More Related Content Similar to DMP Diabetes & Orthopädieschuhtechnik (20) DMP Diabetes & Orthopädieschuhtechnik1. Comprehensive Outcome Assessment
in a shared care model and
Budget Impact Analysis
of therapeutic appliances for patients
with diabetic foot disease
Thomas Bade
Westenstr. 39
85072 Eichstätt
www.thomas-bade.de
2. Versorgungsmanagement DMP-Diabetes
TOPIC
Translations: Using the correct translation of German institutions, terminology, idioms and specific legal definitions into
English a dictionary is provided as reference on page 15.
Key Words
Shared Care, Intersectoral Treatment, Budget-Impact-Analysis, Diabetic Foot Disease, Outcome Assessment, Podiatric Outpatient
Services, Reimbursable Services, Orthotics, Podiatry Care, Pedorthics, Orthotics, Patient-Reported-Outcomes
Health care delivery in Germany is still highly fragmented, resulting in poor vertical and horizontal
integration. Introducing an integrated care paragraph in the German Social Code Five in 20071,
greater interest and focus have evolved around bridging institutional and professional boundaries
within the care sector. At the core of this shift is the movement away from episodic treatment of
acute treatments to the provision of a coordinated continuum of services that will support those
with chronic conditions and enhance the health status. Initiatives for shared care will eventually
establish coherent treatment of the patient through close coordination and cooperation across care
sector boundaries.
Shared care initiatives in general are expected not only to improve communication and
coordination, in particular through electronic referral and therapy protocols, but also to provide
higher quality and efficiency by bridging the divided health care sector and thereby offer more
coherent health services and multidisciplinary treatment regimes.2
A further issue conferred with shared care was the potential impact of information systems,
electronic therapy records and electronic assessment instruments on the health service delivery
system. The German governments initiatives in establishing technological infrastructures to
support shared care resulted in § 67 Social Code Five (electronic communication).3 Although many
case studies can be found in the literature on integrated care, studies based on sound evidence
related to the effectiveness of integrated care strategies are still rare [2]. The major shortcoming in
the 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. therapy
protocols, 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 across
team, institutional and professional boundaries, and between professionals and patients. Informational continuity
concerns the timely availability of relevant information. Relationship continuity means a therapeutic relationship of the
patient with one or more health professionals over time.
© 2010 by Thomas Bade Page 2
3. Versorgungsmanagement DMP-Diabetes
Consequently, it is difficult to review systematically the findings in this area. Furthermore, not many
studies provide quantitative outcome measures and different terminologies are used. Therefore
Thomas Bade suggests the following definition:
Shared care is a concept bringing together inputs, delivery, management and organization of
services related to diagnosis, treatment, care, rehabilitation and health promotion. Integration is a
means to improve the services in relation to access, quality, user satisfaction and efficiency. While
the evaluation of (multiple) outcomes in integrated care systems is hampered by the complexity of
such programmes and the timescale necessary to establish results, many instruments have been
developed in the evaluation sciences that take into account the nature of the intervention [3]. The
aim 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 requirements
regarding the outcome structures of provided care. To improve the quality and cost effectiveness of
health care for chronic conditions, Disease Management Programmes (DMPs) were introduced by
German law in 2002. Minimum standards were defined for the conditions type 2 diabetes, breast
cancer, 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 are
allowed to selectively contract with providers and design their own DMPs for the legally defined
conditions. Criticism is raised by physicians claiming that only minimum standards have been
defined for DMPs and improved outcomes are not very likely. The mandatory evaluation of
programmes will provide empirical evidence on their level of success [4].
Thomas Bade investigated the first published evaluation results of Germany’s Disease
Management Programmes for diabetes [5].
© 2010 by Thomas Bade Page 3
4. Versorgungsmanagement DMP-Diabetes
Diabetes and its complications are important causes of morbidity and mortality in Germany and
contribute substantially to health care costs. Projections suggest that 4 million people in Germany
have diabetes and that direct costs of treatment of diabetes and diabetes-related complications
exceed € 5,2 billion [6]. Most patients with diabetes are managed in primary care and health care
delivery is often fragmented between primary physicians, specialty physicians, podiatry care and
pedorthics.5 Strict sectorization is still a characteristic of German Disease Management
Programmes for diabetes. The report in 2007 by the Advisory Council for the Concerted Action in
Health Care identified much scope for efficiency gains and quality improvement. The report found
evidence of overuse and economic inefficiencies but also of underuse and avoidable harm from
medical care for most common chronic diseases [7]. Based upon a recent OECD study there is
growing doubt over whether the comparatively high level of spending on health care in Germany
translates into high-quality care and cost-effective use of resources [8].
Although implementation of the national DMP-Diabetes programme has been associated with
important improvements in measures of processes of diabetes care, it has not been associated
with improvement in intermediate or long-term outcomes and coordination among different
providers [9]. In Germany, DMP-Diabetes physicians receive financial incentives to use structured
disease management plans and work collaboratively with specialty physicians, podiatry care and
pedorthics in team care arrangements to manage associated diseases. Interdisciplinary teams
should result in diabetes care consistent with national and international diabetes management
guidelines [10]. However, diabetes management is often inadequate despite care plans. Several
barriers prevent physicians from using structured diabetes care plans and different contractual
arrangements among Germanys regional insurance carriers and regional associations of statutory
health insurance physicians do not guarantee nationwide implementation of care plans.
Regulations, care providers and insurance carriers responsible for decision making differ by sector
and region concerning coverage of services, reimbursement of therapeutic appliances,
accreditation of providers, and quality assurance. According to national and international diabetes
guidelines, shared care (joint participation of primary, specialty care physicians and pedorthics in
planned delivery of care) should improve diabetes related foot disease management. Health care
teams have been urged to develop new relationships with relevant medical specialists, and
electronic communication has been proposed as an effective integration strategy consistent with
shared 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 by
disease, congenital condition, overuse or injury.
© 2010 by Thomas Bade Page 4
5. Versorgungsmanagement DMP-Diabetes
Diabetes related foot disease describes a number of complications of diabetes that can occur
simultaneously or in isolation. Peripheral neuropathy, peripheral vascular disease, foot ulceration
and amputation contribute significantly to the high rates of morbidity and mortality affecting
individuals with diabetes. Diabetes related foot disease is costly for the German health care system
because of its chronic nature and particularly because of the gravity of its complications. The
standard treatment of diabetic neuropathic foot ulcers is wound debridement, moist wound
dressing, and off-loading of pressure from the affected lower extremity. The likelihood of successful
treatment for diabetic neuropathic foot ulcers is associated with several baseline factors. 6
Despite the burden of foot disease on both the individual and the health care system, no research
has 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 a
multidisciplinary team [12]. This should closely involve the person with diabetes and his or her
family, along with healthcare professionals from different specialties. Ideally the team will include a
physician, 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 of
therapeutic appliances and technical aids. In these guidelines it is mandatory that prescribing
physicians communicate with health service providers for technical aids, orthopedic and prosthetic
devices. So far, there is no established documentation system available. There are national
guidelines defining standards of care, but the recently published AOK Curaplan data for patients
with diabetes suggest less than optimum care in a number of areas. Statistical AOK data for 2006
and 2007 suggest high rates of measurement of clinical and medical parameters but lower rates of
acting on the results. Massive regional differences for expenditures of therapeutic appliances
suggest that patients do not receive care according to current scientific evidence. Thomas Bade
concludes that in almost all regions the process of care did not reach the standards set out in
national 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 clinical
practice guideline. J Foot Ankle Surg 2006 Sep-Oct;45(5)].
© 2010 by Thomas Bade Page 5
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 insurance
provider. Although the clinical content of the AOK data includes the demographic characteristics
and diagnoses of patients and codes for procedures, these data can not be used to evaluate the
quality of intersectoral multidisciplinary diabetes care. However, gaps in clinical information and the
expenditure context for orthopedic and prosthetic devices compromise the ability to derive valid
outcome appraisals from the AOK data. The collected data allow limited insight into the quality of
team 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. Versorgungsmanagement DMP-Diabetes
The 2009 Quality Report of Disease Management Programmes by the National Association of
Statutory Health Insurance Physicians identified that set therapy goals for diabetic foot
interventions have not been met in all 15 regional Physicians Associations [13]. The current AOK
and National Association of Statutory Health Insurance Physicians (KBV) data are useful as
screening tools that highlight areas in which quality and outcome should be investigated in greater
depth. The growing availability of electronic clinical information will change the nature of data in the
future, enhancing opportunities for quality and outcome measurement.
The AOK and KBV data contain limited interdisciplinary insight and cannot evaluate the technical
quality of processes of care, determine most errors of under- or overuse, or assess the
appropriateness of care. On the other hand, AOK and KBV data are useful as a screening tool for
identifying 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 and
patient reported outcomes.
OBJECTIVES
Health insurance carriers and policymakers are striving to build and manage healthcare systems
that can accommodate delivery of coordinated care services, either through macro-level healthcare
reform 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 of
measurement methods in this area. Comparison of results between existing studies and reports is
difficult owing to differing terminologies, outcome measures and definitions of therapeutic
appliances 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 screening
in DMP-Diabetes settings compared with routine clinical data from German health insurance
carriers.
9
Most studies and reports summarize therapeutic appliances (orthotics, pedorthics) and physical therapy regimes.
© 2010 by Thomas Bade Page 7
8. Versorgungsmanagement DMP-Diabetes
In addition, literature research revealed that Patient Reported Outcomes (PRO) assessment has
become increasingly relevant in the evaluation of health care interventions, for a fundamental
reason [14]. In evaluating health care, as well as in decision-making, clinical and health services
researchers have come to the conclusion that direct self-reports of how disease, illness, and
treatment affects patients are the outcomes that are most significant to patients and health
insurance companies.
In this context an Information and Technology Service should be established that is triggered by
outcome assessment, performance gaps, patient reported outcomes and provided by specialists.
The Information and Technology Service should be used for assessment and evaluation of
orthopedic and rehabilitation referrals (prosthetics, orthotics, technical aids) and home health care
services. The Information and Technology Service records the effectiveness of therapeutic regimes
in routine outpatient practice. Valid and feasible assessment records are implemented to document
and analyse the effectiveness of ambulatory health care services. Clinical practice and outcome
measures in ambulatory care demand complex processing of data and information, usually at the
point of care of different care providers. The availability and capability of computerized systems
offer great potential for effectively acquiring, storing, retrieving, and analyzing data and information
of outpatient services.
The Information and Technology Service data-base does not simply mimic existing paper-based
forms but provides support for the cognitive tasks of physicians and other care providers and for
the 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 from
the data-base, to interpret them and to plan the appropriate treatment. Improved communication,
coordination and information sharing among physicians and pedorthics are recognized as being
essential to the ability of making timely and informed decisions about the adequate treatment
regime for diabetic foot ulcers. There is strong evidence that guidelines-based care can improve
patient outcomes particularly when supported by central computerized systems for patient tracking
and provision of feedback to physicians [15]. Audit and feedback has been shown to be an
effective strategy to improve providers performance of care, assessment strategies and
compliance with guidelines. There is a strong need for evidence of clinical effectiveness of foot
© 2010 by Thomas Bade Page 8
9. Versorgungsmanagement DMP-Diabetes
orthosis therapy in German DMP-Diabetes programmes [16]. The aim of the Information and
Technology Service is to improve the quality of care for patients with diabetes care by identifying
multidisciplinary and organisational factors that predict the implementation of best practice [17].
Therapeutic assessment of therapeutic appliances referred to the Information and Technology
Service are automatically recorded, unless patients did not give their consent. Consent is asked
when patients visit the physicians office or clinic (§ 11 Sec. 4 German Social Code Five). Data on
the physicians management regime for outpatient services are collected retrospectively in the
electronic medical record system of the referring physician, and analysed cross-sectionally by
outpatient service providers (§ 67 German Social Code Five). Different assessment forms have
already been created for physicians and outpatient care providers with tick boxes for quick
completion. Data from the assessment forms is registered anonymously in a database.
Consequently, it is the objective to encourage the adoption, connectivity, and interoperability of
health care information technology. The implementation of information technologies among
interdisciplinary care teams will reduce the cost of information and diminish barriers to inquire,
thereby sustaining the evidence-based medicine movement. Although some technical issues
remain to be solved, such as confidentiality of electronic patient records, financing and quality of
indicators, the Information and Technology Service will be a driving force for the development and
integration of multidisciplinary health care services.
A Budget Impact Analysis (BIA) should be additionally used to understand the financial impact of
diabetic foot health care interventions for the German health care system that has finite financial
resources. One of the key questions that will be answered through the use of BIA is whether
shared care will reduce diabetic foot expenditures. The aim of BIA is to show the financial effects of
shared care not only for the social security system in Germany in total, but also differentiated for all
types of statutory insurance carriers and all German regions. Long year experience with
construction of Budget-Impact-Model (BIM) on Excel basis should be used [18].
© 2010 by Thomas Bade Page 9
10. Versorgungsmanagement DMP-Diabetes
PATIENT SELECTION
Targeted screening
The approach is to screen patients who are classified in one of the risk-groups established by the
German 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 foot
Quality indicators will be based upon the published Medical Device Description for the respective
product groups. A targeted screening programme in the physicians office will exploit the available
DMP-Diabetes data to identify such patients. Once patients give their consent they will be recruited
for participation in the shared care treatment programme.
Model Design
To be transparent and accessible, the budget impact model and supporting report will be designed
in a manner that meets with the needs of the health insurance carriers, explicitly state all choices
and assumptions, use the simplest possible design structure to answer the budget impact
question, and be built using available Microsoft-Excel software.
Perspective
The BIA will be performed from the perspective of the German statutory health insurance and
includes a treatment perspective that includes orthopedic and prosthetic devices costs that are
reimbursed by statutory health insurance companies.
Calculating Costs
When calculating the cost of therapeutic appliances, BIA will include the contractual
reimbursement price. The costs will consider dispensing fees and patient co-payments.
Characterizing Uncertainty
Deterministic sensitivity analyses will be provided with submitted BIA to inform decision makers of
the sensitivity of the model to specific assumptions. Reasonable and/or cited information regarding
© 2010 by Thomas Bade Page 10
11. Versorgungsmanagement DMP-Diabetes
the range of uncertainty associated with each assumption will also be included. When reporting the
uncertainty analysis, a summary of sensitivity analyses performed on the following parameters will
be provided: reimbursement price, quantity of treatments in each risk group, health insurance
carriers expenditures in this segment.
Selection of relevant comparators
When developing BIA, the comparators used in the supporting budget impact model will reflect
diabetic 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 of
appropriate clinical input (e.g., published research).
Forecasting of the market under a Reference Scenario
To 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 over
the 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 healthcare
delivery can be grouped into three areas: 1) measures of precursors of integration (structural and
cultural measures); 2) measures of intermediate outcomes or internal process variables, which
assess 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 their
ultimate purpose (outcome measures) [9].
The Information and Technology Service is developed as an Internet-based system that has
minimal requirements to the local infrastructure at the users and to IT support. The system meets
all official requirements to protection of personal data and patient rights. Users access, the solution
on the Internet via logon with username and password and data is protected with extended
validation 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 Service
provides decision support for physicians in form of automatic indication of missing outcomes in
relation to established therapy goals. Evidence-based guidelines will be used to generate
therapeutical reminders for the treating staff, design automated feedback, notify treating staff
values requiring timely intervention, and form the basis of treatment and/or decision support
algorithms. Risk groups can be identified based on selected criteria for the purpose of closer
evaluation and follow-up. Data is registered and gathered in a structured manner. This gives a
© 2010 by Thomas Bade Page 11
12. Versorgungsmanagement DMP-Diabetes
more consistent documentation and subsequently allows for a better and more precise follow-up
on 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 consent
and provided an e-mail address. The Information and Technology Service will send an e-mail with
logon 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 of
questions 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 and
pedorthists who are using the system. The user interface has to be designed and tested for
usability in cooperation with diabetes clinics and pedorthists so that it supports the daily clinical
workflow in a flexible manner. Data is carefully selected according to relevance, in order to
minimize overlap and double entries. It is imperative that a feedback loop is included in the
Information and Technology Service that allows direct interface between diabetes clinics and
pedorthist. Physicians need to be alerted when values exceed certain thresholds so that rapid
response is enabled and treatment regimens can be altered. Hands-on training has to be provided
to every member of the intersectoral team.
TARGET POPULATION
Participants and Setting
The care provider being assessed should not be a single facility (e.g. diabetic podiatric centre, or
general practice) but a network of providers accountable to eligible patients. Shared care
agreements based upon third-party payer regulations between the medical sector and the diabetes
outpatient pedorthist exist only in a few parts of the country at present. DMP Diabetic Podiatric
Centres and specialized DMP practices participating in regional DMP Diabetes programmes
should use the Information and Technology Service for all referrals of diabetic foot treatments
performed by pedorthist. Existing regional DMP Diabetes programmes and contractual agreements
differ in terms of diabetic foot treatment regimes. In Bavaria it is agreed by contract that DMP
specialty physicians and diabetic podiatric centres must have a contractual agreement for
intersectoral cooperation. Since 2008 participating providers not providing a contractual
© 2010 by Thomas Bade Page 12
13. Versorgungsmanagement DMP-Diabetes
intersectoral cooperation with a pedorthist are sanctioned with a penalty fee. In Berlin a contractual
agreement for intersectoral cooperation is not mandatory and in Saxony there is no direction of
intersectoral cooperation at all.
SAMPLE SIZE
It 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 = 4.470
Treatment data to be allocated to programme after 29 months: n =4.000
Expected 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 participating
pedorthists to work in conjunction with the physician to determine the medical appropriateness of
an orthosis, prosthesis or pedorthic device. The pedorthist must receive a prescription from a
physician that meets the Guidelines for the Prescription of Therapeutic Appliances and Technical
Aids before providing any orthosis, prosthesis or pedorthic device to a patient. Using the
Information and Technology System prescribing physician and pedorthist will monitor and observe
the patient’s treatment condition in connection with the orthotic, prosthetic or pedorthic care and
the prescribed device to make certain the patient is responding appropriately. By definition of the
Guidelines for the Prescription of Therapeutic Appliances and Technical Aids the pedorthist must
notify the physician or referring podiatric centre of changes in the patient’s condition that affect the
patient’s orthotic, prosthetic or pedorthic treatment plan. Any repairs, adjustments, modifications or
replacements 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. Versorgungsmanagement DMP-Diabetes
DATA COLLECTION
System Description
The web-based Information and Technology Service has to be designed and developed for the
German health care market. The service should run on a Linux-webserver with Apache, PHP and a
MySQL database. The front-end should be programmed in PHP, HTML, CSS and Ajax/Javascript.
STATISTICAL ANALYSIS
Statistical analysis should be performed using the SPSS statistical package.
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15. Versorgungsmanagement DMP-Diabetes
DICTIONARY
Advisory Council for the Concerted Action Sachverständigenrat für die konzertierte Aktion im
in Health Care Gesundheitswesen
Care Provider Leistungserbringer im Sinne des SGB V
DMP Physician DMP koordinierender Arzt gemäß § 137 f SGB V
Federal Joint Committee Gemeinsame Bundesausschuss ( G-BA )
Guidelines for the Prescription of
Therapeutic Appliances and Technical Aids Hilfsmittel-Richtlinien des G-BA
Medical Device Description Hilfsmittelverzeichnis der gesetzlichen Krankenkassen
Multiple density insert, custom-molded from
model of patient’s foot diabetesadapierte Fußbettung
National Association of Statutory Health
Insurance Physicians Kassenärztliche Bundesvereinigung ( KBV )
Orthotist (orthopaedic technician) Orthopädietechniker, Leistungserbringer i.S. § 126 SGB V
Pedorthist (orthopaedic shoemaker) Orthopädieschuhtechniker, Leistungserbringer i.S. § 126 SGBV
Physical Therapy Regime Heilmittel-Richtlinien des G-BA
Podiatry Care, Diabetic Podiatric Centre Fußambulanz gemäß § 137 f SGB V
Product Groups Produktgruppen des Hilfsmittelverzeichnisses
Regional Associations of Statutory Health
Insurance Physicians Kassenärztliche Vereinigungen ( regional )
Shared Care Versorgungsmanagement i.S. § 11 Abs. 4 SGB V
Social Code Five Sozial Gesetzbuch Fünf ( SGB V )
Specialty Physicians DMP Schwerpunktpraxis gemäß § 137 f SGB V
Statutory Health Insurance Gesetzliche Krankenversicherung
Therapeutic Appliance Hilfsmittel i.S. § 33 SGB V
© 2010 by Thomas Bade Page 15
16. Versorgungsmanagement DMP-Diabetes
REFERENCES
[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 the
National 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 a
standardized framework ?, International Journal of Integrated Care – Vol. 8, 24 April 2008.
[4] Bundesversicherungsamt [Federal Insurance Authority]. Kriterien des Bundesversicherungsamtes zur Evaluation strukturierter
Behandlungsprogramme bei Diabetes mellitus Typ 2 (4.11.2004): www.bva.de/Fachinformationen/Dmp/Evaluation-Diabetes-2.pdf.
[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 research
directions; International Journal of Integrated Care – Vol. 9, 4 February 2009 .
[10] Bundesärztekammer, Kassenärztliche Bundesvereinigung, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen
Fachgesellschaften: 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 Health
Organization 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 Programms
zum Diabetes Mellitus Typ 2, Oktober 2009: 62 – 67.
[14] Patrick D.: Cochrane Patient Reported Outcomes Methods Group, The Cochrane Collaboration 2007 Issue 3, The Cochrane
Collaboration. 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 in
Denmark, 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 and
organisation 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)-based
approaches for the comparison of patient-reported outcomes in two groups of patients - a simulation study, BMC Medical Research
Methodology 2010, 10:24.
[20] Costa B. M. et al.: Effectiveness of IT-based diabetes management interventions: a review of the literature, BMC Family Practice
2009, 10:72.
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