The effect of a patient-oriented treatment decision aid for risk factor management in patients with diabetes (PORTDA-diab): Study protocol for a randomised controlled trial

Trials

Volumn 13, Issue , 2012, Pages

  Denig, Petra ^a   Dun, Mathijs ^a   Schuling, Jan ^a   Haaijer Ruskamp, Flora M ^a   Voorham, Jaco ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

Cardiovascular diseases; Choice behaviour; Decision support systems; Decision making; Diabetes mellitus; Electronic health records; Patient participation; Primary healthcare; Research design; Risk assessment; Type 2

Indexed keywords

INSULIN; ORAL ANTIDIABETIC AGENT;

ARTICLE; CARDIOVASCULAR RISK; CLINICAL TRIAL; DECISION SUPPORT SYSTEM; DIABETIC PATIENT; DOCTOR PATIENT RELATION; ELECTRONIC MEDICAL RECORD; EMOTION; EMPOWERMENT; HEALTH STATUS; HUMAN; INSULIN TREATMENT; MEDICAL DECISION MAKING; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SATISFACTION; PRESCRIPTION; QUESTIONNAIRE; TREATMENT OUTCOME;

ADULT; DECISION MAKING; DIABETES COMPLICATIONS; DIABETES MELLITUS, TYPE 2; FEMALE; HUMANS; MALE; NETHERLANDS; PATIENT PARTICIPATION; PATIENT-CENTERED CARE; RESEARCH DESIGN; RISK ADJUSTMENT; RISK FACTORS;

EID: 84869217987     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-219     Document Type: Article

References (76)

1. American Diabetes Association Standards of medical care in diabetes--2012. Diabetes Care 2012, Suppl 1:S11-63. American Diabetes Association.
2. Guthrie B, Emslie-Smith A, Morris AD. Which people with type 2 diabetes achieve good control of intermediate outcomes? Population database study in a UK region. Diabet Med 2009, 26:1269-1276. 10.1111/j.1464-5491.2009.02837.x, 20002480.
3. Sidorenkov G, Haaijer-Ruskamp FM, de Zeeuw D, Denig P. A longitudinal study examining adherence to guidelines in diabetes care according to different definitions of adequacy and timeliness. PLoS One 2011, 6:e24278. 10.1371/journal.pone.0024278, 3169586, 21931669.
4. Renders CM, Valk GD, Griffin SJ, Wagner E, van Eijk JT, Assendelft WJJ. Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings. Cochrane Database Syst Rev 2000, 4:CD001481.
5. Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care 2001, 24:561-587. 10.2337/diacare.24.3.561, 11289485.
6. Glasgow RE, Hiss RG, Anderson RM, Friedman NM, Hayward RA, Marrero DG, Taylor CB, Vinicor F. Report of the health care delivery work group: behavioral research related to the establishment of a chronic disease model for diabetes care. Diabetes Care 2001, 24:124-130. 10.2337/diacare.24.1.124, 11194217.
7. Heisler M. Actively engaging patients in treatment decision making and monitoring as a strategy to improve hypertension outcomes in diabetes mellitus. Circulation 2008, 117:1355-1357. 10.1161/CIRCULATIONAHA.108.764514, 18347219.
8. Schulman-Green DJ, Naik AD, Bradley EH, McCorkle R, Bogardus ST. Goal setting as a shared decision making strategy among clinicians and their older patients. Patient Educ Couns 2006, 63:145-151. 10.1016/j.pec.2005.09.010, 16406471.
9. Bairey Merz CN, Buse JB, Tuncer D, Twillman GB. Physician attitudes and practices and patient awareness of the cardiovascular complications of diabetes. J Am Coll Cardiol 2002, 40:1877-1881. 10.1016/S0735-1097(02)02529-9, 12446074.
10. Crosson JC, Heisler M, Subramanian U, Swain B, Davis GJ, Lasser N, Ross S, Schmittdiel JA, Onyemere K, Tseng CW. Physicians' perceptions of barriers to cardiovascular disease risk factor control among patients with diabetes: results from the translating research into action for diabetes (TRIAD) study. J Am Board Fam Med 2010, 23:171-178. 10.3122/jabfm.2010.02.090125, 20207927.
11. Benhamou PY. Improving diabetes management with electronic health records and patients' health records. Diabetes Metab 2011, Suppl 4:S53-56.
12. Larme AC, Pugh JA. Evidence-based guidelines meet the real world: the case of diabetes care. Diabetes Care 2001, 24:1728-1733. 10.2337/diacare.24.10.1728, 11574433.
13. Murray S, Lazure P, Schroter S, Leuschner PJ, Posel P, Kellner T, Jenkins RD. International challenges without borders: a descriptive study of family physicians' educational needs in the field of diabetes. BMC Fam Pract 2011, 12:27. 10.1186/1471-2296-12-27, 3118117, 21569337.
14. van Steenkiste B, van der Weijden T, Stoffers HE, Grol R. Barriers to implementing cardiovascular risk tables in routine general practice. Scan J Prim Health Care 2004, 22:32-37.
15. Wan Q, Harris MF, Zwar N, Vagholkar S. Sharing risk management: an implementation model for cardiovascular absolute risk assessment and management in Australian general practice. Int J Clin Pract 2008, 62:905-911. 10.1111/j.1742-1241.2008.01769.x, 2658000, 18479283.
16. Torley D, Zwar N, Comino EJ, Harris M. GPs' views of absolute cardiovascular risk and its role in primary prevention. Aust Fam Physician 2005, 34:503-504. 507.
17. Morrow AS, Haidet P, Skinner J, Naik AD. Integrating diabetes self-management with the health goals of older adults: a qualitative exploration. Patient Educ Couns 2008, 72:418-423. 10.1016/j.pec.2008.05.017, 2613855, 18621501.
18. Charles C, Gafni A, Whelan T, O'Brien MA. Treatment decision aids: conceptual issues and future directions. Health Expect 2005, 8:114-125. 10.1111/j.1369-7625.2005.00325.x, 15860052.
19. Ali MK, Shah S, Tandon N. Review of electronic decision-support tools for diabetes care: a viable option for low- and middle-income countries?. J Diab Science Technolog 2011, 5:553-570.
20. Black AD, Car J, Pagliari C, Anandan C, Cresswell K, Bokun T, McKinstry B, Procter R, Majeed A, Sheikh A. The impact of eHealth on the quality and safety of health care: a systematic overview. PLoS Med 2011, 8:e1000387. 10.1371/journal.pmed.1000387, 3022523, 21267058.
21. Hirsch O, Keller H, Krones T, Donner-Banzhoff N. Arriba-lib: association of an evidence-based electronic library of decision aids with communication and decision-making in patients and primary care physicians. Int J Evid Based Healthc 2012, 10:68-76. 10.1111/j.1744-1609.2012.00255.x, 22405418.
22. Sposito AC, Ramires JA, Jukema JW, Molina JC, da Silva PM, Ghadanfar MM, Wilson PW. Physicians' attitudes and adherence to use of risk scores for primary prevention of cardiovascular disease: cross-sectional survey in three world regions. Curr Med Res Opin 2009, 25:1171-1178. 10.1185/03007990902846423, 19323611.
23. Graham ID, Logan J, Bennett CL, Presseau J, O'Connor AM, Mitchell SL, Tetroe JM, Cranney A, Hebert P, Aaron SD. Physicians' intentions and use of three patient decisicion aids. BMC Med Inform Dec Making 2007, 7:20.
24. Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ 2005, 330:765. 10.1136/bmj.38398.500764.8F, 555881, 15767266.
25. O'Donnell S, Cranney A, Jacobsen MJ, Graham ID, O'Connor AM, Tugwell P. Understanding and overcoming the barriers of implementing patient decision aids in clinical practice. J Eval Clin Pract 2006, 12:174-181. 10.1111/j.1365-2753.2006.00613.x, 16579826.
26. Mollon B, Chong J, Holbrook AM, Sung M, Thabane L, Foster G. Features predicting the success of computerized decision support for prescribing: a systematic review of randomized controlled trials. BMC Med Inform Decis Mak 2009, 9:11. 10.1186/1472-6947-9-11, 2667396, 19210782.
27. Peiris DP, Joshi R, Webster RJ, Groenestein P, Usherwood TP, Heeley E, Turnbull FM, Lipman A, Patel AA. An electronic clinical decision support tool to assist primary care providers in cardiovascular disease risk management: development and mixed methods evaluation. J Med Internet Res 2009, 11:e51. 10.2196/jmir.1258, 2802562, 20018588.
28. Jones JB, Shah NR, Bruce CA, Stewart WF. Meaningful use in practice using patient-specific risk in an electronic health record for shared decision making. Am J Prev Med 2011, Suppl 2:S179-186.
29. Krones T, Keller H, Sönnichsen A, Sadowski EM, Baum E, Wegscheider K, Rochon J, Donner-Banzhoff N. Absolute cardiovascular disease risk and shared decision making in primary care: a randomized controlled trial. Ann Fam Med 2008, 6:218-227. 10.1370/afm.854, 2384995, 18474884.
30. Maclean CD, Gagnon M, Callas P, Littenberg B. The Vermont diabetes information system: a cluster randomized trial of a population based decision support system. J Gen Intern Med 2009, 24:1303-1310. 10.1007/s11606-009-1147-x, 2787948, 19862578.
31. Holbrook A, Thabane L, Keshavjee K, Dolovich L, Bernstein B, Chan D, Troyan S, Foster G, Gerstein H. COMPETE II Investigators: Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial. CMAJ 2009, 181:37-44. 2704409, 19581618.
32. Holbrook A, Pullenayegum E, Thabane L, Troyan S, Foster G, Keshavjee K, Chan D, Dolovich L, Gerstein H, Demers C, Curnew G. Shared electronic vascular risk decision support in primary care: Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III) randomized trial. Arch Intern Med 2011, 171:1736-1744. 10.1001/archinternmed.2011.471, 22025430.
33. O'Connor PJ, Sperl-Hillen JM, Rush WA, Johnson PE, Amundson GH, Asche SE, Ekstrom HL, Gilmer TP. Impact of electronic health record clinical decision support on diabetes care: a randomized trial. Ann Fam Med 2011, 9:12-21. 10.1370/afm.1196, 3022040, 21242556.
34. Cleveringa FG, Gorter KJ, van den Donk M, Rutten GE. Combined task delegation, computerized decision support, and feedback improve cardiovascular risk for type 2 diabetic patients: a cluster randomized trial in primary care. Diabetes Care 2008, 31:2273-2275. 10.2337/dc08-0312, 2584178, 18796619.
35. Fowler FJ, Levin CA, Sepucha KR. Informing and involving patients to improve the quality of medical decisions. Health Aff 2011, 30:699-706.
36. Heisler M, Vijan S, Anderson RM, Ubel PA, Bernstein SJ, Hofer TP. When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make?. J Gen Intern Med 2003, 18:893-902. 10.1046/j.1525-1497.2003.21132.x, 1494939, 14687274.
37. Zulman DM, Kerr EA, Hofer TP, Heisler M, Zikmund-Fisher BJ. Patient-provider concordance in the prioritization of health conditions among hypertensive diabetes patients. J Gen Intern Med 2010, 25:408-414. 10.1007/s11606-009-1232-1, 2855000, 20127197.
38. Rachmani R, Slavacheski I, Berla M, Frommer-Shapira R, Ravid M. Treatment of high-risk patients with diabetes: motivation and teaching intervention. J Am Soc Nephrol 2005, 16:S22-26. 10.1681/ASN.2004110965, 15938028.
39. Naik AD, Kallen MA, Walder A, Street RL. Improving hypertension control in diabetes mellitus: the effects of collaborative and proactive health communication. Circulation 2008, 117:1361-1368. 10.1161/CIRCULATIONAHA.107.724005, 18316489.
40. Grover SA, Lowensteyn I, Joseph L, Kaouache M, Marchand S, Coupal L, Boudreau G. Cardiovascular Health Evaluation to Improve Compliance and Knowledge Among Uninformed Patients (CHECK-UP) Study Group: Patient knowledge of coronary risk profile improves the effectiveness of dyslipidemia therapy: the CHECK-UP study: a randomized controlled trial. Arch Intern Med 2007, 167:2296-2303. 10.1001/archinte.167.21.2296, 18039987.
41. Sheridan SL, Draeger LB, Pignone MP, Keyserling TC, Simpson RJ, Rimer B, Bangdiwala SI, Cai J, Gizlice Z. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies. BMC Health Serv Res 2011, 11:331. 10.1186/1472-6963-11-331, 3268742, 22141447.
42. Naik AD, Schulman-Green D, McCorkle R, Bradley EH, Bogardus ST. Will older persons and their clinicians use a shared decision-making instrument?. J Gen Intern Med 2005, 20:640-643. 10.1007/s11606-005-0110-8, 1490165, 16050860.
43. Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record. BMJ 2004, 328:1159. 10.1136/bmj.328.7449.1159, 411089, 15142919.
44. Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, Christianson TJ, Mullan RJ, Smith SA. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomised trial. Arch Intern Med 2007, 167:1076-1082. 10.1001/archinte.167.10.1076, 17533211.
45. Corser W, Holmes-Rovner M, Lein C, Gossain V. A shared decision-making primary care intervention for type 2 diabetes. Diabetes Educ 2007, 33:700-708. 10.1177/0145721707304086, 17684171.
46. Coulter A, Ellins J. Effectiveness of strategies for informing, educating, and involving patients. BMJ 2007, 335:24-27. 10.1136/bmj.39246.581169.80, 1910640, 17615222.
47. Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff 2001, 20:64-78.
48. Makoul G, Clayman ML. An integrative model of shared decision making in medical encounters. Patient Educ Couns 2006, 60:301-312. 10.1016/j.pec.2005.06.010, 16051459.
49. Ramadas A, Quek KF, Chan CK, Oldenburg B. Web-based interventions for the management of type 2 diabetes mellitus: a systematic review of recent evidence. Int J Med Inform 2011, 80:389-405. 10.1016/j.ijmedinf.2011.02.002, 21481632.
50. Waldron CA, van der Weijden T, Ludt S, Gallacher J, Elwyn G. What are effective strategies to communicate cardiovascular risk information to patients? A systematic review. Patient Educ Couns 2011, 82:169-181. 10.1016/j.pec.2010.04.014, 20471766.
51. Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med 2009, 169:1560-1568.
52. Breslin M, Mullan RJ, Montori VM. The design of a decision aid about diabetes medications for use during the consultation with patients with type 2 diabetes. Patient Educ Couns 2008, 73:465-472. 10.1016/j.pec.2008.07.024, 18771876.
53. Montori VM, Breslin M, Maleska M, Weymiller AJ. Creating a conversation: insights from the development of a decision aid. PLoS Med 2007, 4:e233. 10.1371/journal.pmed.0040233, 1939861, 17683195.
54. Mann DM, Ponieman D, Montori VM, Arciniega J, McGinn T. The Statin choice decision aid in primary care: a randomized trial. Patient Educ Couns 2010, 80:138-140. 10.1016/j.pec.2009.10.008, 19959322.
55. Pignone M, Sheridan SL, Lee YZ, Kuo J, Phillips C, Mulrow C, Zeiger R. Heart to Heart: a computerized decision aid for assessment of coronary heart disease risk and the impact of risk-reduction interventions for primary prevention. Prev Cardiol 2004, 7:26-33. 10.1111/j.1520-037X.2004.2417.x, 15010625.
56. Elwyn G, O'Connor AM, Bennett C, Newcombe RG, Politi M, Durand MA, Drake E, Joseph-Williams N, Khangura S, Saarimaki A, Sivell S, Stiel M, Bernstein SJ, Col N, Coulter A, Eden K, Härter M, Rovner MH, Moumjid N, Stacey D, Thomson R, Whelan T, van der Weijden T, Edwards A. Assessing the quality of decision support technologies using the International Patient Decision Aid Standards instrument (IPDASi). PLoS One 2009, 4:e4705. 10.1371/journal.pone.0004705, 2649534, 19259269.
57. Huang ES, Gorawara-Bhat R, Chin MH. Self-reported goals of older patients with type 2 diabetes mellitus. J Am Geriatr Soc 2005, 53:306-311. 10.1111/j.1532-5415.2005.53119.x, 2291346, 15673357.
58. Chin MH, Drum ML, Jin L, Shook ME, Huang ES, Meltzer DO. Variation in treatment preferences and care goals among older patients with diabetes and their physicians. Med Care 2008, 46:275-286. 10.1097/MLR.0b013e318158af40, 2659644, 18388842.
59. Rutten GEHM, De Grauw WJC, Nijpels G, Goudswaard AN, Uitewaal PJM, Van der Does FEE, Heine RJ, Van Ballegooie E, Verduijn MM, Bouma M. NHG-Standaard Diabetes mellitus type 2 (Tweede herziening). Huisarts Wet 2006, 49:137-152. [Dutch].
60. Hill S, Pink J, Cadilhac D, Edwards A, Kaufman C, Rogers S, Ryan R, Tonkin A. Absolute risk representation in cardiovascular risk prevention: comprehension and preferences of health care consumers and general practitioners involved in a focus group study. BMC Publ Health 2010, 10:108.
61. Stevens RJ, Kothari V, Adler AI, Stratton IM. United Kingdom Prospective Diabetes Study (UKPDS) Group: UKPDS 56: The UKPDS Risk Engine: a model for the risk of coronary heart disease in type II diabetes. Clin Sci 2001, 101:671-679. 10.1042/CS20000335, 11724655.
62. Anderson KM, Odell PM, Wilson PWF, Kannel WB. Cardiovascular disease risk profiles. Am Heart J 1991, 121:293-298. 10.1016/0002-8703(91)90861-B, 1985385.
63. Clarke PM, Gray AM, Briggs A, Farmer AJ, Fenn P, Stevens RJ, Matthews DR, Stratton IM, Holman RR. UK Prospective Diabetes Study (UKDPS) Group: A model to estimate the lifetime health outcomes of patients with type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model (UKPDS no. 68). Diabetologia 2004, 47:1747-1759. 10.1007/s00125-004-1527-z, 15517152.
64. Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy. Diabetes Care 2000, 23:739-743. 10.2337/diacare.23.6.739, 10840988.
65. Pouwer F, Snoek FJ. Patients' Evaluation of the Quality of Diabetes Care (PEQ-D): development and validation of a new instrument. Qual Saf Health Care 2002, 11:131-136. 10.1136/qhc.11.2.131, 1743604, 12448804.
66. 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 Heal 1999, 14:1-24.
67. Snoek FJ, Pouwer F, Welch GW, Polonsky WH. Diabetes-related emotional distress in Dutch and U.S. diabetic patients. Diabetes Care 2000, 231:1305-1309.
68. Group EQ. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
69. Voorham J, Denig P. Computerized extraction of information on the quality of diabetes care from free text in electronic patient records of general practitioners. J Am Med Inform Assoc 2007, 14:349-354. 10.1197/jamia.M2128, 2244890, 17329733.
70. Eigenmann CA, Colagiuri R, Skinner TC, Trevena L. Are current psychometric tools suitable for measuring outcomes of diabetes education?. Diabet Med 2009, 26:425-436. 10.1111/j.1464-5491.2009.02697.x, 19388974.
71. Garfield SA, Malozowski S, Chin MH, Narayan KM, Glasgow RE, Green LW, Hiss RG, Krumholz HM. Diabetes Mellitus Interagency Coordinating Committee (DIMCC): Considerations for diabetes translation research in real-world settings. Diabetes Care 2003, 26:1670-1674.
72. Feifer C, Ornstein SM. Strategies for increasing adherence to clinical guidelines and improving patient outcomes in small primary care practices. Jt Comm J Qual Saf 2004, 30:432-441.
73. Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Légaré F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011, 10:CD001431.
74. Belcher VN, Fried TR, Agostini JV, Tinetti ME. Views of older adults on patient participation in medication-related decision making. J Gen Intern Med 2006, 21:298-303. 10.1111/j.1525-1497.2006.00329.x, 1484726, 16686804.
75. Murray E, Burns J, See TS, Lai R, Nazareth I. Interactive health communication applications for people with chronic disease. Cochr Database Syst Rev 2005, 4:CD004274.
76. Wolpert HA, Anderson BJ. Management of diabetes: are doctors framing the benefits from the wrong perspective?. BMJ 2001, 323:994-996. 1121514, 11679393.