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DMP Diabetes & Orthopädieschuhtechnik


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IT-Projekt für die elektronische Kommunikation der Leistungserbringer und Versorgungsanalyse bei der Hilfsmittel-Versorgung im Rahmen des DMP-Diabetes entsprechend § 67 und § 11
Abs. 4 SGB V.

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DMP Diabetes & Orthopädieschuhtechnik

  1. 1. Comprehensive Outcome Assessment in a shared care model and Budget Impact Analysisof therapeutic appliances for patients with diabetic foot disease Thomas Bade Westenstr. 39 85072 Eichstätt
  2. 2. Versorgungsmanagement DMP-DiabetesTOPICTranslations: Using the correct translation of German institutions, terminology, idioms and specific legal definitions intoEnglish a dictionary is provided as reference on page 15.Key WordsShared Care, Intersectoral Treatment, Budget-Impact-Analysis, Diabetic Foot Disease, Outcome Assessment, Podiatric OutpatientServices, Reimbursable Services, Orthotics, Podiatry Care, Pedorthics, Orthotics, Patient-Reported-OutcomesHealth care delivery in Germany is still highly fragmented, resulting in poor vertical and horizontalintegration. Introducing an integrated care paragraph in the German Social Code Five in 20071,greater interest and focus have evolved around bridging institutional and professional boundarieswithin the care sector. At the core of this shift is the movement away from episodic treatment ofacute treatments to the provision of a coordinated continuum of services that will support thosewith chronic conditions and enhance the health status. Initiatives for shared care will eventuallyestablish coherent treatment of the patient through close coordination and cooperation across caresector boundaries.Shared care initiatives in general are expected not only to improve communication andcoordination, in particular through electronic referral and therapy protocols, but also to providehigher quality and efficiency by bridging the divided health care sector and thereby offer morecoherent health services and multidisciplinary treatment regimes.2A further issue conferred with shared care was the potential impact of information systems,electronic therapy records and electronic assessment instruments on the health service deliverysystem. The German governments initiatives in establishing technological infrastructures tosupport shared care resulted in § 67 Social Code Five (electronic communication).3 Although manycase studies can be found in the literature on integrated care, studies based on sound evidencerelated to the effectiveness of integrated care strategies are still rare [2]. The major shortcoming inthe literature is that integration or continuity4 is frequently not defined or conceptualized.1 For the purpose of this draft we translate § 11 Sec. 4 Social Code Five (Versorgungsmanagement) into “shared care”based upon the WHO definition [1].2 The German “Versorgungsmanagement” lacks a common terminology and is labelled with different terms, such as‘‘shared care’’, ‘‘transmural care’’, ‘‘intermediate care’’, ‘‘seamless care’’, ‘‘disease management’’, ‘‘case management’’,‘‘continuous care’’, ‘‘integrated care pathways’’ and ‘‘integrated delivery networks’’.3 Electronic communication is here understood as embracing health care and information technology (e.g. therapyprotocols, assessment forms) and multidisciplinary treatment activities involving elements of distance.4 The term continuity of care has a number of meanings and therefore needs explaining or qualifying whenever it is used.It applies to individual patients (rather than groups) over time. Literature distinguish three major types – management,informational and relationship. Management continuity involves the communication of both facts and judgements acrossteam, institutional and professional boundaries, and between professionals and patients. Informational continuityconcerns the timely availability of relevant information. Relationship continuity means a therapeutic relationship of thepatient with one or more health professionals over time.© 2010 by Thomas Bade Page 2
  3. 3. Versorgungsmanagement DMP-DiabetesConsequently, it is difficult to review systematically the findings in this area. Furthermore, not manystudies provide quantitative outcome measures and different terminologies are used. ThereforeThomas Bade suggests the following definition:Shared care is a concept bringing together inputs, delivery, management and organization ofservices related to diagnosis, treatment, care, rehabilitation and health promotion. Integration is ameans to improve the services in relation to access, quality, user satisfaction and efficiency. Whilethe evaluation of (multiple) outcomes in integrated care systems is hampered by the complexity ofsuch programmes and the timescale necessary to establish results, many instruments have beendeveloped in the evaluation sciences that take into account the nature of the intervention [3]. Theaim of integrated care programmes is almost similar to Disease Management Programmes (DMPs)in Germany, but multidisciplinary conditions are not well defined and there are no requirementsregarding the outcome structures of provided care. To improve the quality and cost effectiveness ofhealth care for chronic conditions, Disease Management Programmes (DMPs) were introduced byGerman law in 2002. Minimum standards were defined for the conditions type 2 diabetes, breastcancer, coronary heart disease, and asthma/chronic obstructive lung disease.These minimum requirements included: • treatment guidelines for providers; • necessary quality assurance measures; • conditions and process of patient enrolment; • training of and information for providers and patients; • documentation; • evaluation of effectiveness and costs; and • duration of programme accreditation.Based on these legally defined minimum requirements, statutory health insurance carriers areallowed to selectively contract with providers and design their own DMPs for the legally definedconditions. Criticism is raised by physicians claiming that only minimum standards have beendefined for DMPs and improved outcomes are not very likely. The mandatory evaluation ofprogrammes will provide empirical evidence on their level of success [4].Thomas Bade investigated the first published evaluation results of Germany’s DiseaseManagement Programmes for diabetes [5].© 2010 by Thomas Bade Page 3
  4. 4. Versorgungsmanagement DMP-DiabetesDiabetes and its complications are important causes of morbidity and mortality in Germany andcontribute substantially to health care costs. Projections suggest that 4 million people in Germanyhave diabetes and that direct costs of treatment of diabetes and diabetes-related complicationsexceed € 5,2 billion [6]. Most patients with diabetes are managed in primary care and health caredelivery is often fragmented between primary physicians, specialty physicians, podiatry care andpedorthics.5 Strict sectorization is still a characteristic of German Disease ManagementProgrammes for diabetes. The report in 2007 by the Advisory Council for the Concerted Action inHealth Care identified much scope for efficiency gains and quality improvement. The report foundevidence of overuse and economic inefficiencies but also of underuse and avoidable harm frommedical care for most common chronic diseases [7]. Based upon a recent OECD study there isgrowing doubt over whether the comparatively high level of spending on health care in Germanytranslates into high-quality care and cost-effective use of resources [8].Although implementation of the national DMP-Diabetes programme has been associated withimportant improvements in measures of processes of diabetes care, it has not been associatedwith improvement in intermediate or long-term outcomes and coordination among differentproviders [9]. In Germany, DMP-Diabetes physicians receive financial incentives to use structureddisease management plans and work collaboratively with specialty physicians, podiatry care andpedorthics in team care arrangements to manage associated diseases. Interdisciplinary teamsshould result in diabetes care consistent with national and international diabetes managementguidelines [10]. However, diabetes management is often inadequate despite care plans. Severalbarriers prevent physicians from using structured diabetes care plans and different contractualarrangements among Germanys regional insurance carriers and regional associations of statutoryhealth insurance physicians do not guarantee nationwide implementation of care plans.Regulations, care providers and insurance carriers responsible for decision making differ by sectorand region concerning coverage of services, reimbursement of therapeutic appliances,accreditation of providers, and quality assurance. According to national and international diabetesguidelines, shared care (joint participation of primary, specialty care physicians and pedorthics inplanned delivery of care) should improve diabetes related foot disease management. Health careteams have been urged to develop new relationships with relevant medical specialists, andelectronic communication has been proposed as an effective integration strategy consistent withshared care [11].5 Definition by the American Pedorthic Footwear Association: Pedorthist supports the pedorthic profession at large.Pedorthics is the design, manufacture, modification and fit of shoes and foot orthoses to alleviate problems caused bydisease, congenital condition, overuse or injury.© 2010 by Thomas Bade Page 4
  5. 5. Versorgungsmanagement DMP-DiabetesDiabetes related foot disease describes a number of complications of diabetes that can occursimultaneously or in isolation. Peripheral neuropathy, peripheral vascular disease, foot ulcerationand amputation contribute significantly to the high rates of morbidity and mortality affectingindividuals with diabetes. Diabetes related foot disease is costly for the German health care systembecause of its chronic nature and particularly because of the gravity of its complications. Thestandard treatment of diabetic neuropathic foot ulcers is wound debridement, moist wounddressing, and off-loading of pressure from the affected lower extremity. The likelihood of successfultreatment for diabetic neuropathic foot ulcers is associated with several baseline factors. 6Despite the burden of foot disease on both the individual and the health care system, no researchhas been conducted in order to determine the effectiveness of multidisciplinary teams in Germany.There is strong evidence to indicate that foot care is best delivered when it is provided by amultidisciplinary team [12]. This should closely involve the person with diabetes and his or herfamily, along with healthcare professionals from different specialties. Ideally the team will include aphysician, a nurse, a specialist educator, a podiatrist, a surgeon, a pedorthist and an administrator.In 2009 the Federal Joint Committee has published new guidelines for the prescription oftherapeutic appliances and technical aids. In these guidelines it is mandatory that prescribingphysicians communicate with health service providers for technical aids, orthopedic and prostheticdevices. So far, there is no established documentation system available. There are nationalguidelines defining standards of care, but the recently published AOK Curaplan data for patientswith diabetes suggest less than optimum care in a number of areas. Statistical AOK data for 2006and 2007 suggest high rates of measurement of clinical and medical parameters but lower rates ofacting on the results. Massive regional differences for expenditures of therapeutic appliancessuggest that patients do not receive care according to current scientific evidence. Thomas Badeconcludes that in almost all regions the process of care did not reach the standards set out innational guidelines or set by the insurance carriers themselves.6 Baseline factors are: Daily activities, including work; Footwear; Chemical exposures; Callus formation; Foot deformities;Previous foot infections, surgery; Neuropathic symptoms and Claudication or rest pain [Diabetic foot disorders: a clinicalpractice guideline. J Foot Ankle Surg 2006 Sep-Oct;45(5)].© 2010 by Thomas Bade Page 5
  6. 6. Versorgungsmanagement DMP-Diabetes Expenditures for Therapeutic Appliances (incl. Orthotics & Pedorthics) Diabetes Type 2 vs. Diabetes Type 1 Region Expenditures Type 2 Expenditures Type 1 AOK Sachsen 7 117,32 EURO 286,92 EURO arithmetic mean as of 2006-1 8 (159,0) (261,5) (patients) AOK Berlin 102,17 EURO arithmetic mean as of 2006-1 Not available (245,0) (patients) AOK Rheinland 54,55 EURO 224,43 EURO arithmetic mean as of 2006-1 (87,5) (124,5) (patients) AOK Baden-Württemberg 40,95 EURO 505,55 EURO arithmetic mean as of 2006-1 (138,0) (76,0) (patients) AOK Thüringen 92,28 EURO 288,23 EURO arithmetic mean as of 2006-1 (276,5) (91,5) (patients) AOK Bayern 101,10 EURO 288,81EURO arithmetic mean as of 2006-1 (47,0) (82,5) (patients) AOK Sachsen-Anhalt 109,78 EURO 274,07 EURO arithmetic mean as of 2006-1 (187,0) (66,5) (patients) AOK Schleswig-Holstein 68,14 EURO 134,97EURO arithmetic mean as of 2006-1 (181,0) (52,5) (patients) AOK Hessen 308,56 EURO 250,99 EURO arithmetic mean as of 2006-1 (3,0) (76,5) (patients) Source: AOK Curaplan Diabetes mellitus Typ 1 und Typ 2: 2009 [5]The primary producer of the administrative diabetes data is the regional AOK health insuranceprovider. Although the clinical content of the AOK data includes the demographic characteristicsand diagnoses of patients and codes for procedures, these data can not be used to evaluate thequality of intersectoral multidisciplinary diabetes care. However, gaps in clinical information and theexpenditure context for orthopedic and prosthetic devices compromise the ability to derive validoutcome appraisals from the AOK data. The collected data allow limited insight into the quality ofteam processes of care and the appropriateness of intersectoral multidisciplinary care.7 Expenditures of therapeutic appliances per patient (arithmetic mean as of 2006-1)8 Number of patients (analysable und weighted)© 2010 by Thomas Bade Page 6
  7. 7. Versorgungsmanagement DMP-DiabetesThe 2009 Quality Report of Disease Management Programmes by the National Association ofStatutory Health Insurance Physicians identified that set therapy goals for diabetic footinterventions have not been met in all 15 regional Physicians Associations [13]. The current AOKand National Association of Statutory Health Insurance Physicians (KBV) data are useful asscreening tools that highlight areas in which quality and outcome should be investigated in greaterdepth. The growing availability of electronic clinical information will change the nature of data in thefuture, enhancing opportunities for quality and outcome measurement.The AOK and KBV data contain limited interdisciplinary insight and cannot evaluate the technicalquality of processes of care, determine most errors of under- or overuse, or assess theappropriateness of care. On the other hand, AOK and KBV data are useful as a screening tool foridentifying quality problems and targeting areas that might require in-depth investigation.Administrative diabetes data in the future will rely extensively on electronic clinical databases,generating exciting opportunities for widespread quality enhancement, outcome assessment andpatient reported outcomes.OBJECTIVESHealth insurance carriers and policymakers are striving to build and manage healthcare systemsthat can accommodate delivery of coordinated care services, either through macro-level healthcarereform or through initiatives at organizational (meso) or physician–other care providers interaction(micro) level. However, monitoring the progress potentially associated with the efforts being made,and the gathering and dissemination of evidence-based knowledge is hampered by the lack ofmeasurement methods in this area. Comparison of results between existing studies and reports isdifficult owing to differing terminologies, outcome measures and definitions of therapeuticappliances for diabetic foot complications.9 It is the objective to evaluate the incremental cost-effectiveness of therapeutic appliances for diabetic foot complications based on targeted screeningin DMP-Diabetes settings compared with routine clinical data from German health insurancecarriers.9 Most studies and reports summarize therapeutic appliances (orthotics, pedorthics) and physical therapy regimes.© 2010 by Thomas Bade Page 7
  8. 8. Versorgungsmanagement DMP-DiabetesIn addition, literature research revealed that Patient Reported Outcomes (PRO) assessment hasbecome increasingly relevant in the evaluation of health care interventions, for a fundamentalreason [14]. In evaluating health care, as well as in decision-making, clinical and health servicesresearchers have come to the conclusion that direct self-reports of how disease, illness, andtreatment affects patients are the outcomes that are most significant to patients and healthinsurance companies.In this context an Information and Technology Service should be established that is triggered byoutcome assessment, performance gaps, patient reported outcomes and provided by specialists.The Information and Technology Service should be used for assessment and evaluation oforthopedic and rehabilitation referrals (prosthetics, orthotics, technical aids) and home health careservices. The Information and Technology Service records the effectiveness of therapeutic regimesin routine outpatient practice. Valid and feasible assessment records are implemented to documentand analyse the effectiveness of ambulatory health care services. Clinical practice and outcomemeasures in ambulatory care demand complex processing of data and information, usually at thepoint of care of different care providers. The availability and capability of computerized systemsoffer great potential for effectively acquiring, storing, retrieving, and analyzing data and informationof outpatient services.The Information and Technology Service data-base does not simply mimic existing paper-basedforms but provides support for the cognitive tasks of physicians and other care providers and forthe workflow of the people who actually use the system and treat patients: • Comprehensive data on patients’ conditions, treatments, outcomes and • Cognitive support for multidisciplinary health care professionals to help integrate evidence- based practice guidelines and assessment results into daily practice.Care providers cooperate to acquire prescription and assessment data and to retrieve them fromthe data-base, to interpret them and to plan the appropriate treatment. Improved communication,coordination and information sharing among physicians and pedorthics are recognized as beingessential to the ability of making timely and informed decisions about the adequate treatmentregime for diabetic foot ulcers. There is strong evidence that guidelines-based care can improvepatient outcomes particularly when supported by central computerized systems for patient trackingand provision of feedback to physicians [15]. Audit and feedback has been shown to be aneffective strategy to improve providers performance of care, assessment strategies andcompliance with guidelines. There is a strong need for evidence of clinical effectiveness of foot© 2010 by Thomas Bade Page 8
  9. 9. Versorgungsmanagement DMP-Diabetesorthosis therapy in German DMP-Diabetes programmes [16]. The aim of the Information andTechnology Service is to improve the quality of care for patients with diabetes care by identifyingmultidisciplinary and organisational factors that predict the implementation of best practice [17].Therapeutic assessment of therapeutic appliances referred to the Information and TechnologyService are automatically recorded, unless patients did not give their consent. Consent is askedwhen patients visit the physicians office or clinic (§ 11 Sec. 4 German Social Code Five). Data onthe physicians management regime for outpatient services are collected retrospectively in theelectronic medical record system of the referring physician, and analysed cross-sectionally byoutpatient service providers (§ 67 German Social Code Five). Different assessment forms havealready been created for physicians and outpatient care providers with tick boxes for quickcompletion. Data from the assessment forms is registered anonymously in a database.Consequently, it is the objective to encourage the adoption, connectivity, and interoperability ofhealth care information technology. The implementation of information technologies amonginterdisciplinary care teams will reduce the cost of information and diminish barriers to inquire,thereby sustaining the evidence-based medicine movement. Although some technical issuesremain to be solved, such as confidentiality of electronic patient records, financing and quality ofindicators, the Information and Technology Service will be a driving force for the development andintegration of multidisciplinary health care services.A Budget Impact Analysis (BIA) should be additionally used to understand the financial impact ofdiabetic foot health care interventions for the German health care system that has finite financialresources. One of the key questions that will be answered through the use of BIA is whethershared care will reduce diabetic foot expenditures. The aim of BIA is to show the financial effects ofshared care not only for the social security system in Germany in total, but also differentiated for alltypes of statutory insurance carriers and all German regions. Long year experience withconstruction of Budget-Impact-Model (BIM) on Excel basis should be used [18].© 2010 by Thomas Bade Page 9
  10. 10. Versorgungsmanagement DMP-DiabetesPATIENT SELECTIONTargeted screeningThe approach is to screen patients who are classified in one of the risk-groups established by theGerman health insurance carriers and national diabetes guidelines: DMP-Diabetes Risk-Group Classification Risk-Group Group I Group II Group III Group IV Group V Group VI Intervention Multiple density insert, off-the-shelf Custom-made Total Contact Therapeutic Insoles custom-molded from Orthosis Diabetic Shoe Diabetic Shoe Cast Appliance model of patient’s footQuality indicators will be based upon the published Medical Device Description for the respectiveproduct groups. A targeted screening programme in the physicians office will exploit the availableDMP-Diabetes data to identify such patients. Once patients give their consent they will be recruitedfor participation in the shared care treatment programme.Model DesignTo be transparent and accessible, the budget impact model and supporting report will be designedin a manner that meets with the needs of the health insurance carriers, explicitly state all choicesand assumptions, use the simplest possible design structure to answer the budget impactquestion, and be built using available Microsoft-Excel software.PerspectiveThe BIA will be performed from the perspective of the German statutory health insurance andincludes a treatment perspective that includes orthopedic and prosthetic devices costs that arereimbursed by statutory health insurance companies.Calculating CostsWhen calculating the cost of therapeutic appliances, BIA will include the contractualreimbursement price. The costs will consider dispensing fees and patient co-payments.Characterizing UncertaintyDeterministic sensitivity analyses will be provided with submitted BIA to inform decision makers ofthe sensitivity of the model to specific assumptions. Reasonable and/or cited information regarding© 2010 by Thomas Bade Page 10
  11. 11. Versorgungsmanagement DMP-Diabetesthe range of uncertainty associated with each assumption will also be included. When reporting theuncertainty analysis, a summary of sensitivity analyses performed on the following parameters willbe provided: reimbursement price, quantity of treatments in each risk group, health insurancecarriers expenditures in this segment.Selection of relevant comparatorsWhen developing BIA, the comparators used in the supporting budget impact model will reflectdiabetic foot treatment strategies used to treat the same indication(s) as the shared care model.Identification of the relevant treatment strategies for a budget impact model will involve the use ofappropriate clinical input (e.g., published research).Forecasting of the market under a Reference ScenarioTo forecast changes in a Reference Scenario, the BIA programme will use published forecasts,whenever possible. Forecasts will take into consideration anticipated changes to the market overthe time horizon and should be informed using data from available databases.The BIA programme is based on a systematic approach in terms of selection criteria and a pre-planned search strategy. According to Strandberg-Larsen et al. measures of integrated healthcaredelivery can be grouped into three areas: 1) measures of precursors of integration (structural andcultural measures); 2) measures of intermediate outcomes or internal process variables, whichassess the level of system-wide activity and which are the means to achieving ultimate goals(process measures); and 3) measures which assess the extent to which systems are fulfilling theirultimate purpose (outcome measures) [9].The Information and Technology Service is developed as an Internet-based system that hasminimal requirements to the local infrastructure at the users and to IT support. The system meetsall official requirements to protection of personal data and patient rights. Users access, the solutionon the Internet via logon with username and password and data is protected with extendedvalidation SSL encryption. In addition, all access to the record is registered with the user’s initials,and all use of the record is logged. At the same time the Information and Technology Serviceprovides decision support for physicians in form of automatic indication of missing outcomes inrelation to established therapy goals. Evidence-based guidelines will be used to generatetherapeutical reminders for the treating staff, design automated feedback, notify treating staffvalues requiring timely intervention, and form the basis of treatment and/or decision supportalgorithms. Risk groups can be identified based on selected criteria for the purpose of closerevaluation and follow-up. Data is registered and gathered in a structured manner. This gives a© 2010 by Thomas Bade Page 11
  12. 12. Versorgungsmanagement DMP-Diabetesmore consistent documentation and subsequently allows for a better and more precise follow-upon patients. The result is a more solid foundation for risk calculation and statistical evaluation.Patient Reported Outcomes (PRO) are included, once patients have given their written consentand provided an e-mail address. The Information and Technology Service will send an e-mail withlogon to respective patients after completion of therapy or within set time interval. With the logon,patients have online access using a self-assessment questionnaire which consist of a set ofquestions called items in the literature (Classical Test Theory) [19].The Information and Technology Service has to be built with focus on usability and relevance [20].The solution has to bee developed in the field of actual use – with participation of physicians andpedorthists who are using the system. The user interface has to be designed and tested forusability in cooperation with diabetes clinics and pedorthists so that it supports the daily clinicalworkflow in a flexible manner. Data is carefully selected according to relevance, in order tominimize overlap and double entries. It is imperative that a feedback loop is included in theInformation and Technology Service that allows direct interface between diabetes clinics andpedorthist. Physicians need to be alerted when values exceed certain thresholds so that rapidresponse is enabled and treatment regimens can be altered. Hands-on training has to be providedto every member of the intersectoral team.TARGET POPULATIONParticipants and SettingThe care provider being assessed should not be a single facility (e.g. diabetic podiatric centre, orgeneral practice) but a network of providers accountable to eligible patients. Shared careagreements based upon third-party payer regulations between the medical sector and the diabetesoutpatient pedorthist exist only in a few parts of the country at present. DMP Diabetic PodiatricCentres and specialized DMP practices participating in regional DMP Diabetes programmesshould use the Information and Technology Service for all referrals of diabetic foot treatmentsperformed by pedorthist. Existing regional DMP Diabetes programmes and contractual agreementsdiffer in terms of diabetic foot treatment regimes. In Bavaria it is agreed by contract that DMPspecialty physicians and diabetic podiatric centres must have a contractual agreement forintersectoral cooperation. Since 2008 participating providers not providing a contractual© 2010 by Thomas Bade Page 12
  13. 13. Versorgungsmanagement DMP-Diabetesintersectoral cooperation with a pedorthist are sanctioned with a penalty fee. In Berlin a contractualagreement for intersectoral cooperation is not mandatory and in Saxony there is no direction ofintersectoral cooperation at all.SAMPLE SIZEIt is the goal to recruit 5 pedorthists as field-partner in the regional states serving at least 2 DMP-Diabetes specialty physicians or diabetic podiatric centres. Based upon current enrolled DMP-Diabetes patients Thomas Bade estimates a number of 185 patients p.a. in each medical outlet.Gender aspects do not apply to the research questions.Treatment data to be assessed for eligibility in 29 months: n = 4.470Treatment data to be allocated to programme after 29 months: n =4.000Expected to be analysed without PRO10 (n = 2.500)Expected to be analysed with PRO (n = 1.500)Based upon the current Bavarian intersectoral agreement it is the responsibility of participatingpedorthists to work in conjunction with the physician to determine the medical appropriateness ofan orthosis, prosthesis or pedorthic device. The pedorthist must receive a prescription from aphysician that meets the Guidelines for the Prescription of Therapeutic Appliances and TechnicalAids before providing any orthosis, prosthesis or pedorthic device to a patient. Using theInformation and Technology System prescribing physician and pedorthist will monitor and observethe patient’s treatment condition in connection with the orthotic, prosthetic or pedorthic care andthe prescribed device to make certain the patient is responding appropriately. By definition of theGuidelines for the Prescription of Therapeutic Appliances and Technical Aids the pedorthist mustnotify the physician or referring podiatric centre of changes in the patient’s condition that affect thepatient’s orthotic, prosthetic or pedorthic treatment plan. Any repairs, adjustments, modifications orreplacements that substantially alter the design or function of the originally prescribed devices,must be authorized by the physician or the podiatric centre.10 PRO = Patient Reported Outcome© 2010 by Thomas Bade Page 13
  14. 14. Versorgungsmanagement DMP-DiabetesDATA COLLECTIONSystem DescriptionThe web-based Information and Technology Service has to be designed and developed for theGerman health care market. The service should run on a Linux-webserver with Apache, PHP and aMySQL database. The front-end should be programmed in PHP, HTML, CSS and Ajax/Javascript.STATISTICAL ANALYSISStatistical analysis should be performed using the SPSS statistical package.© 2010 by Thomas Bade Page 14
  15. 15. Versorgungsmanagement DMP-DiabetesDICTIONARYAdvisory Council for the Concerted Action Sachverständigenrat für die konzertierte Aktion imin Health Care GesundheitswesenCare Provider Leistungserbringer im Sinne des SGB VDMP Physician DMP koordinierender Arzt gemäß § 137 f SGB VFederal Joint Committee Gemeinsame Bundesausschuss ( G-BA )Guidelines for the Prescription ofTherapeutic Appliances and Technical Aids Hilfsmittel-Richtlinien des G-BAMedical Device Description Hilfsmittelverzeichnis der gesetzlichen KrankenkassenMultiple density insert, custom-molded frommodel of patient’s foot diabetesadapierte FußbettungNational Association of Statutory HealthInsurance Physicians Kassenärztliche Bundesvereinigung ( KBV )Orthotist (orthopaedic technician) Orthopädietechniker, Leistungserbringer i.S. § 126 SGB VPedorthist (orthopaedic shoemaker) Orthopädieschuhtechniker, Leistungserbringer i.S. § 126 SGBVPhysical Therapy Regime Heilmittel-Richtlinien des G-BAPodiatry Care, Diabetic Podiatric Centre Fußambulanz gemäß § 137 f SGB VProduct Groups Produktgruppen des HilfsmittelverzeichnissesRegional Associations of Statutory HealthInsurance Physicians Kassenärztliche Vereinigungen ( regional )Shared Care Versorgungsmanagement i.S. § 11 Abs. 4 SGB VSocial Code Five Sozial Gesetzbuch Fünf ( SGB V )Specialty Physicians DMP Schwerpunktpraxis gemäß § 137 f SGB VStatutory Health Insurance Gesetzliche KrankenversicherungTherapeutic Appliance Hilfsmittel i.S. § 33 SGB V© 2010 by Thomas Bade Page 15
  16. 16. Versorgungsmanagement DMP-DiabetesREFERENCES[1] Gröne O., Garcia-Barbero M.: Trends in Integrated Care: Reflections on Conceptual Issues. World Health Organization,Copenhagen, 2002, EUR/02/5037864.[2] Freeman G.: Continuity of care 2006: what have we learned since 2000 and what are policy imperatives now ?; Report for theNational Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO) : June 2007.[3] Borgermans L. et al.: Diversity in diabetes care programmes and views on high quality diabetes care: are we in need of astandardized framework ?, International Journal of Integrated Care – Vol. 8, 24 April 2008.[4] Bundesversicherungsamt [Federal Insurance Authority]. Kriterien des Bundesversicherungsamtes zur Evaluation strukturierterBehandlungsprogramme bei Diabetes mellitus Typ 2 (4.11.2004):[5] AOK Curaplan Diabetes mellitus Typ 1 und Typ 2: Evaluation von strukturierten Behandlungsprogrammen (DMP);Auswertungshalbjahre: 2003-2 bis 2008-1; Prognos AG, Düsseldorf; infas Institut für angewandte Sozialwissenschaft GmbH, Bonn;Wissenschaftliches Institut der Ärzte Deutschlands (WIAD) gem. e.V., Bonn: 30.September 2009.[6] Icks A. et al. : Diabetes mellitus, Hrsg. Robert Koch Institut, Gesundheitsberichterstattung des Bundes, Heft 24, 2005.[7] SACHVERSTÄNDIGENRAT zur Begutachtung der Entwicklung im Gesundheitswesen: Kooperation und Verantwortung,Voraussetzungen einer zielorientierten Gesundheitsversorgung, Gutachten 2007.[8] Organisation für wirtschaftliche Zusammenarbeit und Entwicklung (OECD): Health at a Glance (engl.), Dezember 2009, ISBN:9789264061538.[9] Strandberg-Larsen M. et al.: Measurement of integrated healthcare delivery: a systematic review of methods and future researchdirections; International Journal of Integrated Care – Vol. 9, 4 February 2009 .[10] Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen MedizinischenFachgesellschaften: Nationale VersorgungsLeitlinie Typ-2-Diabetes Präventions- und Behandlungsstrategien für Fußkomplikationen,Langfassung Version 2.8: Februar 2010.[11] Singh D.: How can chronic disease management programmes operate across care settings and providers ? World HealthOrganization 2008 and World Health Organization, on behalf of the European Observatory on Health Systems and Policies, 2008.[12] International Consensus on the Diabetic Foot and Practical Guidelines on the Management and the Prevention of the Diabetic Foot.International Working Group on the Diabetic Foot, 2003, Amsterdam, the Netherlands.[13] Kassenärztliche Bundesvereinigung (KBV): Qualitätsbericht 2009; Disease Management Programme, Ergebnisse des Programmszum Diabetes Mellitus Typ 2, Oktober 2009: 62 – 67.[14] Patrick D.: Cochrane Patient Reported Outcomes Methods Group, The Cochrane Collaboration 2007 Issue 3, The CochraneCollaboration. Published by John Wiley & Sons, Ltd. Date of Most Recent Amendment: 14 May 2009.[15] Spencer, S: Pressure relieving interventions for preventing and treating diabetic foot ulcers, The Cochrane Library, Copyright 2006,The Cochrane Collaboration Volume (3), 2006.[16] Granlien M.: Challenges for IT-supported shared care: a qualitative analyses of two shared care initiatives for diabetes treatment inDenmark, International Journal of Integrated Care – Vol. 7, 30 May 2007.[17] Eccles M. P. et al.: Improving the delivery of care for patients with diabetes through understanding optimised team work andorganisation in primary care, Implementation Science 2009, 4:22.[18] Schöffski, O., Sohn, S., Bierbaum, M. (2007): Budget Impact Modell. In: Schöffski, O., Schulenburg, J.-M. Graf v. d. (Hrsg.):Gesundheitsökonomische Evaluationen. Dritte, vollständig überarbeitete Auflage. Berlin, Heidelberg, New York: Springer, S. 311-317.[19] Sébille V. et al.: Methodological issues regarding power of classical test theory (CTT) and item response theory (IRT)-basedapproaches for the comparison of patient-reported outcomes in two groups of patients - a simulation study, BMC Medical ResearchMethodology 2010, 10:24.[20] Costa B. M. et al.: Effectiveness of IT-based diabetes management interventions: a review of the literature, BMC Family Practice2009, 10:72.© 2010 by Thomas Bade Page 16
  17. 17. Versorgungsmanagement DMP-DiabetesDisclaimerUnless otherwise noted, the material contained in this document is copyrighted and may not be used except as providedin a copyright notice or other proprietary notice by Thomas Bade.© 2010 by Thomas BadeJuly 2010Thomas BadeWestenstr. 3985072 Eichstä© 2010 by Thomas Bade Page 17
  18. 18. Information and Technology Service DMP Diabetes Patient Written Consent Physician No. Patient Reported Outcomes Pedorthist No . Logon Physician Logon Pedorthist Internet-Based User Interface Extended Validation SSL Encryption § 67 and § 11 Sec. 4 Social Code FiveTherapeutic Appliance Electronic Assessment Form Access to Assessment Form of Therapeutic Appliance Outcome Assessment Report Quality Assurance Measures Evaluation of Effectiveness Evaluation of Costs Quality Indicators Decision Support to Care Providers Evidence Based Guidelines Alert System exceeding Thresholds External Management Company Electronic Medical Record System (Database) Budget Impact Analysis (BIA) Feedback Loop Therapeutic Assessment Patient Reported Outcome © 2010 Thomas Bade Page 18