Clinician-led improvement in cancer care (CLICC) - testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial - study protocol

Implementation Science

Mary Haines¹  Dianne L O’Connell²  Amanda Dominello⁵  Miranda Xhilaga⁶  Andrew J Brooks³  Andrew B Kneebone⁴  David P Smith⁷  Jane Young¹  Bernadette (Bea) Brown¹ 

[1] School of Public Health, University of Sydney, Camperdown, Australia;Cancer Research Division, Cancer Council NSW, Sydney, Australia;Westmead Clinical School, University of Sydney, Camperdown, Australia;Northern Clinical School, University of Sydney, Camperdown, Australia;Sax Institute, Haymarket, Australia;Prostate Cancer Foundation of Australia, Melbourne, Australia;Griffith Health Institute, Griffith University, Gold Coast, QLD, Australia

关键词: Interventions;    Cancer;    Clinical networks;    Clinical practice guidelines;    Implementation strategies;   

Others  :  801204
DOI  :  10.1186/1748-5908-9-64

 received in 2014-04-18, accepted in 2014-05-22,  发布年份 2014

【 摘 要 】

Background

Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard. There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care. Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals. In Australia, the provision of evidence-based care for men with prostate cancer has been identified as a high priority. Clinical audits have shown that fewer than 10% of patients in New South Wales (NSW) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery. This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer.

Methods/Design

In Phase I, a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation (ACI) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery. The intervention will be introduced in nine NSW hospitals over 10 months using a stepped wedge design. Outcome data (referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy) will be collected through review of patient medical records. In Phase II, mixed methods will be used to identify mechanisms of provider and organisational change. Clinicians’ knowledge and attitudes will be assessed through surveys. Process outcome measures will be assessed through document review. Semi-structured interviews will be conducted to elucidate mechanisms of change.

Discussion

The study will be one of the first randomised controlled trials to test the effectiveness of clinical networks to lead changes in clinical practice in hospitals treating patients with high-risk cancer. It will additionally provide direction regarding implementation strategies that can be effectively employed to encourage widespread adoption of clinical practice guidelines.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611001251910.

【 授权许可】

   
2014 Brown et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Grol R, Grimshaw J: From best evidence to best practice: effective implementation of change in patients’ care. Lancet 2003, 362(9391):1225-1230.
• [2]Haines A, Kuruvilla S, Borchert M: Bridging the implementation gap between knowledge and action for health. Bull World Health Organ 2004, 82(10):724-731.
• [3]Grol R: Successes and failures in the implementation of evidence-based guidelines for clinical practice. Medical Care 2001, 39:II-46-II-54.
• [4]Buchan H, Sewell JR, Sweet M: Adopting Best Evidence in Practice:Translating evidence into practice. Med J Australia 2004, 180(Suppl 6):s43-s44.
• [5]Westfall JM, Mold J, Fagnan L: Practice-Based Research-“Blue Highways” on the NIH Roadmap. J Am Med Assoc 2007, 180(Suppl 6):s43-s44.
• [6]Dougherty D, Conway P: The “3 T’s” road map to transform US health care. JAMA 2008, 299(19):2319-2321.
• [7]Sung N, Crowley WJ, Genel M, Salber P, Sandy L, Sherwood L, Johnson S, Catanese V, Tilson H, Getz K, Larson EL, Scheinberg D, Reece EA, Slavkin H, Dobs A, Grebb J, Martinez RA, Korn A, Rimoin D: Central challenges facing the national clinical research enterprise. JAMA 2003, 289:1278-1287.
• [8]Rubenstein L, Pugh J: Strategies for Promoting Organizational and Practice Change by Advancing Implementation Research. J Gen Intern Med 2006, 21(Suppl 2):S58-S64.
• [9]Hakkennes S, Dodd K: Guideline implementation in allied health professions: a systematic review of the literature. Qual Saf Health Care 2008, 17(4):296-300.
• [10]Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, Robertson N: Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2010, (Issue 3):Art. No.: CD005470.
• [11]Francke AL, Smit MC, de Veer AJ, Mistiaen P: Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decis Mak 2008, 8(1):38. BioMed Central Full Text
• [12]Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR: Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999, 282(15):1458-1465.
• [13]Grol R, Wensing M: What drives change? Barriers to and incentives for achieving evidence-based practice. Med J Aust 2004, 180(6 Suppl):S57-S60.
• [14]Grol R: Has guideline development gone astray? Yes. Br Med J 2010, 340:c306.
• [15]Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O: Diffusion of Innovations in Service Organizations: Systematic Review and Recommendations. Milbank Q 2004, 82(4):581-629.
• [16]Davies P, Walker AE, Grimshaw JM: A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation of the results of rigorous evaluations. Implementation Sci 2010, 5(1):14. BioMed Central Full Text
• [17]Goodwin N, Peck E, Freeman T, Posaner R, 6 P: Managing across diverse networks of care: lessons from other sectors. Report for the National Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO); 2004. [http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/64455/FR-08-1218-039.pdf webcite]
• [18]Stewart GJ, Dwyer JM, Goulston KJ: The Greater Metropolitan Clinical Taskforce: an Australian model for clinician governance. Med J Aust 2006, 184(12):597-598.
• [19]Laliberte L, Fennell ML, Papandonatos G: The relationship of membership in research networks to compliance with treatment guidelines for early-stage breast cancer. Med Care 2005, 43(5):471-479.
• [20]Ray-Coquard I, Philip T, De Laroche G, Froger X, Suchaud JP, Voloch A, Mathieu-Daudé H, Fervers B, Farsi F, Browman GP: A controlled ‘before-after’ study: impact of a clinical guidelines programme and regional cancer network organization on medical practice. Br J Cancer 2002, 86(3):313-321.
• [21]ACIM (Australian Cancer Incidence and Mortality) Books [http://www.aihw.gov.au/acim-books/ webcite]
• [22]Catalona WJ, Smith DS, Ratliff TL, Basler JW: Detection of organ-confined prostate cancer is increased through prostate-specific antigen—based screening. JAMA 1993, 270(8):948-954.
• [23]Partin AW, Kattan MW, Subong ENP, Walsh PC, Wojno KJ, Oesterling JE, Scardino PT, Pearson JD: Combination of prostate-specific antigen, clinical stage, and Gleason score to predict pathological stage of localized prostate cancer [Erratum in JAMA 1997 Jul 9;278(2):118]. JAMA 1997, 277(18):1445-1451.
• [24]Partin AW, Pound CR, Clemens JQ, Epstein JI, Walsh PC: Serum PSA after anatomic radical prostatectomy. The Johns Hopkins experience after 10 years. Urol Clin North Am 1993, 20(4):713-725.
• [25]Pound CR, Partin AW, Epstein JI, Walsh PC: Prostate-specific antigen after anatomic radical retropubic prostatectomy: patterns of recurrence and cancer control. Urol Clin North Am 1997, 24(2):395-406.
• [26]National Health Priority Action Council (NHPAC): National Service Improvement Framework for Cancer. Canberra: Australian Government Department of Health and Ageing; 2006.
• [27]Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset J-F, van Velthoven R, Marechal J-M, Scalliet P, Haustermans K, Pierart M, for the European Organization for Research and Treatment of Cancer: Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet 2005, 366(9485):572-578.
• [28]Swanson GP, Thompson IM, Tangen C, Miller G, Lucia MS, Troyer DA, Paradelo J, Chin JL, Messing EM, Canby-Higano E, Forman J, Crawford DE: Phase III Randomized Study of Adjuvant Radiation Therapy versus Observation in Patients with Pathologic T3 Prostate Cancer (SWOG 8794). Int J Radiat Oncol Biol Phys 2005, 63(1):S1.
• [29]Wiegel T, Bottke D, Steiner U, Siegmann A, Golz R, Storkel S, Willich N, Semjonow A, Souchon R, Stockle M, Rübe C, Weissbach L, Althaus P, Rebmann U, Kälble T, Feldmann HJ, Wirth M, Hinke A, Hinkelbein W, Miller K: Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol 2009, 27(18):2924-2930.
• [30]Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED: Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol 2009, 181(3):956-962.
• [31]Australian Cancer Network Management of Metastatic Prostate Cancer Working Party: Clinical Practice Guidelines for the Management of Locally Advanced and Metastatic Prostate Cancer. Sydney: Cancer Council Australia and Australian Cancer Network; 2010.
• [32]Adjuvant and Salvage Radiotherapy After Prostatectomy: ASTRO/AUA Guideline [http://www.auanet.org/education/guidelines/radiation-after-prostatectomy.cfm webcite]
• [33]Smith DP, King MT, Egger S, Berry MP, Stricker PD, Cozzi P, Ward J, O’Connell DL, Armstrong BK: Quality of life three years after diagnosis of localised prostate cancer: population based cohort study. BMJ 2009, 339:12.
• [34]Bolton D, Severi G, Millar JL, Kelsall H, Davidson A-J, Smith C, Bagnato M, Pedersen J, Giles G, Syme R: A whole of population-based series of radical prostatectomy in Victoria, 1995 to 2000. Aust N Z J Public Health 2009, 33(6):527-533.
• [35]Evans S, Millar J, Davis I, Murphy D, Bolton D, Giles G, Frydenberg M, Andrianopoulos N, Wood J, Frauman A, Costello AJ, McNeil JJ: Patterns of care for men diagnosed with prostate cancer in Victoria from 2008 to 2011. Med J Aust 2013, 198(10):540-545.
• [36]Hoffman K, Nguyen P, Chen M, Chen R, Choueiri T, Hu J, Kuban D, D’Amico A: Recommendations for post-prostatectomy radiation therapy in the United States before and after the presentation of randomized trials. J Urol 2011, 185(1):116-120.
• [37]Flanagan ME, Ramanujam R, Doebbeling BN: The effect of provider-and workflow-focused strategies for guideline implementation on provider acceptance. Implementation Sci 2009, 4(1):71. BioMed Central Full Text
• [38]Grimshaw JM, Shirran L, Thomas R, Mowatt G, Fraser C, Bero L, Grilli R, Harvey E, Oxman A, O’Brien MA: Changing provider behavior: an overview of systematic reviews of interventions. Med Care 2001, 39(8 Suppl 2):II-2-II-45.
• [39]Robertson N, Baker R, Hearnshaw H: Changing the clinical behavior of doctors: a psychological framework. Qual Health Care 1996, 5(1):51-54.
• [40]Grol R: Implementing guidelines in general practice care. Qual Health Care 1992, 1(3):184-191.
• [41]Oxman A, Thomson M, Davis D, Haynes R: No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. Can Med Assoc J 1995, 153(10):1423-1431.
• [42]Flodgren G, Parmelli E, Doumit G, Gattellari M, O’Brien MA, Grimshaw J, Eccles MP: Local opinion leaders: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2011, (Issue 8):Art. No.: CD000125.
• [43]Ivers N, Jamtvedt J, Young J, Odgaard-Jensen J, French S, O’Brien M, Johansen M, Grimshaw J, Oxman A: Audit and Feedback: effects on professional practice and healthcare outcomes (Review). Cochrane Database Syst Rev 2012, (Issue 6):Art.No.: CD000259.
• [44]Giguere A, Legare F, Grimshaw J, Turcotte S, Flander M, Grudniewicz A, Makosso-Kallyth S, Wolf F, Famer A, Gagnon M: Printed educational materials: effects on professional practice and healthcare outcomes (Review). Cochrane Database Syst Rev 2013, (Issue 4):Art.No.: CD004398.
• [45]Forstetlund L, Bjorndal A, Rshidian A, Jamtvedt G, O’Brien M, Wolf F, Davis DA, Odgaard-Jensen J, Oxman A: Continuing education meetings and workshops: effects on professional practice and health care outcomes (Review). Cochrane Database Syst Rev 2012, (Issue 11):Art.No.: CD003030.
• [46]Grimshaw J, Eccles M, Lavis J, Hill S, Squires J: Knowledge translation of research findings. Implementation Sci 2012, 7:50. BioMed Central Full Text
• [47]Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C: Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess 2004, 8(6):1-72. iii-iv
• [48]Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, Group botPT: Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care 2005, 14:26-33.
• [49]Dulko D, Hertz E, Julien J, Beck S, Mooney K: Implementation of cancer pain guidelines by acute care nurse practitioners using an audit and feedback strategy. J Am Acad Nurse Pract 2010, 22(1):45-55.
• [50]Prior M, Guerin M, Grimmer-Somers K: The effectiveness of clinical guideline implementation strategies–a synthesis of systematic review findings. J Eval Clin Pract 2008, 14(5):888-897.
• [51]Boaz A, Baeza J, Fraser A, (EIS) EISCG: Effective implementation of research into practice: an overview of systematic reviews of the health literature. BMC Res Notes 2011, 4:212. BioMed Central Full Text
• [52]Davis DA, Taylor-Vaisey A: Translating guidelines into practice: a systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. Can Med Assoc J 1997, 157(4):408-416.
• [53]Hysong SJ, Best RG, Pugh JA: Clinical practice guideline implementation strategy patterns in Veterans Affairs primary care clinics. Health Serv Res 2007, 42(1 Pt 1):84-103.
• [54]Lankshear S, Brierley JD, Imrie K, Yurcan M: Changing physician practice: an evaluation of knowledge transfer strategies to enhance physician documentation of cancer stage. Healthcare quarterly (Toronto, Ont) 2010, 13(1):84-92.
• [55]Boxer M, Forstner D, Kneebone A, Delaney G, Koh E-S, Fuller M, Kaadan N: Impact of a real-time peer review audit on patient management in a radiation oncology department. J Med Imaging Radiat Oncol 2009, 53(4):405-411.
• [56]Blayney DW, McNiff K, Hanauer D, Miela G, Markstrom D, Neuss M: Implementation of the Quality Oncology Practice Initiative at a university comprehensive cancer center. J Clin Oncol 2009, 27(23):3802-3807.
• [57]Brouwers MC, Garcia K, Makarski J, Daraz L, EE CICPRTE: The landscape of knowledge translation interventions in cancer control: What do we know and where to next? A review of systematic reviews. Implementation Sci 2011, 6:130. BioMed Central Full Text
• [58]Davey P, Brown E, Fenelon L, Finch R, Gould I, Hartman G, Holmes A, Ramsay C, Taylor E, Wilcox M, Wiffen PJ: Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev 2005, (Issue 4):Art. No.: CD003543.
• [59]Arnold SR, Straus SE: Interventions to improve antibiotic prescribing practices in ambulatory care. Cochrane Database Syst Rev 2005, (Issue 4):Art. No.: CD003539.
• [60]Chaillet N, Dubé E, Dugas M, Audibert F, Tourigny C, Fraser WD, Dumont A: Evidence-based strategies for implementing guidelines in obstetrics: a systematic review. Obstet Gynecol 2006, 108(5):1234-1245.
• [61]Chaillet N, Dumont A: Evidence-based strategies for reducing cesarean section rates: a meta-analysis. Birth 2007, 34(1):53-64.
• [62]Davis D, Evans M, Jadad A, Perrier L, Rath D, Ryan D, Sibbald G, Straus S, Rappolt S, Wowk M, Zwarenstein M: The case for knowledge translation: shortening the journey from evidence to effect. BMJ 2003, 327(7405):33-35.
• [63]Green LW, Kreuter MW: Health Promotion Planning: An Educational and Environmental Approach. 2nd edition. Mountain View, California: Mayfield Publishing; 1991.
• [64]Sales A, Smith J, Curran G, Kochevar L: Models, strategies, and tools. Theory in implementing evidence-based findings into health care practice. J Gen Intern Med 2006, 21(Suppl 2):S43-S49.
• [65]Greenhalgh T, Robert G, Bate P, Kyriakidou O, Macfarlane F, Peacock R: How to spread good ideas: A systematic review of the literature on diffusion, dissemination and sustainability of innovations in health service delivery and organisation. Report for the National Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO); 2004. [http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/64340/FR-08-1201-038.pdf webcite]
• [66]Michie S, van Stralen MM, West R: The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implementation Sci 2011, 6:42. BioMed Central Full Text
• [67]Brown CA, Lilford RJ: The stepped wedge trial design: a systematic review. BMC Med Res Methodol 2006, 6:54. BioMed Central Full Text
• [68]Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, group C, Pragmatic Trials in Healthcare g: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008, 14:2390.
• [69]Campbell M, Piaggio G, Elbourne D, Altman D, Group. ftC: Consort 2010 statement: extension to cluster randomised trials. Br Med J 2012, 345:e5661.
• [70]ARIA [http://www.adelaide.edu.au/apmrc/research/projects/category/aria.html webcite]
• [71]Australian Bureau of Statistics: Information paper: an introduction to socio-economic indexes for areas (SEIFA). Canberra: ABS; 2008.
• [72]Young JM, Leong DC, Armstrong K, O’Connell D, Armstrong BK, Spigelman AD, Ackland S, Chapuis P, Kneebone AB, Solomon MJ: Concordance with national guidelines for colorectal cancer care in New South Wales: a population-based patterns of care study. MJA 2007, 186:292-295.
• [73]Vinod SK, O’Connell DL, Simonella L, Delaney GP, Boyer M, Peters M, Miller D, Supramaniam R, McCawley L, Armstrong B: Gaps in optimal care for lung cancer. J Thorac Oncol 2008, 3(8):871-879.
• [74]Vinod SK, Simonella L, Goldsbury D, Delaney GP, Armstrong B, O’Connell DL: Underutilization of radiotherapy for lung cancer in New South Wales. Aust Cancer 2010, 116(3):686-694.
• [75]Sladek R, Bond M, Huynh L, Chew D, Phillips P: Thinking styles and doctors’ knowledge and behaviours relating to acute coronary syndromes guidelines. Implementation Sci 2008, 3:23. BioMed Central Full Text
• [76]Hakkennes S, Green S: Measures for assessing practice change in medical practitioners. Implementation Sci 2006, 1:29. BioMed Central Full Text
• [77]Haines M, Brown B, Craig J, D’Este C, Elliott E, Klineberg E, McInnes E, Middleton S, Paul C, Redman S, Yano EM, on behalf of the Clinical Networks Research Group: Determinants of successful clinical networks: the conceptual framework and study protocol. Implementation Sci 2012, 7:16. BioMed Central Full Text