Assessing the effect of a regional integrated care model over ten years using quality indicators based on claims data - the basic statistical methodology of the INTEGRAL project.

BACKGROUND: The regional integrated health care model "Healthy Kinzigtal" started in 2006 with the goal of optimizing health care and economic efficiency. The INTEGRAL project aimed at evaluating the effect of this model on the quality of care over the first 10 years. METHODS: This methodological protocol supplements the study protocol and the main publication of the project. Comparing quality indicators based on claims data between the intervention region and 13 structurally similar control regions constitutes the basic scientific approach. Methodological key issues in performing such a comparison are identified and solutions are presented. RESULTS: A key step in the analysis is the assessment of a potential trend in prevalence for a single quality indicator over time in the intervention region compared to the corresponding trends in the control regions. This step has to take into account that there may be a common - not necessarily linear - trend in the indicator over time and that trends can also appear by chance. Conceptual and statistical approaches were developed to handle this key step and to assess in addition the overall evidence for an intervention effect across all indicators. The methodology can be extended in several directions of interest. CONCLUSIONS: We believe that our approach can handle the major statistical challenges: population differences are addressed by standardization; we offer transparency with respect to the derivation of the key figures; global time trends and structural changes do not invalidate the analyses; the regional variation in time trends is taken into account. Overall, the project demanded substantial efforts to ensure adequateness, validity and transparency.

[Operationalization of Quality Indicators with Routine Data Using the Example of the Evaluation of "Integrated Care Healthy Kinzigtal"]. / Operationalisierung von Qualitätsindikatoren mittels Routinedaten am Beispiel der Evaluation der "Integrierten Versorgung Gesundes Kinzigtal".

AIM: As part of the 10-year evaluation of Gesundes Kinzigtal Integrated Care (IVGK, Innovation Fund Project 01VSF16002), a multidisciplinary group of experts agreed on 101 quality indicators (QI) to evaluate the quality of regionally integrated care with its focus on health and prevention programs. One criterion was that the selected QI should in principle be suitable for mapping using routine data. The aim of the study was to investigate how many and in what way the QI developed can actually be mapped in Germany with routine data and for what reasons operationalization was restricted or not possible. MATERIAL AND METHODS: The operationalization of the QIs was performed using pseudonymized billing data of the AOK Baden-Württemberg from 2006 to 2015, which the Scientific Institute of the AOK (WIdO) provided to the evaluation team. All operationalized indicators were binary coded (criterion fulfilled yes/no). The diagnoses, procedures, or drugs named in the numerator and denominator definitions were operationalized using ICD-10 codes (inclusion and exclusion diagnoses), EBM codes, OPS codes, ATC codes. Indicator prevalences were examined over time to check for abnormalities as an indication of possible misscoding. RESULTS: Ninety of the 101 indicators were operationalizable with routine data. Fourteen of the 90 indicators could only be operationalized with restrictions, as corresponding service codes were only introduced or existing codes were changed during the observation period. Seventy-six of 90 indicators could be operationalized without restrictions. In this context, 15 of these 76 indicators required pre- and follow-up periods, which meant that they could not be presented for all years. Eleven of 101 QIs could not be operationalized because EBM codes were only introduced after 2015 or were not recorded as individual services for all physician groups (e. g., spirometry and long-term ECG). Striking trends in indicator prevalences could be explained. CONCLUSION: Routine data enable resource-saving quality monitoring. A change in the data basis during the observation period, for example through the introduction or deletion of billing codes, makes the longitudinal, routine data-based quality assessment more difficult, but enables further or new indicators to be operationalized for later periods.

Ten-Year Evaluation of the Population-Based Integrated Health Care System "Gesundes Kinzigtal".

BACKGROUND: The population-based integrated health care system called "Gesundes Kinzigtal" (Integrierte Versorgung Gesundes Kinzigtal, IVGK) was initiated more than 10 years ago in the Kinzig River Valley region, which is located in the Black Forest in the German state of Baden-Württemberg. IVGK is intended to optimize health care while maximizing cost-effectiveness. It consists of programs for promoting health and for enabling cooperation among service providers, as well as of a shared-savings contract that has enabled resources to be saved every year. The goal of the present study was to investigate trends in the quality of care provided by IVGK over the past ten years in comparison to conventional care. METHODS: This is a non-randomized observational study with a control-group design (Kinzig River Valley versus 13 structurally comparable control regions), employing data collected by AOK, a large statutory health-insurance provider in Germany, over the period 2006-2015. Quality assessment was conducted with the aid of a set of indicators, developed by the authors, that was based exclusively on claims data. The statistical analysis of the trends in these indicators over time was conducted with preset criteria for the relevance of any observed changes, as well as preset mechanisms of controlling for confounding factors. RESULTS: For 88 of the 101 evaluable indicators, no relevant difference was seen between the trend over time in the region of the intervention and the average trend in the control regions. Relevant differences in favor of the IVGK were observed for six indicators, and negatively divergent trends compared to the controls were observed for seven indicators. In the main summarizing statistical analysis, no positive or negative difference was found between the Kinzig River Valley and the other regions with respect to trends in the health-care indicators over time. CONCLUSION: An evaluation based on 101 indicators derived from health-insurance data did not reveal any improvement of the quality of care by IVGK and the totality of the programs that were implemented under it. However, under the conditions of the shared-savings contract, no relevant diminution in the quality of care was observed over a period of 10 years either, compared with structurally similar control regions without an integrated care model.

[Development of an indicator set for the evaluation of the population-based integrated healthcare model 'Gesundes Kinzigtal' (Healthy Kinzigtal)]. / Entwicklung eines Indikatorensets zur Evaluation der Integrierten Versorgung Gesundes Kinzigtal.

INTRODUCTION: The project "INTEGRAL-10-year evaluation of the population-based integrated health care model 'Gesundes Kinzigtal' (Healthy Kinzigtal)" (ICM-GK) is funded by the Innovation Committee of the Federal Joint Committee (G-BA) (grant no. 01VSF16002). The evaluation is to be based on a set of indicators that can be captured in routine data. On the one hand, they can be used to assess ICM-GK programs that are program-specific and geared towards prevention and disease management. On the other hand, possible negative side effects of the ICM-GK, which is designed as a "shared savings contract", are to be examined by also observing care needs not covered by the ICM-GK contract. Since an indicator set for the evaluation of regional integrated care (IC) programs in Germany is not yet available, a suitable indicator set should be developed. METHODS: RESULTS: The methodological framework links the OECD concept for quality assessment of health systems with Kessner's tracer methodology. Disease groups with a high prevalence ("common diseases"), prevention potential and potential for improvement through IC were selected as tracers. The literature search resulted in 239 QIs and the QI database search in 293 QIs, which were supplemented by 21 QIs from the focus groups. Out of a total of 553 QIs, 251 QIs remained after removal of duplicates and comparison with the data basis. This preliminary QI set was reduced to 101 QIs by consensus. In addition, 48 health reporting indicators were supplemented which serve to classify regional quality results. The final QI set maps the following 19 disease categories/tracers: heart failure (16 QIs), myocardial infarction (4 QIs), CHD (10 QIs), stroke (6 QIs), metabolic syndrome (7 QIs of which 5 were diabetes-related), COPD (6 QIs), asthma (3 QIs), chronic pain (5 QIs), back pain (3 QIs), geriatrics (7 QIs), dementia (8 QIs), osteoporosis (3 QIs), rheumatism (3 QIs), multiple sclerosis (2 QIs), depression (4 QIs), antibiotic therapy (3 QIs), drug safety (1 QI), child care (5 QIs), early detection/prevention (5 QIs). 33 of these QIs are dedicated to five tracers that are not explicitly ICM-GK programs. Most QIs assess aspects of the effectiveness of care for the chronically ill and measure process quality. DISCUSSION: The set of indicators initially enables the quality assessment of regional, cross-indication care quality in the population-based integrated health care model 'Gesundes Kinzigtal' on the basis of routine data. Although the QI set focuses on effectiveness and process quality, it also includes QIs for preventive and acute care, coordination of care, patient orientation and safety, and outcomes. In contrast to other QI sets, both primary care and specialist health care and integrated, cross-sectoral and cross-professional care aspects have been considered. The benefits of the QI set for comparisons of regional quality and the evaluation of different IC programs remain to be tested. CONCLUSION: On the basis of a broadly based research and participatory development process, a set of indicators has been developed that enables comprehensive evaluation of the regional quality of care of cross-indication, integrated care models focusing on common diseases. In order to be able to increasingly evaluate aspects of care coordination and patient orientation, health promotion as well as nursing, palliative and emergency care in the future, it would be helpful if routine data were collected or made accessible in these areas as well.

Study protocol for a quasi-experimental claims-based study evaluating 10-year results of the population-based integrated healthcare model 'Gesundes Kinzigtal' (Healthy Kinzigtal): the INTEGRAL study.

INTRODUCTION: Patients often experience interface problems when treated by different specialists and in different healthcare sectors. Integrated care concepts aim to reduce these problems. While most integrated healthcare models focus on individual diseases, the integrated care model 'Gesundes Kinzigtal' applies a population-based approach and addresses the full spectrum of morbidities for a population defined by area of residence-the Kinzigtal. A special feature of the model is the joint savings contract between the regional management company and the statutory health insurers. The INTEGRAL study aims at assessing the effectiveness of 'Gesundes Kinzigtal' under routine conditions in comparison to conventional care over a period of 10 years in order to understand the benefits but also the potential for (unintended) harms. METHODS AND ANALYSIS: Database Claims data from statutory health insurance funds 2005-2015. The evaluation consists of a quasi-experimental study, with Kinzigtal as intervention region, at least 10 further regions with a similar population and healthcare infrastructure as primary controls and an additional random sample of insurees from the federal state of Baden-Württemberg as secondary controls. Model-specific and 'non-specific' indicators adopted from the literature and enriched by focus group interviews will be used to evaluate the model's effectiveness and potential unintended consequences by analysing healthcare utilisation in general. Temporal trends per indicator in the intervention region will be compared with those in each control region. The overall variation in trends for the indicators across all regions provides information about the potential to modify an indicator due to local differences in the healthcare system. ETHICS AND DISSEMINATION: Ethic Commission of the Faculty of Medicine, Philipps-University Marburg (ek_mr_geraedts_131117). Results will be discussed in workshops, submitted for publication in peer-review journals and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00012804.

[Anti-Diabetic Medication During the First Four Years of Treatment. A Study Based on Claims Data]. / Antidiabetische Medikation in den ersten vier Therapiejahren. Eine Studie auf Basis von Krankenkassendaten.

Background Ever since the UKPDS study reassessed the usefulness of the substance metformin in 1998, it has been the first-line medication in anti-diabetic treatment. In addition, new classes and agents released on the market have given rise to new treatment options. The present study investigates prescription practice at the onset of treatment and in the years thereafter and measures it against German diabetes guidelines. Database and Methods Database: Statutory health insurance sample AOK/KV Hesse; Ages: 40 and over (N = 142514). STUDY POPULATION: New users of anti-diabetic medication in 2008 (no medication during the preceding 730 days) (n = 1882). Investigation of anti-diabetic medication for four years after initial prescription with regard to substance spectrum, combination treatments, changes in treatment. Log-binomial model: factors influences onset of treatment with metformin versus sulfonylureas (age, sex, duration of illness, comorbidity). Results In 2008 67.9 % of patients began treatment exclusively with metformin, 17.8 % exclusively with sulfonylureas, and 6.7 % exclusively with insulin. Patients diagnosed as obese were significantly more likely to receive metformin. Elderly (80 years and over) or who had been diagnosed with diabetes at least three years prior or patients with renal or cerebrovascular illnesses were significantly less likely to receive metformin. Over the course of treatment, the number of patients receiving multiple medications increased from 5 % to 30 %. (The most frequent combinations were metformin/DPP4 inhibitor, metformin/sulfonylureas, and metformin/insulin.) Conclusion The findings show that German patient care guidelines on diabetes are reflected in prescription practice. Renal diseases are taken into account as potential contraindications for metformin treatment. In the wake of the expansion of approval for metformin in 2015 - reducing the creatinine clearance level to which application is possible - this first-line medication will be available for an ever larger circle of patients in the future.

[Evaluation of the population-based 'Integrated Health Care System Gesundes Kinzigtal' (IHGK). Findings on health care quality based on administrative data]. / Evaluation der populationsbezogenen 'Integrierten Versorgung Gesundes Kinzigtal' (IVGK). Ergebnisse zur Versorgungsqualität auf der Basis von Routinedaten.

BACKGROUND AND OBJECTIVES: The management company "Gesundes Kinzigtal GmbH" signed an agreement on integrated healthcare with the statutory health insurer AOK Baden-Württemberg, effective as of November 1, 2005. The aim of the evaluation was to check whether the extent of overuse and underuse of healthcare services in the area of intervention declined or increased compared with usual care. METHODS: Longitudinal study with non-randomised control group based on health insurers' claims data from the years 2004-2011. Intervention group: residents of the Kinzigtal region insured by AOK. CONTROL GROUP: persons insured with the AOK in other regions of Baden-Württemberg. Healthcare quality indicators were derived from other studies and guidelines. Fifteen out of the 18 indicators related to overuse or underuse; three related to an outcome, namely avoidable hospital stays, the appearance of fractures in patients with osteoporosis, and mortality. Trend and outcome analyses rely on Poisson and Cox regressions adjusted for age, sex, the Charlson Index, and multimorbidity. RESULTS: Two out of 5 indicators for overuse and 2 out of 10 for underuse showed significant improvement for the intervention population relative to the control group. The risk of a fracture in patients with osteoporosis (HR: 0.809; 95 % CI: 0.740 to 0.885; p<0.0001) and mortality (HR: 0.944; 95% CI; 0.899-0.991; p=0.0194) were significantly lower in the Kinzigtal population. No negative trends were found. CONCLUSIONS: Compared with the control group, which represents the secular trend, significant improvements of healthcare quality in the intervention group (6 out of 18 indicators) are considerably more frequent than significant changes for the worse (0 out of 18 indicators). To date, the effects are not very strong, as all insured persons from the Kinzigtal form the basis of the analysis irrespective of their participation in the integrated care program. Claims data are appIicable to indicator based evaluation, but it would be necessary to consider additional years to see whether observed positive trends could be enhanced.

[Pursuing the triple aim: evaluation of the integrated care system Gesundes Kinzigtal: population health, patient experience and cost-effectiveness]. / Triple Aim - Evaluation in der Integrierten Versorgung Gesundes Kinzigtal - Gesundheitszustand, Versorgungserleben und Wirtschaftlichkeit.

BACKGROUND: The integrated care system Gesundes Kinzigtal (ICSGK), one of the most comprehensive population-based ICS in Germany, started its work nearly 9 years ago. The ICSGK is pursuing the Triple Aim: improving the health of the population, improving the individual's experience of care, and at the same time reducing the per capita costs of care. OBJECTIVES: To evaluate the impact of the ICSGK on the Triple Aim. MATERIALS AND METHODS: The ICSGK is being evaluated externally and internally via a mix of diverse quantitative and qualitative methods. This paper presents selected results for each Triple Aim dimension. RESULTS AND CONCLUSIONS: Regarding population health, most of the quality indicators examined by the external scientific evaluation show positive development. For example, the prevalence of patients with fractures among all insurants with osteoporosis is presented. In 2011, this prevalence was approximately 26 % in the "Kinzigtal" population (aged ≥ 20 years old) in comparison to 33 % in the control group. As far as patient experience is concerned, to the question "Would you recommend becoming a member of Gesundes Kinzigtal to your friends or relatives?" 92.1 % of those questioned answered "Yes, for sure" or "Yes, probably." Twenty-four percent of those questioned further stated that they would now live "more healthy" than before enrolment in the ICSGK. In the subgroup of questioned insurants who had objective agreements with their doctors 45.4 % answered in this way. On the subject of cost-effectiveness, for both participating socil health insurance schemes, cost savings relative to the costs normally expected for the ICSGK population concerned are observed every year. In the seventh intervention year (2012) the total is 4.56 million Euros for the AOK Baden-Württemberg (BW), which is a contribution margin of 146 Euros per insurant for the 31.156 insurants concerned (LKK BW = 322 Euros per insurant relative to cost savings). The results presented in this paper indicate positive effects in all three Triple Aim dimensions. Further longitudinal studies are recommended to validate those first results together with a detailed analysis to obtain in-depth insights into the specific influence of subcomponents of the total intervention.