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Orthogeriatric co-management (OGCM) may provide benefits for geriatric fragility fracture patients in terms of more frequent osteoporosis treatment and fewer re-fractures. Yet, we did not find higher costs in OGCM hospitals for re-fractures or antiosteoporotic medication for most fracture sites within 12 months, although antiosteoporotic medication was more often prescribed. PURPOSE: Evidence suggests benefits of orthogeriatric co-management (OGCM) for hip fracture patients. Yet, evidence for other fractures is rare. The aim of our study was to conduct an evaluation of economic and health outcomes after the German OGCM for geriatric fragility fracture patients. METHODS: This retrospective cohort study was based on German health and long-term care insurance data. Individuals were 80 years and older, sustained a fragility fracture in 2014-2018, and were treated in hospitals certified for OGCM (ATZ group), providing OGCM without certification (OGCM group) or usual care (control group). Healthcare costs from payer perspective, prescribed medications, and re-fractures were investigated within 6 and 12 months. We used weighted gamma and two-part models and applied entropy balancing to account for the lack of randomization. All analyses were stratified per fracture site. RESULTS: We observed 206,273 patients within 12-month follow-up, of whom 14,100 were treated in ATZ, 133,353 in OGCM, and 58,820 in other hospitals. Total average inpatient costs per patient were significantly higher in the OGCM and particularly ATZ group for all fracture sites, compared to control group. We did not find significant differences in costs for re-fractures or antiosteoporotic medication for most fracture sites, although antiosteoporotic medication was significantly more often observed in the OGCM and particularly ATZ group for hip, pelvic, and humerus fractures. CONCLUSION: The observed healthcare costs were higher in ATZ and OGCM hospitals within 12 months. Antiosteoporotic medication was prescribed more often in both groups for most fracture sites, although the corresponding medication costs did not increase.
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Fraturas do Quadril , Osteoporose , Fraturas por Osteoporose , Humanos , Idoso , Fraturas por Osteoporose/prevenção & controle , Estudos Retrospectivos , Fraturas do Quadril/terapia , Custos de Cuidados de Saúde , Osteoporose/complicações , Osteoporose/tratamento farmacológicoRESUMO
BACKGROUND: Effective care coordination may increase clinical efficiency, but its measurement remains difficult. The established metric "care density" (CD) measures care coordination based on patient-sharing among physicians, but it may be too rigid to generalize across disorders and countries. Therefore, we propose an extension called fragmented care density (FCD), which allows varying weights for connections between different types of providers. We compare both metrics in their ability to predict hospitalizations due to schizophrenia. METHODS: We conducted a longitudinal cohort study based on German claims data from 2014 through 2017 to predict quarterly hospital admissions. 21,016 patients with schizophrenia from the federal state Baden-Württemberg were included. CD and FCD were calculated based on patient-sharing networks. The weights of FCD were optimized to predict hospital admissions during the first year of a 24-month follow-up. Subsequently, we employed likelihood ratio tests to assess whether adding either CD or FCD improved a baseline model with control variables for the second follow-up year. RESULTS: The inclusion of FCD significantly improved the baseline model, Χ2(1) = 53.30, p < 0.001. We found that patients with lower percentiles in FCD had an up to 21% lower hospitalization risk than those with median or higher values, whereas CD did not affect the risk. CONCLUSIONS: FCD is an adaptive metric that can weight provider relationships based on their relevance for predicting any outcome. We used it to better understand which medical specialties need to be involved to reduce hospitalization risk for patients with schizophrenia. As FCD can be modified for different health conditions and systems, it is broadly applicable and might help to identify barriers and promoting factors for effective collaboration.
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Hospitalização , Esquizofrenia , Humanos , Estudos Longitudinais , Esquizofrenia/diagnóstico , Esquizofrenia/terapia , Estudos de CoortesRESUMO
BACKGROUND: In Germany, geriatricians deliver acute geriatric care during acute hospital stay and post-acute rehabilitation after transfer to a rehabilitation clinic. The rate patients receive acute geriatric care (AGC) or are transferred to post-acute rehabilitation (TPR) differs between hospitals. This study analyses the association between the two geriatric treatment systems (AGC, TPR) and second hip fracture in patients following an index hip fracture. METHODS: Nationwide health insurance data are used to identify the rate of AGC and TPR per hospital following hip fracture surgery in patients aged ≥ 80 years. Outcomes are a second hip fracture after surgery or after discharge within 180 or 360 days and new specific anti-osteoporotic drugs. Cox proportional hazard models and generalised linear models are applied. RESULTS: Data from 29,096 hip fracture patients from 652 hospitals were analysed. AGC and TPR are not associated with second hip fracture when follow-up started after surgery. However, during the first months after discharge patients from hospitals with no AGC or low rates of TPR have higher rates of second hip fracture than patients from hospitals with high rates of AGC or high rates of TPR (Hazard Ratio (95% CI) 1.35 (1.01-1.80) or 1.35 (1.03-1.79), respectively). Lower rates of AGC are associated with lower probabilities of new prescriptions of specific anti-osteoporotic drugs. CONCLUSIONS: Our study suggests beneficial relationships of geriatric treatment after hip fracture with a) the risk of second hip fractures during the first months after discharge and b) an improvement of anti-osteoporotic drug treatment.
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Conservadores da Densidade Óssea , Fraturas do Quadril , Humanos , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/cirurgia , Feminino , Idoso de 80 Anos ou mais , Masculino , Estudos Retrospectivos , Conservadores da Densidade Óssea/uso terapêutico , Estudos de Coortes , Alemanha/epidemiologia , Osteoporose/tratamento farmacológico , Osteoporose/epidemiologia , Fraturas por Osteoporose/epidemiologia , IdosoRESUMO
BACKGROUND: Orthogeriatric co-management (OGCM) addresses the special needs of geriatric fracture patients. Most of the research on OGCM focused on hip fractures while results concerning other severe fractures are rare. We conducted a health-economic evaluation of OGCM for pelvic and vertebral fractures. METHODS: In this retrospective cohort study, we used German health and long-term care insurance claims data and included cases of geriatric patients aged 80 years or older treated in an OGCM (OGCM group) or a non-OGCM hospital (non-OGCM group) due to pelvic or vertebral fractures in 2014-2018. We analyzed life years gained, fracture-free life years gained, healthcare costs, and cost-effectiveness within 1 year. We applied entropy balancing, weighted gamma and two-part models. We calculated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: We included 21,036 cases with pelvic (71.2% in the OGCM, 28.8% in the non-OGCM group) and 33,827 with vertebral fractures (72.8% OGCM, 27.2% non-OGCM group). 4.5-5.9% of the pelvic and 31.8-33.8% of the vertebral fracture cases were treated surgically. Total healthcare costs were significantly higher after treatment in OGCM compared to non-OGCM hospitals for both fracture cohorts. For both fracture cohorts, a 95% probability of cost-effectiveness was not exceeded for a willingness-to-pay of up to 150,000 per life year or 150,000 per fracture-free life year gained. CONCLUSION: We did not obtain distinct benefits of treatment in an OGCM hospital. Assigning cases to OGCM or non-OGCM group on hospital level might have underestimated the effect of OGCM as not all patients in the OGCM group have received OGCM.
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Análise Custo-Benefício , Fraturas por Osteoporose , Fraturas da Coluna Vertebral , Humanos , Idoso de 80 Anos ou mais , Masculino , Feminino , Estudos Retrospectivos , Análise Custo-Benefício/métodos , Fraturas da Coluna Vertebral/terapia , Fraturas da Coluna Vertebral/economia , Fraturas por Osteoporose/economia , Fraturas por Osteoporose/terapia , Fraturas por Osteoporose/epidemiologia , Custos de Cuidados de Saúde , Alemanha/epidemiologia , Ossos Pélvicos/lesõesRESUMO
Orthogeriatric co-management (OGCM) describes a collaboration of orthopedic surgeons and geriatricians for the treatment of fragility fractures in geriatric patients. While its cost-effectiveness for hip fractures has been widely investigated, research focusing on fractures of the upper extremities is lacking. Thus, we conducted a health economic evaluation of treatment in OGCM hospitals for forearm and humerus fractures.In a retrospective cohort study with nationwide health insurance claims data, we selected the first inpatient stay due to a forearm or humerus fracture in 2014-2018 either treated in hospitals that were able to offer OGCM (OGCM group) or not (non-OGCM group) and applied a 1-year follow-up. We included 31,557 cases with forearm (63.1% OGCM group) and 39,093 cases with humerus fractures (63.9% OGCM group) and balanced relevant covariates using entropy balancing. We investigated costs in different health sectors, length of stay, and cost-effectiveness regarding total cost per life year or fracture-free life year gained.In both fracture cohorts, initial hospital stay, inpatient stay, and total costs were higher in OGCM than in non-OGCM hospitals. For neither cohort nor effectiveness outcome, the probability that treatment in OGCM hospitals was cost-effective exceeded 95% for a willingness-to-pay of up to 150,000.We did not find distinct benefits of treatment in OGCM hospitals. Assigning cases to study groups on hospital-level and using life years and fracture-free life years, which might not adequately reflect the manifold ways these fractures affect the patients' health, as effectiveness outcomes, might have underestimated the effectiveness of treatment in OGCM hospitals.
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Análise Custo-Benefício , Fraturas do Úmero , Humanos , Alemanha , Feminino , Masculino , Idoso , Estudos Retrospectivos , Idoso de 80 Anos ou mais , Fraturas do Úmero/terapia , Fraturas do Úmero/economia , Revisão da Utilização de Seguros , Tempo de Internação/estatística & dados numéricos , Tempo de Internação/economia , Traumatismos do Antebraço/terapia , Traumatismos do Antebraço/economiaRESUMO
BACKGROUND: Older people receiving home-based care (HBC) often face barriers to access preventive oral health care (OHC) and dental treatments. Leading to deterioration of their oral healthcare. It is further deteriorated by factors such as increasing burden of systemic diseases, medicinal side effects, limited mobility, financial constraints and lack of professional OHC at home. Older people also struggle to maintain necessary daily oral hygiene, leading to malnutrition, weight loss, and a risk of a further health degradation. This cross-sectional survey aimed to investigate the oral health-related quality of life (OHRQoL) and their associated factors in HBC recipients. METHODS: 5,280 older people (≥ 60 years) living in Hamburg, who were in need of care and insured with statutory health insurance DAK-Gesundheit received the questionnaire, which included the German version of the Oral Health Impact Profile (OHIP G-14) and, the EQ-5D health-related quality of life (HRQoL) measure as well as further questions regarding the extent of informal social support, subjective oral health status, oral health behaviour, subjective cognitive status, and socio-demographic variables. RESULTS: The participants (n = 1,622) had a median age of 83.2 years, with 72.0% of the sample being female. Nearly two thirds of the sample reported that their independence or abilities were significantly impaired (care level 2). Regarding oral health impacts, 40.0% of the participants reported experiencing at least one of the fourteen possible prevalent impacts of the OHIP-G14 fairly often or very often. A multivariate regression model on the severity of oral health impacts revealed, that a better HRQoL, a positive perception of one's own dental status, fewer visits to dental practices, and no need for support in OHC were associated with better OHRQoL. Conversely, respondents with a negative perception of their oral health status, more frequent visits to a dental practice, a need for support in OHC, and subjective memory impairment showed poorer OHRQoL. CONCLUSIONS: The results highlight the risk for poor oral health among older people in HBC. We conclude that there is an urgent need to prioritise oral health, especially as poor oral health can further compromise the systemic wellbeing of these already care dependent population.
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Serviços de Assistência Domiciliar , Saúde Bucal , Qualidade de Vida , Humanos , Alemanha , Feminino , Idoso , Masculino , Estudos Transversais , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Apoio Social , Nível de Saúde , Comportamentos Relacionados com a Saúde , Higiene Bucal , Acessibilidade aos Serviços de Saúde , Inquéritos e QuestionáriosRESUMO
BACKGROUND: In Germany, different models of orthogeriatric co-management have been implemented in certified geriatric trauma centers. So far, it is not clear how the different models are implemented and what influence the certification has on the structures and processes within the centers. The present study examined the extent of cooperation between surgery and geriatrics and if the quality of care had changed since the certification of the centers. METHODS: In this study 4 guided focus group interviews (FGI) were conducted in different teams of certified geriatric trauma centers in 3 federal states with 16 participants. To specify the content of the FGI, two additional interviews were conducted with system auditors. Both types of interview were analyzed by content analysis. RESULTS: The certification supported the implementation of structures and processes in the different orthogeriatric models; however, the quality of care and cooperation between surgery and geriatrics depends on the spatial proximity and the orthogeriatric care model in the geriatric trauma centers. Simultaneously, challenges in the area of geriatric syndromes and the recruitment of skilled staff became relevant. DISCUSSION: The results can help to reflect processes in the certified geriatric trauma centers and to treat geriatric syndromes more effectively. In the future, the challenge will be to establish geriatric care under the existing shortage of skilled staff.
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Certificação , Geriatria , Centros de Traumatologia , Alemanha , Centros de Traumatologia/organização & administração , Humanos , Idoso , Geriatria/normas , Geriatria/organização & administração , Modelos Organizacionais , Masculino , Feminino , Idoso de 80 Anos ou mais , Colaboração Intersetorial , Traumatologia/normas , Traumatologia/organização & administração , Serviços de Saúde para Idosos/normas , Serviços de Saúde para Idosos/organização & administração , Cirurgia de Cuidados CríticosRESUMO
BACKGROUND: Fragility fractures are one of the leading causes of disability in older adults. Yet, evidence for effectiveness and cost-effectiveness of preventive approaches combining bone health and fall prevention is rare. OBJECTIVE: To conduct a health-economic evaluation of the German osteoporotic fracture prevention program in rural areas (OFRA). DESIGN: Secondary cluster-randomized intervention study based on routine data. PARTICIPANTS: All districts in five federal states in Germany were cluster-randomized as intervention or control districts. OFRA was offered to community-living (a) women aged 75-79 years or (b) women and men aged 70-84 years with a prior fragility fracture in the intervention districts. Individuals who meet these criteria in the control districts were assigned to the control group. INTERVENTION: OFRA comprised mobility and falls prevention classes, examination of bone health by bone density measurement, and consultation on safety in the home living environment. MAIN MEASURES: We measured health-care costs and effectiveness in terms of time to fragility fracture or death within 1 year after initial contact, based on health insurance claims data. Implementation costs were recorded by the intervention performers. We calculated an incremental cost-effectiveness ratio (ICER) and employed the net-benefit approach to construct a cost-effectiveness acceptability curve (CEAC). KEY RESULTS: There were 9408 individuals in the intervention group and 27,318 in the control group. Mean time to fragility fracture or death (difference: 0.82 days) and health-care costs (difference: 111.73, p < .01) were reduced, but mean intervention costs (difference: 260.10) increased total costs (difference: 148.37, p < .001) in the intervention group. The ICER per fracture-free year of survival was 66,094.63. The CEAC showed no acceptable probability of cost-effectiveness at a reasonable willingness to pay. CONCLUSION: OFRA showed reduced rates of fragility fractures, but had high implementation costs, resulting in an unfavorable ICER. The cost-effectiveness of OFRA may improve with a longer follow-up.
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Fraturas por Osteoporose , Idoso , Feminino , Humanos , Masculino , Densidade Óssea , Análise Custo-Benefício , Fraturas por Osteoporose/epidemiologia , Fraturas por Osteoporose/prevenção & controle , Encaminhamento e ConsultaRESUMO
PURPOSE: Major lockdowns were imposed in Germany from March until May 2020 and from December 2020 until May 2021. We studied the influence of these lockdowns, the strain on intensive care units and the strictness of COVID-19-related containment strategies on the utilization of mental health care among patients with severe mental disorders. METHODS: We used health insurance claims data to identify n = 736,972 patients with severe mental disorders shortly before the pandemic and n = 735,816 patients a year earlier. We applied entropy balancing to adjust for baseline differences by district. For a 12-month follow-up, we modeled monthly changes in utilization through meta-analytic models using both the COVID-19 stringency index and intensive care unit cases per 100,000 inhabitants as predictors. Our outcomes were changes in psychiatric hospital days and time treated by outpatient psychiatrists. RESULTS: Psychiatric hospital days declined by at least 7.7% in all calender month during the pandemic. Peak reduction rates were observed in April (- 27.9%), May (- 22.3%) 2020 and January 2021 (- 18.3%). Utilization changes were associated with the stringency index and the second lockdown. Time treated by psychiatrists was shorter in April (- 16.2%) and May (- 11.5%) 2020 and in January 2021 (- 10.5%), which was partially offset by higher utilization in June and September 2020. These utilization changes were associated with the stringency index and the strain on intensive care units during both lockdowns. CONCLUSION: Hospitals did not maintain the level of utilization during the pandemic, while outpatient psychiatrists adapted more quickly, presumably due to digital and telemedical care.
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PURPOSE: In this study, we assess how the first and second waves of the COVID-19 pandemic influenced the suicide risk of patients with severe mental disorders in Germany. METHODS: We analyzed German health insurance claims data to compare the suicide risk of patients with severe mental disorders before and during the pandemic. We included n = 690,845 patients between October 2019 and March 2020 and n = 693,457 patients the corresponding period of the previous year and applied entropy balancing to adjust for confounding covariates. Given that the cause of death was unknown, we defined potential suicides as deaths of patients with a history of intentional self-harm whose passing could not be explained by COVID-19. Potential suicides were tracked in both cohorts over one year and compared using logistic regression. RESULTS: 128 potential suicides were identified in the period during and 101 before the pandemic. This corresponded to a significant increase in the risk for potential suicide of 27.4% compared to the control period (ß = 0.24, z = 1.82, p < 0.05). CONCLUSION: The noticeable increase in the risk for potential suicide for patients with severe pre-existing mental disorders emphasizes the call for additional efforts to prevent suicide and to help patients cope with their mental illness in the aftermath of the COVID-19 crisis.
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BACKGROUND: Fractures are a major health problem in aging societies. Preventive approaches combining bone health and fall prevention are rare. The osteoporotic fracture prevention program in rural areas (OFRA) is a health care fund-driven program for older people in randomly selected districts in Germany. The components of the program were falls prevention exercise classes, examination of bone health by a dual-energy X-ray absorptiometry (DXA) scan, and a consultation about "safety in the living environment." The aim of this study was to evaluate this complex preventive intervention in a routine health care setting. METHODS: This cluster-randomized trial was performed from October 2015 to October 2018 and took place in 186 administrative districts in five federal states, 47 districts served as intervention districts, and 139, as controls. Within these districts, we included (a) all community-living women and men aged 70-85 years with prior fragility fractures and (b) all community-living women aged 75-80 years. The analysis used routine data collected by a health insurance company. The primary endpoint was all fragility fractures combined. Fracture types, mortality, and nursing home admission were explorative endpoints. Cox frailty models were used for comparative analyses with a median follow-up time of 365 days (interquartile range: 0 days). RESULTS: Nine thousand four hundred eight individuals were approached to participate in one of the program components, 27,318 individuals served as controls. The mean age was 78.7 years. Of those approached to participate, nearly 30% joined the exercise classes. DXA measurement was reimbursed for 13.6%, and 51.8% received advice about measures to increase "safety in the living environment." The incidence of fragility fractures did not differ between the intervention and the control group (HR 0.94; 95% CI 0.80-1.11). However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59-0.99). Mortality and nursing home admission did not differ between the intervention and the control group. CONCLUSIONS: A comprehensive fracture prevention program for older people living in rural areas was implemented. The program did not affect the primary endpoint of all fragility fractures combined. It has to be considered that we used a modified intention to treat approach based on geographic randomization and information about endpoints relied exclusively on routine data of the health care insurance. TRIAL REGISTRATION: German Clinical Trials Register DRKS-ID: 00009000.
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Fraturas por Osteoporose , Absorciometria de Fóton , Idoso , Idoso de 80 Anos ou mais , Feminino , Alemanha/epidemiologia , Humanos , Incidência , Masculino , Fraturas por Osteoporose/epidemiologia , Fraturas por Osteoporose/prevenção & controleRESUMO
PURPOSE: Comparisons of ureteroscopy (URS), extracorporeal shockwave lithotripsy (SWL) and percutaneous nephrolithotomy (PCNL) for urolithiasis considering long-term follow-up are rare. We aimed to analyze re-intervention rates, costs and sick leave days of URS, SWL and PCNL patients within 7 years. METHODS: This retrospective cohort study was based on German health insurance claims data. We included 54,609 urolithiasis patients incidentally treated in 2008-2010. We investigated time to re-intervention, number of sick leave days and healthcare costs. We applied negative binomial, extended Cox regression and gamma models. RESULTS: 54% were incidentally treated with URS, 40% with SWL and 6% with PCNL. 15% of URS, 26% of SWL and 23% of PCNL patients were re-treated within 7 years. Time to re-intervention was significantly lower for PCNL (955 days) and SWL (937 days) than URS (1078 days) patients. Costs for incident treatment were significantly higher for PCNL (2760) and lower for SWL (1342) than URS (1334) patients. Yet, total costs including re-interventions were significantly higher for PCNL (5783) and SWL (3240) than URS (2979) patients. Total number of sick leave days was increased for PCNL (13.0 days) and SWL (10.1 days) compared to URS (6.8 days) patients. CONCLUSION: This study describes outcomes after use of different intervention options for urolithiasis. URS patients showed longest time free of re-interventions and lowest number of sick leave days. Although SWL patients initially had lower costs, URS patients had lower costs in the long run. PCNL patients showed high costs and sick leave days.
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Cálculos Renais , Litotripsia , Nefrolitotomia Percutânea , Urolitíase , Humanos , Ureteroscopia , Estudos Retrospectivos , Urolitíase/cirurgia , Seguro Saúde , Resultado do Tratamento , Cálculos Renais/cirurgiaRESUMO
BACKGROUND: In Germany, geriatricians deliver acute geriatric care during an acute hospital stay and subacute rehabilitation after transfer to a rehabilitation clinic. However, the proportion of patients who receive acute geriatric care (AGC) or are transferred to subacute rehabilitation (TSR) differs considerably between hospitals. The aim of this study was to analyse the association between the two geriatric treatment systems and care home admission or mortality in patients following hip fracture. METHODS: Health insurance claims data were used to identify the rate of AGC per hospital and the rate of TSR per hospital following hip fracture surgery in patients aged ≥ 80 years. Outcomes were cumulative admission to a care home and cumulative mortality within 6 months after hospital admission. RESULTS: Data from 23,046 hip fracture patients from 561 hospitals were analysed. The rate of AGC was not associated with care home admission. However, compared to high rates of AGC medium rates or no AGC were associated with increased death rates by 12% or 20%, respectively. Treatment in hospitals with low rates of TSR was associated with a 8% higher risk of care home admission and a 10% increased risk of death compared to treatment in hospitals with high rates of TSR. CONCLUSIONS: Our study suggests potential effects of geriatric treatment: reduction of mortality in hospitals with high rates of AGC or reduction of care home admission and mortality in hospitals with high rates of TSR.
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Fraturas do Quadril , Idoso , Alemanha , Fraturas do Quadril/cirurgia , Hospitalização , Hospitais , Humanos , Tempo de InternaçãoRESUMO
INTRODUCTION: Older people in need of home care are at risk of declining oral health as their visits to dentists are becoming less frequent due to restricted mobility. There is increasing evidence that poor oral health and systemic diseases are closely associated, for example, in cardiological, metabolic or neurodegenerative conditions. Thus, Interaction of Systemic Morbidity and Oral Health in Ambulatory Patients in Need of Home Care (InSEMaP) is investigating the need, provision and utilisation of oral healthcare, systemic morbidity and clinical status of the oral cavity in older people. METHODS AND ANALYSIS: InSEMaP consists of four subprojects (SP), all involving the target population of older people in need of home care. In SP1 part a, a sample is surveyed using a self-report questionnaire. In SP1 part b, stakeholders (general practitioners, dentists, medical assistants, family and professional caregivers) are interviewed regarding barriers and facilitators using focus groups and personal interviews. In SP2, a retrospective cohort study, health insurance claims data are examined to investigate the utilisation of oral healthcare, its association with systemic morbidity and healthcare costs. In SP3, a clinical observational study will assess the oral health of participants by a dentist's visit at home. SP4 synthesises the results of SP1, SP2 and SP3 to develop integrated clinical pathways, identifying strategies to uphold oral healthcare in older people. In assessing and evaluating the process of oral healthcare, and its associated systemic morbidity, InSEMaP aims to improve general healthcare across the sector boundary of dental and general practitioner care. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Board of the Hamburg Medical Chamber (approval number: 2021-100715-BO-ff). The results of this study will be disseminated through conference presentations and publications in peer-reviewed journals. An expert advisory board to support the InSEMaP study group will be established. TRIAL REGISTRATION NUMBER: German Clinical Trials Register: DRKS00027020.