A flexible approach to measure care coordination based on patient-sharing networks.

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.

Temporal and spatial changes in the provision of mental health care during the COVID-19 pandemic in Germany: a claims-based cohort study on patients with severe mental disorders.

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.

The development of suicide risk in people with severe mental disorders during the first year of the COVID-19 pandemic: a claims-based cohort study.

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.

Depression treatment in Germany - using claims data to compare a collaborative mental health care program to the general practitioner program and usual care in terms of guideline adherence and need-oriented access to psychotherapy.

BACKGROUND: Societies strive for fast-delivered, evidence-based and need-oriented depression treatment within budget constraints. To explore potential improvements, selective contracts can be implemented. Here, we evaluate if the German collaborative psychiatry-neurology-psychotherapy contract (PNP), which extends the gatekeeping-based general practitioner (GP) program, improved guideline adherence or need-oriented and timely access to psychotherapy compared to usual care (UC). METHODS: We conducted a retrospective observational cohort study based on health insurance claims data. After we identified patients with depression who were on sick leave due to a mental disorder in 2015, we applied entropy balancing to adjust for selection effects and employed chi-squared tests to compare guideline adherence of the received treatment between PNP, the GP program and UC. Subsequently, we applied an extended cox regression to assess need-orientation by comparing the relationship between accumulated sick leave days and waiting times for psychotherapy across health plans. RESULTS: N = 23,245 patients were included. Regarding guideline adherence, we found no significant differences for most severity subgroups; except that patients with a first moderate depressive episode received antidepressants or psychotherapy more often in UC. Regarding need-orientation, we observed that the effect of each additional month of sick leave on the likelihood of starting psychotherapy was increased by 6% in PNP compared to UC. Irrespective of the health plan, we found that within the first 12 months only between 24.3 and 39.7% (depending on depression severity) received at least 10 psychotherapy sessions or adequate pharmacotherapy. CONCLUSIONS: The PNP contract strengthens the relationship between sick leave days and the delay until the beginning of psychotherapy, which suggests improvements in terms of need-oriented access to care. However, we found no indication for increased guideline adherence and - independent of the health plan - a gap in sufficient utilization of adequate treatment options.

Early sonographic evaluation of the placenta in cases with IUGR: a pilot study.

PURPOSE: The objective of this study was to evaluate the feasibility and value of measuring early placental echogenicity to predict fetal intrauterine growth restriction (IUGR). METHODS: This is a single center, retrospective cohort study. Early ultrasound examination (6 + o to 8 + 6 weeks of gestation in singleton pregnancies) was used to measure placental dimensions and placental echogenicity. A ratio between placental echogenicity and myometrial echogenicity (PE/ME-ratio) was calculated for each patient. Study population was assigned to either the IUGR group or the control group based on clinical data. RESULTS: 184 eligible pregnancies were analysed. 49 patients were included in our study. Of those, 9 (18.37%) cases were affected by IUGR and 40 (81.63%) were controls. Measuring the placental echogenicity was feasible in all cases. IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed. CONCLUSION: Our results showed that measuring placental echogenicity is feasible in the early first trimester and demonstrated a significantly lower placental echogenicity in fetuses with subsequent IUGR. Further prospective studies are needed to validate those results.

Outcome of monochorionic twins with prenatally diagnosed bipartite placenta.

PURPOSE: The objective of this study was to identify possible implications and risk factors in monochorionic (MC) twin pregnancies having a bipartite placenta. MATERIALS: Between 2014 and 2019 data on such pregnancies was prospectively collected and retrospectively analyzed. Monochorionicity was confirmed either by the presence of a T-sign, one chorion and two separate amnion cavities, or by histological examination postnatally. Bipartite placenta was diagnosed when two placenta lobes were identified with no placental connection between them. Risks of bipartite placenta in MCDA twins were evaluated by background data, prenatal and postnatal outcome. RESULTS: Five twin pregnancies were included in the study. 60 % (n = 3) were complicated by twin-twin-transfusion syndrome (TTTS), 20 % by selective intrauterine growth restriction (sIUGR) (n = 1) and 20 % (n = 1) by severe fetal malformations. In every case an intervention was indicated, but in only 60% (n = 3) possible, due to poor surgical conditions. Overall fetal survival rate at birth was 90 %. Neonatal survival rate was 66.63%. CONCLUSION: Bipartite placenta is a very rare phenomenon in MCDA twin pregnancies. It seems to be associated with a higher rate of complications, such as TTTS and sIUGR and might induce surgical difficulties in prenatal interventions.

Collaborative mental health care program versus a general practitioner program and usual care for treatment of patients with mental or neurological disorders in Germany: protocol of a multiperspective evaluation study.

BACKGROUND: German statutory health insurances are pursuing the goal of improving treatment of chronically ill people by promoting networks of health care providers and supporting treatments that reflect the current medical knowledge. The so-called PNP program is a collaborative care program developed by a German statutory health insurance, which defines specific rules on psychiatric, neurological, psychosomatic, and psychotherapeutic treatment. It aims to strengthen provision of guideline-based outpatient treatment and collaboration between different health care providers. It includes the general practitioners' program, which aims to strengthen the coordinating role of GPs. This study aims to evaluate the PNP program. METHODS: To evaluate the effectiveness of the PNP program, we will conduct a prospective non-randomized controlled trial with primary data comparing patients enrolled in the PNP program and in the general practitioner program (intervention group) to patients enrolled only in the general practitioner program and patients who receive usual care (control groups). To evaluate costs and level of detail of diagnoses in care of patients with PNP program, we will use routinely collected secondary administrative health data in a retrospective quasi-experimental design. Patients who are at least 18 years old, insured by the statutory health insurance AOK, and on sick leave due to one of the mental or neurological diagnoses (affective, anxiety, somatoform or adjustment disorders, alcohol use disorders, schizophrenia, multiple sclerosis) will be included. We will collect data at baseline and at 12-months follow-up. Health-related quality of life (primary data) and direct costs (secondary data) caused by outpatient and inpatient service utilization and medication will be the primary outcomes. We will analyze data using (generalized) linear mixed models and exploratory analyses. We will use entropy balancing to control for possible differences between the groups. We will use an exploratory sequential design including qualitative and descriptive statistical analyses to assess the structure and process quality of the PNP program among health care providers. DISCUSSION: The results will help to develop a comprehensive picture of collaborative care programs for mental and neurological health care from the perspective of patients, health care providers, and health insurance companies. TRIAL REGISTRATION: German Clinical Trial Register DRKS00013114.

Tissuepatch is biocompatible and seals iatrogenic membrane defects in a rabbit model.

OBJECTIVE: To evaluate novel sealing techniques for their biocompatibility and sealing capacity of iatrogenic fetal membrane defects in a pregnant rabbit model. METHOD: At day 23 of gestation (term = d31), a standardized fetoscopy was performed through a 14G cannula. The resulting fetal membrane defect was closed with condensed collagen, collagen with fibrinogen, Tissuepatch, Duraseal, or a conventional collagen plug (Lyostypt) as reference. At d30, the fetuses were harvested and full thickness fetal membrane samples were analyzed. The study consisted of 2 consecutive parts: (1) biocompatibility testing by fetal survival, apoptosis, and infiltration of polymorphonuclear cells in the membranes and (2) the efficacy to seal fetal membrane defects. RESULTS: Three sealants (collagen with fibrinogen, Duraseal, or Lyostypt) were associated with a higher fetal mortality compared to control unmanipulated littermates and hence were excluded from further analysis. Tissuepatch was biocompatible, and amniotic fluid levels were comparable to those of control untouched littermates. Compared to the condensed collagen, Tissuepatch was also easier in surgical handling and induced limited cell proliferation. CONCLUSION: Tissuepatch had the best biocompatibility and efficacy in sealing an iatrogenic fetal membrane defect in the pregnant rabbit compared to other readily available sealants.

Pericardio-Amniotic Shunting for Incomplete Pentalogy of Cantrell.

A 27-year-old woman, gravida 2, para 0, presented with an incomplete Pentalogy of Cantrell with an omphalocele, diaphragmatic hernia, and a pericardial defect at 32 weeks' gestation. A large pericardial effusion compressed the lungs and had led to a reduced lung growth with an observed-to-expected total lung volume of 28% as measured by MRI. The effusion disappeared completely after the insertion of a pericardio-amniotic shunt at 33 weeks. After birth, the newborn showed no signs of pulmonary hypoplasia and underwent a surgical correction of the defect. Protracted wound healing and a difficult withdrawal from opioids complicated the neonatal period. The child was discharged on postnatal day 105 in good condition. This case demonstrates that in case of Pentalogy of Cantrell with large pericardial effusion, the perinatal outcome might be improved by pericardio-amniotic shunting.

Antenatal BAY 41-2272 reduces pulmonary hypertension in the rabbit model of congenital diaphragmatic hernia.

Infants with congenital diaphragmatic hernia (CDH) fail to adapt at birth because of persistent pulmonary hypertension (PH), a condition characterized by excessive muscularization and abnormal vasoreactivity of pulmonary vessels. Activation of soluble guanylate cyclase by BAY 41-2272 prevents pulmonary vascular remodeling in neonatal rats with hypoxia-induced PH. By analogy, we hypothesized that prenatal administration of BAY 41-2272 would improve features of PH in the rabbit CDH model. Rabbit fetuses with surgically induced CDH at day 23 of gestation were randomized at day 28 for an intratracheal injection of BAY 41-2272 or vehicle. After term delivery (day 31), lung mechanics, right ventricular pressure, and serum NH2-terminal-pro-brain natriuretic peptide (NT-proBNP) levels were measured. After euthanasia, lungs were processed for biological or histological analyses. Compared with untouched fetuses, the surgical creation of CDH reduced the lung-to-body weight ratio, increased mean terminal bronchial density, and impaired lung mechanics. Typical characteristics of PH were found in the hypoplastic lungs, including increased right ventricular pressure, higher serum NT-proBNP levels, thickened adventitial and medial layers of pulmonary arteries, reduced capillary density, and lower levels of endothelial nitric oxide synthase. A single antenatal instillation of BAY 41-2272 reduced mean right ventricular pressure and medial thickness of small resistive arteries in CDH fetuses. Capillary density, endothelial cell proliferation, and transcripts of endothelial nitric oxide synthase increased, whereas airway morphometry, lung growth, and mechanics remained unchanged. These results suggest that pharmacological activation of soluble guanylate cyclase may provide a new approach to the prenatal treatment of PH associated with CDH.

A novel translational model for fetoscopic intratracheal delivery of nanoparticles in piglets.

OBJECTIVES: The aim of this study was to assess the feasibility of fetal tracheal injection in the late-gestational pig to target the airways. METHODS: Following laparotomy and hysterotomy, fetoscopy was performed in pregnant sows to access the fetal trachea. Two volumes of fluospheres were injected (1 and 3 mL). Fluosphere distribution to the different lung lobes was investigated by microscopy. Possible fetal airway injury, caused by the surgical procedure or intratracheal injection, was investigated. Lung morphology and fetal lung volumes were calculated by micro computed tomography (µCT). RESULTS: Intratracheal administration was successfully performed in 20/21 fetuses. Analysis by confocal microscopy demonstrated that 3 mL, and not 1 mL, most efficiently targeted all lung lobes. On high-resolution µCT, total airway volume was estimated at 2.9 mL; strengthening that 3 mL is appropriate to target all lung lobes. No procedural damage was evidenced in the lungs or trachea. CONCLUSIONS: Intratracheal injection of nanoparticles is feasible in the pregnant pig and does not cause procedural lung damage. Using an injection volume of 3 mL, all lung lobes were efficiently targeted. This nanoparticle delivery model to fetal airways opens perspectives for therapeutic interventions. © 2016 John Wiley & Sons, Ltd.

Thrombin Generation by Fetoscopic Trauma to the Fetal Membranes: An in vivo and in vitro Study.

OBJECTIVE: We first aimed to investigate in vivo thrombin generation induced by fetoscopy, and second we used term membrane explants for measurement of thrombin generation, thrombin receptor location and induction of selected matrix metalloproteinases (MMPs) in tissue culture. MATERIALS AND METHODS: In vivo study (37 cases): samples of amniotic fluid were taken at the beginning and end of fetoscopy (mean gestational age 26.7 weeks) and analyzed by ELISA for thrombin-antithrombin complexes. In vitro study: fetal membranes were put in culture and punctured for measurement of thrombin generation by calibrated automated thrombography and ELISA. Induction of MMP-9 and MMP-2 was analyzed by zymography. PAR-1 was localized by immunohistochemistry. RESULTS: No significant increase in thrombin-antithrombin was measured in amniotic fluid obtained during fetoscopy. In vitro, thrombin generation induced by needle trauma of membrane cultures is correlated to the amount of plasma. Activity of MMP-9 but not MMP-2 was elevated in cultured membranes but could not be inhibited by a thrombin inhibitor. On histology, the thrombin receptor PAR-1 was located in the chorion and decidua, but not in the amnion. DISCUSSION: Despite the influence of thrombin on punctured fetal membranes in vitro, the role of thrombin in iatrogenic preterm premature rupture of membranes is questionable.

Fetoscopic versus Open Repair for Spina Bifida Aperta: A Systematic Review of Outcomes.

OBJECTIVE: To compare outcomes of fetoscopic spina bifida aperta repair (FSBAR) with the results of the open approach (OSBAR) as in the Management Of Myelomeningocele Study (MOMS). METHODS: This was a systematic comparison of reports on FSBAR with data from the MOMS (n = 78). Inclusion criteria were studies of spina bifida aperta patients who underwent FSBAR and were followed for ≥12 months. Primary outcome was perinatal mortality. Secondary outcomes included operative, maternal, fetal, neonatal and infant outcomes. RESULTS: Out of 16 reports, we included 5 from 2 centers. Due to bias and heterogeneity, analysis was restricted to two overlapping case series (n = 51 and 71). In those, FSBAR was technically different from OSBAR, had comparable perinatal mortality (7.8 vs. 2.6%, p = 0.212) and shunt rate at 12 months (45 vs. 40%, p = 0.619), longer operation time (223 vs. 105 min, p < 0.001), higher preterm prelabor membrane rupture rate (84 vs. 46%, p < 0.001), earlier gestational age at birth (32.9 vs. 34.1 weeks, p = 0.03), higher postnatal reoperation rate (28 vs. 2.56%, p < 0.001) and absence of uterine thinning or dehiscence (0 vs. 36%, p < 0.001). Functional outcomes were not available. CONCLUSION: FSBAR utilizes a different neurosurgical technique, takes longer to complete, induces more prematurity, requires additional postnatal procedures, yet has a comparable shunt rate and is not associated with uterine thinning or dehiscence. Long-term functional data are awaited.

Mesh contraction: in vivo documentation of changes in apparent surface area utilizing meshes visible on magnetic resonance imaging in the rabbit abdominal wall model.

INTRODUCTION AND HYPOTHESIS: Our aim was to analyze the apparent contraction of meshes in vivo after abdominal wall reconstruction and evaluate histological and biomechanical properties after explantation. METHODS: Nine New Zealand female rabbits underwent repair of two full-thickness 25 × 30-mm midline defects in the upper and lower parts of the abdomen. These were primarily overlaid by 35 × 40-mm implants of a polyvinylidene fluoride (PVDF) DynaMesh (n = 6) or polypropylene meshes Ultrapro (n = 6) and Marlex (n = 6). Edges of the meshes were secured with iron(II,III) oxide (Fe(3)O(4))-loaded PVDF sutures. Magnetic resonance images (MRIs) were taken at days 2, 30 and 90 after implantation. The perimeter of the mesh was traced using a 3D spline curve. The apparent surface area or the area within the PVDF sutures was compared with the initial size using the one-sample t test. A two-way repeat analysis of variance (ANOVA) was used to compare the apparent surface area over time and between groups. RESULTS: PVDF meshes and sutures with Fe(3)O(4) could be well visualized on MRI. DynaMesh and Marlex each had a 17 % decrease in apparent surface area by day 2 (p < 0.001 and p = 0.001), respectively, which persisted after day 90. Whereas there was a decrease in apparent surface area in Ultrapro, it did not reach significance until day 90 (p = 0.01). Overall, the apparent surface area decreased 21 % in all meshes by day 90. No differences in histological or biomechanical properties were observed at day 90. CONCLUSIONS: There was a reduction in the apparent surface area between implantation and day 2, indicating that most mesh deformation occurs prior to tissue in-growth.

Does website-based information add any value in counseling mothers expecting a baby with severe congenital diaphragmatic hernia?

OBJECTIVE: We aimed to measure whether website-provided information about congenital diaphragmatic hernia (CDH) and fetal therapy for severe cases provides added value compared with clinical counseling of parents. METHODS: This is a single center study in 102 couples who earlier opted for fetoscopic endoluminal tracheal occlusion (FETO) because of isolated severe CDH. They were asked to fill out an anonymized web-based survey of 12 questions. Then, they were offered access to information on the web pages of the randomized Tracheal Occlusion to Accelerate Lung Growth (TOTAL) trial. One week later, their appreciation was measured again by a second questionnaire. RESULTS: Eighty-two (80%) parents completed the first questionnaire, and 48 (47%) completed the entire survey. Several items became more clear to the parents after reading the website, such as the length of hospital stay (23.2% prior to web information, 60.4% after; P = 0.004), maternal risk, or the requirement of fetal anesthesia for FETO (43.9% resp. 79.2%; P = <0.001). CONCLUSION: Complementing prenatal counseling on CDH and FETO by standardized information via website is perceived by parents as of added value. Maternal risks and the need for fetal medication need more clarification during the verbal counseling prior to prenatal interventions.

Effectiveness of a coordinated ambulatory care program for patients with mental disorders or multiple sclerosis: results of a prospective non-randomized controlled trial in South Germany.

Background: The Psychiatry, Neurology, Psychosomatics and Psychotherapy (PNP) program of the German statutory health insurance AOK BW promotes coordinated and evidence-based specialist care with the aim of providing individualized, guideline-based outpatient care, strengthening the collaboration between health care providers, as well as reducing care costs. The purpose of this study was to evaluate its effectiveness regarding patient-reported outcomes compared to the less specialized general practitioner program (GP) and usual care (UC). Materials and methods: AOK insured patients, who were on sick leave due to a mental disorder (affective disorder, anxiety disorder, adjustment disorder, somatoform disorder, alcohol abuse disorder, schizophrenia) or multiple sclerosis were included in the prospective non-randomized controlled study. All patients either participated in the PNP program (intervention group, IG-PNP), the general practitioner program (control group, CG-GP) or usual care (control group, CG-UC). Entropy balancing was used to adjust for baseline imbalance between groups. Primary outcome was health-related quality of life, assessed by the Short-form health survey (SF-36) 12 months after diagnosis. Secondary outcomes included symptom severity, functional health, and treatment satisfaction. Results: Of the 14,483 insured patients who were contacted, 1,104 patients participated at baseline and 725 at follow-up. The adjusted mean differences of SF-36 sum score did not significantly differ between groups: -1.89 (95%-CI = -4.60; 0.81, p = 0.170) between IG-PNP and CG-GP, and -1.42 (95%-CI = -4.05; 1.22, p = 0.293) between PNP and CG-UC. The adjusted mean differences of secondary outcomes did not differ between groups, except for a slightly higher increase of functional health in CG-UC. Conclusion: We found no evidence that the PNP program is superior to the GP program or to usual care in terms of patient-reported outcomes or treatment satisfaction. The results are limited by the low response rate. Accordingly, future studies should strive for more representative samples. To improve the program, an integration of further collaborative care elements and guideline recommendations might be useful. Clinical trial registration: DRKS (German Clinical Trials Register https://drks.de/search/en); identifier (DRKS00013114).

Prenatal detection of a giant isolated coronary fistula.

Prenatal detection of an isolated congenital coronary artery fistula (ICCAF) requires an examination of the affected fetal hemodynamic situation by the fistula. Early pediatric cardiological presentation is needed, since prenatal changes may have relevant postpartal consequences.

Rationale and design of an interventional study of cross-sectoral, coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare).

INTRODUCTION: Stroke has a long-term impact on functional status and quality of life in multiple health domains. A well-coordinated managed care program for stroke patients is crucial for ameliorating patients' health and cost-efficient use of resources. The aim of this study is the implementation and evaluation of an optimised cross-sectoral, coordinated and managed care program for stroke patients bridging secondary and tertiary care. METHODS: In this multi-center mixed method sequentially controlled intervention study, stroke patients with ischemic stroke (I63), transient ischemic attack and related syndromes (G45), or intracerebral haermorrhage (I64) will be invited to participate. For a 12-months period, 235 consecutive patients are expected to be enrolled and assigned standard of care treatment as an active control group. During the following 12 months, 235 consecutive patients will be enrolled and assigned to a post stroke intervention program. The StroCare intervention consists of repeated outpatient visits with specialized stroke teams, the implementation of a case manager, the use of an electronical tool for communication between acute care, rehabilitation facilities, and out-patient care, and the definition of individualized treatment targets. Patients will be followed up for 24 months. The primary outcome is health-related quality of life measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10) at 12 months after the index event, i.e. stroke or TIA. For the qualitative survey of the implementation process, 21 patients in the intervention group will be interviewed after implementation of the interventions. In addition, 20 health care providers and staff members will be interviewed before and after implementation. Additionally, economic outcomes will be evaluated after 6 and 12 months. PERSPECTIVE: The study will not only provide information about the tested intervention but is likely to be helpful for clinicians, suppliers of reimbursement, and researchers in implementing and evaluating complex interventions in stroke care in general. With this program, the health care system will have a reference model at its disposal for transfer to other regions and settings. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov ( NCT04159324 ). Approval of the local ethics committee (Ethik-Kommission der Ärztekammer Hamburg, Niedersachsen, Schleswig-Holstein) has been obtained.

How does the integration of collaborative care elements in a gatekeeping system affect the costs for mental health care in Germany?

Mental disorders are widespread, debilitating and associated with high costs. In Germany, usual care (UC) for mental disorders is afflicted by poor coordination between providers and long waiting times. Recently, the primary alternative to UC-the gatekeeping-based general practitioners (GP) program-was extended by the collaborative Psychiatry-Neurology-Psychotherapy (PNP) program, which is a selective contract designed to improve mental health care and the allocation of resources. Here, we assess the effects of the GP program and the PNP program on costs for mental health care. We analyzed claims data from 2014 to 2016 of 55,472 adults with a disorder addressed by PNP to compare costs and sick leave days between PNP, the GP program and UC. The individuals were grouped and balanced via entropy balancing to adjust for potentially confounding covariates. We employed a negative binomial model to compare sick leave days and two-part models to compare sick pay, outpatient, inpatient and medication costs over a 12-month period. The PNP program significantly reduced sick pay by 164€, compared to UC, and by 177€, compared to the GP program. Consistently, sick leave days were lower in PNP. We found lower inpatient costs in PNP than in UC (-194€) and in the GP program (-177€), but no reduction in those shares of inpatient costs that accrued in psychiatric or neurological departments. Our results suggest that integrating collaborative care elements in a gatekeeping system can favourably impact costs. In contrast, we found no evidence that the widely implemented GP program reduces costs for mental health care.