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Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | 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

Authors: Maciek Godycki-Cwirko, Izabela Zakowska, Katarzyna Kosiek, Michel Wensing, Jaroslaw Krawczyk, Anna Kowalczyk

Published in: Trials | Issue 1/2014

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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.
Appendix
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Literature
1.
2.
3.
4.
Niepsuj GKJ, Niepsuj K, Ziora D, Polonska A, Cieslicki J: Przewlekla obturacyjna choroba pluc wsrod mieszkancow miasta Zabrze. [Chronic obstructive pulmonary disease among residents of the city of Zabrze]. Wiad Lek. 2002, 55: 354-359.PubMed
5.
Plywaczewski R, Bednarek M, Jonczak L, Zielinski J: Czestosc wystepowania POCHP wsrod mieszkancow prawobrzeznej Warszawy. [Prevalence of COPD in Warsaw population]. Pneumonol Alergol Pol. 2003, 71: 329-335.PubMed
6.
European Respiratory Society/European Lung Foundation: Chronic obstructive pulmonary disease. European lung white book - the first comprehensive survey on respiratory health in Europe. Edited by: Loddenkemper R, Gibson GJ, Sibille Y. 2003, Sheffield: ERSJ, 34-43.
7.
Czermak G, Głaz M, Głowacka-Smolis K, Lipowska E, Marikin M, Ostrowska A, Pilaszek K, Rybak-Nguyen E, Szczepańska A, Szydłowska G: Rocznik statystyczny Rzeczpospolitej Polskiej. [Statistical yearbook of the Republic of Poland]. 2008, 204-Statistical Publishing Establishment, Warsaw, Poland. Warsaw. 2008
8.
Sagan A, Panteli D, Borkowski W, Dmowski M, Domanski F, Czyzewski M, Gorynski P, Karpacka D, Kiersztyn E, Kowalska I, Ksiezak M, Kuszewski K, Lesniewska A, Lipska I, Maciag R, Madowicz J, Madra A, Marek M, Mokrzycka A, Poznanski D, Sobczak A, Sowada C, Swiderek M, Terka A, Trzeciak P, Wiktorzak K, Wlodarczyk C, Wojtyniak B, Wrzesniewska-Wal I, Zelwianska D: Poland health system review. Health Syst Transit. 2011, 13: 1-193.PubMed
9.
van den Bemt L, Schermer T, van Weel C: Rational monitoring of COPD: where do current clinical guidelines stand?. Eur Respir J. 2007, 29: 1078-1081. 10.1183/09031936.00043107. 10.1183/09031936.00043107CrossRefPubMed
10.
Miravitlles M, Soler-Cataluña JJ, Calle M, Molina J, Almagro P, Quintano JA, Riesco JA, Trigueros JA, Piñera P, Simón A, López-Campos JL, Soriano JB, Ancochea J, Spanish Society of Pulmonology and Thoracic Surgery: Spanish COPD Guidelines (GesEPOC): pharmacological treatment of stable COPD. Spanish Society of Pulmonology and Thoracic Surgery. Arch Bronconeumol. 2012, 48: 247-257.PubMed
11.
Godycki-Cwirko M, Koziarska-Rosciszewska M, Kosiek K: The delivery of prevention programmes for cardiovascular disease and chronic obstructive pulmonary disease in Lodz by primary care physicians. Archives of Medical Science. 2010, 6: 208-213.CrossRefPubMedPubMedCentral
12.
Meulepas MA, Jacobs JE, Smeenk FW, Smeele I, Lucas AE, Bottema BJ, Grol RP: Effect of an integrated primary care model on the management of middle-aged and old patients with obstructive lung diseases. Scand J Prim Health Care. 2007, 25: 186-192. 10.1080/02813430701573943.CrossRefPubMedPubMedCentral
13.
van den Bemt L, Schermer TR, Smeele IJ, Boonman-de Winter LJ, van Boxem T, Denis J, Grootens-Stekelenburg JG, Grol RP, van Weel C: An expert-supported monitoring system for patients with chronic obstructive pulmonary disease in general practice: results of a cluster randomized controlled trial. Med J Aust. 2009, 191: 249-254.PubMed
14.
Mejza F, Nizankowska-Mogilnicka E, Kurzawa R, Gorski P, Wirkijowski B, Jaeschke R: Outpatients specialist care of chronic obstructive pulmonary disease patients in Poland — results of the KOMPAS study. Pneumonol Alergol Pol. 2009, 77: 507-516.PubMed
15.
Zielinski J, Roszkowski-Sliz K: Narodowy program wczesnego rozpoznawania i profilaktyki POChP [National program of early diagnoais and prevention of COPD]. Pneumonol Alergol Pol. 2002, 70: 125-129.PubMed
16.
Zielinski J, Kuca P, Ptasznik P, Plywaczewski R: Management of COPD: pulmonologists’ adherence to Polish guidelines. Pneumonol Alergol Pol. 2005, 73: 135-141.PubMed
17.
Jones RC, Dickson-Spillmann M, Mather MJ, Marks D, Shackell BS: Accuracy of diagnostic registers and management of chronic obstructive pulmonary disease: the Devon primary care audit. Respir Res. 2008, 9: 62-10.1186/1465-9921-9-62.CrossRefPubMedPubMedCentral
18.
Rutschmann OT, Janssens JP, Vermeulen B, Sarasin FP: Knowledge of guidelines for the management of COPD: a survey of primary care physicians. Respir Med. 2004, 98: 932-937. 10.1016/j.rmed.2004.03.018.CrossRefPubMed
19.
Schneider A, Gantner L, Maag I, Borst MM, Wensing M, Szecsenyi J: Are ICD-10 codes appropriate for performance assessment in asthma and COPD in general practice? Results of a cross sectional observational study. BMC Health Serv Res. 2005, 5: 11-10.1186/1472-6963-5-11.CrossRefPubMedPubMedCentral
20.
Wensing M, Oxman A, Baker R, Godycki-Cwirko M, Flottorp S, Szecsenyi J, Grimshaw J, Eccles M: Tailored implementation for chronic diseases (TICD): A project protocol. Implementation Science. 2011, 6: 103-10.1186/1748-5908-6-103.CrossRefPubMedPubMedCentral
21.
Donner A, Klar N: Design and Analysis of Cluster Randomization Trials in Health Research. 2000, London: Arnold
22.
Eccles M, Grimshaw J, Campbell M, Ramsay C: Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003, 12: 47-52. 10.1136/qhc.12.1.47.CrossRefPubMedPubMedCentral
23.
Campbell MK, Thomson S, Ramsay CR, MacLennan GS, Grimshaw JM: Sample size calculator for cluster randomized trials. Comput Biol Med. 2004, 34: 113-125. 10.1016/S0010-4825(03)00039-8.CrossRefPubMed
24.
Murphy K, Casey D, Devane D, Cooney A, McCarthy B, Mee L, Nichulain M, Murphy AW, Newell J, O’ Shea E: A cluster randomized controlled trial evaluating the effectiveness of a structured pulmonary rehabilitation education programme for improving the health status of people with chronic obstructive pulmonary disease (COPD): the PRINCE study protocol. Bmc Pulm Med. 2011, 11: 4-10.1186/1471-2466-11-4.CrossRefPubMedPubMedCentral
25.
Smeeth L, Ng ESW: Intraclass correlation coefficients for cluster randomized trials in primary care: data from the MRC trial of the assessment and management of older people in the community. Control Clin Trials. 2002, 23: 409-421. 10.1016/S0197-2456(02)00208-8.CrossRefPubMed
26.
Marcinowicz L, Chlabicz S, Grebowski R: Open-ended questions in surveys of patients’ satisfaction with family doctors. J Health Serv Res Policy. 2007, 12: 86-89. 10.1258/135581907780279639.CrossRefPubMed
27.
Muras M, Krajewski J, Nocun M, Godycki-Cwirko M: A survey of patient behaviours and beliefs regarding antibiotic self-medication for respiratory tract infections in Poland. Arch Med Sci. 2013, 9 (5): 854-857. doi:10.5114/aoms.2012.29217CrossRefPubMed
28.
Prakash A, Risser RC, Mallinckrodt CH: The impact of analytic method on interpretation of outcomes in longitudinal clinical trials. Int J Clin Pract. 2008, 62: 1147-1158. 10.1111/j.1742-1241.2008.01808.x.CrossRefPubMedPubMedCentral
29.
Flottorp SA, Oxman AD, Krause J, Musila NR, Wensing M, Godycki-Cwirko M, Baker R, Eccles MP: A checklist for identifying determinants of practice: a systematic review and synthesis of frameworks and taxonomies of factors that prevent or enable improvements in healthcare professional practice. Implementation Science. 2013, 8: 35-10.1186/1748-5908-8-35.CrossRefPubMedPubMedCentral
30.
31.
32.
Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schünemann H, Wedzicha W, MacDonald R, Shekelle P, for the American College of Physicians; American College of Chest Physicians, the American Thoracic Society and European Respiratory Society: Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society and European Respiratory Society. Annals of Internal Medicine. 2011, 155: 179-191. 10.7326/0003-4819-155-3-201108020-00008.CrossRefPubMed
33.
Gorecka D, Jassem E, Pierzchala W, Sliwinski P: Zalecenia Polskiego Towarzystwa Chorób Płuc dotyczące rozpoznawania i leczenia przewlekłej obturacyjnej choroby płuc (POChP [Recommendations of the polish society of lung diseases for diagnosis and treatment of chronic obstructive pulmonary disease (COPD)]. Pneumonol Alergol Pol. 2012, 80: 220-254.PubMed
34.
Jager CJ, Freund T, Steinhäuser J, Aakhus E, Flottorp S, Godycki-Cwirko M, van Lieshout J, Krause J, Szecsenyi J, Wensing M: Tailored Intervention for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries. Trials. 2014, 15: 87-10.1186/1745-6215-15-87. 10.1186/1745-6215-15-87CrossRefPubMedPubMedCentral
35.
Schermer TR, Akkermans RP, Crockett AJ, van Montfort M, Grootens-Stekelenburg J, Stout JW, Pieters W: Effect of e-learning and repeated performance feedback on spirometry test quality in family practice: a cluster trial. Ann Fam Med. 2011, 9: 330-336. 10.1370/afm.1258.CrossRefPubMedPubMedCentral
36.
Kennedy A, Bower P, Reeves D, Blakeman T, Bowen R, Chew-Graham C, Eden M, Fullwood C, Gaffney H, Gardner C, Lee V, Morris R, Protheroe J, Richardson G, Sanders C, Swallow A, Thompson D, Rogers A, Salford National Institute for Health Research Gastrointestinal programme Grant Research Group: Implementation of self management support for long term conditions in routine primary care settings: cluster randomized controlled trial. BMJ. 2013, 346: f2882-10.1136/bmj.f2882.CrossRefPubMedPubMedCentral
Metadata
Title
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
Authors
Maciek Godycki-Cwirko
Izabela Zakowska
Katarzyna Kosiek
Michel Wensing
Jaroslaw Krawczyk
Anna Kowalczyk
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-109

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