Cost-effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: design of a cluster-randomized controlled trial

BMC Psychiatry

Maurits W van Tulder²  Harm WJ van Marwijk¹  Petra JM Elders¹  Judith E Bosmans²  Marcel C Adriaanse²  Alide D Pols¹  Susan EM van Dijk² 

[1] Department of General Practice and the EMGO institute for Health and Care research, VU University Medical Centre, Amsterdam, The Netherlands;Department of Health Sciences and the EMGO institute for Health and Care research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, Amsterdam, HV, 1081, The Netherlands

关键词: Nurse led treatment;    Primary care;    Stepped-care;    Coronary heart disease;    Type 2 diabetes mellitus;    Cost-effectiveness;    Depression prevention;    Subthreshold depression;   

Others  :  1124065
DOI  :  10.1186/1471-244X-13-128

 received in 2013-04-10, accepted in 2013-04-24,  发布年份 2013

【 摘 要 】

Background

Co-morbid major depression is a significant problem among patients with type 2 diabetes mellitus and/or coronary heart disease and this negatively impacts quality of life. Subthreshold depression is the most important risk factor for the development of major depression. Given the highly significant association between depression and adverse health outcomes and the limited capacity for depression treatment in primary care, there is an urgent need for interventions that successfully prevent the transition from subthreshold depression into a major depressive disorder. Nurse led stepped-care is a promising way to accomplish this. The aim of this study is to evaluate the cost-effectiveness of a nurse-led indicated stepped-care program to prevent major depression among patients with type 2 diabetes mellitus and/or coronary heart disease in primary care who also have subthreshold depressive symptoms.

Methods/design

An economic evaluation will be conducted alongside a cluster-randomized controlled trial in approximately thirty general practices in the Netherlands. Randomization takes place at the level of participating practice nurses. We aim to include 236 participants who will either receive a nurse-led indicated stepped-care program for depressive symptoms or care as usual. The stepped-care program consists of four sequential but flexible treatment steps: 1) watchful waiting, 2) guided self-help treatment, 3) problem solving treatment and 4) referral to the general practitioner. The primary clinical outcome measure is the cumulative incidence of major depressive disorder as measured with the Mini International Neuropsychiatric Interview. Secondary outcomes include severity of depressive symptoms, quality of life, anxiety and physical outcomes. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline and 3, 6, 9 and 12 months.

Discussion

The intervention being investigated is expected to prevent new cases of depression among people with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression, with subsequent beneficial effects on quality of life, clinical outcomes and health care costs. When proven cost-effective, the program provides a viable treatment option in the Dutch primary care system.

Trial registration

Dutch Trial Register NTR3715

【 授权许可】

   
2013 van Dijk et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Smits F, Smits N, Schoevers R, Deeg D, Beekman A, Cuijpers P: An epidemiological approach to depression prevention in old age. Am J Geriatr Psychiatr 2008, 16:444-453.
• [2]Cuijpers P, Van Straten A, Smit F, Mihalopoulos C, Beekman A: Preventing the onset of depressive disorders: a meta-analytic review of psychological interventions. Am J Psychiatr 2008, 165:1272-1280.
• [3]Mathers CD, Loncar D: Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med 2006, 3:e442.
• [4]de Graaf R, ten Have M, van Gool C, van Dorsselaer S: Prevalence of mental disorders and trends from 1996 to 2009. Results from the Netherlands Mental Health Survey and Incidence Study-2. Soc Psychiatr Psychiatr Epidemiol 2012, 47:203-213.
• [5]Kessler RC, Ustun T (Eds): The WHO World Mental Health Surveys. Cambridge: Cambridge University Press; 2008.
• [6]Anderson RJ, Freedland KE, Clouse RE, Lustman PJ: The prevalence of comorbid depression in adults with diabetes. Diabetes Care 2001, 24:1069-1078.
• [7]Härter M, Baumeister H, Reuter K, Jacobi F, Höfler M, Bengel J, Wittchen HU: Increased 12-month prevalence rates of mental disorders in patients with chronic somatic diseases. Psychother Psychosom 2007, 76:354-360.
• [8]Rudisch B, Nemeroff CB: Epidemiology of comorbid coronary artery disease and depression. Biol Psychiatr 2003, 54:227-240.
• [9]Bot M, Pouwer F, Ormel J, Slaets JPJ, De Jonge P: Predictors of incident major depression in diabetic outpatients with subthreshold depression. Diabet Med 2010, 27:1295-1301.
• [10]Thombs BD, Bass EB, Ford DE, Stewart KJ, Tsilidis KK, Patel U, Fauerbach JA, Bush DE, Ziegelstein RC: Prevalence of depression in survivors of acute myocardial infarction. J Gen Intern Med 2006, 21:30-38.
• [11]Hance M, Carney RM, Freedland KE, Skala J: Depression in patients with coronary heart disease: A 12-month follow-up. Gen Hosp Psychiatr 1996, 18:61-65.
• [12]Gehi A, Haas D, Pipkin S, Whooley MA: Depression and medication adherence in outpatients with coronary heart disease: findings from the Heart and Soul Study. Arch Int Med 2005, 165:2508-2513.
• [13]Lin EHB, Katon W, Von Korff M, Rutter C, Simon GE, Oliver M, Ciechanowski P, Ludman EJ, Bush T, Young B: Relationship of depression and diabetes self-care, medication adherence, and preventive care. Diabetes Care 2004, 27:2154-2160.
• [14]Ruo B, Rumsfeld JS, Hlatky MA, Liu H, Browner WS, Whooley MA: Depressive symptoms and health-related quality of life: the heart and soul study. JAMA 2003, 290:215-221.
• [15]Ali S, Stone M, Skinner TC, Robertson N, Davies M, Khunti K: The association between depression and health-related quality of life in people with type 2 diabetes: a systematic literature review. Diabetes Metab Res Rev 2010, 26:75-89.
• [16]Lin EHB, Heckbert SR, Rutter CM, Katon WJ, Ciechanowski P, Ludman EJ, Oliver M, Young BA, McCulloch DK, Von Korff M: Depression and increased mortality in diabetes: unexpected causes of death. Ann Fam Med 2009, 7:414-421.
• [17]Katon W, Lin EHB, Von Korff M, Ciechanowski P, Ludman E, Young B, Rutter C, Oliver M, McGregor M: Integrating depression and chronic disease care among patients with diabetes and/or coronary heart disease: the design of the TEAMcare study. Contemp Clin Trials 2010, 31:312-322.
• [18]Simon GE, Katon WJ, Lin EHB, Ludman E, VonKorff M, Ciechanowski P, Young BA: Diabetes complications and depression as predictors of health service costs. Gen Hosp Psychiatr 2005, 27:344-351.
• [19]Rutledge T, Vaccarino V, Johnson BD, Bittner V, Olson MB, Linke SE, Cornell CE, Eteiba W, Sheps DS, Francis J: Depression and cardiovascular health care costs among women with suspected myocardial ischemia: prospective results from the WISE (Women's Ischemia Syndrome Evaluation) Study. J Am Coll Cardiol 2009, 53:176-183.
• [20]Bosmans JE, Adriaanse MC: Outpatient costs in pharmaceutically treated diabetes patients with and without a diagnosis of depression in a Dutch primary care setting. BMC Health Serv Res 2012, 12:46. BioMed Central Full Text
• [21]Egede LE, Zheng D, Simpson K: Comorbid depression is associated with increased health care use and expenditures in individuals with diabetes. Diabetes Care 2002, 25:464-470.
• [22]Smit F, Willemse G, Koopmanschap M, Onrust S, Cuijpers P, Beekman A: Cost-effectiveness of preventing depression in primary care patients. Br J Psychiatr 2006, 188:330-336.
• [23]Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H: Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatr 2004, 184:526-533.
• [24]Cuijpers P, Beekman ATF, Reynolds CF: Preventing depression: a global priority. JAMA 2012, 307:1033-1034.
• [25]Muñoz RF, Cuijpers P, Smit F, Barrera AZ, Leykin Y: Prevention of major depression. Annu Rev Clin Psychol 2010, 6:181-212.
• [26]van't Veer-Tazelaar PJ, van Marwijk HWJ, van Oppen P, van Hout HPJ, van der Horst HE, Cuijpers P, Smit F, Beekman ATF: Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatr 2009, 66:297-304.
• [27]van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van der Horst HE, Smit F, Cuijpers P, Beekman AT: Prevention of late-life anxiety and depression has sustained effects over 24 months: a pragmatic randomized trial. Am J Geriatr Psychiatr 2011, 19:230-239.
• [28]Katon WJ, Von Korff M, Lin EHB, Simon G, Ludman E, Russo J, Ciechanowski P, Walker E, Bush T: The Pathways Study: a randomized trial of collaborative care in patients with diabetes and depression. Arch Gen Psychiatr 2004, 61:1042-1049.
• [29]Katon WJ, Russo JE, Von Korff M, Lin EHB, Ludman E, Ciechanowski PS: Long-term effects on medical costs of improving depression outcomes in patients with depression and diabetes. Diabetes Care 2008, 31:1155-1159.
• [30]Katon W, Unützer J, Fan MY, Williams JW Jr, Schoenbaum M, Lin EHB, Hunkeler EM: Cost-effectiveness and net benefit of enhanced treatment of depression for older adults with diabetes and depression. Diabetes Care 2006, 29:265-270.
• [31]Katon WJ, Lin EHB, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D: Collaborative care for patients with depression and chronic illnesses. N Engl J Med 2010, 363:2611-2620.
• [32]Kroenke K, Spitzer RL: The PHQ-9: a new depression diagnostic and severity measure. Psychiatr Ann 2002, 32:509-515.
• [33]Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC: The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatr 1998, 59:22-33.
• [34]Kroenke K, Spitzer RL, Williams JBW: The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care 2003, 41:1284-1292.
• [35]Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N, Fishman T, Falloon K, Hatcher S: Validation of PHQ-2 and PHQ-9 to screen for major depression in the primary care population. Ann Fam Med 2010, 8:348-353.
• [36]Zuithoff NPA, Vergouwe Y, King M, Nazareth I, van Wezep MJ, Moons KGM, Geerlings MI: The Patient Health Questionnaire-9 for detection of major depressive disorder in primary care: consequences of current thresholds in a crosssectional study. BMC Fam Pract 2010, 11:98. BioMed Central Full Text
• [37]Van Vliet I, De Beurs E: Het Mini Internationaal Neuropsychiatrisch Interview (MINI) Een kort gestructureerd diagnostisch psychiatrisch interview voor DSM-IV- en ICD-10-stoornissen. Tijdschr Psychiatr 2007, 49:393-397.
• [38]Voordouw I, van Osch B, Terweij M: De cursus Leven met een chronische ziekte. Utrecht: Trimbos-instituut; 2005.
• [39]Bosmans JE, Brook OH, van Hout HPJ, de Bruijne MC, Nieuwenhuyse H, Bouter LM, Stalman WAB, van Tulder MW: Cost effectiveness of a pharmacy-based coaching programme to improve adherence to antidepressants. Pharmacoeconomics 2007, 25:25-37.
• [40]Mynors-Wallis L, Davies I, Gray A, Barbour F, Gath D: A randomised controlled trial and cost analysis of problem-solving treatment for emotional disorders given by community nurses in primary care. Br J Psychiatr 1997, 170:113-119.
• [41]Platform Vitale Vaten: Zorgstandaard Vasculair Risicomanagement deel I (voor zorgverleners). Den Haag: Platform Vitale Vaten; 2009.
• [42]Trimbos-instituut: Naar een zorgstandaard voor depressie: Checklists depressiezorg voor zorgaanbieders en zorgverzekeraars. Utrecht: Trimbos-instituut; 2007.
• [43]Nederlandse Diabetes Federatie: NDF Care Standard: Transparency and quality of diabetes care for people with type 2 diabetes. Amersfoort: Nederlandse Diabetes Federatie; 2007.
• [44]Wittkampf K, van Ravesteijn H, Baas K, van de Hoogen H, Schene A, Bindels P, Lucassen P, van de Lisdonk E, van Weert H: The accuracy of Patient Health Questionnaire-9 in detecting depression and measuring depression severity in high-risk groups in primary care. Gen Hosp Psychiatr 2009, 31:451-459.
• [45]Brooks R: EuroQol: the current state of play. Health Policy 1996, 37:53-72.
• [46]Roijen L, Straten A, Tiemens B, Donker M: Handleiding Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P). Rotterdam: Institute of Medical Technology Assessment (iMTA); 2002.
• [47]Robins LN, Helzer JE, Croughan J, Ratcliff KS: National Institute of Mental Health diagnostic interview schedule: its history, characteristics, and validity. Arch General Psychiatr 1981, 38:381-389.
• [48]Kriegsman DMW, Penninx BWJH, Van Eijk JTM, Boeke AJP, Deeg DJH: Self-reports and general practitioner information on the presence of chronic diseases in community dwelling elderly: A study on the accuracy of patients' self-reports and on determinants of inaccuracy. J Clin Epidemiol 1996, 49:1407-1417.
• [49]Pearlin LI, Schooler C: The Structure of Coping. J Health Soc Behav 1978, 19:2-21.
• [50]Penninx BWJH, Van Tilburg T, Kriegsman DMW, Deeg DJH, Boeke AJP, van Eijk JTM: Effects of social support and personal coping resources on mortality in older age: the Longitudinal Aging Study Amsterdam. Am J Epidemiol 1997, 146:510-519.
• [51]Bijl D, Van Marwijk H, Beekman A, De Haan M, Van Tilburg W: A randomized controlled trial to improve the recognition, diagnosis and treatment of major depression in elderly people in general practice: design, first results and feasibility of the West Friesland Study. Int J Psychiatr Clin Pract 2003, 8:135-140.
• [52]Spinhoven PH, Ormel J, Sloekers PPA, Kempen GIJM, Speckens AEM, Hemert AM: A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med 1997, 27:363-370.
• [53]De Brey H: A cross-national validation of the client satisfaction questionnaire: the Dutch experience. Eval Program Plann 1983, 6:395-400.
• [54]De Wilde EF, Hendriks VM: The Client Satisfaction Questionnaire: psychometric properties in a Dutch addict population. Eur Addict Res 2005, 11:157-162.
• [55]Twisk JW: Applied multilevel analysis: a practical guide. Cambridge: Cambridge University Press; 2006.
• [56]Van Buuren S, Groothuis-Oudshoorn K: MICE: Multivariate imputation by chained equations in R. J Stat Softw 2011, 45:1-68.
• [57]Rubin DB: Multiple imputation for nonresponse in surveys. New York: John Wiley & Sons; 1987.
• [58]Thompson SG, Barber JA: How should cost data in pragmatic randomised trials be analysed? BMJ 2000, 320:1197-1200.
• [59]Fenwick E, O'Brien BJ, Briggs A: Cost-effectiveness acceptability curves–facts, fallacies and frequently asked questions. Health Econ 2004, 13:405-415.
• [60]Simon GE, Katon WJ, Lin EHB, Rutter C, Manning WG, Von Korff M, Ciechanowski P, Ludman EJ, Young BA: Cost-effectiveness of systematic depression treatment among people with diabetes mellitus. Arch Gen Psychiatr 2007, 64:65-72.
• [61]Katon WJ, Schoenbaum M, Fan MY, Callahan CM, Williams J Jr, Hunkeler E, Harpole L, Zhou XHA, Langston C, Unutzer J: Cost-effectiveness of improving primary care treatment of late-life depression. Arch Gen Psychiatr 2005, 62:1313-1320.
• [62]Katon W, Russo J, Von Korff M, Lin E, Simon G, Bush T, Ludman E, Walker E: Long-term Effects of a Collaborative Care Intervention in Persistently Depressed Primary Care Patients. J Gen Intern Med 2002, 17:741-748.