Implementation of integrated care for type 2 diabetes Mellitus and Periodontitis in Germany: study protocol for a practice-based and cluster-randomized trial.

BACKGROUND: Type 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral health care continue to operate separate from each other and fail to synchronize care for patients with T2DM and periodontitis. The purpose of this practice-based trial is to evaluate the implementation of a new integrated care pathway for patients with T2DM and periodontitis. The new approach integrates a screening for T2DM risk in dental care settings in patients with periodontitis, a screening for periodontitis risk in primary care settings in patients with T2DM, and mutual referrals between dentists and primary care physicians. METHODS: Two practice-based studies will be carried out in parallel: (i) In dental care settings: a practice-based, multi-centric, cluster-randomized, controlled trial with a control and an intervention group; (ii) in primary care settings: a practice-based, multi-centric, non-randomized, controlled trial with a synthetic control group calculated from claims data. Following a two-step recruitment approach, 166 dentists and 248 general practitioners will be recruited, who themselves will recruit a total of 3808 patients in their practices. Patient data will be collected at baseline, 12 months, and 24 months after study enrollment. The evaluation comprises: (i) impact evaluation, using a hierarchical linear mixed model; (ii) process evaluation, based on surveys alongside the trials; (iii) economic evaluation. In addition, a Discrete-Choice-Experiment will identify provider's payment preferences for the new care approach. DISCUSSION: Upon successful implementation, the intervention will enable health care providers to detect a risk for T2DM and periodontitis in patients at an early stage, thus providing patients an opportunity for timely diagnosis and therapy. Ultimately, this can lead to increased quality of life and reduced health care expenditures. On a methodologic level, the project provides novel insights into a complex intervention on the intersection of general practice and dental care. TRIAL REGISTRATION: The study was prospectively registered at the German Clinical Trials Register ( https://drks.de/search/de/trial/DRKS00030587 ) on 3. July 2023 under ID "DRKS00030587".

Evaluation of a Digital Decision Support System to Integrate Type 2 Diabetes Mellitus and Periodontitis Care: Case-Vignette Study in Simulated Environments.

BACKGROUND: As highlighted by the recent World Health Organization Oral Health Resolution, there is an urgent need to better integrate primary and oral health care. Despite evidence and guidelines substantiating the relevance of integrating type 2 diabetes mellitus (T2DM) and periodontitis care, the fragmentation of primary and oral health care persists. OBJECTIVE: This paper reports on the evaluation of a prototype digital decision support system (DSS) that was developed to enhance the integration of T2DM and periodontitis care. METHODS: The effects of the prototype DSS were assessed in web-based simulated environments, using 2 different sets of case vignettes in combination with evaluation surveys among 202 general dental practitioners (GDPs) and 206 general practitioners (GPs). Each participant evaluated 3 vignettes, one of which, chosen at random, was assisted by the DSS. Logistic regression analyses were conducted at the participant and case levels. RESULTS: Under DSS assistance, GPs had 8.3 (95% CI 4.32-16.03) times higher odds of recommending a GDP visit. There was no significant impact of DSS assistance on GP advice about common risk factors for T2DM and periodontal disease. GDPs had 4.3 (95% CI 2.08-9.04) times higher odds of recommending a GP visit, 1.6 (95% CI 1.03-2.33) times higher odds of giving advice on disease correlations, and 3.2 (95% CI 1.63-6.35) times higher odds of asking patients about their glycated hemoglobin value. CONCLUSIONS: The findings of this study provide a proof of concept for a digital DSS to integrate T2DM and periodontal care. Future updating and testing is warranted to continuously enhance the functionalities of the DSS in terms of interoperability with various types of data sources and diagnostic devices; incorporation of other (oral) health dimensions; application in various settings, including via telemedicine; and further customization of end-user interfaces.

Engaging patients to develop a customized digital health companion for periodontitis: Study protocol.

Periodontitis is a chronic inflammatory disease resulting in the destruction of tooth-supporting tissues. It affects billions of people around the globe and substantiates an enormous economic burden to society. Digital tools such as mobile Health (mHealth) applications have the potential to increase patient engagement, knowledge about the disease, and adherence to treatment recommendations. Digital health companions represent a new kind of digital tool aiming to support patients throughout their course of periodontal care. This paper presents the study protocol of the Paro-ComPas project which aims to co-develop and evaluate a digital patient companion application ("app") to empower patients along their journey with periodontitis. As a first step, a qualitative study design encompassing semi-structured interviews with patients and experts as well as focus group discussions (FGD) will be used. Patients in different stages of periodontal care will be recruited from dental practices across Germany and are invited to share their experiences and opinions about their care and potential areas for support. Experts from relevant areas (e.g., mHealth, behavior change psychology, oral health, and dental hygiene) will be interviewed to map a holistic view on the current delivery of care and best practices of mHealth development. After setting up a minimal viable product (MVP) based on a requirements analysis, FGDs with patients will take place to incorporate user feedback and finalize the development of the prototypic app. The prototypic app will then be evaluated in a randomized, multi-center clinical trial in comparison with the current standard of care. Finally, a comprehensive implementation roadmap will be developed together with all relevant stakeholders. This comprehensive approach will allow us to map the patient journey and develop a digital health companion tailored to the needs of patients with periodontitis using an already existing indication independent medical companion toolbox. Novel insights into patients' knowledge and perception of periodontal disease as well as barriers in adherence to periodontal care pathways will be provided. This knowledge will be converted in a systematically tailored companion app to serve the needs and preferences of people to better address periodontitis. The results from the clinical trial will provide unique insights into the extent to which the patient companion app contributes to adherence to periodontal care. Although mHealth applications have become popular in recent years, only few apps focusing on promotion of oral health have been released so far. Our study presents a novel and comprehensive approach to both co-developing and evaluating a proof of concept for a digital health companion for patients with periodontitis.

Effects of provider incentives on dental X-raying in NHS Scotland: what happens if patients switch providers?

BACKGROUND: In many market settings individuals are encouraged to switch health care providers as a means of ensuring more competition. Switching may have a potentially undesirable side effect of increasing unnecessary treatment. Focusing on the most common source of medical radiation (dental X-rays), the purpose of this study was to assess whether, upon switching dentist, X-ray exposure increases depending on the type of provider payment. METHODS: The analysis used longitudinal data from 2005 to 2016 covering a 5% random sample of the Scottish adult population covered by the National Health Service (NHS). Multiple fixed-effects panel regression analyses were employed to determine the correlation of provider remuneration with patients' likelihood of receiving an X-ray upon switching to a new dentist other things equal. A broad set of covariates including a patient's copayment status was controlled for. RESULTS: Upon switching to a dentist who was paid fee-for-service, patients had a by 9.6%-points (95% CI 7.4-11.8%) higher probability of receiving an X-ray, compared to switching to a salaried dentist. Results were robust when accounting for patient exemption status, as well as unobserved patient and dentist characteristics. CONCLUSIONS: In comparison to staying with the same dentist, patients may be exposed to substantially more X-rays upon switching to a dentist who is paid fee-for-service. There may need to be better guidance and regulation to protect the health of those who have to switch provider due to moving and greater caution in advocating voluntary switching.

Development and evaluation of a mobile patient application to enhance medical-dental integration for the treatment of periodontitis and diabetes.

INTRODUCTION: People around the world are increasingly affected by multimorbidity, where conditions in different medical specialties can correlate in complex ways. This increases the relevance of multidisciplinary integrated care pathways. Modern software solutions provide vast opportunities to enhance information exchange between patients and various healthcare professionals, thereby improving patient-centered and inter-professional care. This paper describes the development and validation of a mobile patient application which exploits Patient Reported Outcomes to enhance patient-centered medical-dental integration with a focus on integrated management of periodontitis and diabetes. METHODS: This study was part of a multidisciplinary project for enhancement of medical-dental integration. The Intervention Mapping Protocol was supplemented by the RAND/UCLA Appropriateness Method, including literature reviews, focus group discussions and a Delphi panel in cooperation with various stakeholders. A mobile application was developed in close collaboration with patients, physicians and dentists. The usability of the application's core components was validated in two medical and two dental practices using the System Usability Scale (SUS). RESULTS: 39 questions were identified to provide relevant patient-reported information which can be collected via a mobile application to enhance integrated management of periodontitis and diabetes. Usability testing of the application's core components (14 questions) among 137 participants in medical and dental practices indicated a good SUS score of 77.88 (±12.17). DISCUSSION: The systematically developed mobile application offers the potential to provide physicians and dentists with treatment-relevant information to enhance medical-dental integration, thereby reducing the workload of medical staff, improving the quality of routinely collected data, and enabling automated data processing. This unique, novel, and validated approach can serve as an open framework for the development and evaluation of interdisciplinary healthcare software.

Accuracy of a 7-Item Patient-Reported Stand-Alone Tool for Periodontitis Screening.

Periodontitis is interrelated with various other chronic diseases. Recent evidence suggests that treatment of periodontitis improves glycemic control in diabetes patients and reduces the costs of diabetes treatment. So far, however, screening for periodontitis in non-dental settings has been complicated by a lack of easily applicable and reliable screening tools which can be applied by non-dental professionals. The purpose of this study was to assess the diagnostic accuracy of a short seven-item tool developed by the German Society for Periodontology (DG PARO) to screen for periodontitis by means of patient-reported information. A total of 88 adult patients filled in the patient-reported Periodontitis Risk Score (pPRS; range: 0 points = lowest periodontitis risk; 20 points = very high periodontitis risk) questionnaire before dental check-up at Heidelberg University Hospital. Subsequent clinical assessments according to Periodontal Screening and Recording (PSR®) were compared with pPRS scores. The diagnostic accuracy of pPRS at different cutoff values was assessed according to sensitivity, specificity, positive, and negative predictive values, as well as Receiver-Operator-Characteristic curves, Area Under the Curve (AUC), and logistic regression analysis. According to combined specificity and sensitivity (AUC = 0.86; 95%-CI: 0.76-0.95), the diagnostic accuracy of the pPRS for detecting periodontal inflammation (PSR® ≥ 3) was highest for a pPRS cutoff distinguishing between pPRS scores < 7 vs. ≥ 7. Patients with pPRS scores ≥ 7 had a 36.09 (95%-CI: 9.82-132.61) times higher chance of having a PSR® ≥ 3 than patients with scores < 7. In conclusion, the pPRS may be considered an appropriately accurate stand-alone tool for the screening for periodontitis.

Effect of periodontal treatment on diabetes-related healthcare costs: a retrospective study.

INTRODUCTION: Periodontitis has been considered a sixth complication of diabetes. The aim of this study was to assess the impact of periodontal treatment on diabetes-related healthcare costs in patients with diabetes. RESEARCH DESIGN AND METHODS: A retrospective analysis was done, exploiting unique and large-scale claims data of a Dutch health insurance company. Data were extracted for a cohort of adults who had been continuously insured with additional dental coverage for the years 2012-2018. Individuals with at least one diabetes-related treatment claim in 2012 were included for analysis. A series of panel data regression models with patient-level fixed effects were estimated to assess the impact of periodontal treatment on diabetes-related healthcare costs. RESULTS: A total of 41 598 individuals with diabetes (age range 18-100 years; 45.7% female) were included in the final analyses. The median diabetes-related healthcare costs per patient in 2012 were €38.45 per quarter (IQR €11.52-€263.14), including diagnoses, treatment, medication and hospitalization costs. The fixed effect models showed €12.03 (95% CI -€15.77 to -€8.29) lower diabetes-related healthcare costs per quarter of a year following periodontal treatment compared with no periodontal treatment. CONCLUSIONS: Periodontitis, a possible complication of diabetes, should receive appropriate attention in diabetes management. The findings of this study provide corroborative evidence for reduced economic burdens due to periodontal treatment in patients with diabetes.

Correction to: Determinants of healthcare seeking and out-of-pocket expenditures in a "free" healthcare system: evidence from rural Malawi.

An amendment to this paper has been published and can be accessed via the original article.

Determinants of healthcare seeking and out-of-pocket expenditures in a "free" healthcare system: evidence from rural Malawi.

BACKGROUND: Monitoring financial protection is a key component in achieving Universal Health Coverage, even for health systems that grant their citizens access to care free-of-charge. Our study investigated out-of-pocket expenditure (OOPE) on curative healthcare services and their determinants in rural Malawi, a country that has consistently aimed at providing free healthcare services. METHODS: Our study used data from two consecutive rounds of a household survey conducted in 2012 and 2013 among 1639 households in three districts in rural Malawi. Given our explicit focus on OOPE for curative healthcare services, we relied on a Heckman selection model to account for the fact that relevant OOPE could only be observed for those who had sought care in the first place. RESULTS: Our sample included a total of 2740 illness episodes. Among the 1884 (68.75%) that had made use of curative healthcare services, 494 (26.22%) had incurred a positive healthcare expenditure, whose mean amounted to 678.45 MWK (equivalent to 2.72 USD). Our analysis revealed a significant positive association between the magnitude of OOPE and age 15-39 years (p = 0.022), household head (p = 0.037), suffering from a chronic illness (p = 0.019), illness duration (p = 0.014), hospitalization (p = 0.002), number of accompanying persons (p = 0.019), wealth quartiles (p2 = 0.018; p3 = 0.001; p4 = 0.002), and urban residency (p = 0.001). CONCLUSION: Our findings indicate that a formal policy commitment to providing free healthcare services is not sufficient to guarantee widespread financial protection and that additional measures are needed to protect particularly vulnerable population groups.

Once bitten, twice shy? Lessons learned from an experiment to liberalize price regulations for dental care.

In 2012, The Netherlands established the so-called "free market experiment", which allowed providers of dental care to set the prices for their dental services themselves. The introduction of market mechanisms is intended to improve the quality of care and to contribute to cost containment, but increasing health expenditures for citizens have been observed in this context. Using large-volume health insurance claims data and exploiting the 2012 experiment in Dutch dental care, we identified the effects of a liberalization of service prices. Using pooled regression with individual fixed effects, we analyzed changes in utilization patterns of prevention-oriented dental services in response to the experiment as well as the elasticities in demand in response to variations in out-of-pocket (OOP) prices. We found substantial increases in prices and patients' OOP contributions for dental services following the liberalization with differences in increases between types of services. In response to the experiment, the proportion of treatment sessions containing preventive-oriented services decreased significantly by 3.4% among adults and by 5.3% for children and adolescents. Estimates of short-run price elasticities of demand for different services point towards differences in price sensitivity. One potential explanation for the observed variations in prices and utilization could be different extents of asymmetric information for first-stage and follow-on services. Price liberalization seems to have affected the composition of treatment sessions towards a decreasing use of preventive services, suggesting a shift in the reason for seeing a dental care provider from a regular-preventive perspective to a symptom-based restorative approach.

Implementation of altered provider incentives for a more individual-risk-based assignment of dental recall intervals: evidence from a health systems reform in Denmark.

Equipping health systems with suitable incentives for efficient resource allocation remains a major health policy challenge. This study examines the impacts of 2015 regulatory changes in Danish dental care which aimed at effectuating a transition from six-to-twelve-monthly dental recall intervals, for every patient, towards a model where patients with higher need receive dental recalls systematically more frequently than patients with lower need. Exploiting administrative data from the years 2012-2016 from the Danish National Health Insurance database containing 72,155,539 treatment claims for 3,759,721 unique patients, we estimated a series of interrupted time-series regression models with patient-level fixed-effects. In comparison to the pre-reform period, the proportion of patients with recall intervals of up to 6 months was by 1.2%-points larger post-implementation; that of patients with 6-12-monthly recalls increased by 0.7%-points; that of patients with more than 12-monthly dental recalls decreased by 1.9%-points. The composition of care shifted more substantially: the proportion of treatment sessions including preventive care increased by 31.5%-points (95%-CI: 31.4;31.6); that of sessions including scaling increased by 24.1%-points (24.0;24.2); that of sessions including diagnostics decreased by 34.5%-points (34.4;34.6). These findings suggest that dental care providers may have responded differently to regulatory changes than intended by the health policy.

Determinants of health seeking behavior for chronic non-communicable diseases and related out-of-pocket expenditure: results from a cross-sectional survey in northern Bangladesh.

BACKGROUND: In spite of high prevalence rates, little is known about health seeking and related expenditure for chronic non-communicable diseases in low-income countries. We assessed relevant patterns of health seeking and related out-of-pocket expenditure in Bangladesh. METHODS: We used data from a household survey of 2500 households conducted in 2013 in Rangpur district. We employed multinomial logistic regression to assess factors associated with health seeking choices (no care or self-care, semi-qualified professional care, and qualified professional care). We used descriptive statistics (5% trimmed mean and range, median) to assess related patterns of out-of-pocket expenditure (including only direct costs). RESULTS: Eight hundred sixty-six (12.5%) out of 6958 individuals reported at least one chronic non-communicable disease. Of these 866 individuals, 139 (16%) sought no care or self-care, 364 (42%) sought semi-qualified care, and 363 (42%) sought qualified care. Multivariate analysis confirmed that the following factors increased the likelihood of seeking qualified care: a higher education, a major chronic non-communicable disease, a higher socio-economic status, a lower proportion of chronic household patients, and a shorter distance between a household and a sub-district public referral health facility. Seven hundred fifty-four (87 %) individuals reported out-of-pocket expenditure, with drugs absorbing the largest portion (85%) of total expenditure. On average, qualified care seekers encountered the highest out-of-pocket expenditure, followed by those who sought semi-qualified care and no care, or self-care. CONCLUSION: Our study reveals insufficiencies in health provision for chronic conditions, with more than half of all affected people still not seeking qualified care, and the majority still encountering considerable out-of-pocket expenditure. This calls for urgent measures to secure better access to care and financial protection.

Needs-based planning for the oral health workforce - development and application of a simulation model.

BACKGROUND: The World Health Organization's global strategy on human resources for health includes an objective to align investment in human resources for health with the current and future needs of the population. Although oral health is a key indicator of overall health and wellbeing, and oral diseases are the most common noncommunicable diseases affecting half the world's population, oral health workforce planning efforts have been limited to simplistic target dentist-population or constant services-population ratios which do not account for levels of and changes in population need. Against this backdrop, our aim was to develop and operationalise an oral health needs-based workforce planning simulation tool. METHODS: Using a conceptual framework put forward in the literature, we aimed to build the model in Microsoft Excel and apply it in a hypothetical context to demonstrate its operability. The model incorporates a provider supply component and a provider requirement component, enabling a comparison of the current and future supply of and requirement for oral health workers. Publicly available data, including the Special Eurobarometer 330 Oral Health Survey, were used to populate the model. Assumptions were made where data were not publicly available and key assumptions were tested in scenario analyses. RESULTS: We have systematically developed a needs-based workforce planning model for the oral health workforce and applied the model in a hypothetical context over a 30-year time span. In the 2017 baseline scenario, the model produced a full-time equivalent (FTE) provider requirement figure of 899 dentists compared with an FTE provider supply figure of 1985. In the scenario analyses, the FTE provider requirement figure ranged from 1123 to 1629 illustrating the extent of the impact of changing parameter values. CONCLUSIONS: In response to policy makers' recognition of the pressing need to better plan human resources for health and the scarcity of work in this area for dentistry, we have demonstrated the feasibility of producing a workable, practical and useful needs-based workforce planning simulation tool for the oral health workforce. In doing so, we have highlighted the challenges faced in accessing timely and relevant data needed to populate such models and ensure the reliability of model outputs.

Detecting and Resolving Data Conflicts when Using International Claims Data for Research.

Using claims data for research is well established. However, most claims data analyses are focused on single countries. Multi-national approaches are scarce. The application of different anonymization techniques before data are shared for research as well as differences in the reimbursement systems hamper the use of claims data from multiple countries. This paper analyses data conflicts that occur when international claims data sets are used for research and develops a generic process to detect and resolve these conflicts. The approach was successfully applied in the EU-funded ADVOCATE (Added Value for Oral Care) project that acquired data from health insurance providers, health funds or health authorities in six European countries.

The economic burden of chronic non-communicable diseases in rural Malawi: an observational study.

BACKGROUND: Evidence from population-based studies on the economic burden imposed by chronic non-communicable diseases (CNCDs) is still sparse in Sub-Saharan Africa. Our study aimed to fill this existing gap in knowledge by estimating both the household direct, indirect, and total costs incurred due to CNCDs and the economic burden households bear as a result of these costs in Malawi. METHODS: The study used data from the first round of a longitudinal household health survey conducted in 2012 in three rural districts in Malawi. A cost-of-illness method was applied to estimate the economic burden of CNCDs. Indicators of catastrophic spending and impoverishment were used to estimate the economic burden imposed by CNCDs on households. RESULTS: A total 475 out of 5643 interviewed individuals reported suffering from CNCDs. Mean total costs of all reported CNCDs were 1,040.82 MWK, of which 56.8 % was contributed by direct costs. Individuals affected by chronic cardiovascular conditions and chronic neuropsychiatric conditions bore the highest levels of direct, indirect, and total costs. Using a threshold of 10 % of household non-food expenditure, 21.3 % of all households with at least one household member reporting a CNCD and seeking care for such a condition incurred catastrophic spending due to CNCDs. The poorest households were more likely to incur catastrophic spending due to CNCDs. An additional 1.7 % of households reporting a CNCD fell under the international poverty line once considering direct costs due to CNCDs. CONCLUSION: Our study showed that the economic burden of CNCDs is high, causes catastrophic spending, and aggravates poverty in rural Malawi, a country where in principle basic care for CNCDs should be offered free of charge at point of use through the provision of an Essential Health Package (EHP). Our findings further indicated that particularly high direct, indirect, and total costs were linked to specific diagnoses, although costs were high even for conditions targeted by the EHP. Our findings point at clear gaps in coverage in the current Malawian health system and call for further investments to ensure adequate affordable care for people suffering from CNCDs.

Out-of-pocket expenditure on chronic non-communicable diseases in sub-Saharan Africa: the case of rural Malawi.

In Sub-Saharan Africa (SSA) the disease burden of chronic non-communicable diseases (CNCDs) is rising considerably. Given weaknesses in existing financial arrangements across SSA, expenditure on CNCDs is often borne directly by patients through out-of-pocket (OOP) payments. This study explored patterns and determinants of OOP expenditure on CNCDs in Malawi. We used data from the first round of a longitudinal household health survey conducted in 2012 on a sample of 1199 households in three rural districts in Malawi. We used a two-part model to analyze determinants of OOP expenditure on CNCDs. 475 respondents reported at least one CNCD. More than 60% of the 298 individuals who reported seeking care incurred OOP expenditure. The amount of OOP expenditure on CNCDs comprised 22% of their monthly per capita household expenditure. The poorer the household, the higher proportion of their monthly per capita household expenditure was spent on CNCDs. Higher severity of disease was significantly associated with an increased likelihood of incurring OOP expenditure. Use of formal care was negatively associated with the possibility of incurring OOP expenditure. The following factors were positively associated with the amount of OOP expenditure: being female, Alomwe and household head, longer duration of disease, CNCDs targeted through active screening programs, higher socio-economic status, household head being literate, using formal care, and fewer household members living with a CNCD within a household. Our study showed that, in spite of a context where care for CNCDs should in principle be available free of charge at point of use, OOP payments impose a considerable financial burden on rural households, especially among the poorest. This suggests the existence of important gaps in financial protection in the current coverage policy.

Health seeking behaviour and the related household out-of-pocket expenditure for chronic non-communicable diseases in rural Malawi.

Malawi is facing a rising chronic non-communicable disease (CNCD) epidemic. This study explored health seeking behaviour and related expenditure on CNCDs in rural Malawi, with specific focus on detecting potential differences across population groups. We used data from the first round of a panel household health survey conducted in rural Malawi between August and October 2012 on a sample of 1199 households. Multinomial logistic regression was used to analyse factors associated with health seeking choices for CNCDs, distinguishing between no care, informal care and formal care. Descriptive statistics (mean, standard deviation and median) were used to describe related household out-of-pocket expenditure. There were 475 individuals (equivalent to 8.4% of all respondents) reporting at least one CNCD. Among them, 37.3% did not seek any care, 42.5% sought formal care (facility-based care), and 20.2% opted for informal care (traditional or home treatment). Regression analysis showed that illness severity and duration, socio-economic status, being a household head, and the proportion of household members living with a CNCD were significantly associated with health care utilization. Among those seeking care, 65.8% incurred out-of-pocket expenditure with an average of USD 1.49 spent on medical treatment and an additional USD 0.50 spent on transport. Further qualitative inquiry is needed to understand the reasons for low service utilization and to explore the potential role of supply-side factors. To increase access to care for people suffering from CNCDs, the provision of a free Essential Health Package in Malawi ought to be strengthened through the integration of system-wide screening, risk factor modification and continuity of care options for people suffering from CNCDs. This would ensure affordable services to modulate health seeking behaviour of patients at risk of major chronic illnesses.