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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
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
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
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
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
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
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
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
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
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
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
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
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
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.




© 2010 by Thomas Bade                                                                             Page 14
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
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.




© 2010 by Thomas Bade                                                                                                                Page 16
Versorgungsmanagement DMP-Diabetes




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in a copyright notice or other proprietary notice by Thomas Bade.




© 2010 by Thomas Bade
July 2010
Thomas Bade
Westenstr. 39
85072 Eichstätt
www.thomas-bade.de




© 2010 by Thomas Bade                                                                                            Page 17
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DMP Diabetes & Orthopädieschuhtechnik

  • 1. 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. © 2010 by Thomas Bade Page 14
  • 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. © 2010 by Thomas Bade Page 16
  • 17. Versorgungsmanagement DMP-Diabetes Disclaimer Unless otherwise noted, the material contained in this document is copyrighted and may not be used except as provided in a copyright notice or other proprietary notice by Thomas Bade. © 2010 by Thomas Bade July 2010 Thomas Bade Westenstr. 39 85072 Eichstätt www.thomas-bade.de © 2010 by Thomas Bade Page 17
  • 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 Five Therapeutic 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