Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial

Trials

Tobias Freund⁵  Martina Kamradt⁵  Marion Kiel⁵  Sandra Schmitt¹  Ralf Brandner¹  Hans-Joachim Salize³  Christian O Jacke³  Johannes Krisam⁴  Manfred Mayer²  Werner Besier²  Dominik Ose⁵  Joachim Szecsenyi⁵  Kayvan Bozorgmehr⁵ 

[1] InterComponentWare AG, Altrottstraße 31, Walldorf 69190, Germany;Genossenschaft Gesundheitsprojekt Mannheim e G, Liebfrauenstrasse 21, Mannheim 68259, Germany;Central Institute of Mental Health (ZI), Medical Faculty Mannheim, Heidelberg University, D6-5, Mannheim 69159, Germany;Department for Medical Biometry, Institute for Medical Biometry and Informatics, University Hospital Heidelberg, Im Neuenheimer Feld 305, Heidelberg 69120, Germany;Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstrasse 2, Gebäude 37, Heidelberg 69115, Germany

关键词: Self-care;    Primary care;    Multi-morbidity;    Diabetes;    Chronic care;    Care management;   

Others  :  802537
DOI  :  10.1186/1745-6215-15-243

 received in 2014-03-07, accepted in 2014-05-29,  发布年份 2014

【 摘 要 】

Background

Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network–based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions.

Methods/Design

The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios.

Discussion

We hope that the results of this study will provide insights into the efficacy of practice network–based care management among patients with complex health-care needs.

Trial registration

Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014).

【 授权许可】

   
2014 Bozorgmehr et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Wolff JL, Starfield B, Anderson G: Prevalence, expenditures, and complications of multiple chronic conditions in the elderly. Arch Intern Med 2002, 162:2269-2276.
• [2]Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen [Advisory Council on the Assessment of Developments in the Health Care System]: [Sondergutachten 2009: Koordination und Integration–Gesundheitsversorgung in einer Gesellschaft des längeren Lebens] Special Report 2009: Coordination and Integration–Health Care in an Ageing Society . Baden-Baden, Germany: Nomos-Verlag; 2010. English version available at http://www.svr-gesundheit.de/fileadmin/user_upload/Gutachten/2009/KF_engl_final.pdf webcite (accessed 5 June 2014)
• [3]Valderas JM, Starfield B, Sibbald B, Salisbury C, Roland M: Defining comorbidity: implications for understanding health and health services. Ann Fam Med 2009, 7:357-363.
• [4]Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A: Improving chronic illness care: translating evidence into action. Health Aff (Millwood) 2001, 20:64-78.
• [5]Rosenthal TC: The medical home: growing evidence to support a new approach to primary care. J Am Board Fam Med 2008, 21:427-440.
• [6]Freund T, Peters-Klimm F, Rochon J, Mahler C, Gensichen J, Erler A, Beyer M, Baldauf A, Gerlach FM, Szecsenyi J: Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]. Trials 2011, 12:163. BioMed Central Full Text
• [7]Bodenheimer TS, Berry-Millett R: Care Management of Patients with Complex Health Care Needs (Research Synthesis Report 19). Princeton, NJ: Robert Wood Johnson Foundation; 2009. Available at http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2009/rwjf49853/subassets/rwjf49853_1 webcite
• [8]Boult C, Wieland GD: Comprehensive primary care for older patients with multiple chronic conditions: “nobody rushes you through”. JAMA 2010, 304:1936-1943.
• [9]Toobert DJ, Hampson SE, Glasgow RE: The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care 2000, 23:943-950.
• [10]Fisher EB, Chan JCN, Nan H, Sartorius N, Oldenburg B: Co-occurrence of diabetes and depression: conceptual considerations for an emerging global health challenge. J Affect Disord 2012, 142(Supplement):S56-S66.
• [11]Norris SL, Engelgau MM, Venkat Narayan KM: Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care 2001, 24:561-587.
• [12]Busse R: Disease management programs in Germany’s statutory health insurance system. Health Aff (Millwood) 2004, 23:56-67.
• [13]Smith SM, Soubhi H, Fortin M, Hudon C, O’Dowd T: Managing patients with multimorbidity: systematic review of interventions in primary care and community settings. BMJ 2012, 345:e5205.
• [14]Renders CM, Valk GD, Griffin SJ, Wagner EH, van Eijk JT, Assendelft WJJ: Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care 2001, 24:1821-1833.
• [15]Du S, Yuan C: Evaluation of patient self-management outcomes in health care: a systematic review. Int Nurs Rev 2010, 57:159-167.
• [16]Gandhi GY, Murad M, Fujiyoshi A, Mullan RJ, Flynn DN, Elamin MB, Swiglo BA, Isley WL, Guyatt GH, Montori VM: Patient-important outcomes in registered diabetes trials. JAMA 2008, 299:2543-2549.
• [17]Rosemann T, Joos S, Laux G, Gensichen J, Szecsenyi J: Case management of arthritis patients in primary care: a cluster-randomized controlled trial. Arthritis Rheum 2007, 57:1390-1397.
• [18]Gensichen J, von Korff M, Peitz M, Muth C, Beyer M, Güthlin C, Torge M, Petersen JJ, Rosemann T, König J, Gerlach FM, PRoMPT (Primary care Monitoring for depressive Patients Trial): Case management for depression by health care assistants in small primary care practices: a cluster randomized trial. Ann Intern Med 2009, 151:369-378.
• [19]Peters-Klimm F, Campbell S, Hermann K, Kunz CU, Müller-Tasch T, Szecsenyi J, the Competence Network Heart Failure: Case management for patients with chronic systolic heart failure in primary care: the HICMan exploratory randomised controlled trial. Trials 2010, 11:56. BioMed Central Full Text
• [20]Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008, 337:a1655.
• [21]Perera R, Heneghan C, Yudkin P: Graphical method for depicting randomised trials of complex interventions. BMJ 2007, 334:127-129.
• [22]Gemeinshamer Bundesausschuss: Richtlinie des gemeinsamen Bundesausschusses zur Umsetzung der Regelungen in § 62 für schwerwiegende chronische Erkrankte (“Chroniker Richtlinie”). 20 August 2008. Available at https://www.g-ba.de/downloads/62-492-278/Chr-RL_2008-06-19.pdf webcite (accessed 5 June 2014)
• [23]Rabin R, de Charro F: EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001, 33:337-343.
• [24]Freund T, Gensichen J, Goetz K, Szecsenyi J, Mahler C: Evaluating self-efficacy for managing chronic disease: psychometric properties of the six-item Self-Efficacy Scale in Germany. J Eval Clin Pract 2013, 19:39-43.
• [25]Roick C, Kilian R, Matschinger H, Bernert S, Mory C, Angermeyer MC: [German adaptation of the Client Socio-Demographic and Service Receipt Inventory: an instrument for the cost of mental health care] [Article in German]. Psychiatr Prax 2001, 28(Suppl 2):S84-S90.
• [26]Chrisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B: Client Socio-Demographic and Service Receipt Inventory–European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl 2000, (39):s28-s33.
• [27]Goetz K, Freund T, Gensichen J, Miksch A, Szecsenyi J, Steinhaeuser J: Adaptation and psychometric properties of the PACIC short form. Am J Manag Care 2012, 18:e55-e60.
• [28]Bundesärztekammer, Kassenärztliche Bundesvereinigung Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften: NVL Diabetes–Strukturierte Schulungsprogramme, Praxishilfe – PAID (Kurzform). Berlin: Ärztliches Zentrum für Qualität in der Medizin (ÄZQ); 23 November 2012, version 1.0. Available at http://www.versorgungsleitlinien.de/praxishilfen/dm2schulung_praxis/pdf/paid-kurzform-mit-erlaeuterung.pdf webcite (accessed 5 June 2014)
• [29]Psychiatric Research Unit, WHO Collaborating Centre in Mental Health: Fragebogen zum Wohlbefinden (fünf). [German version of the WHO-Five Well-being Index (WHO-5)]. Hillerød, Denmark: Frederiksborg General Hospital; 1998. Available at http://www.psykiatri-regionh.dk/NR/rdonlyres/3F12728C-B0CD-4C50-A714-B6064159A314/0/WHO5_German.pdf webcite (accessed 5 June 2014)
• [30]AUDIT-C-Fragebogen. Freiburg, Germany: Universitätsklinikum Freiburg Suchtforschungsverbund Baden-Württemberg. Available at http://www.bundesaerztekammer.de/downloads/AlkAUDITCFragebogen.pdf webcite (accessed 5 June 2014)
• [31]Schenk L, Bau AM, Borde T, Butler J, Lampert T, Neuhauser H, Razum O, Weilandt C: [A basic set of indicators for mapping migrant status: recommendations for epidemiological practice] [Article in German]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2006, 49:853-860.
• [32]Hoffmeyer-Zlotnik JHP, Glemser A, Heckel C, von der Heyde C, Quitt H, Hanefeld U, Herter-Eschweiler R, Mohr S: Statistik und Wissenschaft: Demographische Standards Ausgabe 2010 (Band 17). Statistisches Bundesamt: Wiesbaden, Germany; 2010. Available at https://www.destatis.de/DE/Methoden/StatistikWissenschaftBand17.pdf?__blob=publicationFile.; webcite (accessed 5 June 2014)
• [33]Noll HH, Weick S: Schichtzugehörigkeit nicht nur vom Einkommen bestimmt. Informationsdienst Soziale Indikatoren 2011, 45:1-7. Available at http://www.gesis.org/fileadmin/upload/forschung/publikationen/zeitschriften/isi/isi-45.pdf.; webcite (accessed 5 June 2014)
• [34]Glazier RH, Bajcar J, Kennie NR, Willson K: A systematic review of interventions to improve diabetes care in socially disadvantaged populations. Diabetes Care 2006, 29:1675-1688.
• [35]Instut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG): Abschlussbericht: Urin- und Blutzuckerselbstmessung bei Diabetes mellitus Typ 2. Cologne, Germany: IQWiG; 4 October 2009. Available at https://www.iqwig.de/download/A05-08_Abschlussbericht_Zuckerselbstmessung_bei_Diabetes_mellitus_Typ_2.pdf webcite (accessed 5 June 2014
• [36]Malanda UL, Welschen LMC, Riphagen II, Dekker JM, Nijpels G, Bot SDM: Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. Cochrane Database Syst Rev 2012., 1CD005060. doi:10.1002/14651858.CD005060.pub3
• [37]Farmer AJ, Perera R, Ward A, Heneghan C, Oke J, Barnett AH, Davidson MB, Guerci B, Coates V, Schwedes U, O’Malley S: Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabetes. BMJ 2012, 344:e486.
• [38]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.
• [39]Majumdar SJ, Johnson JA, Bowker SL, Booth GL, Dolovich L, Ghali W, Harris S, Hux JE, Holbrook A, Lee HN, Toth EL, Yale J: A Canadian consensus for the standardized evaluation of quality improvement interventions in type 2 diabetes. Can J Diabetes 2005, 29(3):220.
• [40]Tang TS, Funnell MM, Noorulla S, Oh M, Brown MB: Sustaining short-term improvements over the long-term: results from a 2-year diabetes self-management support (DSMS) intervention. Diabetes Res Clin Pract 2012, 95:85-92.
• [41]Wangberg SC: An Internet-based diabetes self-care intervention tailored to self-efficacy. Health Educ Res 2008, 23:170-179.
• [42]Lee H, Ahn S, Kim Y: Self-care, self-efficacy, and glycemic control of Koreans with diabetes mellitus. Asian Nurs Res (Korean Soc Nurs Sci) 2009, 3:139-146.
• [43]Tugwell P, de Savigny D, Hawker G, Robinson V: Applying clinical epidemiological methods to health equity: the equity effectiveness loop. BMJ 2006, 332:358-361. doi:10.1136/bmj.7537.358
• [44]Rothwell PM: Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 2005, 365:176-186.
• [45]Salize HJ, Kilian R: Gesundheitsökonomie in der Psychiatrie: Konzepte, Methoden, Analysen. 1st edition. Kohlhammer: Stuttgart, Germany; 2010.
• [46]Glick HA, Doshi JA, Sonnad SS, Polsky D: Economic Evaluation in Clinical Trials. Oxford: Oxford University Press; 2007.
• [47]Carpenter J, Bithell J: Bootstrap confidence intervals: when, which, what? A practical guide for medical statisticians. Stat Med 2000, 19:1141-1164.
• [48]Löthgren M, Zethraeus N: Definition, interpretation and calculation of cost-effectiveness acceptability curves. Health Econ 2000, 9:623-630.
• [49]Fenwick E, Marshall DA, Levy AR, Nichol G: Using and interpreting cost-effectiveness acceptability curves: an example using data from a trial of management strategies for atrial fibrillation. BMC Health Serv Res 2006, 6:52. BioMed Central Full Text
• [50]Hoch JS, Briggs AH, Willan AR: Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ 2002, 11:415-430.