Structured decision support to prevent hospitalisations of community-dwelling older adults in Denmark (PATINA): an open-label, stepped-wedge, cluster-randomised controlled trial.

BACKGROUND: Ageing populations and health-care staff shortages encourage efforts in primary care to recognise and prevent health deterioration and acute hospitalisation in community-dwelling older adults. The PATINA algorithm and decision-support tool alerts home-based-care nurses to older adults at risk of hospitalisation. The study aim was to test whether use of the PATINA tool was associated with changes in health-care use. METHODS: An open-label, stepped-wedge, cluster-randomised controlled trial was done in three Danish municipalities, covering 20 area teams providing home-based care to around 7000 recipients. During a period of 12 months, area teams were randomly assigned to an intervention crossover for older adults (aged 65 years or older) who received care at home. The primary outcome was hospitalisation within 30 days of identification by the algorithm as being at risk of hospitalisation. Secondary outcomes were hospital readmission and other hospital contacts, outpatient contacts, contact with primary care physicians (PCPs), temporary care, and death, within 30 days of identification. This study was registered at ClinicalTrials.gov (NTC04398797). FINDINGS: In total, 2464 older adults participated in the study: 1216 (49·4%) in the control phase and 1248 (50·6%) in the intervention phase. In the control phase, 102 individuals were hospitalised within 30 days during 33 943 days of risk (incidence 0·09 per 30 days), compared with 118 individuals within 34 843 days of risk (0·10 per 30 days) during the intervention phase. The intervention was not associated with a reduction in the number of first hospitalisations within 30 days (incidence rate ratio [IRR] 1·10 [90% CI 0·90-1·40]; p=0·28). Furthermore it was not associated with reduced rates of other hospital contacts (IRR 1·10 [95% CI 0·90-1·40]; p=0·28), outpatient contacts (1·10 [0·88-1·40]; p=0·42), or mortality (0·82 [0·58-1·20]; p=0·25). The intervention was associated with a 59% reduction in readmissions within 30 days of hospital discharge (IRR 0·41 [95% CI 0·24-0·68]; p=0·0007), a 140% increase in contacts with PCPs (2·40 [1·18-3·20]; p<0·0001), and a 150% increase in use of temporary care (2·50 [1·40-4·70]; p=0·0027). INTERPRETATION: Despite having no effect on the primary outcome, the PATINA tool showed other benefits for older adults receiving home-based care. Such algorithms have the potential to shift health-care use from secondary to primary care but need to be tested in other home-based care settings. Implementation of algorithms in clinical practice should be informed by analysis of cost-effectiveness and potential harms as well as the benefits. FUNDING: Innovation Fund Denmark and Region of Southern Denmark. TRANSLATIONS: For the Danish, French and German translations of the abstract see Supplementary Materials section.

Conceptual framework for acute community health care services - Illustrated by assessing the development of services in Denmark.

Acute community health care services can support continuity of care by acting as a bridge between the primary and secondary health care sectors in the early detection of acute disease and provision of treatment and care. Although acute community health care services are a political priority in many countries, the literature on their organization and effect is limited. We present a conceptual framework for describing acute community health care services that can be used to support the policies and guidelines for such services. For illustrative purposes, we apply the framework to the Danish acute community health care services using implementation data from 2020 and identify gaps and opportunities for learning. The framework identifies two key pairs of dimensions: (1) capacity & capability, and (2) coordination & collaboration. These dimensions, together with the governance structure and quality assurance initiatives, are of key importance to the effect of acute community health care services. While all Danish municipalities have implemented acute community health care services, application of the framework indicates considerable variation in their approaches. The conceptual framework provides a systematic approach supporting the development, implementation, evaluation, and monitoring of acute community health care services and can assist policymakers at both national and local levels in this work.

"SDM:HOSP"- a generic model for hospital-based implementation of shared decision making.

BACKGROUND: Shared decision making (SDM) is a core element in the meeting between patient and healthcare professionals, but has proved difficult to implement and sustain in routine clinical practice. One of five Danish regions set out to succeed and to develop a model that ensures lasting SDM based on learnings from large-scale real-world implementation initiatives that go beyond the 'barriers' and 'facilitators' research approach. This paper describes this process and development of a generic implementation model, SDM:HOSP. METHODS: This project was carried out in the Region of Southern Denmark with five major hospital units. Based on existing theory of SDM, SDM implementation, implementation science and improvement methodology, a process of four phases were described; development of conceptual elements, field-testing, evaluation, and development of the final implementation model. The conceptual elements developed aimed to prepare leaders, train SDM teachers, teach clinicians to perform SDM, support development of patient decision aids, and support systematic planning, execution and follow-up. Field testing was done including continuous participant evaluations and an overall evaluation after one year. RESULTS: Data from field testing and learnings from the implementation process, illustrated the need for a dynamic and easy adjustable model. The final SDM:HOSP model included four themes; i)Training of Leaders, ii) Training of Teachers and Clinicians, iii) Decision Helper, and iv) 'Process', each with details in three levels, 1) shared elements, 2) recommendations, and 3) local adaption. CONCLUSIONS: A feasible and acceptable model for implementation of SDM across hospitals and departments that accounts for different organizations and cultures was developed. The overall design can easily be adapted to other organizations and can be adjusted to fit the specific organization and culture. The results from the ongoing and overall evaluation suggest promising avenues for future work in further testing and research of the usability of the model.

Prevention of AcuTe admIssioN algorithm (PATINA): study protocol of a stepped wedge randomized controlled trial.

BACKGROUND: The challenges imposed by ageing populations will confront health care systems in the years to come. Hospital owners are concerned about the increasing number of acute admissions of older citizens and preventive measures such as integrated care models have been introduced in primary care. Yet, acute admission can be appropriate and lifesaving, but may also in itself lead to adverse health outcome, such as patient anxiety, functional loss and hospital-acquired infections. Timely identification of older citizens at increased risk of acute admission is therefore needed. We present the protocol for the PATINA study, which aims at assessing the effect of the 'PATINA algorithm and decision support tool', designed to alert community nurses of older citizens showing subtle signs of declining health and at increased risk of acute admission. This paper describes the methods, design and intervention of the study. METHODS: We use a stepped-wedge cluster randomized controlled trial (SW-RCT). The PATINA algorithm and decision support tool will be implemented in 20 individual area home care teams across three Danish municipalities (Kerteminde, Odense and Svendborg). The study population includes all home care receiving community-dwelling citizens aged 65 years and above (around 6500 citizens). An algorithm based on home care use triggers an alert based on relative increase in home care use. Community nurses will use the decision support tool to systematically assess health related changes for citizens with increased risk of acute hospital admission. The primary outcome is acute admission. Secondary outcomes are readmissions, preventable admissions, death, and costs of health care utilization. Barriers and facilitators for community nurse's acceptance and use of the algorithm will be explored too. DISCUSSION: This 'PATINA algorithm and decision support tool' is expected to positively influence the care for older community-dwelling citizens, by improving nurses' awareness of citizens at increased risk, and by supporting their clinical decision-making. This may increase preventive measures in primary care and reduce use of secondary health care. Further, the study will increase our knowledge of barriers and facilitators to implementing algorithms and decision support in a community care setup. TRIAL REGISTRATION: ClinicalTrials.gov , identifier: NCT04398797 . Registered 13 May 2020.

Provision of protein and energy in relation to measured requirements in intensive care patients.

BACKGROUND & AIMS: Adequacy of nutritional support in intensive care patients is still a matter of investigation. This study aimed to relate mortality to provision, measured requirements and balances for energy and protein in ICU patients. DESIGN: Prospective observational cohort study of 113 ICU patients in a tertiary referral hospital. RESULTS: Death occurred earlier in the tertile of patients with the lowest provision of protein and amino acids. The results were confirmed in Cox regression analyses which showed a significantly decreased hazard ratio of death with increased protein provision, also when adjusted for baseline prognostic variables (APACHE II, SOFA scores and age). Provision of energy, measured resting energy expenditure or energy and nitrogen balance was not related to mortality. The possible cause-effect relationship is discussed after a more detailed analysis of the initial part of the admission. CONCLUSION: In these severely ill ICU patients, a higher provision of protein and amino acids was associated with a lower mortality. This was not the case for provision of energy or measured resting energy expenditure or energy or nitrogen balances. The hypothesis that higher provision of protein improves outcome should be tested in a randomised trial.

Retrospective evaluation of a decision support system for controlled mechanical ventilation.

Management of mechanical ventilation in intensive care patients is complicated by conflicting clinical goals. Decision support systems (DSS) may support clinicians in finding the correct balance. The objective of this study was to evaluate a computerized model-based DSS for its advice on inspired oxygen fraction, tidal volume and respiratory frequency. The DSS was retrospectively evaluated in 16 intensive care patient cases, with physiological models fitted to the retrospective data and then used to simulate patient response to changes in therapy. Sensitivity of the DSS's advice to variations in cardiac output (CO) was evaluated. Compared to the baseline ventilator settings set as part of routine clinical care, the system suggested lower tidal volumes and inspired oxygen fraction, but higher frequency, with all suggestions and the model simulated outcome comparing well with the respiratory goals of the Acute Respiratory Distress Syndrome Network from 2000. Changes in advice with CO variation of about 20% were negligible except in cases of high oxygen consumption. Results suggest that the DSS provides clinically relevant and rational advice on therapy in agreement with current 'best practice', and that the advice is robust to variation in CO.

Minimal model quantification of pulmonary gas exchange in intensive care patients.

Mathematical models are required to describe pulmonary gas exchange. The challenge remains to find models which are complex enough to describe physiology and simple enough for clinical practice. This study aimed at finding the necessary 'minimal' modeling complexity to represent the gas exchange of both oxygen and carbon dioxide. Three models of varying complexity were compared for their ability to fit measured data from intensive care patients and to provide adequate description of patients' gas exchange abnormalities. Pairwise F-tests showed that a two parameter model provided superior fit to patient data compared to a shunt only model (p<0.001), and that a three parameter model provided superior fit compared to the two parameter model (p<0.1). The three parameter model describes larger ranges of ventilation to perfusion ratios than the two parameter model, and is identifiable from data routinely available in clinical practice.

Hypocoagulability, as evaluated by thrombelastography, at admission to the ICU is associated with increased 30-day mortality.

Thrombelastography (TEG), a cell-based whole blood assay, may better reflect haemostatic competence than conventional coagulation assays and this was therefore evaluated including the clot forming parameters: R, angle and maximal amplitude in patients at ICU admission. This was a prospective, observational study of patients admitted to a general ICU at a tertiary care university hospital with an expected stay of more than 24 h. Blood samples for TEG and standard coagulation analysis were obtained at admission. The APACHE II and sequential organ failure assessment (SOFA) scores and 30-day mortality were recorded. At ICU admission, 106 patients (42%) showed hypocoagulability as evaluated by TEG and these patients had higher first day SOFA score (P < 0.0001) and higher 30-days (42 vs. 13%, P < 0.0001) mortality than patients presenting with a normal TEG. In 30-day survivors, admission platelet count (P = 0.05), angle (P < 0.001) and maximal amplitude (P = 0.001) were higher and R decreased (P = 0.0013) compared with nonsurvivors. Hypocoagulability at admission as evaluated by TEG was an independent risk factor for 30-day mortality [adjusted odds ratio (OR) 3.5; 95% confidence interval (CI) 1.7-7.1]. Hypocoagulability as evaluated by TEG was frequent at admission in general ICU patients and associated with a higher rate of ventilator treatment, higher rate of renal replacement therapy and a higher use of blood products. Hypocoagulability is an independent risk factor for 30-day mortality.

Variation in the PaO2/FiO2 ratio with FiO2: mathematical and experimental description, and clinical relevance.

INTRODUCTION: Previous studies have shown through theoretical analyses that the ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2) varies with the FiO2 level. The aim of the present study was to evaluate the relevance of this variation both theoretically and experimentally using mathematical model simulations, comparing these ratio simulations with PaO2/FiO2 ratios measured in a range of different patients. METHODS: The study was designed as a retrospective study using data from 36 mechanically ventilated patients and 57 spontaneously breathing patients studied on one or more occasions. Patients were classified into four disease groups (normal, mild hypoxemia, acute lung injury and acute respiratory distress syndrome) according to their PaO2/FiO2 ratio. On each occasion the patients were studied using four to eight different FiO2 values, achieving arterial oxygen saturations in the range 85-100%. At each FiO2 level, measurements were taken of ventilation, of arterial acid-base and of oxygenation status. Two mathematical models were fitted to the data: a one-parameter 'effective shunt' model, and a two-parameter shunt and ventilation/perfusion model. These models and patient data were used to investigate the variation in the PaO2/FiO2 ratio with FiO2, and to quantify how many patients changed disease classification due to variation in the PaO2/FiO2 ratio. An F test was used to assess the statistical difference between the two models' fit to the data. A confusion matrix was used to quantify the number of patients changing disease classification. RESULTS: The two-parameter model gave a statistically better fit to patient data (P < 0.005). When using this model to simulate variation in the PaO2/FiO2 ratio, disease classification changed in 30% of the patients when changing the FiO2 level. CONCLUSION: The PaO2/FiO2 ratio depends on both the FiO2 level and the arterial oxygen saturation level. As a minimum, the FiO2 level at which the PaO2/FiO2 ratio is measured should be defined when quantifying the effects of therapeutic interventions or when specifying diagnostic criteria for acute lung injury and acute respiratory distress syndrome. Alternatively, oxygenation problems could be described using parameters describing shunt and ventilation/perfusion mismatch.

[What is intensive care medicine? Multidisciplinary intensive care units]. / Hvad er intensiv medicinsk terapi? Multidisciplinaer intensivafdeling.

Intensive care medicine is described from a multidisciplinary point of view. The term "multidisciplinary" is used, although "multispeciality" may be more appropriate. Intensive care medicine is defined as an observational, diagnostical and therapeutical approach to the critically-ill patient, requiring specialized medical and nursing skills that cannot be met in a general ward. Critical illness is considered as overt or threatening, potentially reversible severe organ dysfunction. Intensive care medicine is conducted in the high-technology environment of intensive care units. These are further classified according to their own competency base as well as the level of the hospital in which they are situated.

[Capacity in Danish intensive care units. A national survey of capacity, cancellations and transfers of critically ill patients]. / Kapaciteten på danske intensivafdelinger. En national survey af kapacitet, aflysninger og overflytninger af kritisk syge patienter.

INTRODUCTION: A shortage of intensive care beds and fully-booked intensive care units has a range of undesirable consequences for patients and personnel, eg. transfer to other intensive care units, cancellation of operations, tighter visitation criteria and an increase in the work-load. The problem is illustrated in a national survey. MATERIALS AND METHODS: The survey was undertaken in 3 parts and comprised all 50 adult intensive care units in Denmark. Part 1 was a questionnaire encompassing demographic data, the number of open intensive care beds and how often under or over capacity was experienced in the department. Parts 2 and 3 consisted of a daily registry of the capacity and occupancy rate in the intensive care departments for two weeks along with a contemporary registry of the number of admittances, transfers and cancellations of operations. RESULTS: In Denmark only 2% of all somatic beds are intensive care beds. Under capacity, defined as a 100% occupancy rate, was experienced weekly or monthly in 80% of all intensive care units in Denmark. Occupancy rate was high, a medium of 78%, highest in level III intensive care units with an 88% occupancy rate. The numbers for transfers were equivalent to 800-1000 patient transfers per year. The number of cancelled operations was equivalent to 2000 per year. CONCLUSION: This survey documents that there is a problem with the capacity in Danish intensive care units. Establishing more intensive care beds in selected departments, ensuring personnel for the beds already established and establishing intermediate care beds could relieve the shortage of beds.

[Capacity problems in Danish intensive care units?]. / Er der kapacitetsproblemer på danske intensivafdelinger?

There are documented capacity problems in Danish ICUs. The indications for intensive care have increased in the last decade without any increase in the number of ICU beds. The result is massive pressure on many ICUs and many negative consequences in relation to healthcare, healthcare economics and patient comfort. Possible solutions: 1) an increase in the number of ICU beds, 2) re-organization of Danish ICUs into larger units and 3) creation of "step-down"-units. Intensive care is a costly area in the healthcare system, where there must be distinct guidelines for visitation and use of expensive medicine and advanced technology.

Increased colorectal permeability in patients with severe sepsis and septic shock.

OBJECTIVE: To develop a method for the assessment of colorectal permeability in septic patients. DESIGN AND SETTING: Observational study in ICUs at two university hospitals. PARTICIPANTS: Nine patients with septic shock and abdominal focus of infection, 7 with severe sepsis and pulmonary focus and 8 healthy subjects. MEASUREMENTS AND RESULTS: Colorectal permeability was assessed as the initial appearance rate of (99m)Tc-DTPA in plasma after instillation into the rectal lumen and as the cumulative systemic recovery at 1h. To calculate the latter, volume of distribution and renal clearance of (99m)Tc-DTPA was estimated by an i.v. bolus of (51)Cr-EDTA. The initial rate of permeability was increased in patients with septic shock and severe sepsis compared with controls [29.0 (3.7-83.3), 20.6 (3.6-65.5) and 6.0 (2.2-9.6)cpm ml(-1)min(-1), respectively, p<0.05)] with a positive linear trend (r (2)=0.27, p=0.01) and correlated to L-lactate concentrations in the rectal lumen (r (2)=0.39, p<0.05). The cumulative permeability was also increased in patients with septic shock and severe sepsis compared with controls [2.07 (0.05-15.7), 0.32 (0.01-1.2) and 0.03 (0.01-0.06) per thousand, respectively, p<0.01] and correlated to the initial permeability rate (r (2)=0.26, p=0.01). CONCLUSIONS: In septic patients, the systemic recovery of a luminally applied marker of paracellular permeability was increased and related to the luminal concentrations of L-lactate and possibly to disease severity. This suggests that the assessment of colorectal permeability by systemic recovery of (99m)Tc-DTPA is valid and that metabolic dysfunction of the mucosa contributes to increased permeability of the large bowel in patients with severe sepsis and septic shock.

Procalcitonin increase in early identification of critically ill patients at high risk of mortality.

OBJECTIVE: To investigate day-by-day changes in procalcitonin and maximum obtained levels as predictors of mortality in critically ill patients. DESIGN: Prospective observational cohort study. SETTING: : Multidisciplinary intensive care unit at Rigshospitalet, Copenhagen University Hospital, a tertiary reference hospital in Denmark. PATIENTS: Four hundred seventy-two patients with diverse comorbidity and age admitted to this intensive care unit. INTERVENTIONS: Equal in all patient groups: antimicrobial treatment adjusted according to the procalcitonin level. MEASUREMENTS AND MAIN RESULTS: Daily procalcitonin measurements were carried out during the study period as well as measurements of white blood cell count and C-reactive protein and registration of comorbidity. The primary end point was all-cause mortality in a 90-day follow-up period. Secondary end points were mortality during the stay in the intensive care unit and in a 30-day follow-up period. A total of 3,642 procalcitonin measurements were evaluated in 472 critically ill patients. We found that a high maximum procalcitonin level and a procalcitonin increase for 1 day were independent predictors of 90-day all-cause mortality in the multivariate Cox regression analysis model. C-reactive protein and leukocyte increases did not show these qualities. The adjusted hazard ratio for procalcitonin increase for 1 day was 1.8 (95% confidence interval 1.3-2.7). The relative risk for mortality in the intensive care unit for patients with an increasing procalcitonin was as follows: after 1 day increase, 1.8 (95% confidence interval 1.4-2.4); after 2 days increase, 2.2 (95% confidence interval 1.6-3.0); and after 3 days increase: 2.8 (95% confidence interval 2.0-3.8). CONCLUSIONS: A high maximum procalcitonin level and a procalcitonin increase for 1 day are early independent predictors of all-cause mortality in a 90-day follow-up period after intensive care unit admission. Mortality risk increases for every day that procalcitonin increases. Levels or increases of C-reactive protein and white blood cell count do not seem to predict mortality.

[Vitamin E and excessive bleeding]. / E-vitamin og blødningstendens.

A case of excessive postoperative bleeding in a 50-year-old woman undergoing breast surgery is reported. Preoperatively, the patient consumed a daily dose of vitamin E of 500 mg, which is far more than the recommended daily intake of 8-10 mg. There is reason to believe that the extensive postoperative bleeding was due to vitamin E-induced inhibition of protein kinase C, which decreases platelet adhesion. Preoperatively, blood samples showed normal prothrombin time index, activated partial thromboplastin time and platelet count, and no other explanation for the excessive bleeding was found.

Use of recombinant activated factor VII for bleeding in pancreatitis: a case series.

OBJECTIVES: To describe the effects of recombinant activated factor VII (rFVIIa) in the treatment of bleeding in a series of patients with acute or chronic pancreatitis. METHODS: Twelve patients (age, 2.5-65 years) with pancreatitis and bleeding were treated with 18.5 to 120 microg/kg of rFVIIa. Eight patients also had sepsis/infection and/or disseminated intravascular coagulation (DIC). The effects of rFVIIa on bleeding, coagulation status, and transfusion requirements were noted. RESULTS: Bleeding stopped in 4 patients, was markedly reduced in 4 patients, was reduced in 3 patients, and was remained unchanged in 1 patient. For most patients with pre- and post-rFVIIa data, coagulation parameters improved and transfusion requirements reduced. No thrombotic adverse events occurred. Seven patients died for reasons considered to be unrelated to rFVIIa treatment. CONCLUSIONS: This case series indicates that rFVIIa may be an effective hemostatic treatment of patients with pancreatitis suffering from massive bleeding. There were no thromboembolic events in any patient, including those with sepsis or DIC.

The human spleen as an erythrocyte reservoir in diving-related interventions.

Twelve subjects without and ten subjects with diving experience performed short diving-related interventions. After labeling of erythrocytes, scintigraphic measurements were continuously performed during these interventions. All interventions elicited a graduated and reproducible splenic contraction, depending on the type, severity, and duration of the interventions. The splenic contraction varied between approximately 10% for "apnea" (breath holding for 30 s) and "cold clothes" (cold and wet clothes applied on the face with no breath holding for 30 s) and approximately 30-40% for "simulated diving" (simulated breath-hold diving for 30 s), "maximal apnea" (breath holding for maximal duration), and "maximal simulated diving" (simulated breath-hold diving for maximal duration). The strongest interventions (simulated diving, maximal apnea, and maximal simulated diving) elicited modest but significant increases in hemoglobin concentration (0.1-0.3 mmol/l) and hematocrit (0.3-1%). By an indirect method, the splenic venous hematocrit was calculated to 79%. No major differences were observed between the two groups. The splenic contraction should, therefore, be included in the diving response on equal terms with bradycardia, decreased peripheral blood flow, and increased blood pressure.