A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management

NCT01893476 | Completed

• 1 other identifier: 258837
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease; implementation

Outcome Measures

Primary Outcomes (1)

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

  Brief anti-smoking counseling will be provided for GPs.

  1 year

Secondary Outcomes (1)

• Health outcomes in patients' medical records.

  1 year

Other Outcomes (1)

• Adherence to the selected guidelines by GPs in primary care settings.

  1 year

Study Arms (2)

control

NO INTERVENTION

In this arm, practitioners will provide usual care for COPD patients.

adherence to guideline

OTHER

Implementation educational programme: guideline adherences. The results of this trial will be directly applicable to primary care settings. Should the interventions delivered at the level of the GP practice be found to be effective in improving patients' quality of life then the findings would have a wider application.

Other: Implementation educational programme

Interventions

Implementation educational programme OTHER

Implementation educational programme will include: brief anti-smoking counseling, mMRC scale, checklist, training patient on correct use of inhaling. Participating physicians will receive training in brief anti-smoking counselling and will be asked to record information about. Additional form containing the mMRC dyspnoea scale will be inserted into patients' medical records. We will elaborate a checklist for practitioners with information about what should be done while consulting a patient with COPD. Investigators will provide practices with training inhaler and train staff. Practitioners will be asked to teach patients in correct use of each device. Practitioners will be asked to put this information to the patient's medical records.

Also known as: implementation programme

adherence to guideline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• terminal illness
• cognitive impairments

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz

Lodz, Łódź Voivodeship, 90-419, Poland

Location

Related Publications (1)

• Godycki-Cwirko M, Zakowska I, Kosiek K, Wensing M, Krawczyk J, Kowalczyk A. Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial. Trials. 2014 Apr 4;15:109. doi: 10.1186/1745-6215-15-109.

  PMID: 24708623 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maciej Godycki-Cwirko, MD, PhD

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

PL (1)