Implementation salvage experiences from the Melbourne diabetes prevention study

BMC Public Health

Rob Carter²  Greg Johnson⁵  Catherine M Bennett³  Elizabeth Stewart³  Amy Timoshanko⁵  Sharleen O’Reilly³  Dino Asproloupos³  Nathalie Davis-Lameloise¹  Edward Janus⁴  Andrea Hernan¹  James Dunbar¹ 

[1] Greater Green Triangle University Department of Rural Health, Flinders University and Deakin University, Warrnambool, VIC, 3280, Australia;Deakin Health Economics, Deakin Strategic Research Centre - Population Health, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia;Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia;Department of Medicine, North West Academic Centre, The University of Melbourne, Western Hospital, Footscray, VIC, 3011, Australia;Diabetes Australia – Victoria, 570 Elizabeth Street, Melbourne, VIC, 3000, Australia

关键词: Randomised controlled trial;    Effectiveness;    Prevention;    Type 2 diabetes;    Salvage strategy;    Implementation;   

Others  :  1163057
DOI  :  10.1186/1471-2458-12-806

 received in 2012-04-24, accepted in 2012-09-17,  发布年份 2012

【 摘 要 】

Background

Many public health interventions based on apparently sound evidence from randomised controlled trials encounter difficulties when being scaled up within health systems. Even under the best of circumstances, implementation is exceedingly difficult. In this paper we will describe the implementation salvage experiences from the Melbourne Diabetes Prevention Study, which is a randomised controlled trial of the effectiveness and cost-effectiveness nested in the state-wide Life! Taking Action on Diabetes program in Victoria, Australia.

Discussion

The Melbourne Diabetes Prevention Study sits within an evolving larger scale implementation project, the Life! program. Changes that occurred during the roll-out of that program had a direct impact on the process of conducting this trial. The issues and methods of recovery the study team encountered were conceptualised using an implementation salvage strategies framework. The specific issues the study team came across included continuity of the state funding for Life! program and structural changes to the Life! program which consisted of adjustments to eligibility criteria, referral processes, structure and content, as well as alternative program delivery for different population groups. Staff turnover, recruitment problems, setting and venue concerns, availability of potential participants and participant characteristics were also identified as evaluation roadblocks. Each issue and corresponding salvage strategy is presented.

Summary

The experiences of conducting such a novel trial as the preliminary Melbourne Diabetes Prevention Study have been invaluable. The lessons learnt and knowledge gained will inform the future execution of this trial in the coming years. We anticipate that these results will also be beneficial to other researchers conducting similar trials in the public health field. We recommend that researchers openly share their experiences, barriers and challenges when conducting randomised controlled trials and implementation research. We encourage them to describe the factors that may have inhibited or enhanced the desired outcomes so that the academic community can learn and expand the research foundation of implementation salvage.

【 授权许可】

   
2012 Dunbar et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Stolberg HO, Norman G, Trop I: Randomized controlled trials. Am J Roentgenol 2004, 183(6):1539.
• [2]Glasgow RE, Lichtenstein E, Marcus AC: Why don't we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. Am J Public Health 2003, 93(8):1261-1267.
• [3]Rychetnik L, Frommer M, Hawe P, Shiell A: Criteria for evaluating evidence on public health interventions. J Epidemiol Community Health 2002, 56(2):119.
• [4]Salkind N: Internal and external validity. In The SAGE Dictionary of Quantitative Management Research. Edited by Moutinho L, Hutcheson G. London: SAGE Publications Ltd; 2011:147-149.
• [5]Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA: Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. BMJ 1998, 317(7156):465-468.
• [6]Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B: Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health 2009, 36(1):24-34.
• [7]Stetler CB, McQueen L, Demakis J, Mittman BS: An organizational framework and strategic implementation for system-level change to enhance research-based practice: QUERI Series. Implement Sci 2008, 3(1):30. BioMed Central Full Text
• [8]Tansella M, Thornicroft G: Implementation science: understanding the translation of evidence into practice. Br J Psychiatry 2009, 195(4):283-285.
• [9]Mittman B: Implementation research: Using science to guide implementation of evidence-based practices. In 34th Annual National Conference, "PREP for the New Decade – Policy Research Education and Practice", Association for Medical Education and Research in Substance Abuse (AMERSA). Maryland US; 2010. http://www.amersa.org/Mittman-Implementation%20Research.ppt webcite
• [10]Pressman G, Wildavsky A: Implementation: how great expectations in Washington are dashed in Oakland. 3rd edition. Berkley and Los Angeles: University of California Press; 1984.
• [11]Hoagwood K, Chaffin M, Chamberlain P, Bickman L, Mittman B: Implementation salvage strategies: maximizing methodological flexibility in children's mental health research. In 4th Annual NIH Conference on the Science of Dissemination and Implementation: Policy and Practice. Edited by Hoagwood K, Chaffin M, Chamberlain P, Bickman L, Mittman B. Maryland US; 2011. http://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/1C%20Hoagwood%20Session%20Implementation%20Salvage%20Strategies%20NIH%20DI%20Conference%20FINAL%20%5BRead-Only%5D.pdf webcite
• [12]International Diabetes Federation 5th Edition, The Global Burden 5th Edition, The Burden. http://www.idf.org/diabetesatlas/5e/the-global-burden webcite
• [13]Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM: Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, 346(6):393-403.
• [14]Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, et al.: Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997, 20(4):537-544.
• [15]Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, et al.: Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001, 344(18):1343-1350.
• [16]Diabetes Prevention Program Research G: 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet 2009, 374(9702):1677-1686.
• [17]Gillies CL, Abrams KR, Lambert PC, Cooper NJ, Sutton AJ, Hsu RT, Khunti K: Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. BMJ 2007, 334(7588):299-302.
• [18]Absetz P, Valve R, Oldenberg B, Heinonen H, Nissinen A, Fogelholm M, Ilvesmaki V, Talja M, Uutela A: Type 2 diabetes prevention in the “real world” - one-year results of the GOAL implementation trial. Diabetes Care 2007, 30(10):2465-2470.
• [19]Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG: Translating the diabetes prevention program into the community: The DEPLOY Pilot study. Am J Prev Med 2008, 35(4):357-363.
• [20]Laatikainen T, Dunbar J, Chapman A, Kilkkinen A, Vartiainen E, Heistaro S, Philpot B, Absetz P, Bunker S, O'Neil A, et al.: Prevention of type 2 diabetes by lifestyle intervention in an Australian primary health care setting: Greater Green Triangle (GGT) diabetes prevention project. BMC Public Health 2007, 7(1):249. BioMed Central Full Text
• [21]Simmons RK, Unwin N, Griffin SJ: International diabetes federation: an update of the evidence concerning the prevention of type 2 diabetes. Diabetes Research and Clinical Practice 2010, 87(2):143-149.
• [22]Venkat Narayan K, Benjamin E, Gregg E, Norris S, Engelgau M: Diabetes translation research: where are we and where do we want to be? Ann Intern Med 2004, 140(11):958.
• [23]Lindström J, Neumann A, Sheppard K, Gilis-Januszewska A, Greaves C, Handke U, Pajunen P, Puhl S, Pölönen A, Rissanen A: Take action to prevent diabetes - the IMAGE toolkit for the prevention of type 2 diabetes in Europe. Horm Metab Res 2010, 42:37.
• [24]Schwarz PE, Greaves CJ, Lindström J, Yates T, Davies MJ: Nonpharmacological interventions for the prevention of type 2 diabetes mellitus. Nat Rev Endocrinol 2012, 8:363-373.
• [25]Finnish Diabetes Association: Programme for the Prevention and Care of Diabetes in Finland 2003–2010 (DEHKO). Jyväskylä, Finland: Finnish Diabetes Association; 2003.
• [26]Saaristo T, Peltonen M, Keinanen-Kiukaanniemi S, Vanhala M, Saltevo J, Niskanen L, Oksa H, Korpi-Hyovalti E, Tuomilehto J: National type 2 diabetes prevention programme in Finland: FIN-D2D. Int J Circumpolar Health 2007, 66(2):101-112.
• [27]Schwarz P, Lindström J, Kissimova-Scarbeck K, Szybinski Z, Barengo N, Peltonen M, Tuomilehto J: The European perspective of type 2 diabetes prevention: diabetes in Europe-prevention using lifestyle, physical activity and nutritional intervention (DE-PLAN) project. Exp Clin Endocrinol Diabetes 2008, 116(3):167-172.
• [28]Dunbar J, Colagiuri S, Reddy P, Vita P, Timoshanko A, Audehm R, Milat A: Scaling up type 2 diabetes prevention programs: national and state interventions in Australia. In Diabetes Prevention in Practice. Edited by Schwarz P, Reddy P, Greaves C, Dunbar J, Schwarz J. Dresden: Tumaini Institute for Prevention Management; 2010.
• [29]Reddy P, Rankins D, Timoshanko A, Dunbar JA: Life! in Australia: translating prevention research into a large-scale intervention. Br J Diabetes Vasc Dis 2011, 11(4):193-197.
• [30]Moore SM, Hardie EA, Hackworth NJ, Critchley CR, Kyrios M, Buzwell SA, Crafti NA: Can the onset of type 2 diabetes be delayed by a group-based lifestyle intervention? A randomised control trial. Psychol Health 2011, 26(4):485-499.
• [31]Reddy P, Vaughan C, Dunbar J: Training facilitators of group-based diabetes prevention programs: recommendations from a public health intervention in Australia. In Diabetes Prevention in Practice. Edited by Schwarz P, Reddy P, Greaves C, Dunbar J, Schwarz J. Dresden: Tumaini Institute for Prevention Management; 2010.
• [32]Gillies CL, Lambert PC, Abrams KR, Sutton AJ, Cooper NJ, Hsu RT, Davies MJ, Khunti K: Different strategies for screening and prevention of type 2 diabetes in adults: cost effectiveness analysis. BMJ 2008, 336(7654):1180.
• [33]Vos T, Carter R, Barendregt J, Mihalopoulos C, Veerman J, Magnus A, Cobiac L, Bertram M, Wallace A: Assessing cost-effectiveness in prevention (ACE-Prevention): final report. In ACE–Prevention Team: Assessing cost-effectiveness in prevention (ACE-Prevention): final report. Brisbane and Deakin University, Melbourne: University of Queensland; 2010.
• [34]Goyder EC: Screening for and prevention of type 2 diabetes. BMJ 2008, 336(7654):1140.
• [35]Janus E, Best JD, Davis-Lameloise N, Philpot B, Hernan A, Bennett C, O'Reilly S, Carter R, Vartiainen E, Dunbar J: Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne diabetes prevention study. Trials 2012. Accepted in press
• [36]Chen L, Magliano D, Balkau B, Colagiuri S, Zimmet P, Tonkin A, Mitchell P, Phillips P, Shaw J: AUSDRISK: an Australian type 2 diabetes risk assessment tool based on demographic, lifestyle and simple anthropometric measures. Med J Aust 2010, 192(4):197-202.
• [37]Bandura A: Self-efficacy: The exercise of control. New York: Freeman; 1997.
• [38]Schwarzer R: Self-efficacy in the adoption and maintenance of health behaviors: theoretical approaches and a new model. In Self-efficacy: thought control of action. Edited by Schwarzer R. Washington, DC: Hemisphere; 1992:217-242.
• [39]Schwarzer R, Fuchs R: Self efficacy and health behaviors. In Predicting health behavior: Research and practice with social cognition models. Edited by Connor M, Norman P. Buckingham, U.K: Open University Press; 1996:163-196.
• [40]Caldwell PHY, Hamilton S, Tan A, Craig JC: Strategies for increasing recruitment to randomised controlled trials: systematic review. PLoS Med 2010, 7(11):e1000368.
• [41]Gul RB, Ali PA: Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs 2010, 19(12):227-233.
• [42]Netta-Turner D, Bucher L, Dixon L, Layton NJ: Riding the research roller coaster: what went right, what went wrong? J Wound Ostomy Continence Nurs 2008, 35(5):469.
• [43]Thomson CL, Morley KC, Teesson M, Sannibale C, Haber PS: Issues with recruitment to randomised controlled trials in the drug and alcohol field: a literature review and Australian case study. Drug Alcohol Rev 2008, 27(2):115-122.
• [44]Vedelø TW, Lomborg K: Reported challenges in nurse led randomised controlled trials: an integrative review of the literature. Scand J Caring Sci 2011, 25(1):194-200.
• [45]Watson J, Torgerson D: Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol 2006, 6(1):34. BioMed Central Full Text
• [46]Puffer S, Torgerson D: Recruitment difficulties in randomised controlled trials. Control Clin Trials 2003, 24(3):214-215.
• [47]Wilson S, Delaney BC, Roalfe A, Roberts L, Redman V, Wearn AM, Hobbs F: Randomised controlled trials in primary care: case study. BMJ 2000, 321(7252):24.
• [48]Freedman B: Equipoise and the ethics of clinical research. N Engl J Med 1987, 317(3):141-145.
• [49]Chard J, Lilford R: The use of equipoise in clinical trials. Soc Sci Med 1998, 47(7):891-898.
• [50]Rankins D, Hellinger H, Murphy B, Reddy P, Dunbar J: Effective recruitment in the Melbourne diabetes prevention study. In 2010 PHCRED Tri-State Conference: 16–17 September 2010. Warrnambool Victoria Australia; 2010. http://www.greaterhealth.org/resources/635/ webcite
• [51]Aby JS, Pheley AM, Steinberg P: Motivation for participation in clinical trials of drugs for the treatment of asthma, seasonal allergic rhinitis, and perennial nonallergic rhinitis. Ann Allerg Asthma Im 1996, 76(4):348-354.
• [52]Berryman D, Gill M, Pietsch J, Halloran H: Consulting consumers to develop marketing and recruitment strategies for a diabetes prevention program. Aust J Prim Health 2009, 15(2):173-179.
• [53]Page M, French S, McKenzie J, O'Connor D, Green S: Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners' recruitment of patients. BMC Med Res Methodol 2011, 11(1):35. BioMed Central Full Text
• [54]Walker C, Reddy P, Hernan A, Dunbar J: What works in diabetes prevention programs: A qualitative evaluation of consumers responses. In 2010 Primary Health Care Research Conference: 30 June - 2 July 2010. Darwin, Australia; 2010. http://www.greaterhealth.org/resources/595 webcite
• [55]Bandura A: Social foundations of thought and action: A social cognitive theory. Upper Saddle River, New Jersey, USA: Prentice Hall; 1986.
• [56]Schwarzer R, Renner B: Social-cognitive predictors of health behavior: action self-efficacy and coping self-efficacy. Health Psychol 2000, 19(5):487-495.
• [57]Schwarzer R: Modeling health behavior change: how to predict and modify the adoption and maintenance of health behaviors. Appl Psychol - Int Rev 2008, 57(1):1-29.
• [58]Vaughan C, Reddy P, Dunbar J: From rural beginnings to statewide roll out: Evaluation of facilitator training for a group based diabetes prevention program. Aust J Rural Health 2010, 18(2):59-65.
• [59]WorkHealth - Home. http://www.workhealth.vic.gov.au/ webcite
• [60]City of Knox - How old are we?. http://profile.id.com.au/Default.aspx?id=114&pg=102&gid=10&type=enum webcite
• [61]Who is at risk of diabetes?. http://www.diabetesvic.org.au/diabetes-prevention/are-you-at-risk webcite