A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: Results of the clinical pathways for effective and appropriate care study

BMC Medicine

Volumn 10, Issue , 2012, Pages

  Panella, Massimiliano ^a,e   Marchisio, Sara ^a,b   Brambilla, Romeo ^c   Vanhaecht, Kris ^d,e   Di Stanislao, Francesco ^b  

^a UNIVERSITY OF EASTERN PIEDMONT   (Italy)

^b Unit for Quality Improvement   (Italy)

^c School of Public Health   (Italy)

^d UNIVERSITY OF LEUVEN   (Belgium)

^e European Pathway Association   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

AGED; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL PATHWAY; CLUSTER ANALYSIS; CONTROLLED STUDY; EVIDENCE BASED PRACTICE; FEMALE; HEALTH CARE PERSONNEL; HOSPITAL READMISSION; HUMAN; INSTITUTIONALIZATION; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; STROKE; TOTAL QUALITY MANAGEMENT; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; EMERGENCY HEALTH SERVICE; FOLLOW UP; MIDDLE AGED; NEUROSURGERY; PATHOPHYSIOLOGY; STANDARD; SURVIVAL; TREATMENT OUTCOME;

FIBRINOLYTIC AGENT;

AGED; AGED, 80 AND OVER; CRITICAL PATHWAYS; EMERGENCY MEDICAL SERVICES; FEMALE; FIBRINOLYTIC AGENTS; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEUROSURGICAL PROCEDURES; QUALITY IMPROVEMENT; STROKE; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84863578106     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/1741-7015-10-71     Document Type: Article

References (55)

1. Donnan GA, Fisher M, Macleod M, Davis SM. Stroke. Lancet 2008, 371:1612-1623. 10.1016/S0140-6736(08)60694-7, 18468545.
2. Bejot Y, Benatru I, Rouaud O, Fromont A, Besancenot JP, Moreau T, Giroud M. Epidemiology of stroke in Europe: geographic and environmental differences. J Neurol Sci 2007, 262:85-8. 10.1016/j.jns.2007.06.025, 17761197.
3. American Heart Association American Stroke Association Heart disease and stroke statistics 2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. 2008, 117:e25-146. American Heart Association American Stroke Association.
4. Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, de SG, Ferguson TB, Ford E, Furie K, Gillespie C, et al. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation 2010, 121:948-954.
5. Schwamm LH, Pancioli A, Acker JE, Goldstein LB, Zorowitz RD, Shephard TJ, Moyer P, Gorman M, Johnston SC, Duncan PW, et al. Recommendations for the establishment of stroke systems of care: recommendations from the American Stroke Association's Task Force on the Development of Stroke Systems. Stroke 2005, 36:690-703.
6. Fonarow GC, Reeves MJ, Smith EE, Saver JL, Zhao X, Olson DW, Hernandez AF, Peterson ED, Schwamm LH. Characteristics, performance measures, and in-hospital outcomes of the first one million stroke and transient ischemic attack admissions in get with the guidelines-stroke. Circ Cardiovasc Qual Outcomes 2010, 3:291-302. 10.1161/CIRCOUTCOMES.109.921858, 20177051.
7. Fonarow GC, Smith EE, Saver JL, Reeves MJ, Bhatt DL, Grau-Sepulveda MV, Olson DM, Hernandez AF, Peterson ED, Schwamm LH. Timeliness of tissue-type plasminogen activator therapy in acute ischemic stroke: patient characteristics, hospital factors, and outcomes associated with door-to-needle times within 60 minutes. Circulation 2011, 123:750-758. 10.1161/CIRCULATIONAHA.110.974675, 21311083.
8. Saposnik G, Fang J, O'Donnell M, Hachinski V, Kapral MK, Hill MD. Escalating levels of access to in-hospital care and stroke mortality. Stroke 2008, 39:2522-2530. 10.1161/STROKEAHA.107.507145, 18617667.
9. Kalra L, Evans A, Perez I, Knapp M, Swift C, Donaldson N. A randomised controlled comparison of alternative strategies in stroke care. Health Technol Assess 2005, 9:iii-79.
10. Kjellstrom T, Norrving B, Shatchkute A. Helsingborg Declaration 2006 on European stroke strategies. Cerebrovasc Dis 2007, 23:231-241.
11. National Stroke Foundation Clinical guidelines for stroke management 2010. 2010, Melbourne: National Stroke Foundation, National Stroke Foundation.
12. Kwan J, Sandercock P. In-hospital care pathways for stroke. Cochrane Database Syst Rev 2004, CD002924.
13. Kwan J. Care pathways for acute stroke care and stroke rehabilitation: from theory to evidence. J Clin Neurosci 2007, 14:189-200. 10.1016/j.jocn.2006.01.026, 17258128.
14. Vanhaecht K, Ovretveit J, Elliott MJ, Sermeus W, Ellershaw JE, Panella M. Have we drawn the wrong conclusions about the value of care pathways? Is a Cochrane review appropriate?. Eval Health Prof 2011, 35:28-42.
15. 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, 2585086, 18980664.
16. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010, 8:18. 10.1186/1741-7015-8-18, 2860339, 20334633.
17. 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, 321:694-696. 10.1136/bmj.321.7262.694, 1118564, 10987780.
18. Loeb MB. Application of the development stages of a cluster randomized trial to a framework for valuating complex health interventions. BMC Health Serv Res 2002, 2:13. 10.1186/1472-6963-2-13, 117443, 12110157.
19. Medical Research Council (MRC) Cluster randomised trials: Methodological and ethical considerations. 2002, Medical Research Trials Series. London: MRC, Medical Research Council (MRC).
20. 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, 2204000, 17986361.
21. 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, 18:369-373. 10.1136/qshc.2008.026559, 19812099.
22. 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(Suppl A):1655.
23. De Luca A, Toni D, Lauria L, Sacchetti ML, Giorgi RP, Ferri M, Puca E, Prencipe M, Guasticchi G. An emergency clinical pathway for stroke patients--results of a cluster randomised trial (isrctn41456865). BMC Health Serv Res 2009, 9:14. 10.1186/1472-6963-9-14, 2640375, 19159477.
24. Panella M, Brambilla R, Marchisio S, Di Stanislao F. Reducing stroke in-hospital mortality: organized care is a complex intervention. Stroke 2008, 39:e186. 10.1161/STROKEAHA.108.533877, 18802201.
25. Fisher M. Stroke and TIA: epidemiology, risk factors, and the need for early intervention. Am J Manag Care 2008, 14(Suppl 2):S204-S211.
26. van der Worp HB, van GJ. Clinical practice. Acute ischemic stroke. N Engl J Med 2007, 357:572-579. 10.1056/NEJMcp072057, 17687132.
27. Medical Research Council A framework for development and evaluation of RCTs for complex interventions to improve health. London: Medical Research Council 2000, 1:19. Medical Research Council.
28. Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA, Burney PG. Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technol Assess 1999, 3:iii-92.
29. Campbell MK, Mollison J, Grimshaw JM. Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med 2001, 20:391-399. 10.1002/1097-0258(20010215)20:3<391::AID-SIM800>3.0.CO;2-Z, 11180309.
30. Yudkin PL, Moher M. Putting theory into practice: a cluster randomized trial with a small number of clusters. Stat Med 2001, 20:341-349. 10.1002/1097-0258(20010215)20:3<341::AID-SIM796>3.0.CO;2-G, 11180305.
31. Inzitari D. The Italian Guidelines for stroke prevention. The Stroke Prevention and Educational Awareness Diffusion (SPREAD) Collaboration. Neurol Sci 2000, 21:5-12. 10.1007/s100720070112, 10938196.
32. Inzitari D, Carlucci G. Italian Stroke Guidelines (SPREAD): evidence and clinical practice. Neurol Sci 2006, 27(Suppl 3):S225-S227.
33. Gensini GF, Dilaghi B, Zaninelli A. Italian SPREAD Guidelines: from past to future. Neurol Sci 2006, 27(Suppl 3):S254-S257.
34. Gensini GF, Gusinu R. The systematic review of organised stroke care: a model for an unbiased assessment of trials on the effects of service organisation. The clinician's point of view. Intern Emerg Med 2006, 1:77-78. 10.1007/BF02934728, 16941820.
35. Pearson SD, Goulart-Fisher D, Lee TH. Critical pathways as a strategy for improving care: problems and potential. Ann Intern Med 1995, 123:941-948.
36. Panella M, Marchisio S, Di Stanislao F. Reducing clinical variations with clinical pathways: do pathways work?. Int J Qual Health Care 2003, 15:509-521. 10.1093/intqhc/mzg057, 14660534.
37. Vanhaecht K, Panella M, Van Zelm RT, Sermeus W. An overview on the concept and history of care pathways as complex interventions. Int J of Care Pathw 2010, 14:117-123.
38. Provinciali L. Role of scientific societies in implementation of stroke guidelines and clinical pathways promotion. Neurol Sci 2006, 27(Suppl 3):S284-S286.
39. Twisk J. Applied Multilevel Analysis. A practical guide. 2006, Cambridge. Cambridge University Press.
40. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and statistics in medicine. Stat Med 2007, 26:2-19. 10.1002/sim.2731, 17136746.
41. Needham DM, Scales DC, Laupacis A, Pronovost PJ. A systematic review of the Charlson comorbidity index using Canadian administrative databases: a perspective on risk adjustment in critical care research. J Crit Care 2005, 20:12-19. 10.1016/j.jcrc.2004.09.007, 16015512.
42. Pezzella FR, Picconi O, De LA, Lyden PD, Fiorelli M. Development of the Italian version of the National Institutes of Health Stroke Scale: It-NIHSS. Stroke 2009, 40:2557-2559. 10.1161/STROKEAHA.108.534495, 19520997.
43. Hahn S, Puffer S, Torgerson DJ, Watson J. Methodological bias in cluster randomised trials. BMC Med Res Methodol 2005, 5:10. 10.1186/1471-2288-5-10, 554774, 15743523.
44. Fonarow GC, Gregory T, Driskill M, Stewart MD, Beam C, Butler J, Jacobs AK, Meltzer NM, Peterson ED, Schwamm LH, et al. Hospital certification for optimizing cardiovascular disease and stroke quality of care and outcomes. Circulation 2010, 122:2459-2469. 10.1161/CIR.0b013e3182011a81, 21098429.
45. The Joint Commission website. 2011, , http://www.jointcommission.org/certification/primary_stroke_centers.aspx
46. Lichtman JH, Jones SB, Wang Y, Watanabe E, Leifheit-Limson E, Goldstein LB. Outcomes after ischemic stroke for hospitals with and without Joint Commission-certified primary stroke centers. Neurology 2011, 6:1976-1982.
47. Loeb M, Carusone SC, Goeree R, Walter SD, Brazil K, Krueger P, Simor A, Moss L, Marrie T. Effect of a clinical pathway to reduce hospitalizations in nursing home residents with pneumonia: a randomized controlled trial. JAMA 2006, 295:2503-2510. 10.1001/jama.295.21.2503, 16757722.
48. Gorelick AR, Gorelick PB, Sloan EP. Emergency department evaluation and management of stroke: acute assessment, stroke teams and care pathways. Neurol Clin 2008, 26:923-942. 10.1016/j.ncl.2008.05.008, 19026897.
49. Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D'Este C, Drury P, Griffiths R, Cheung NW, Quinn C, et al. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet 2011, 378:1699-1706. 10.1016/S0140-6736(11)61485-2, 21996470.
50. Moser DK, Kimble LP, Alberts MJ, Alonzo A, Croft JB, Dracup K, Evenson KR, Go AS, Hand MM, Kothari RU, et al. Reducing delay in seeking treatment by patients with acute coronary syndrome and stroke: a scientific statement from the American Heart Association Council on cardiovascular nursing and stroke council. Circulation 2006, 114:168-182. 10.1161/CIRCULATIONAHA.106.176040, 16801458.
51. Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health 2004, 94:416-422. 10.2105/AJPH.94.3.416, 1448267, 14998805.
52. Hawe P, Shiell A, Riley T. Complex interventions: how "out of control" can a randomised controlled trial be?. BMJ 2004, 328:1561-1563. 10.1136/bmj.328.7455.1561, 437159, 15217878.
53. Vanhaecht K, De Witte K, Panella M, Sermeus W. Do pathways lead to better organized care processes?. J Eval Clin Pract 2009, 15:782-788. 10.1111/j.1365-2753.2008.01068.x, 19811589.
54. Savitz LA, Kaluzny AD. Assessing the implementation of clinical process innovations: a cross-case comparison. J Healthc Manag 2000, 45:366-379.
55. Wolfe CD, Rudd AG. Improvement of care in acute stroke units. Lancet 2011, 378:1679-1680. 10.1016/S0140-6736(11)61545-6, 21996469.