Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol

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• 作者：John S Furler (1)
  Doris Young (1)
  James Best (2)
  Elizabeth Patterson (3)
  David O’Neal (4)
  Danny Liew (5)
  Jane Speight (6) (7) (8)
  Leonie Segal (9)
  Carl May (10)
  Jo-Anne Manski-Nankervis (1)
  Elizabeth Holmes-Truscott (6) (7)
  Louise Ginnivan (1)
  Irene D Blackberry (1)
  
• 关键词：Type 2 diabetes ; Primary care ; Nursing ; Randomized trial ; Insulin ; Implementation ; Australia ; Health services research
• 刊名：Implementation Science
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：9
• 期：1
• 全文大小：202 KB
• 参考文献：1. Diabetes: the cost of diabetes. fact sheet 236 [http://www.who.int/mediacentre/factsheets/fs312/en/index.html]
  2. Australian Institute of Health and Welfare: / Diabetes: Australian facts 2008. Canberra: AIHW; 2008.
  3. Lee CMY, Colagiuri R, Magliano DJ, Cameron AJ, Shaw J, Zimmet P, Colagiuri S: The cost of diabetes in adults in Australia. / Diabetes Res Clin Pract 2013,99(3):385-90. CrossRef
  4. International Diabetes Federation: / IDF diabetes atlas 6th edn. 6th edition. Brussels, Belgium: International Diabetes Federation; 2013.
  5. UK Prospective Diabetes Study (UKPDS) G: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). / Lancet 1998,352(9131):837-53. CrossRef
  6. Jenkins AJ, Best JD, Klein LR, Lyons TJ: lsquoLipoproteins, glycoxidation and diabetic angiopathyrsquo. / Diabetes Metab Res Rev 2004,20(5):349-68. CrossRef
  7. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW: 10-Year follow-up of intensive glucose control in type 2 diabetes. / N Engl J Med 2008,359(15):1577-589. CrossRef
  8. Cheung NW, Conn JJ, d’Emden MC, Gunton JE, Jenkins AJ, Ross GP, Sinha AK, Andrikopoulos S, Colagiuri S, Twigg SM: Position statement of the Australian diabetes society: individualisation of glycated haemoglobin targets for adults with diabetes mellitus. / Med J Aust 2009,191(6):339-44.
  9. Rydén L, Grant PJ, Members ATF, / et al.: ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: The Task Force on diabetes, prediabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). / European Heart Journal 2013. August 30, 2013. doi:10.1093/eurheartj/eht108 Punblished online advance access Aug 2013
  10. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B: Management of Hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. / Diabetes Care 2008,31(1):173-75. CrossRef
  11. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR: Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). / Diabetes Care 2012, 35:1364-379. CrossRef
  12. Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A: Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study (Achieving Control Through Insulin plus Oral ageNts). / Diabetes Obes Metab 2009,11(1):27-2. CrossRef
  13. Davies M, Lavalle-González F, Storms F, Gomis R: Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial*. / Diabetes Obes Metab 2008,10(5):387-99. CrossRef
  14. Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R: Improvement of glycemic control in subjects with poorly controlled type 2 diabetes. / Diabetes Care 2005,28(6):1282-288. CrossRef
  15. Pradhan AD, Everett BM, Cook NR, Rifai N, Ridker PM: Effects of initiating insulin and metformin on glycemic control and inflammatory biomarkers among patients with type 2 diabetes: the LANCET randomized trial. / JAMA 2009,302(11):1186-194. CrossRef
  16. Bretzel RG, Nuber U, Landgraf W, Owens DR, Bradley C, Linn T: Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial. / Lancet 2008,371(9618):1073-084. CrossRef
  17. Davis TME, Davis WA, Bruce DG: Glycaemic levels triggering intensification of therapy in type 2 diabetes in the community: the Fremantle Diabetes Study. / Med J Aust 2006,184(7):325-28.
  18. Blak BT, Smith HT, Hards M, Maguire A, Gimeno V: A retrospective database study of insulin initiation in patients with type 2 diabetes in UK primary care. / Diabet Med 2012,29(8):e191-e198. CrossRef
  19. Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV: Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. / Diabetes Care 2005,28(10):2543-545. CrossRef
  20. Parchman ML, Pugh JA, Romero RL, Bowers KW: Competing demands or clinical inertia: the case of elevated glycosylated hemoglobin. / Ann Fam Med 2007,5(3):196-01. CrossRef
  21. AIHW Australian GP Statistics and Classification Center: / SAND abstract No. 135 from the BEACH program: diabetes in general practice patients. Sydney: AGPSCC University of Sydney; 2009.
  22. Waddingham S: Time to start insulin in general practice. / Brit J Primary Care Nurs 2012,9(3):114-17.
  23. Britt H, Miller GC, Charles J, Henderson J, Bayram C, Valenti L, Pan Y, Harrison C, Fahridin S, O’Halloran J: / General practice activity in Australia 2008-9. Canberra: AIHW; 2009.
  24. Department of Health and Ageing: / Towards a national primary healthcare strategy: a discussion paper from the Australian Government. Canberra: Commonwealth of Australia; 2008.
  25. Shah BR, Hux JE, Laupacis A, Zinman B, van Walraven C: Clinical inertia in response to inadequate glycemic control: do specialists differ from primary care physicians? / Diabetes Care 2005,28(3):600-06. CrossRef
  26. Harris S, Gerstein H, Yale J-F, Berard L, Stewart J, Webster-Bogaert S, Tompkins J: Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial. / BMC Health Serv Res 2013,13(1):71. CrossRef
  27. Dale J, Martin S, Gadsby R: Insulin initiation in primary care for patients with type 2 diabetes: 3-year follow-up study. / Primary Care Diabetes 2010,4(2):85-9. CrossRef
  28. Australian Medicare Local Alliance: / General practice nurse national survey report, 2012. Manuka, Canberra: Australian Medicare Local Alliance; 2012.
  29. Furler J, Blackberry I, Walker C, Anderson J, Nanski-Mankervis J, Young D, Audehm R, Best J: Stepping up: a nurse-led model of care for insulin initiation for people with type 2 diabetes. / Fam Pract 2014,00(No. 00):1-.
  30. Pen Computer Systems: Pen computer systems. [http://www.pencs.com.au/about.html]
  31. Richardson J, Iezzi A: Reserach paper 71: psychometric validity and the AQoL-8D multi attribute utility instrument. In / Center for Health Economics. Melbourne, Victoria: Monash University; 2011.
  32. Kroenke K, Spitzer RL, Williams JBW: The PHQ-9 - validity of a brief depression severity measure. / J Gen Intern Med 2001, 16:606-13. CrossRef
  33. Welch GW, Jacobson AM, Polonsky WH: The problem areas in diabetes scale. An evaluation of its clinical utility . / Diabetes Care 1997,20(5):760-66. CrossRef
  34. Horne R, Weinman J, Hankins M: The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. / Psychol Health 1999,14(1):1-4. CrossRef
  35. Snoek F, Skovlund S, Pouwer F: Development and validation of the insulin treatment appraisal scale (ITAS) in patients with type 2 diabetes. / Health Qual Life Outcomes 2007,5(1):69. CrossRef
  36. Polonsky WH, Hajos TRS, Dain MP, Snoek FJ: Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population. / Curr Med Res Opin 2011,27(6):1169-174. CrossRef
  37. Manual for general practice assessment questionnaire GPAQ V3 [http://www.gpaq.info/GPAQV3manual.pdf]
  38. Southern DM: / Measuring Consumers-experience of health information flow: development and validation of a measure of ‘perceived informational continuity-for use in general practice quality improvement. Melbourne: The University of Melbourne; 2011.
  39. Peyrot M, Rubin RR, Lauritzen T, Skovlund SE, Snoek FJ, Matthews DR, Landgraf R, Kleinebreil L: Resistance to insulin therapy among patients and providers. / Diabetes Care 2005,28(11):2673-679. CrossRef
  40. Gittell JH: / Relational coordination: guidelines for theory, measurement and analysis. Waltham, MA: Brandeis University; 2011.
  41. Weiss SJ, Davis HP: Validity and reliability of the collaborative practice scales. / Nurs Res 1985,34(5):299-05. CrossRef
  42. Normalization process theory on-line users manual and toolkit [http://www.normalizationprocess.org/]
  43. San Martin-Rodriguez L, Beaulieu M-D, D’Amour D, Ferrada-Videla M: The determinants of successful collaboration: a review of theoretical and empirical studies. / J Interprof Care 2005,19(2):S132-S147. CrossRef
  44. Blackberry ID, Furler JS, Best JD, Chondros P, Vale M, Walker C, Dunning T, Segal L, Dunbar J, Audehm R, / et al.: Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement And Coaching for Health (PEACH) pragmatic cluster randomised controlled trial. / BMJ 2013, 347:f5272. CrossRef
  45. Beilby J, Holton C, Bubner T, Harris M, PD G, Proudfoot J: / Building practice capacity for chronic disease management in general practice. Adelaide and Sydney: Department of General Practice, University of Adelaide and Center for GP Integration Studies, UNSW; 2004.
  46. Watts I, Foley E, Hutchinson R, Pascoe T, Whitecross L, Snowdon T: / General practice nursing in Australia. Melbourne: Royal Australian College of General Practitioners and the Royal College of Nursing Australia; 2004.
  47. Young D, Furler J, Vale M, Walker C, Segal L, Dunning P, Best J, Blackberry I, Audehm R, Sulaiman N, / et al.: Patient Engagement and Coaching for Health: The PEACH study - a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol. / BMC Fam Pract 2007.,8(20): doi:10.1186/1471-296--20
  48. Furler J, Walker C, Blackberry I, Dunning T, Sulaiman N, Dunbar J, Best J, Young D: The emotional context of self-management in chronic illness: a qualitative study of the role of health professional support in the self-management of type 2 diabetes. / BMC Health Serv Res 2008,8(1):214. CrossRef
  49. Furler J, Blackberry I, Walker C, Vale M, Young D: Barriers to innovation in the role of practice nurses: lessons learnt from the patient engagement and coaching for health (PEACH) study. In / General practice and primary care conference. Hobart: Primary Health Care and Research Information Service; 2008.
  
• 作者单位：John S Furler (1)
  Doris Young (1)
  James Best (2)
  Elizabeth Patterson (3)
  David O’Neal (4)
  Danny Liew (5)
  Jane Speight (6) (7) (8)
  Leonie Segal (9)
  Carl May (10)
  Jo-Anne Manski-Nankervis (1)
  Elizabeth Holmes-Truscott (6) (7)
  Louise Ginnivan (1)
  Irene D Blackberry (1)
  
  1. General Practice and Primary Healthcare Academic Center, University of Melbourne, 200 Berkeley St, Carlton, VIC, 3053, Australia
  2. School of Medicine, University of Melbourne, Parkville, Australia
  3. School of Nursing, University of Melbourne, Parkville, Australia
  4. Department of Medicine, St Vincent’s Hospital, University of Melbourne, Fitzroy, Australia
  5. Melbourne EpiCenter, the University of Melbourne, c/-The Royal Melbourne Hospital, 7 East, Main Building, Grattan St, Parkville, VIC, 3050, Australia
  6. The Australian Center for Behavioural Research in Diabetes, Diabetes Australia -Victoria, Melbourne, Australia
  7. Center for Mental Health and Wellbeing Research, School of PsychologyDeakin University, Burwood, VIC, Australia
  8. AHP Research, Hornchurch, Essex, UK
  9. School of Population Health Division of Health Sciences, University of South Australia, Playford Building P4-26, City East Campus, CEA-24, North Terrace, Adelaide, SA, 5000, Australia
  10. Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK
  
• ISSN：1748-5908

文摘

Background Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care. Methods This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ?.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice. Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs. Discussion The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12612001028897