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Background A SARS-CoV-2 infection can lead from asymptomatic through to critical disease in a dynamic and unpredictable course within a few days. The challenge in outpatient monitoring the highly contagious COVID-19 disease during the ongoing pandemic is to filter severe courses followed by admission to hospital with the aim of preventing an overburdening of clinics. However, little is known of the effect of risk factors on the course of the infection of outpatient patients. To support general practices in managing high risk patients, we designed a COVID-19 surveillance and care tool (CovidCare). It includes an initial assessment of yet known risk factors and symptoms and a continuous telephone monitoring of signs and symptoms. This study aims to investigate the effects of different risk factors on the course of the COVID-19 disease, utilisation of different health care services and to gain insights into the utilisation of CovidCare in general practices. Methods We will conduct a multi-centered prospective, longitudinal non-controlled observational trial of COVID-19 patients in general practices. Overall, 700 GPs who participate in general-practice centered care by the AOK Baden-Württemberg (large German sickness fund) are eligible and will be invited for study participation, including adult, outpatient COVID-19 patients (or urgent suspicion and ≥ 50 years) with at least one additional known risk factor, who participate in general-practice centered care. The primary outcome is hospitalisation due to COVID-19. Secondary outcomes are diagnosis of pneumonia, utilisation of palliative care, mortality rate, anxiety and identification of predictive risk factors. Quantitative data analysis will focus on valid descriptive figures and mixed regression models. The accompanying process evaluation is based on interviews and questionnaires from general practice staff and patients. The analysis of the process evaluation is descriptive and explorative. Discussion The use of the COVID-19 surveillance and care tool is expected to encourage the provision of structured quality of care during the ongoing pandemic. This trial will provide an understanding of the COVID-19-disease and the effect of several risk factors on the course of the disease and health care utilisation. The results can be used for a better management of the COVID-19 pandemic and its consequences. Trial registration German Clinical Trials Register DRKS00022054.

Patients with chronic disease usually need to take multiple medications. Drug-related interactions, adverse events, suboptimal adherence, and self-medication are components that can affect medication safety and lead to serious consequences for the patient. At present, regular medication reviews to check what medicines have been prescribed and what medicines are actually taken by the patient or the structured evaluation of drug-related problems rarely take place in Germany. The process of "medication reconciliation" or "medication review" as developed in the USA and the UK aim at increasing medication safety and therefore represent an instrument of quality assurance. Within the HeiCare(®) project a structured medication management was developed for general practice, with medical assistants playing a major role in the implementation of the process. Both the structured medication management and the tools developed for the medication check and medication counselling will be outlined in this article; also, findings on feasibility and acceptance in various projects and experiences from a total of 200 general practices (56 HeiCare(®), 29 HiCMan,115 PraCMan) will be described. The results were obtained from questionnaires and focus group discussions. The implementation of a structured medication management intervention into daily routine was seen as a challenge. Due to the high relevance of medication reconciliation for daily clinical practice, however, the checklists - once implemented successfully - have been applied even after the end of the project. They have led to the regular review and reconciliation of the physicians' documentation of the medicines prescribed (medication chart) with the medicines actually taken by the patient.

Zusammenfassung Hintergrund Patienten mit Herzinsuffizienz haben einen komplexen Versorgungsbedarf, dem in Form von Case Management begegnet werden kann. Im Rahmen einer klinischen Studie zu komplexem hausarztlichen Case Management bei Herzinsuffizienz (HICMan) wurden Telefon- und Hausbesuchsmonitoringslisten entwickelt und regelmasig eingesetzt. Methode Ziel dieser Arbeit war die Darstellung von Entwicklung und Anwendung der Monitoringlisten in der HICMan-Studie. Dabei sollten Brauchbarkeit und der mit ihrer Anwendung verbundene Zeitaufwand evaluiert werden. Es erfolgte hierzu eine Sekundardatenanalyse mit Hilfe deskriptiv-statistischer Verfahren. Ergebnisse Fur das Monitoring wurde leitlinienbasiert eine Telefon- bzw. Hausbesuchsmonitoringliste mit Fragen zum Erkennen bestehender und drohender Dekompensationen sowie zum klinischen Routinemonitoring entwickelt. 97 Patienten (64 NYHA I/II, 33 NYHA III) erhielten uber 12 Monate regelmasiges Monitoring im Rahmen der HICMan-Studie. Insgesamt wurden dabei 18 kritische Ereignisse (z.B. akute Angina pectoris, akute schwere Luftnot) dokumentiert, die in zwei Fallen zur sofortigen Krankenhauseinweisung fuhrten. Beim klinischen Monitoring zeigten sich bei Patienten des NYHA-Stadium III signifikant haufiger auffallige Befunde als bei Patienten der NYHA-Stadien I und II. Der Zeitaufwand fur Telefonmonitoring und Hausbesuche lag bei 10 min [± 5 min, 2-38 min] bzw. 53 min [± 13 min, 18-90 min]. Insgesamt erwiesen sich die vorgestellten Monitoringlisten als brauchbare Instrumente hausarztlichen Case Managements.

Background. As part of a trial aiming to improve care for patients with chronic (systolic) heart failure, a standardized, multifaceted case management approach was evaluated in German general practices. It consisted of regular telephone monitoring, home visits, health counselling, diagnostic screening and booklets for patients. Practice-based doctors’ assistants (equivalent to a nursing role) adopted these new tasks and reported regularly to the employing general practitioner (GP). Objective. To explore GPs’ perceptions of case management, subsequent changes in relationships within the practice team and the potential future role. Method. Twenty-four GPs participated in five moderated, semi-structured, audio-taped focus groups. Full transcription and thematic content analysis was undertaken. Results. GPs rated all elements and instruments of case management conducted by doctors’ assistants feasible, except for the geriatric assessment as patients had not been at risk. GPs perceived difficulties in their own role in delivering health behaviour counselling. Relationships between doctors’ assistants and patients and between GPs and patients or doctors’ assistants remained stable or improved. All GPs perceived a variety of role changes in doctors’ assistants including more in-depth medical knowledge and higher responsibilities yielding more recognition by patients and GPs. Some GPs suggested transferring the case management programme to other chronic conditions and that it should form part of a further education curriculum for doctors’ assistants. Conclusion. This primary care-based case management model characterized by the orchestrated delegation of tasks to doctors’ assistants offers a promising strategy of enhanced chronic illness care, but it needs further adaptation and evaluation.

Background Care management programmes are an effective approach to care for high risk patients with complex care needs resulting from multiple co-occurring medical and non-medical conditions. These patients are likely to be hospitalized for a potentially "avoidable" cause. Nurse-led care management programmes for high risk elderly patients showed promising results. Care management programmes based on health care assistants (HCAs) targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need. Methods/Design PraCMan is a cluster randomized controlled trial with primary care practices as unit of randomisation. The study evaluates a complex primary care practice-based care management of patients at high risk for future hospitalizations. Eligible patients either suffer from type 2 diabetes mellitus, chronic obstructive pulmonary disease, chronic heart failure or any combination. Patients with a high likelihood of hospitalization within the following 12 months (based on insurance data) will be included in the trial. During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and resources as well as regular structured monitoring of symptoms. Assessment and monitoring will be performed by trained HCAs from the participating practices. Additionally, patients will receive written information, symptom diaries, action plans and a medication plan to improve self-management capabilities. This intervention is addition to usual care. Patients from the control group receive usual care. Primary outcome is the number of all-cause hospitalizations at 12 months follow-up, assessed by insurance claims data. Secondary outcomes are health-related quality of life (SF12, EQ5D), quality of chronic illness care (PACIC), health care utilisation and costs, medication adherence (MARS), depression status and severity (PHQ-9), self-management capabilities and clinical parameters. Data collection will be performed at baseline, 12 and 24 months (12 months post-intervention). Discussion Practice-based care management for high risk individuals involving trained HCAs appears to be a promising approach to face the needs of an aging population with increasing care demands. Trial registration Current Controlled Trials ISRCTN56104508