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Open Access Study protocol

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

Maciek Godycki-Cwirko1*, Izabela Zakowska1, Katarzyna Kosiek1, Michel Wensing2, Jaroslaw Krawczyk1 and Anna Kowalczyk1

Author Affiliations

1 Centre for Family and Community Medicine, Medical University of Lodz, 20 Kopcinskiego Street, Lodz 90-153, Poland

2 Radboud University Medical Centre, Scientific Institute for Quality of Healthcare, P.O. Box 9101, 114, Nijmegen 6500, HB, The Netherlands

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Trials 2014, 15:109  doi:10.1186/1745-6215-15-109

Published: 4 April 2014

Abstract

Background

Chronic obstructive pulmonary disease (COPD) remains a major health problem, strongly related to smoking. Despite the publication of practice guidelines on prevention and treatment, not all patients with the disease receive the recommended healthcare, particularly with regard to smoking cessation advice where applicable. We have developed a tailored implementation strategy for enhancing general practitioners’ adherence to the disease management guidelines. The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners’ adherence to guidelines.

Methods/Design

A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care. The study will involve 18 general practices (9 in the intervention group and 9 in the control group) in Poland, each with at least 80 identified (at the baseline) patients with diagnosed COPD. The nine control practices will provide usual care without any interventions. Tailored interventions to implement four recommendations will be delivered in the remaining nine practices. At follow-up after nine months, data will be collected for all 18 general practices. The primary outcome measure is physicians’ adherence to all four recommendations: brief anti-smoking advice, dyspnea assessment, care checklist utilization and demonstration to patients of correct inhaler use. This measurement will be based on data extracted from identified patients’ records. Additionally, we will survey and interview patients with chronic obstructive pulmonary disease about the process of 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.

Trial registration

This trial has been registered with Clinical Trials Protocol Registration System. Trial number: NCT01893476.

Keywords:
Chronic obstructive pulmonary disease; Implementation science; Primary health care