Background Currently 21% of the German population is older than 65 years. Above this age, the risk of suffering from chronic disease and mental disorders increases rapidly. Therefore, physical inactivity is one of the most important public health concerns among older people. To address this issue, we have conceptualised and evaluated a simple and low-threshold intervention, which requires only minimal demand on the participants, targeting older people with inadequate activity levels. The aim of the POWER Study is to investigate whether volunteer-supported outdoor-walking improves physical function and quality of life in older people. Methods/design In a randomised, controlled interventional superiority-trial, individuals older than 65 years of age living in the community or nursing homes will be randomised into two groups. The study will be conducted in two study centres with assessments at baseline, 6 and 12 months. The intervention group will participate in a supported physical activity intervention for 6 months. An assigned volunteer will visit them three times a week for an outdoor walk between 30 and 50 min, or equivalent indoor activity. Persons in the control group will be invited to two lectures covering topics related to health. Primary endpoint is the physical function measured by the Short Physical Performance Battery (SPPB) at baseline, after 6 and 12 months. Secondary and safety endpoints will be quality of life (EQ. 5D), fear of falling (Falls Efficacy Scale), physical activity (activity diary), cognitive executive function (clock drawing test), falls requiring medical attention, hospitalisation and death. Primary analysis will be carried out by intention to treat. Discussion We expect the intervention to improve the overall health status of the participants in a wide range of health-related outcomes. If effectiveness can be shown, the intervention will close an important gap in current services for older people. We will disseminate our experiences and results in the form of informational documents (training manual) to allow municipalities and health care organisations to implement a similar intervention. Trial registration The trial was registered on 31 Aug 2018; German Clinical Trials Register (www.germanctr.de), Deutsches Register Klinischer Studien: DRKS00015188.
Background In 2014 a new system for drug expenditures, the Wirkstoffvereinbarung (WSV) was implemented in Bavaria. In pre-defined indication groups, cost-effectiveness for the prescription of medications shall be enabled based on the selection, quantity, and the proportion of an individual drug. Ambulatory care physicians receive quarterly trend reports on their prescribing behavior. This study examines physicians’ perceptions of the WSV. Methods Qualitative interviews (n = 20) and seven focus groups (n = 36) were conducted with ambulatory care physicians (e.g. general practitioners, cardiologists, pneumologists). The methodology followed Qualitative Content Analysis. Results Physicians generally accepted the necessity of prescribing economically. The majority of them rated the WSV positively and better than the previous system. As improvement, they especially named timely feedback in form of easily understandable trend reports, encouraging self-reflection as well as allowing early control options. Problems perceived were drug discount contracts that were strongly criticized as leading to patients mixing up medications. Some perceived constraints of therapeutic freedom. Conclusions The WSV was seen as useful to reach the accepted goal of cost control. The restrictions of therapeutic freedom partially perceived might be met by improved information on the reasons why some drugs are rated as less economic than others. Trial registration number: Main ID: DRKS00019820 (German Register of Clinical Studies and World Health Organization)
Zusammenfassung Hintergrund und Ziel Zur transparenten Steuerung der Arzneimittelausgaben im Rahmen des Wirtschaftlichkeitsgebots (§ 12 Fünftes Buch Sozialgesetzbuch (SGB V)) hat die Kassenärztliche Vereinigung Bayerns im Jahr 2014 die Wirkstoffvereinbarung (WSV) eingeführt. Diese hat die Richtgrößensystematik abgelöst. Mit Bezug auf die Rolle der WSV werden im Artikel die Gründe der Hausärzt*innen (HÄ) für oder gegen eine Weiterverordnung von Arzneimitteln aus dem Krankenhaus beschrieben. Material und Methode In einem qualitativen Studiendesign wurden im Zeitraum 11/2019 bis 03/2020 mit bayerischen HÄ Einzelinterviews (n = 18) und 2 Fokusgruppen (n = 10) durchgeführt und nach der qualitativen Inhaltsanalyse ausgewertet. Ergebnisse Mit der Einführung der WSV nahmen die Regresssorgen der HÄ insgesamt ab. Große Bedeutung bei Verordnungen haben – vor der Wirtschaftlichkeit – die patient*innenorientierte Versorgung und fachliche Richtigkeit von Therapieentscheidungen. Mit der Entlassmedikation ergeben sich wirtschaftliche Herausforderungen, besonders mit dem Leitsubstanzziel der oralen Antikoagulation, den Generikazielen bei Antidiabetika und bei Therapeutika für das Herz-Kreislauf-System. Allgemein kritisiert werden Rabattverträge, die oft zu Umstellungen von Arzneimitteln führen. Vereinzelt wird von einer „Vormachtstellung“ der Klinikärzt*innen berichtet, die dem hausärztlichen wirtschaftlichen Handeln entgegenstehen. Es fehlt laut HÄ eine sektorenübergreifende Kostenverantwortung. Diskussion Ein reibungsloser Schnittstellenübergang ist aus Sicht der HÄ trotz des Rahmenvertrags Entlassmanagement und der neuen Steuerungssystematik der WSV im ambulanten Sektor noch nicht vorhanden. Für eine wirtschaftliche Arzneimittelversorgung bedarf es weiterhin einer sektorenübergreifenden, aber auch bundesländerübergreifenden politischen Diskussion.
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