographic changes in many countries. The national survey conducted in Poland in 2007 indicated that 34% of men smoked daily, 2% were occasional smokers, 19% were former smokers and 45% never smoked. In women, these percentages were, respectively, 23%, 3%, 10% and 64%. Although COPD has received increasing attention from the medical community in some countries in recent years, it is still relatively unknown or ignored by the public as well as many healthcare providers and government officials. Epidemiological studies of COPD on a representative sample have not been performed in Poland, but estimates from smaller suggested a relatively high prevalence. Studies which covered a selected geographical population found that signs and symptoms of COPD are seen in about 10% of patients over 40 years old. Studies in big cities in Poland showed a 9,8% prevalence of COPD in populations between 41 and 72 years old. These data are similar to European data, describing prevalence rates of 4-11% of COPD in adults in Europe. The absolute number of people suffering from COPD in Poland is estimated on about 2 million. This places COPD as the third most frequent - concerning frequency - chronic illness, and it is the fourth most common cause of death in Poland. In Poland, many guidelines on COPD are used, some of which are national and some are international. There is no guideline in Poland which is designed for primary care. Implementation of interventions directed on health professionals knowledge programme can change the professionals behavior. In this study the support strategy is applied to improve implementation process.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr Maciej Godycki-Ćwirko

PhD, MD

Medical University of Lodz

Eligibility Criteria

Inclusion Criteria

  • patients with diagnosed COPD via the medical records with code J44

Exclusion Criteria

  • terminal illness
  • cognitive impairments

Outcomes

Primary Outcomes

The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records.

Time Frame: 1 year

Brief anti-smoking counseling will be provided for GPs.

Secondary Outcomes

  • Health outcomes in patients' medical records.(1 year)

Study Sites (1)

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