Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2010

Open Access 01-12-2010 | Study protocol

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

Authors: Kris Vanhaecht, Walter Sermeus, Jan Peers, Cathy Lodewijckx, Svin Deneckere, Fabrizio Leigheb, Marc Decramer, Massimiliano Panella, the EQCP Study Group

Published in: Trials | Issue 1/2010

Login to get access

Abstract

Background

Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes.

Methods

An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups.

Discussion

The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work.

Trial Registration number

NCT00962468
Appendix
Available only for authorised users
Literature
1.
Pearson SD, Goulart-Fisher D, Lee TH: Critical pathways as a strategy for improving care: problems and potential. Ann Intern Med. 1995, 123 (12): 941-8.CrossRefPubMed
2.
3.
4.
Vanhaecht K, De Witte K, Sermeus W: The impact of clinical pathways on the organisation of care processes. 2007, Leuven: ACCO
5.
Panella M, Marchisio S, Di Stanislao F: Reducing clinical variations with clinical pathways: do pathways work?. Int J Qual Health Care. 2003, 15 (6): 509-21. 10.1093/intqhc/mzg057.CrossRefPubMed
6.
Vanhaecht K, Bollmann M, Bower K, Gallagher C, Gardini A, Guezo J, Jansen U, Massoud R, Moody K, Sermeus W, Van Zelm RT, Whittle CL, Yazbeck AM, Zander K, Panella M: Prevalence and use of clinical pathways in 23 countries - an international survey by the European Pathway Association E-P-A.org. J INTEGR CARE PATHWAYS. 2006, 10: 28-34.CrossRef
7.
Bower KA: Clinical pathways: 12 lessons learned over 25 years of experience. International Journal of Care Pathways. 2009, 13: 78-81. 10.1258/jicp.2009.009008.CrossRef
8.
Panella M, Vanhaecht K: Is there still need for confusion about pathways?. International Journal of Care Pathways. 2010, 14: 1-3. 10.1258/jicp.2010.010008.CrossRef
9.
10.
Panella M, Brambilla R, Marchisio S, Di Stanislao F: Reducing stroke in-hospital mortality: organized care is a complex intervention. Stroke. 2008, 39 (11): e186-10.1161/STROKEAHA.108.533877.CrossRefPubMed
11.
Panella M, Marchisio S, Demarchi ML, Manzoli L, Di Stanislao F: Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial. Qual Saf Health Care. 2009, 18 (5): 369-73. 10.1136/qshc.2008.026559.CrossRefPubMed
12.
Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P: Framework for design and evaluation of complex interventions to improve health. BMJ. 2000, 321 (7262): 694-6. 10.1136/bmj.321.7262.694.CrossRefPubMedPubMedCentral
13.
Medical Research Council: A framework for development and evaluation of RCTs for complex interventions to improve health. 2000, Medical Research Council
14.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008, 337: a1655-10.1136/bmj.a1655.CrossRefPubMedPubMedCentral
15.
Rotter T, Kinsman L, James E, Machotta A, Gothe H, Willis J, Snow P, Kugler J: Clinical pathways: effects on professional practice, patient outcomes, length of stay and hospital costs. Cochrane Database Syst Rev. 2010, CD006632-
16.
17.
Barbieri A, Vanhaecht K, Van Herck P, Sermeus W, Faggiano F, Marchisio S, Panella M: Effects of clinical pathways in the joint replacement: a meta-analysis. BMC Med. 2009, 7 (1): 32-10.1186/1741-7015-7-32.CrossRefPubMedPubMedCentral
18.
Vanhaecht K, Sermeus W, Peers J, Deneckere S, Lodewijckx C, Leigheb F, Panella M: The European Quality of Care Pathway (EQCP) Study: history, project management & approach. International Journal of Care Pathways. 2010, 14 (2): 52-6. 10.1258/jicp.2010.010015.CrossRef
19.
Seemungal TA, Hurst JR, Wedzicha JA: Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009, 4: 203-23.CrossRefPubMedPubMedCentral
20.
Gold PM: The 2007 GOLD Guidelines: a comprehensive care framework. Respir Care. 2009, 54 (8): 1040-9.PubMed
21.
Izquierdo JL, Barcina C, Jimenez J, Munoz M, Leal M: Study of the burden on patients with chronic obstructive pulmonary disease. Int J Clin Pract. 2009, 63 (1): 87-97. 10.1111/j.1742-1241.2008.01936.x.CrossRefPubMedPubMedCentral
22.
Cao Z, Ong KC, Eng P, Tan WC, Ng TP: Frequent hospital readmissions for acute exacerbation of COPD and their associated factors. Respirology. 2006, 11 (2): 188-95. 10.1111/j.1440-1843.2006.00819.x.CrossRefPubMed
23.
Garcia-Aymerich J, Farrero E, Felez MA, Izquierdo J, Marrades RM, Anto JM: Risk factors of readmission to hospital for a COPD exacerbation: a prospective study. Thorax. 2003, 58 (2): 100-5. 10.1136/thorax.58.2.100.CrossRefPubMedPubMedCentral
24.
Lodewijckx C, Sermeus W, Vanhaecht K, Panella M, Deneckere S, Leigheb F, Decramer M: Inhospital management of COPD exacerbations: a systematic review of the literature with regard to adherence to international guidelines. Journal of Evaluation in Clinical Practice. 2009, 15: 1101-10. 10.1111/j.1365-2753.2009.01305.x.CrossRefPubMed
25.
Decramer M, Bartsch P, Pauwels R, Yernault JC: Management of COPD according to guidelines. A national survey among Belgian physicians. Monaldi Arch Chest Dis. 2003, 59 (1): 62-80.PubMed
26.
McManus TE, Marley A, Kidney JC: The Mater Hospital multiprofessional care pathway for acute exacerbations of chronic obstructive pulmonary disease. J INTEGR CARE PATHWAYS. 2005, 9 (1): 32-6.
27.
Santamaria N, Conners A, Osteraas J, Ham J, Boodram B: A prospective cohort study of the effectiveness of clinical pathways for the in-patient management of acute exacerbation of chronic obstructive pulmonary disease (COPD). Collegian. 2004, 11 (1): 12-6.CrossRef
28.
Almagro P, Barreiro B, Ochoa de EA, Quintana S, Rodriguez CM, Heredia JL, Garau J: Risk factors for hospital readmission in patients with chronic obstructive pulmonary disease. Respiration. 2006, 73 (3): 311-7. 10.1159/000088092.CrossRefPubMed
29.
Groenewegen KH, Schols AM, Wouters EF: Mortality and mortality-related factors after hospitalization for acute exacerbation of COPD. Chest. 2003, 124 (2): 459-67. 10.1378/chest.124.2.459.CrossRefPubMed
30.
Panella M, Marchisio S, Gardini A, Di Stanislao F: A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population. BMC Health Serv Res. 2007, 7: 179-10.1186/1472-6963-7-179.CrossRefPubMedPubMedCentral
31.
Panella M, Marchisio S, Barbieri A, Di Stanislao F: A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]. BMC Health Serv Res. 2008, 8: 223-10.1186/1472-6963-8-223.CrossRefPubMedPubMedCentral
32.
Celli BR, Macnee W: Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004, 23 (6): 932-46. 10.1183/09031936.04.00014304.CrossRefPubMed
33.
34.
Siafkas N, Wedzicha J: Management of acute exacerbation of chronic obstructive pulmonary disease. Management of chronic obstructive pulmonary disease. Edited by: Siafkas N. 2006, Sheffield: European Respiratory Society Ltd, 387-400.CrossRef
35.
National Institute for Clinical Excellence (NICE): Chronic obstructive pulmonary disease: national clinical guideline for management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax. 2004, 59 (Suppl I): 1-53.
36.
37.
Farley K: The COPD critical pathway: a case study in progress. Qual Manag Health Care. 1995, 3 (2): 43-54.CrossRefPubMed
38.
Bustamante-Fermosel A, De Miguel-Yanes JM, Duffort-Falco M, Munoz J: Mortality-related factors after hospitalization for acute exacerbation of chronic obstructive pulmonary disease: the burden of clinical features. Am J Emerg Med. 2007, 25 (5): 515-22. 10.1016/j.ajem.2006.09.014.CrossRefPubMed
39.
Cullen DL: Long term oxygen therapy adherence and COPD: what we don't know. Chron Respir Dis. 2006, 3 (4): 217-22. 10.1177/1479972306070506.CrossRefPubMed
40.
Fink JB, Rubin BK: Problems with inhaler use: a call for improved clinician and patient education. Respir Care. 2005, 50 (10): 1360-74.PubMed
41.
Gudmundsson G, Gislason T, Janson C, Lindberg E, Hallin R, Ulrik CS, Brondum E, Nieminen MM, Aine T, Bakke P: Risk factors for rehospitalisation in COPD: role of health status, anxiety and depression. Eur Respir J. 2005, 26 (3): 414-9. 10.1183/09031936.05.00078504.CrossRefPubMed
42.
Gunen H, Hacievliyagil SS, Kosar F, Mutlu LC, Gulbas G, Pehlivan E, Sahin I, Kizkin O: Factors affecting survival of hospitalised patients with COPD. Eur Respir J. 2005, 26 (2): 234-41. 10.1183/09031936.05.00024804.CrossRefPubMed
43.
Rau JL: Determinants of patient adherence to an aerosol regimen. Respir Care. 2005, 50 (10): 1346-56.PubMed
44.
Roberts CM, Lowe D, Bucknall CE, Ryland I, Kelly Y, Pearson MG: Clinical audit indicators of outcome following admission to hospital with acute exacerbation of chronic obstructive pulmonary disease. Thorax. 2002, 57 (2): 137-41. 10.1136/thorax.57.2.137.CrossRefPubMedPubMedCentral
45.
Roberts CM, Barnes S, Lowe D, Pearson MG: Evidence for a link between mortality in acute COPD and hospital type and resources. Thorax. 2003, 58 (11): 947-9. 10.1136/thorax.58.11.947.CrossRefPubMedPubMedCentral
46.
Yohannes AM, Baldwin RC, Connolly MJ: Predictors of 1-year mortality in patients discharged from hospital following acute exacerbation of chronic obstructive pulmonary disease. Age Ageing. 2005, 34 (5): 491-6. 10.1093/ageing/afi163.CrossRefPubMed
47.
Pawson R, Tilley N: Realistic Evaluation. 1997, London: SAGE Publications Ltd
48.
Oakley A, Strange V, Bonell C, Allen E, Stephenson J: Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006, 332 (7538): 413-6. 10.1136/bmj.332.7538.413.CrossRefPubMedPubMedCentral
49.
Hawe P, Shiell A, Riley T: Complex interventions: how "out of control" can a randomised controlled trial be?. BMJ. 2004, 328 (7455): 1561-3. 10.1136/bmj.328.7455.1561.CrossRefPubMedPubMedCentral
Metadata
Title
The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial
Authors
Kris Vanhaecht
Walter Sermeus
Jan Peers
Cathy Lodewijckx
Svin Deneckere
Fabrizio Leigheb
Marc Decramer
Massimiliano Panella
the EQCP Study Group
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Trials / Issue 1/2010
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-11-111

Other articles of this Issue 1/2010

Trials 1/2010 Go to the issue

Study protocol

Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol

Methodology

Assessing the potential for outcome reporting bias in a review: a tutorial

Study protocol

Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: the clinical evaluation of the dose of erythropoietins (C.E. DOSE) trial protocol

Study protocol

A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

Commentary

Legislation for trial registration and data transparency

Research

Case management for patients with chronic systolic heart failure in primary care: The HICMan exploratory randomised controlled trial