Thrombolysis ImPlementation in Stroke (TIPS): evaluating the effectiveness of a strategy to increase the adoption of best evidence practice – protocol for a cluster randomised controlled trial in acute stroke care
Tóm tắt
Stroke is a leading cause of death and disability internationally. One of the three effective interventions in the acute phase of stroke care is thrombolytic therapy with tissue plasminogen activator (tPA), if given within 4.5 hours of onset to appropriate cases of ischaemic stroke. To test the effectiveness of a multi-component multidisciplinary collaborative approach compared to usual care as a strategy for increasing thrombolysis rates for all stroke patients at intervention hospitals, while maintaining accepted benchmarks for low rates of intracranial haemorrhage and high rates of functional outcomes for both groups at three months. A cluster randomised controlled trial of 20 hospitals across 3 Australian states with 2 groups: multi- component multidisciplinary collaborative intervention as the experimental group and usual care as the control group. The intervention is based on behavioural theory and analysis of the steps, roles and barriers relating to rapid assessment for thrombolysis eligibility; it involves a comprehensive range of strategies addressing individual-level and system-level change at each site. The primary outcome is the difference in tPA rates between the two groups post-intervention. The secondary outcome is the proportion of tPA treated patients in both groups with good functional outcomes (modified Rankin Score (mRS <2) and the proportion with intracranial haemorrhage (mRS ≥2), compared to international benchmarks. TIPS will trial a comprehensive, multi-component and multidisciplinary collaborative approach to improving thrombolysis rates at multiple sites. The trial has the potential to identify methods for optimal care which can be implemented for stroke patients during the acute phase. Study findings will include barriers and solutions to effective thrombolysis implementation and trial outcomes will be published whether significant or not. Australian New Zealand Clinical Trials Registry:
ACTRN12613000939796
Tài liệu tham khảo
Mackay J, Mensah G: The Atlas of Heart Disease and Stroke. 2004, Geneva: WHO
Compressed Mortality File 1999-2009: Underlying cause-of-death 1999–2009. CDC WONDER Online Database, compiled for Compressed Mortality File 1999–2009 Series 20, No. 20. 2012, Accessed August 20, 2012 [http://wonder.cdc.gov/mortSQl.html]
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS: Heart disease and stroke statistics—2013 update a report from the American heart association. Circulation. 2013, 127 (1): e6-e245. 10.1161/CIR.0b013e31828124ad.
Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A: Forecasting the future of cardiovascular disease in the United States a policy statement from the American heart association. Circulation. 2011, 123 (8): 933-944. 10.1161/CIR.0b013e31820a55f5.
Household component summary data table. 2012,http://meps.ahrq.gov/mepsweb/,
Australian Bureau of Statistics: Cardiovascular Disease in Australia: a snapshot, 2004-05. 2006, Canberra: ABS
Australian Institute of Health and Welfare: Australia's health 2006. The Economic Impact of Stroke in Australia. 2006, Canberra: AIHW, Melbourne: NSF; 2013
Deloitte Access Economics: The economic impact of stroke in Australia. 2013, Melbourne: NSF
Australian Institute of Health and Welfare: Stroke and its management in Australia: an update. Cardiovascular Disease Series. 2013, Canberra: AIHW
National Stroke Foudation: National Stroke Audit – Acute Services Clinical Audit Report 2011. 2011, Melbourne: NSF
Hankey GJ, Jamrozik K, Broadhurst RJ, Forbes S, Anderson CS: Long-term disability after first-ever stroke and related prognostic factors in the Perth community stroke study, 1989–1990. Stroke. 2002, 33 (4): 1034-1040. 10.1161/01.STR.0000012515.66889.24.
International Stroke Trial Collaborative Group: The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19,435 patients with acute ischaemic stroke. Lancet. 1997, 349 (9065): 1569-1581.
Gilligan A, Thrift A, Sturm J, Dewey H, Macdonell R, Donnan G: Stroke units, tissue plasminogen activator, aspirin and neuroprotection: which stroke intervention could provide the greatest community benefit?. Cerebrovasc Dis. 2005, 20 (4): 239-244. 10.1159/000087705.
Saver J, Fonarow G, Smith E, Reeves M, Grau-Sepulveda M, Pan W, Olson D, Hernandez A, Peterson E, Schwamm L: Time to treatment with intravenous tissue plasminogen activator and outcome from acute ischemic stroke. JAMA. 2013, 309 (23): 2480-2488. 10.1001/jama.2013.6959.
Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T: Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008, 359 (13): 1317-1329. 10.1056/NEJMoa0804656.
Wardlaw JM, Murray V, Berge E, del Zoppo G, Sandercock P, Lindley RL, Cohen G: Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet. 2012, 379 (9834): 2364-2372. 10.1016/S0140-6736(12)60738-7.
IST-3 Collaborative Group: Effect of thrombolysis with alteplase within 6 h of acute ischaemic stroke on long-term outcomes (the third International Stroke Trial [IST-3]): 18- month follow-up of a randomised controlled trial. Lancet Neurol. 2013, 12 (8): 768-776.
Hacke W, Donnan G, Fieschi C, Kaste M, Von Kummer R, Broderick J, Brott T, Frankel M, Grotta J, Haley E: Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004, 363 (9411): 768-774.
Wahlgren N, Ahmed N, Dávalos A, Hacke W, Millán M, Muir K, Roine R, Toni D, Lees K, Investigators S: Thrombolysis with alteplase 3-4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study. Lancet. 2008, 372 (9646): 1303-1309. 10.1016/S0140-6736(08)61339-2.
Saver J, Gornbein J, Grotta J, Liebeskind D, Lutsep H, Schwamm L, Scott P, Starkman S: Number needed to treat to benefit and to harm for intravenous tissue plasminogen activator therapy in the 3- to 4.5-hour window: joint outcome table analysis of the ECASS 3 trial. Stroke. 2009, 40 (7): 2433-2437. 10.1161/STROKEAHA.108.543561.
del Zoppo G, Saver J, Jauch E, Adams H, American Heart Association Stroke Council: Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator: a science advisory from the American heart Association/American Stroke Association. Stroke. 2009, 40 (8): 2945-2948. 10.1161/STROKEAHA.109.192535.
Buchan A, Barber P, Newcommon N, Karbalai H, Demchuk A, Hoyte K, Klein G, Feasby T: Effectiveness of t-PA in acute ischemic stroke: outcome relates to appropriateness. Neurology. 2000, 54 (3): 679-684. 10.1212/WNL.54.3.679.
Saver J: Number needed to treat estimates incorporating effects over the entire range of clinical outcomes: novel derivation method and application to thrombolytic therapy for acute stroke. Arch Neurol. 2004, 61 (7): 1066-1070.
Wardlaw J, Warlow C, Counsell C: Systematic review of evidence on thrombolytic therapy for acute ischaemic stroke. Lancet. 1997, 350 (9078): 607-614. 10.1016/S0140-6736(97)03022-5.
Hoffman JR, Cooper RJ: How is more negative evidence being used to support claims of benefit: the curious case of the third international stroke trial (IST-3). Emerg Med Australas. 2012, 24 (5): 473-476. 10.1111/j.1742-6723.2012.01604.x.
Canadian Stroke Best Practices and Standards Working Group Canadian Best Practice Recommendations for Stroke Care: Canadian best practice recommendations for stroke care. Edited by: Lindsay M, Gubitz G, Bayley M, Phillips S. 2013, Ottawa: Canadian Stroke Network, Fourth
Party ISW: National Clinical Guideline for Stroke. 2012, London: Royal College of Physicians, 4
National Stroke Foundation: Clinical guidelines for stroke management. 2010, Melbourne: NSF
Jauch EC, Saver JL, Adams HP, Bruno A, Demaerschalk BM, Khatri P, McMullan PW, Qureshi AI, Rosenfield K, Scott PA: Guidelines for the early management of patients with acute ischemic stroke a guideline for healthcare professionals from the American heart association/American stroke association. Stroke. 2013, 44 (3): 870-947. 10.1161/STR.0b013e318284056a.
Samsa G, Reutter R, Parmigiani G, Ancukiewicz M, Abrahamse P, Lipscomb J, Matchar D: Performing cost-effectiveness analysis by integrating randomized trial data with a comprehensive decision model: application to treatment of acute ischemic stroke. J Clin Epidemiol. 1999, 52 (3): 259-271. 10.1016/S0895-4356(98)00151-6.
Fagan S, Morgenstern L, Petitta A, Ward R, Tilley B, Marler J, Levine S, Broderick J, Kwiatkowski T, Frankel M, Brott T, Walker M: Cost-effectiveness of tissue plasminogen activator for acute ischemic stroke. Neurology. 1998, 50 (4): 883-890. 10.1212/WNL.50.4.883.
Moodie M: Trial application of a Model of Resource Utilization, Costs, and Outcomes for Stroke (MORUCOS) to assist priority setting in stroke. Stroke. 2004, 35 (5): 1041-1046. 10.1161/01.STR.0000125012.36134.89.
Sandercock P, Berge E, Dennis M, Forbes J, Hand P, Kwan J, Lewis S, Lindley R, Neilson A, Wardlaw J: Cost-effectiveness of thrombolysis with recombinant tissue plasminogen activator for acute ischemic stroke assessed by a model based on UK NHS costs. Stroke. 2004, 35 (6): 1490-1497. 10.1161/01.STR.0000126871.98801.6E.
Nguyen-Huynh MN, Johnston SC: Is hospitalization after TIA cost-effective on the basis of treatment with tPA?. Neurology. 2005, 65 (11): 1799-1801. 10.1212/01.wnl.0000187067.93321.fa.
National Health Priority Action Council (NHPAC): National service improvement framework for heart, stroke and vascular disease. 2006, Canberra: Australian Govenement Department of Health and Ageing
Adams HP, Brott TG, Furlan AJ, Gomez CR, Grotta J, Helgason CM, Kwiatkowski T, Lyden PD, Marler JR, Torner J: Guidelines for thrombolytic therapy for acute stroke: a supplement to the guidelines for the management of patients with acute ischemic stroke a statement for healthcare professionals from a special writing group of the stroke council, American heart association. Circulation. 1996, 94 (5): 1167-1174. 10.1161/01.CIR.94.5.1167.
Fang M, Cutler D, Rosen A: Trends in thrombolytic use for ischemic stroke in the United States. J Hosp Med. 2010, 5 (7): 406-409. 10.1002/jhm.689.
Rudd A, Hoffman A, Grant R, Campbell J, Lowe D, Intercollegiate Working Party for Stroke: Stroke thrombolysis in England, Wales and Northern Ireland: how much do we do and how much do we need?. J Neurol Neurosurg Psychiatry. 2011, 82 (1): 14-19. 10.1136/jnnp.2009.203174.
Improving patient care: the implementation of change in clinical practice. Edited by: Grol R, Wensing M, Eccles M, Davis D. 2005, London: Elsevier: Butterworth-Heinemann
Quain DA, Parsons MW, Loudfoot AR, Spratt NJ, Evans MK, Russell ML, Royan AT, Moore AG, Miteff F, Hullick C: Improving access to acute stroke therapies: a controlled trial of organised pre-hospital and emergency care. Med J Aust. 2008, 189 (8): 429-433.
Cadilhac D, Ibrahim J, Pearce D, Ogden K, McNeill J, Davis S, Donnan G, SCOPES Study Group: Multicenter comparison of processes of care between stroke units and conventional care wards in Australia. Stroke. 2004, 35 (5): 1035-1040. 10.1161/01.STR.0000125709.17337.5d.
Schwamm L, Fonarow G, Reeves M, Pan W, Frankel M, Smith E, Ellrodt G, Cannon C, Liang L, Peterson E, LaBresh K: Get with the guidelines – stroke is associated with sustained improvement in care for patients hospitalized with acute stroke or transient ischemic attack circulation. Circulation. 2009, 119: 107-115. 10.1161/CIRCULATIONAHA.108.783688.
Dirks M, Niessen L, van Wijngaarden J, Koudstaal P, Franke C, van Oostenbrugge R, Huijsman R, Lingsma H, Minkman M, Dippel D, PRomoting ACute Thrombolysis in Ischemic StrokE (PRACTISE) Investigators: Promoting thrombolysis in acute ischemic stroke. Stroke. 2011, 42 (5): 1325-1330. 10.1161/STROKEAHA.110.596940.
Schouten LM, Hulscher ME, Everdingen JJ, Huijsman R, Grol RP: Evidence for the impact of quality improvement collaboratives: systematic review. BMJ. 2008, 336 (7659): 1491-1494. 10.1136/bmj.39570.749884.BE.
Jones K, Piterman L: The effectiveness of the breakthrough series methodology. Aust J Prim Health. 2008, 14 (1): 59-65. 10.1071/PY08008.
Scott PA, Meurer WJ, Frederiksen SM, Kalbfleisch JD, Xu Z, Haan MN, Silbergleit R, Morgenstern LB: A multilevel intervention to increase community hospital use of alteplase for acute stroke (INSTINCT): a cluster-randomised controlled trial. Lancet Neurol. 2013, 12 (2): 139-148. 10.1016/S1474-4422(12)70311-3.
Michie S, van Stralen MM, West R: The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011, 6 (1): 42-10.1186/1748-5908-6-42.
Ghia D, Thomas P, Cordato D, Worthington J, Cappelen-Smith C, Griffith N, Hanna I, Hodgkinson S, McDougall A, Beran R: Validation of emergency and final diagnosis coding in transient ischemic attack: South Western Sydney transient ischemic attack study. Neuroepidemiology. 2010, 25 (1): 53-58.
Gattellari M, Worthington J, Jalaludin B, Mohsin M: Stroke unit care in a real-life setting Can results from randomized controlled trials be translated into every-day clinical practice? An observational study of hospital data in a large Australian population. Stroke. 2009, 40 (1): 10-17. 10.1161/STROKEAHA.108.523548.
Wang Y, Levi C, Attia J, D'Este C, Spratt N, Fisher J: Seasonal variation in stroke in the Hunter region, Australia: a 5-year hospital-based study, 1995-2000. Stroke. 2003, 34 (5): 1144-1150. 10.1161/01.STR.0000067703.71251.B6.
Wang Y, Levi C, D’Este C, Attia J, Fisher J: Variation of stroke attack rates in rural, urban, and coalfields areas of the Hunter region, Australia, 1995-2000. J Stroke Cerebrovasc Dis. 2003, 12 (2): 103-110. 10.1053/jscd.2003.12.
Henderson T, Shepheard J, Sundararajan V: Quality of diagnosis and procedure coding in ICD-10 administrative data. Med Care. 2006, 44 (11): 1011-1019. 10.1097/01.mlr.0000228018.48783.34.
Marsden D, Spratt N, Walker R, Barker D, Attia J, Pollack M, Parsons M, Levi C: Trends in stroke attack rates and case fatality in the Hunter region Australia 1996–2008. Cerebrovasc Dis. 2010, 30 (5): 500-507. 10.1159/000319022.
Kokotailo R, Hill M: Coding of stroke and stroke risk factors using international classification of diseases, revisions 9 and 10. Stroke. 2005, 36 (8): 1776-1781. 10.1161/01.STR.0000174293.17959.a1.
Rankin L: Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957, 2 (5): 200-215.
Wahlgren N, Ahmed N, Dávalos A, Ford G, Grond M, Hacke W, Hennerici M, Kaste M, Kuelkens S, Larrue V, Lees K, Roine R, Soinne L, Toni D, Vanhooren G, SITS-MOST Investigators: Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007, 369 (9558): 275-282. 10.1016/S0140-6736(07)60149-4.
Banks J, Marotta C: Outcomes validity and reliability of the modified Rankin scale implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007, 38 (3): 1091-1096. 10.1161/01.STR.0000258355.23810.c6.
Valente T, Davis R: Accelerating the diffusion of innovations using opinion leaders. ANNALS Am Acad Polit Soc Sci. 1999, 566: 55-67. 10.1177/0002716299566001005.
Katz E: The two-step flow of communication: an up-to-date report on a hypothesis. Publ Opin Q. 1957, 21: 61-78. 10.1086/266687.
Strecher V, Seijts G, Kok G, Latham G, Glasgow R, DeVellis B, Meertens R, Bulger D: Goal setting as a strategy for behaviour change. Health Educ Behav. 1995, 22 (3): 190-
Kilo C: A framework for collaborative improvement: lessons from the institute for healthcare improvement's breakthrough series. Qual Manag Health Care. 1998, 6 (4): 1-13. 10.1097/00019514-199806040-00001.
Plsek P: Collaborating across organizational boundaries to improve the quality of care. Am J Infect Control. 1997, 25 (2): 85-95. 10.1016/S0196-6553(97)90033-X.
Hirokawa R: Group communication and problem-solving effectiveness: an investigation of group phases. Hum Commun Res. 1983, 9 (4): 291-305. 10.1111/j.1468-2958.1983.tb00700.x.
Casebeer L, Engler S, Bennett N, Irvine M, Sulkes D, DesLauriers M, Zhang S: A controlled trial of the effectiveness of internet continuing medical education. BMC Med. 2008, 6: 37-10.1186/1741-7015-6-37.
Grimshaw J, Thomas R, MacLennan G, Fraser C, Ramsay C, Vale L, Whitty P, Eccles M, Matowe L, Shirran L: Effectiveness and efficiency of guideline dissemination and implementation strategies. 2004
Kawamoto K, Houlihan C, Balas E, Lobach D: Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ. 2005, 330 (7494): 765-10.1136/bmj.38398.500764.8F.
Hayes R, Moulton L: Cluster Randomised Trials. 2009, London: Chapman and Hall