Self-determined and supported living in the neighborhood - networking, implementation and evaluation of dementia guides
Joint project in the research network Autonomy in old age
- August 2019 – December 2021
- Böhm, Fabiola
- Friedrichs, Juliane
- Grünzig, Manuela
- Klatt, Thomas
- Müller, Julia
- Geyer, Jennifer
- Schiller, Christine
The aim of the project is to enable people with dementia and their family carers to live a self-determined life in their own neighborhood by providing them with support and guidance. Qualified dementia guides will accompany people with dementia and their family carers through the various stages of the illness as if they were case managers and provide assistance as a continuous contact person. It is intended to identify the needs of people with dementia in order to make resources available and to ensure high quality care. The goal is to enable those affected to remain in their own homes, to optimize the care arrangements and to provide relief for the family carers. The evaluation of the outreach assistance will be conducted according to process, outcome and health-economic aspects.
A further aim is to set up and maintain an online platform that is as barrier-free as possible and in an easy-to-understand language. The platform would offer information about regional offers and events and provide up-to-date knowledge for people with dementia, relatives, interested citizens as well as professionals.
BEVOR – Planning in advance the patient-relevant effects of treatment: a cluster randomized intervention study in nursing facilities for senior citizens
- 1 Sept. 2019 - 31 Aug. 2022
- Heinrich Heine University Düsseldorf, Institute for General Medicine
Consortium leader: Prof. Dr. Jürgen in der Schmitten, Kornelia Götze
- Medical Faculty of the Martin Luther University Halle-Wittenberg, Institute for Health and Nursing Sciences, Project leader: Prof. Dr. Gabriele Meyer
- Medical Faculty of the Martin Luther University Halle-Wittenberg, Institute for History and Ethics in Medicine, Project leader: Prof. Dr. Jan Schildmann, MA
- Medical University Göttingen (UMG), Institute for General Medicine, Project leader: Prof. Dr. Eva Hummers
- Medical University Göttingen (UMG), Clinic for Palliative Medicine, Project leader: Prof. Dr. Friedemann Nauck
- Clinic of the University Munich, Clinic for Palliative Medicine, Project leader: Prof. Dr. Dr. Berend Feddersen
- LMU Munich, Institute for Ethics, History and Theory of Medicine, Project leader: Prof. Dr. Georg Marckmann, MPH
- Heinrich Heine University Düsseldorf, Coordination Center for Clinical Studies (KKS), Project leader: Henrike Kolbe
- Heinrich Heine University Düsseldorf, Institute for Health Care Research and Health Economics, Project leader: Prof. Dr. Dr. Andrea Icks MBA,
- UKE Hamburg, Institute for Medicinal Biometry and Epidemiology, Project leader: Prof. Dr. Karl Wegscheider
- BARMER Head Office Wuppertal, Project leader: Sonja Laag
Research assistants (study center in Halle (Saale) - IGPW)
- Innovation Commission of the Federal Joint Committee, Berlin
To make self-determined decisions about medical treatment in the future is becoming increasingly important, particularly for elderly and chronically ill people. For situations in which people are no longer able to express their decisions and wishes themselves, it is possible to set up a patient’s directive containing these wishes. Even 11 years after the legal anchoring of patients’ directives, these are still not widely spread in Germany or frequently cannot be applied practically in their intended sense due to the lack of conclusiveness and validity. This lack of knowledge of preferences about medical treatments can lead to overuse, underuse, or misuse of care.
Advance Care Planning (ACP) – in German “Behandlung im Voraus Planen (BVP)” – is a process that uses a discussion process to assist people in setting up a conclusive, valid patient’s directive. In order to ensure the resulting directives are available at the right time and are heeded by the actors involved, efforts are also being made to implement them at different levels of the health care system.
It is intended to use the BEVOR study to examine the effectivity of a ACP program for people in residential nursing homes. The ACP program is based on the Respecting Choices Program in the United States and has been adapted and further developed to suit conditions in Germany.
A prospective, multi-centered cluster randomized controlled study (cRCT) will be carried out over a period of 21 months. In the intervention group, the accompanying discussion process will be implemented in residential nursing homes in the frame of a complex intervention and according to the standards of the German Interprofessional Association – Behandlung im Voraus Planen (DiV-BVP) e.V. (Advanced Care Planning). The facilities in the control group will receive standard care. At the same time, facilities and health system actors in the area will be incorporated in the program by means of a network. A total of 40 residential nursing facilities each with an average of 80 residents will be recruited and then randomly allocated to one of the two groups.
In the intervention group, discussion facilitators will be trained who are either employed in the nursing home itself or belong to a pool of external staff working in the homes. In direct conversations, they assist the residents and their relatives to reflect on their preferences regarding medical treatment and also take care of the written documentation and organization. The nursing homes support the implementation of the program, for example by holding further education sessions or by optimizing the concepts for palliative care. In doing so, they are assisted by regional coordinators, who are active on all levels of the program, networking and supporting the discussion facilitators. The coordinators promote and accompany the implementation in the nursing homes and inform and train regional actors such as hospitals, emergency services or general practitioners, strengthening the cooperation in general.
As the primary outcome measure, the rate of hospital admissions will be compared using an anonymous survey of all the inhabitants in the residential nursing homes. The secondary endpoints will be the actual conformity of the medical treatments with the preferences of those residents who had agreed to participate in the corresponding data collection.
The study will be complemented by a comprehensive evaluation in terms of health economy and a detailed evaluation of the selected processes.
- Registered under ClinicalTrials.gov Identifier: NCT04333303
BE-UP Study - Effect of the birth environment on birth procedure and well-being of women when giving birth
- October 2017 - December 2021
- Dr. Sabine Striebich Med. Päd.
- Ronja Ocker
- Elke Mattern M.Sc.
- Nadine Schmitt
- Cooperation with the University for Health, Department for Applied Health Sciences, Bochum (Prof. Dr. Rainhild Schäfers, Elke Mattern M.Sc.).
- 12 clinics with obstetrical departments in Saxony-Anhalt, Thüringen, Saxony, Berlin and North Rhine-Westphalia.
- The online randomization and data management for the BE-UP Study were conducted by the Coordination Center for Clinical Studies Halle/Saale (KKS Halle), a service facility of the Faculty of Medicine at the Martin Luther University Halle-Wittenberg (see www.kks-halle.de).
- Statistical analysis of the data was conducted by mediStatistica (Dr. Burkhard Haastert).
- The health-economy evaluation of the intervention was carried out by the Institute for Health Services Research and Health Economics at the Centre for Health and Society, Heinrich Heine University Düsseldorf (Prof. Dr. Dr. Andrea Icks)
- Federal Ministry for Education and Research, Reg. No.: 01KG1715
- Registered in the German Register of Clinical Studies (Deutsche Register Klinischer Studien) under DRKS00012854
Further details can be found under: https://be-up-studie.de/
In Germany, the rate of caesarean sections connected with higher maternal and neonatal morbidity is above that recommended by the WHO. To date, there is no RCT with sufficient statistical power to examine the independent effect of the birth environment on the birth procedure. This clinical trial is conducted in accordance with the German national health goal “Health in childbirth”.
The RCT examines the effectiveness of an alternatively designed birthing room (intervention) on the primary outcome “vaginal birth” in 12 obstetric clinics[VK1] in Saxony-Anhalt, Thüringen, Saxony, Berlin and North Rhine-Westphalia.
An actively controlled clinical trial with two parallel study arms to test the superiority of the intervention (alternatively designed birthing room: no central birthing bed, and various components that are not included in the normal (control) birthing room). The study participants (probands) are primiparous and multiparous women with a singleton pregnancy in the cephalic position at term who are planning a vaginal birth.
The randomization is centrally controlled and conducted covertly. It is not possible to blind the participants or the staff members. Data review by external monitors, follow-up survey 3 months postpartum, and health economic evaluation are planned.
The effect of the intervention will be shown in an increase in vaginal births from an absolute 5% (baseline rate: 72%) to 7 7% [VK2] with a statistical power of 90%, a significance level of 5%, and allowing for a dropout rate of up to 10%.
Expected outcomes are: better client-oriented outcomes, greater self-determination during the birth, fewer medicinal interventions and fewer caesarean sections during future pregnancies as well as a reduction in intervention-related costs. If the intervention is effective and can be implemented nationwide, approx. 21,000 birthing mothers annually would be able to experience a vaginal birth.
Allocation to the research area
Health care by midwives and family midwives.
Cochrane Review: Interventions to reduce physical restraints (FEM) in hospitals
- Cochrane Review
- February 2017 – June 2021
- Cochrane Deutschland, Freiburg University Hospital
- No external funding
National and international studies show that mechanical physical restraints (FEM) in the care of people with cognitive impairments (e. g. dementia) are regularly applied, despite the fact that their effectivity has not been proven. For this reason, care without physical restraints (FEM) is being called for internationally.
The project aims to set up a systematic overview on the effectivity of interventions to prevent and reduce physical restraints (FEM) in acute hospitals (not including ICUs or psychiatric wards).
The systematic overview will be set up in accordance with the methods of the Cochrane Collaboration.
- Möhler R, Nürnberger C, Abraham J, Köpke S, Meyer G. Interventions for preventing and reducing the use of physical restraints of older people in general hospital settings. Cochrane Database of Systematic Reviews 2016, Issue 12. Art. No.: CD012476. DOI: 10.1002/14651858.CD012476.
Family conferences in cases of frailty: Increasing patients’ safety through joint prioritization
- March 2018 to August 2021
Project leader in Halle
- Institute for General Medicine (ifam), Faculty of Medicine, Heinrich Heine University Düsseldorf, Project coordinator: Dr. med. Achim Mortsiefer, Consortium management: Prof. Dr. med. Stefan Wilm
- Dipl. Math. Birgitt Wiese, Medical Statistics and IT-Infrastructure, Institute for General Medicine, Medical University Hanover
- Prof. Dr. med. Attila Altiner, Institute for General Medicine, University Medical Center Rostock (2nd Study Center)
- Prof. Dr. Petra Thürmann, Institute for Clinical Pharmacology, University Witten/Herdecke (planning and accompanying the intervention)
- Prof. Dr. Gabriele Meyer, Institute for Health and Nursing Sciences, University Halle-Wittenberg (planning the process evaluation of the intervention)
- Prof. Dr. Dr. Andrea Icks MBA, Institute for Health Care Research and Health Economics, University Düsseldorf (health economic evaluation)
Cooperating partners (advising on future site implementation)
- AOK Nordost
- Henrik Wiegelmann, self-help organization “Wir pflegen” (We Care);
- Prof. Dr. Christoph Ostgathe, Department of Palliative Medicine, University Clinic Erlangen
- Marjan van den Akker, PhD, Maastricht University, School CAPHRI, Department of Family Medicine
- Innovation Commission of the Federal Joint Committee, (Registration No.: 01VSF17053)
Research issues and working hypothesis
The geriatric frailty syndrome describes the condition of physical frailty connected to reduced life expectancy and increased risk of states of confusion, falls and hospital admission. Medical care for frail patients is complex, since there are many simultaneous health problems and the benefit of many of the medicinal and non-medicinal therapies for this group of patients is not assured. A special role is played by polypharmacy (taking five or more active pharmaceutical substances), which is seen as an intensifying factor for the geriatric frailty syndrome.
The COFRAIL project aims to improve the care provided by family doctors to outpatients. Here the family doctors, patients and their informal carers should discuss together which treatment goals are to be pursued with which means. The aim is to reach a joint decision about which medical measures should be continued or undertaken and which should be dispensed with. Special attention should be given to the prioritization of the pharmaceutical therapy
In the project, three family conferences will be held for each of 670 patients. For this, the family doctors will receive several training sessions. In the end, the impact of family conferences on care will be examined and any differences to normal care will be identified.
Development of a model for nurses’ role in interprofessional pharmaceutical care
- DeMoPhaC - Development of a model for nurses' role in interprofessional pharmaceutical care
- September 2018 to August 2021
- Antwerp University (Belgium), Coordination
- Martin Luther University Halle-Wittenberg (Germany)
- University of Peloponnese (Greece)
- Swansea University (Great Britain)
- Anaste – Assiciazione Nazionale Strutture per l Terza Età (Italy)
- Stiching Hogeschool Utrecht (Netherlands)
- University St Kliment Ohridski Bitola (North Macedonia)
- Østfold University College (Norway)
- Escola Superior de Enfermagem de Coimbra (Portugal)
- Slovenska Zdravotnicka Univerzit v Bratislave (Slovakia)
- Univerza Na Primorskem Universit Del Litorale (Slovenia)
- Universidad de Alicante (Spain)
- Univerzita Karlova (Czech Republic)
- University of Pécs (Hungary)
Because of a lack of transparency and recognition about the role of nurses as well as many differences in nurses‘ training and clinical practice in European countries, a model for the role of nurses in the interprofessional pharmaceutical care in Europe might be very helpful towards improving the quality of care.
The aim of this study, therefore, is to create a SWOT analysis of the nurses’ role in the interprofessional pharmaceutical care in the various countries and in Europe as a whole. This analysis will form the base for the development of a model.
What strengths and limitations does the role of the nurse have in pharmaceutical care in Europe, seen from the perspective of the nurses, physicians and apothecaries?
And what are the chances and risks for the future?
EDCP-BRCA - Evaluation of a Decisions Coaching Program to support decision-making within the frame of prevention among carriers of the BRCA1/2 mutation.
- August 2018 to July 2021
Head of consortium
- Prof. Dr. Stephanie Stock – Cologne University Hospital, Institute for Health Economy and Clinical Epidemiology, Cologne
- Cologne University Hospital; Martin Luther University Halle-Wittenberg; University of Wuppertal; University of Constance
- Anna Isselhard - Cologne University Hospital, Institute for Health Economy and Clinical Epidemiology, Cologne
- Maren Töpper - Cologne University Hospital, Institute for Health Economy and Clinical Epidemiology, Cologne
- Prof. Dr. med. Rita Schmutzler - Cologne University Hospital, Center for Familial Breast and Ovarian Cancer, Cologne
- PD Dr. med. Kerstin Rhiem - Cologne University Hospital, Center for Familial Breast and Ovarian Cancer, Cologne
- Prof. Dr. Anke Steckelberg – Martin Luther University Halle-Wittenberg, Faculty of Medicine, Institute for Health and Nursing Science, Halle
- Birte Berger-Höger - Martin Luther University Halle-Wittenberg, Faculty of Medicine, Institute for Health and Nursing Science, Halle
- Dr. med. Frank Vitinius - Cologne University Hospital, Clinic and Polyclinic for Psychosomatics and Psychotherapy, Cologne
- Prof. Dr. Juliane Köberlein-Neu – University of Wuppertal, Competence Center for Health Economics and Health Services Research, Wuppertal
- Joint Federal Committee Innovation Fund
In Germany, around 70,000 women are diagnosed with breast cancer and almost 7,800 with ovarian cancer every year. Approximately 30% of the patients have a familial frequency of breast and ovarian cancer and around 25% of these women have a pathogenic BRCA1 or BRCA2 mutation. Women carrying this mutation have a considerably higher cumulative risk of getting breast and/or ovarian cancer. The affected women have various preventive treatment options. For example, they can have healthy breast tissue and both ovaries/fallopian tubes removed prophylactically or they can take part in the intensified early breast detection program. For this decision-making process, it is enormously important that those affected receive good counseling.
The project aims at supporting the women’s decision-making through structured, modular and needs-adapted coaching and is intended to increase understanding of the benefits and risks of the prevention strategies offered. This should contribute to improving the decision-making competence and quality of those seeking advice.
Nationwide, a multicentered, randomized, controlled study with approx. 400 women will be conducted in six centers for familiar breast and ovarian cancer. Those seeking advice will be recruited for the study during the initial medical consultation and randomly assigned to the intervention or control group. Participants in the control group will receive routine treatment, while those in the intervention group will also receive special coaching in decision-making. The intervention group participants will be actively supported in their decision-making by trained nursing staff. The project is being funded for three years with a total of ca. 2.1 million euros.
ELISE - Easing the load on the care infrastructure through IT-based involvement of spontaneous commitment on the part of ordinary citizens
- 01.02.2021 - 31.01.2024
- Prof. Dr. Gabriele Meyer
- Manuela Grünzig
Federal Ministry for Education and Research
Other project partners:
- brain SCC GmbH (coordinator)
- Chair for Business Information Systems/ Corporate Information Management at MLU
- Halle-Neustädter Wohnungsgenossenschaft e.G.
The ELISE project aims at developing, piloting and evaluating an IT-supported coordination system for procuring spontaneous support services. The users’ (volunteers and advice seekers) acceptance will be examined as well as the effect on actual everyday work relief. The methods include literature reviews, market analyses, focus group interviews, individual interviews, Delphi method and surveys. The aim is to create an offer that mobilizes spontaneous helpers in the neighborhood, improves participation, generates contacts and relieves the burden of everyday life, and that is rewarding for volunteers.
Evaluation of a structured, guideline-based, multimodal care concept for people with acne inversa
- 1 May 2019 to 30 April 2022
- Skin Clinic and Polyclinic of the University Medical Center of the Johannes Gutenberg University Mainz
- German Society for Wound Healing and Wound Treatment (DGfW)
- Techniker Krankenkasse, Rhineland-Palatinate State Representative Office
- Innovation Commission of the Federal Joint Committee Berlin – Registration No.: 01NVF18008
Acne inversa is an inflammatory disease of the inverse skin regions from which approx. 1% of the population suffers. Abscesses and fistulas are formed mainly in the armpits and groin and cause malodorous secretion and severe pain. Acne inversa is a disease that dominates the patient’s life; it occurs mostly in young people, often has a progressive course and can lead to permanent bodily impediments, disability and social isolation. The aim is to reduce the burden of the disease, improve the patient’s quality of life and in the long-term to bring relief for the health care system. To this end, heterogeneous service providers are qualified to become acne inverse centers (AiC).
Patients are randomized and either receive normal care or are transferred to an AiC. There the patient is integrated into a structured, interdisciplinary, cross-sectoral form of care.
- Mai 2020 bis März 2023
Leitung des Konsortiums
- Universität Witten/Herdecke, Fakultät für Gesundheit, Institut für Forschung in der Operativen Medizin, Projektleitung: Dr. rer. medic. Tim Mathes
- Martin-Luther-Universität Halle-Wittenberg, Interdisziplinäres Wissenschaftliches Zentrum Medizin - Ethik – Recht, Projektleitung: Prof. Dr. Henning Rosenau
- Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, Institut für Gesundheits- und Pflegewissenschaft, Projektleitung: Prof. Dr. Anke Steckelberg
Mitarbeiter*innen (Studienzentrum Halle (Saale) -IGPW)
- Innovationsfonds des Gemeinsamen Bundesausschusses (Förderkennzeichen: 01VSF19025)
In Deutschland müssen alle Patient*innen vor der Einwilligung zu einem medizinischen Eingriff von ihren Ärzt*innen angemessen aufgeklärt werden. Regelhaft werden Aufklärungsbögen genutzt, um das Arzt-Patienten-Gespräch zu unterstützen und zu dokumentieren. Studien haben gezeigt, dass aufgrund der hohen Haftungsrisiken der Ärzt*innen für Behandlungsfehler oftmals eine risikozentrierte Aufklärung im Vordergrund steht. Eine informierte Entscheidung wird, wenn überhaupt, zu wenig unterstützt. Zudem kann sich die Art der Darstellung von Risiken einer Behandlung auf die Angst von Patient*innen und den Nocebo-Effekt auswirken.
Das primäre Ziel dieser Pilot-Studie ist es zu untersuchen, ob evidenzbasierte Aufklärungsbögen für die Operation und Anästhesie am Beispiel des Kniegelenkersatzes diese Defizite ausgleichen, d.h. die Risikoeinschätzung verbessern und die Angst der Patient*innen vor Komplikationen sowie die Anzahl an tatsächlich auftretenden unerwünschten Ereignissen bzw. den Nocebo-Effekt reduzieren.
Das Projekt folgt dem UK MRC-Framework für die Entwicklung und Evaluation komplexer Interventionen und beinhaltet die Elemente der Entwicklung und Pilotierung. Im Zeitraum von Mai 2020 bis März 2023 erfolgen 1) die Exploration von Informations- und Entscheidungsprozessen, 2) die Entwicklung und Pilotierung von Aufklärungsbögen, 3) die Durchführung einer Interrupted-Time-Series Studie und 4) die Prozessevaluation.
- Mithilfe von semi-strukturierten Interviews mit Patient*innen und Ärzt*innen wird der gesamte Prozess der Entscheidungsfindung und die Verwendung von Informationsmaterialien beschrieben. Ziel ist es zu verstehen, wann, wie und von wem Entscheidungen getroffen werden und welche Informationen entscheidend sind. Darüber hinaus werden schriftliche Informationen, die während des Entscheidungsprozesses genutzt werden, hinsichtlich der Kriterien evidenzbasierter Gesundheitsinformationen bewertet und deskriptiv analysiert.
- Die Aufklärungsbögen werden nach der Leitlinie zur Erstellung evidenzbasierter Gesundheitsinformation entwickelt. Parallel erfolgt eine umfassende Auswertung von Rechtsprechung und Literatur zu den rechtlichen Anforderungen an die Aufklärung. Die Pilotierung hinsichtlich der Machbarkeit erfolgt mittels Think-Aloud und Fokusgruppeninterviews. Die Pilotierung und Revision der Aufklärungsbögen erfolgt bis zur Datensättigung. Anschließend werden die Aufklärungsbögen durch Fachgesellschaften und klinische Experten überprüft.
- Zum Vergleich der evidenzbasierten Aufklärungsbögen mit den Standard-Aufklärungsbögen wird eine Interrupted-Time-Series Studie durchgeführt. Es ist geplant, 110 Proband*innen vor und 110 Proband*innen nach Einführung der Intervention im Krankenhaus einzuschließen. Darüber hinaus wird Ärzt*innen, die nach der Einführung der Intervention die informierte Einwilligung durchführen, eine Schulung in evidenzbasierter Entscheidungsfindung angeboten. Zielgrößen sind: Angst, Nocebo-Effekt, Nutzen- und Risikoeinschätzung, Zufriedenheit der Patient*innen mit dem Arzt-Patienten-Gespräch und Lebensqualität. Die Daten werden deskriptiv aufbereitet und mittels Regressionsanalysen für Zeitreihen ausgewertet.
- Die Beschreibung der Intervention und des Umsetzungsprozesses erfolgt in Anlehnung an den Prozessbewertungsrahmen des MRC unter Nutzung quantitativer und qualitativer Methoden. Es erfolgt die Untersuchung des Kontextes und der Bereitschaft zu Veränderungen auf der Ebene des Gesundheitspersonals. Barrieren und förderliche Faktoren bei der Umsetzung werden mittels semi-strukturierter Interviews mit Patient*innen und Ärzt*innen erhoben.
Durch eine evidenzbasierte, verständliche und auf Vermeidung von verzerrter Risikodarstellung ausgerichtete Aufklärung in den evidenzbasierten Aufklärungsbögen könnte die Kompetenz der Patient*innen zur korrekten Einschätzung der Risiken des Eingriffs gestärkt werden. Dadurch könnten negative Erwartungshaltungen, Ängste vor unerwarteten Ereignissen und das Auftreten des Nocebo-Effekts reduziert werden. Zugleich kann die Akzeptanz einer rechtlich abgesicherten Aufklärung unter Ärzt*innen gestärkt werden.
Implementation of "Guideline Evidence-based Health Information"
- 15.06.2018 – 14.09.2021
- Dr. phil. Birte Berger-Höger (B.Sc., M.Ed.)
- Jana Hinneburg (B.Sc., M.Ed.)
- Prof. Dr. phil., Dipl. Psych. Jürgen Kasper
- Dr. phil. Julia Lühnen
- Health Sciences, MIN-Faculty, University of Hamburg
- Innovation Funds (Health Service Research) ID: ISRCTN96941060, registered 07. 03. 2019
Latest changes as from April 2020:
Due to the restrictions caused by the Covid-19 pandemic, the project proceedings were adapted so that no meetings in person are required. The teaching program was converted to e-learning only and was re-piloted. It is now being offered within the frame of the randomized-controlled study and the funding period was extended by nine months to cope with the required adaptions.
Evidence-based health information (EBGI) is a prerequisite for informed, joint decision-making. Although the quality criteria for EBGI have been defined for years, the practical implementation is not successful at present.
Guidelines can generally contribute to quality criteria being taken into consideration. The “Guideline Evidence-based Health Information” is aimed at the compilers of health information with the intention of improving the quality of the information material. The evidence-based guideline was developed in a joint project between the University of Hamburg and the German Network of Evidence-based Medicine (DNEbM) and adopted in February 2017, following a public consultation phase. It is publicly available under the web site www.leitlinie-gesundheitsinformation.de.
Parallel to the development of the guideline, the competences of the information compilers were explored and a five-day training program was developed, consisting of an EbM training module and a module about how to use the guideline.
Objective of this study is to evaluate the implementation of the “Guideline Evidence-based Health Information” in combination with a training program for information compilers. It is assumed that the guideline-based development of EBGI accompanied by complementary training will lead to an improvement in the quality of the information materials in comparison to compilation processes without such training.
The methodological approach follows the guideline of the UK Medical Research Council (MRC) for the development and evaluation of complex interventions. A qualitative pilot study (study protocol)and a randomized-controlled study were conducted between June 2018 and December 2020.
The five-day training unit will be adapted to a blended learning format and thus shortened by two presence days. The entire intervention will be piloted and, if necessary, optimized with regard to feasibility and acceptance during at least 2 to 3 training units with health information compilers. Data will be collected via structured observation and focus group interviews; the analysis will follow the structuring qualitative content analysis according to Mayring.
- In the randomized-controlled study, 26 groups of compilers of health information (1 – 10 people per group) will be included to compare the intervention (guideline & training unit in a blended learning format) with the usual care offered (publicly accessible guideline). Primary endpoint is the degree of implementation of recommendations made in the guideline. For this, each compiler group in the study will develop an EBGI to a self-selected topic. An evaluation tool based on the guideline will be developed and validated during the project. The tool will include criteria related to the EBGI compilation process as well as quality criteria regarding relevant content and presentation methods. At the same time, a qualitative process evaluation will take place.
- Kasper J, Lühnen J, Hinneburg J, Siebenhofer A, Posch N, Berger-Höger B, Grafe A, Keppler J, Steckelberg A: MAPPinfo, mapping quality of health information: study protocol for a validation study of an assessment instrument. BMJ Open 2020. 10(11):e040572.
- Lühnen J, Berger-Höger B, Haastert B, Hinneburg J, Kasper J, Steckelberg A: Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial. Trials 2020. 21(1):425.
- Hinneburg J, Lühnen J, Steckelberg A, Berger-Höger B: A blended learning training programme for health information providers to enhance implementation of the Guideline Evidence-based Health Information: development and qualitative pilot study. BMC Medical Education 2020, 20(1):77.
- Lühnen J, Albrecht M, Hanßen K, Hildebrandt J, Steckelberg A: Leitlinie evidenzbasierte Gesundheitsinformation: Einblick in die Methodik der Entwicklung und Implementierung. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2015. 109(2): 159-65.
INTenSE - Improving demeNtia care Through Self-Experience
- November 2020 – October 2022
Project team leaders Halle
- Dublin City University, Ireland
- University of Maastricht, The Netherlands
- Gruppo SPES, Italy
The increase in dementia disease underlines the importance of understanding better the needs of people with dementia and of forming a creative environment for the best possible care. Professional dementia carers are rare. Although various dementia-related further education programs have been initiated in recent years, there are no European efforts worth mentioning. Further education and training programs often do not provide the necessary insights into the needs of people with dementia, which is why the staff requires additional training in order to be able to work successfully with people with dementia. The project “Improving dementia care Through Self-Experience (INTenSE)” trains professional carers to improve dementia-related support through innovative learning approaches and IT tools, enabling them to relate to the experiences of people with dementia. In the field of further education and training, INTenSE aims to use self-awareness methods to promote dementia-related knowledge and understanding of the experience of dementia throughout Europe. As a form of experimental learning, simulation strategies incorporate different ways of generating knowledge (e.g., thinking, feeling, and acting) that can be used to improve dementia care and support. Virtual Dementia Tours (VDT), role-playing or theater performances are examples of such methods. INTenSE intends to link these approaches innovatively to
- improve cooperation and knowledge-sharing between the organizations active in the field of nursing and care,
- develop a new network of professional carers,
- support the digital competences of professional carers by means of a newly developed IT platform,
- develop social understanding for the opportunities of self-awareness to improve dementia care and support and
- to integrate self-awareness techniques into the daily activities of professional carers.
INTenSE intends making self-awareness techniques available for present and future generations of professional carers in the field of dementia. The project activities are designed to achieve the following project objectives:
- Determining the status of international experiences relating to VDT, dementia-related role-playing and theatrical activities by means of a scoping review and a focus group study. The findings will form the basis for the INTenSE e-booklet and thus the fundament for further methodical steps.
- Creating an INTenSE e-booklet and an INTenSE Dementia Simulation Tool-kit (DST), with the help of which symptoms of dementia are simulated so that is will be possible to use enhanced empathy and understanding to improve nursing and healthcare. The DST will contain various elements, such as a compilation of IT applications for simulating sensory deficits, a description of VDT interventions for simulating physical and cognitive symptoms, details about role-playing and theatrical performances to simulate psychological symptoms and include also the corresponding treatment instructions.
- Developing an internet platform to facilitate learning from each other and to promote the digital competencies of the professionals involved.
An INTenSE training course with a participative approach will help a total of 20 professional carers to learn about techniques for self-awareness. The subsequent focus group interviews are linked to the principles of active participation, which should help achieve the INTenSE goals.
Another INTenSE training refers to using DST and the IT platform in the participating countries.
The project aims at significantly improving the abilities and competences of professional players by using methods of active participation, innovative self-awareness techniques and by using the IT platform. Organizations involved in the project can participate in the development and application of innovative approaches in dementia care and training of professional players by strengthening cooperation and management skills.
By making use of the experiences and networks of the project partners, the path will be paved for developing innovative teaching courses for future professional players and thus advance the professionalization in the field of dementia care.
Last but not least, the project has the potential to bring innovative approaches to care policy through increased awareness of dementia-related needs. The participative approach of the INTenSE project will promote transnational cooperation and facilitate the development of innovative tools that are based on self-awareness. The methodology can be applied throughout Europe, whereby the experiences in different socio-cultural settings can be of use.
MoNoPol-Sleep – a multi-modal, non-pharmacological intervention for sleep disorders of people with dementia in nursing homes
- October 2018 – Dezember 2021
Participating study centers:
- Coordinating study center: University of Lübeck, Institute for Social Medicine and Epidemiologiy, Section for Research and Teaching in Nursing
Project leader: Prof. Dr. Sascha Köpke
- Faculty of Medicine at the Martin Luther University Halle-Wittenberg, Institute for Health and Nursing Science
Project leader: Prof. Dr. Gabriele Meyer
Researcher: Dr. Almuth Berg
- German Center for Neurodegenerative Diseases (DZNE), Witten
Project leader: Prof. Dr. Margareta Halek
- Federal Ministry for Education and Research – Reg. No.: 01GL1802B
Abstract Website: www.monopol-sleep.de
People with dementia frequently suffer from sleep disorders which lead to a number of other problems. Current research shows that medicinal treatment cannot be recommended as first-line therapy. Non-pharmacological interventions are in principle effective but at present there is no “gold standard” intervention for preventing sleep disorders in people with dementia. Existing interventions are characterized by the heterogeneity of the (usually complex) interventions and by the insufficient knowledge about the possibilities and challenges of the implementation.
The project aims at developing and piloting a complex, non-pharmacological intervention for preventing sleep disorders in people with dementia in nursing homes.
The main phase of the project is planned as a cluster-randomized study over a period of 12 months in three study centers. Twelve nursing homes each will be allocated to both the intervention and the control group. An extensive process evaluation will conducted in addition.
Study registration no.: ISRCTN36015309
Improving oral health through dentist-delegated, nurse-assisted remotivation and reinstruction
- June 2019 to May 2022
- Innovation Commission of the Federal Joint Committee Berlin – Registration No.: 01VSF18021
The aim is to develop and evaluate a nurse-assisted dental support concept for the oral hygiene and care of residents in residential care facilities for the elderly (care level 3 – 5) in order to improve quality of life in relation to oral health.
The primary hypothesis: The reinstruction and remotivation of the nursing staff with the help of dental assistants following the instructions of dentists will improve the quality of life in relation to oral health of residents with care level 3 -5.
The existing dental concept for the care of older (and/or disabled) people stipulates that dentists conduct a regular 6-monthly evaluation of the oral health and hygiene status of care-dependent people. It also provides for the nursing staff to receive instruction based on a form sheet and for any necessary referral recommendations for dental therapy. The aim of this current project is the short-term development and medium-term testing of individualized assigned care reinstruction and remotivation measures for nursing staff who deal with oral hygiene and care. These measures are to be conducted with the help of dental assistants following the instructions of dentists. The long-term target is to improve the oral health related quality of life and the oral health of residents in care facilities for the elderly and to reduce dental-related emergencies and comorbidity by expanding the AuB concept as described.
Concept for the consolidation of the violence prevention project PEKo
- PEKo 1.1
- October 2020 - December 2022
- Lübeck University
- Fulda University
- Techniker Krankenkasse Hamburg
The COVID-19 pandemic has caused enormous unprecedented challenges for residential care facilities and its impact had considerable influence on the course of the PEKo project. The cooperating care facilities had get used to adhering to the legal requirements for the prevention of COVID-19 and for dealing with infections. At the same time, they had to guarantee the nursing care for their residents. Some of the existing test guidelines and documentation requirements were suspended and the psychosocial situation of the residents was influenced by the ban on contacts. In this situation, the risk of residents becoming victims of structural, cultural and also personal violence increased considerably. This becomes noticeable when the WHO definition of violence is balanced against the consequences of the protective measures planned for the pandemic. Yet this risk does not apply solely to residents in care facilities but also to persons involved directly in the provision of nursing, care and home economics.
Against the background of the project’s subject of violence prevention in residential care facilities, a completely new perspective of the situation in such facilities unfolds. The interventions intended as preventive measures correspond largely to the WHO definition of violence, and the isolation of the facilities hinders a corrective social effect.
The challenges and changes brought on by COVID-19 in the residential care facilities involved in the PEKo project and also in others should be investigated as a supplement to the original research issues of the study.
PoiSe - Prevention, online feedback and interdisciplinary therapy of acute vertigo using e-health
- March 2020 - February 2024
Project team leader in Halle:
- Dr. med. Filipp Filippopulos (project leader), German Vertigo and Balance Center (DSGZ) and Clinic and Policlinic for Neurology, LMU Munich
- Prof. Dr. med. Doreen Huppert (deputy project leader), German Vertigo and Balance Center (DSGZ), LMU Munich
- Prof. Dr. med. Thomas Brandt, German Vertigo and Balance Center (DSGZ), LMU Munich
- Prof. Dr. Eva Grill, German Vertigo and Balance Center (DSGZ) and Institute for Medicinal Information Processing, Biometry and Epidemiology (IBE), LMU Münich
- AOK Bavaria
- Association of Statutory Health Insurance Physicians, Bavaria (KVB)
- Institute for Health and Nursing Science (IGPW) at the Martin Luther University Halle-Wittenberg (Evaluation)
- Joint Federal Committee Innovation Fund, Reg.-No. 01NVF19030
Vertigo is one of the most frequent complaints with which patients confront their doctors. It can have a severe impact on the daily life of those affected, up to and including loss of work and greatly reduced quality of life. Although many causes of vertigo are easily recognizable and treatable, general practitioners often perform unnecessary and stressful diagnostic procedures. This can lead to a longer treatment period and to chronification of the complaints or overlaying through somatization processes.
The cluster-randomized intervention study aims at improving the care and quality of life of patients treated for vertigo by general practitioners. The intervention is based on the following elements:
- Training for the participating physicians
- PoiSe web platform for physicians to support the diagnosis, monitor the course of the illness and for interdisciplinary exchange with a network of experts
- PoiSe application for installation on the patient’s smart phone, providing information about therapy, checking the course of the symptoms, and giving warnings if the therapy has no response.
After three months, all patients will be invited to the German Center for Vertigo and Balance in the Clinic Großhadern where the quality of the diagnosis will be checked.
Making care easier by means of cooperating robotics
- May 2020 - April 2023
Project leader in Halle
- Chris Diers, DIERS International GmbH
- Prof. Dr. Catherine Disselhorst-Klug, Rehabilitation and Prevention Technology, RWTH Aachen
- Maike Ketelhut, Institute for Control Technology, RWTH Aachen
- Prof. Dr. Astrid Stephan, Nursing Director University Clinic, RWTH Aachen
- Bernd Bogert, St Gereon Seniorendienste GmbH
- Prof. Dr. Gernot Marx, Clinic for Operative Intensive Medicine and Intermediate Care, RWTH Aachen
- Federal Ministry for Education and Research
PfleKoRo aims at providing physical and temporal relief for nursing staff in the care of severe and very severely bedridden patients. For this purpose, a robotic system is to be designed that gives needs-oriented support, integrates itself smoothly into the actual nursing tasks, and takes over physically strenuous lifting and repositioning tasks. The challenge here is to coordinate the robotic assistance and human interaction, taking into consideration the needs of both the nursing staff and patients according to the actual situation. This challenge is met by an iterative development process jointly supported by nursing professionals, care recipients and developers. The final result should be the PfleKoRo system.
PPE - Intensity of care and nurse sensitive outcome indicators (NSI) in German acute wards [PPE]
- April 2018 – März 2021
Project tetam leader in Halle
- Prof. Dr. Jonas Schreyögg, Hamburg Center for Health Economics (HCHE)
Other consortium partners
- Techniker Krankenkasse (Hamburg)
- Joint Federal Committee Innovation Fund (Reg.-No.: 01VSF17038)
The PPE project is investigating the relation between quality and outcome of nursing care and nurse staffing levels. So-called routine data from hospitals and health insurance companies that are usually used for documentation and billing, will be evaluated. To include the subjectively experienced treatment quality, patients will be asked about their stay in hospital.
The findings can supply valuable information about how the hospitals can use their nursing staff to achieve the best nursing care. The results can also be used by health policy makers to utilize subsidies for care improvement in the best possible way.
In hospitals, the quality of nursing care can have a relevant influence on the quality and success of treatment. The nurse-patient-ratio must be seen as a structural component and is at the same time a prerequisite for the quality of care. It outlines the number of patients that one nurse must care for and provides information about the care intensity. It is also interesting to discover whether the care provided corresponds to the needs of the patients. The success of the nursing care can be seen after the patient has been discharged, for example from the physical condition of the patient (through so-called care-sensitive outcome indicators).
Knowledge about the relation between the care intensity in hospital and care-sensitive outcome indicators provide a basis on which the quality (of care) in hospitals can be improved and in which departments/wards more staff must be allocated in order to ensure high-quality and safe care. By introducing minimum standards in the allocation of staff to care-sensitive departments/wards, it might be possible to provide more certainty for the patients when selecting a hospital and also improve the patient orientation.
To date, the relation between the staffing levels and patient-related outcomes has rarely been empirically examined. Previous research dealt mainly with patient-related outcomes that could be proven during the stay in hospital. In contrast, the perspective of post-discharge care and the patient perspective have been largely neglected.
The PPE study investigates the relation between the staffing levels in German hospitals and the post-discharge outcomes of the patients cared for there. A further aim is to determine nurse-patient-ratios, particularly with regard to the care-sensitive departments/wards where an increase in staff levels might achieve the best improvement in care quality.
Care-sensitive patient outcomes will be identified systematically from the literature. Indicators that can be recorded not only during, but also after hospitalization are of particular interest. These indicators are collected from the billing data of inpatient and outpatient service providers. In addition, a standardized questionnaire will be used to collect information from the patient's perspective with regard to the quality of care on the ward and adverse events and conditions of care that occurred after the hospitalization.
Subsequently, these data can be put in relation to the nurse-patient-ratio. Information regarding staffing on the wards will be taken from the hospitals’ quality reports
Professional competence in nursing
- September 2017 - August 2021
Overall project management
- Prof. Dr. Helena Leino-Kilpi, Turku University, Finland
Project management Germany
- Juliane Stubner M.Sc. (study coordination and implementation Germany)
- Christin Richter M.Sc.
- PD Dr. Gero Langer
- Coordination: Turku University, Finland
- Dublin City University and National University of Ireland, Galway
- University of Iceland
- Klaipeda University and Vilnius University
- Universitat Internacional de Catalunya, Barcelona
- (University) Clinics and Training Centers for Healthcare and Nursing in Germany
The overarching objectives of this study are:
- To appraise and compare on a European level how the skills/competences of healthcare and nursing trainees develop in the first year after starting their career.
- To determine individual, training-related, organizational and value-based factors that accompany the development of competences.
- To determine factors that enable a high level of competence development and a successful start in the professional life of healthcare nurses.
- Cross-sectional studies: Using questionnaires, the competences of healthcare and nursing trainees will be recorded at the end of their training (competence assessment) along with the related factors (individual, training-related, organizational and values-based factors). The healthcare and nursing exam candidates (n=500/country) will be questioned and also the patients they cared for (n=300/country) along with nurse managers on wards or in practices (n=100/country).
- A follow-up study will be conducted one year after the first survey. Using questionnaires, data will be collected regarding the development in the competences of the healthcare nurses (n=500/country), who have now been working for one year, as well as ward managers (n=100/country).
- The assessment of the competences and the related factors will take place in all the cooperating countries at around the same time – at the time of the exams and one year after.
Quality of life in clinical oncology
- Prof. Dr. med. Vordermark
- University Clinic and Polyclinic for Radiation Therapie, Halle (Saale)
- Central Services 1 - Information and Communication, University Clinic Halle (Saale)
- Krukenberg Cancer Center, University Clinic Halle (Saale)
- Evaluation Software Development
- European Fond for Regional Development (EFRE)
The assessment of patient-reported, health-related quality of life (HRQOL=Health-Related Quality of Life) provides relevant information about how cancer patients experience their illness and therapy and what strain this places on them. It helps to involve the patieneets’ perspective more in the treatment process. Although many studies verify the benefit of systematic supportive therapy, up to now a standard assessment of HRQOL does not take place in most clinics. One reason for this is the fact that incorporating it in the clinical routine would amount to a complex intervention for which many aspects, components and involved people would have to be taken into account. Therefore, a scientifically based, carefully planned and structured approach is essential.
This project aims to plan, conduct and evaluate the implementation of the electronic assessment of HRQOL in an oncological department and according to scientific standards. Based on the knowledge gained during the process evaluation, a guideline for the implementation in other clinical settings is to be developed.
The project will be carried out in five stages: 1. Identification of optimization requirements and department-specific support factors and barriers to implementation through a current status analysis with internship as observer, documentation analysis and survey; 2. Selection of tools and development of treatment paths for relevant findings of the HRQOL assessment (e.g. for specific symptoms); 3. Development and implementation of a training session for clinic personnel on how to deal with the electronic HRQOL assessment; 4. Step-by-step implementation accompanied by continuous monitoring; 5. Evaluation of the success of the implementation by means of documentation analysis, assessment of patient satisfaction by means of a survey, and creating the guideline for the implementation.
The project is expected to provide knowledge about setting-specific supportive factors and barriers to the implementation of the electronic assessment of HRQOL. These will serve as a basis for creating a guideline for the implementation in other clinical settings. The guideline is to be tested within the framework of a subsequent multicentered study in order to improve the generalizability and to promote the use of further implementations of routine HRQOL assessment in various departments.
- May 2021 to April 2024
- Dr. Jens Abraham
- Susan Gottschalk, B.Sc.
- Fabian Wilde, B.Sc.
- Selina Jasmin Wilkens
- Federal Ministry of Education and Research (BMBF) – Grant number: 01GY2008
Physical restraints (PR), e.g. bed rails and belts in chairs or beds are commonly used in general hospital settings in many countries despite their unclear effectiveness and potential risks for harm. Their use is associated with negative consequences such as decreased mobility and well-being for patients. In an own previous feasibility study (MARAH), a complex intervention programme to prevent PR-use for the acute care setting was developed according to the UK Medical Research Council (MRC) framework for the development and evaluation of complex interventions. Overall, the intervention has proven to be feasible and was mostly positively evaluated by the target groups. However, it has been shown that further development of the intervention, implementation strategy, and study procedures is needed.
Therefore, the proposed study aims to refine and pilot this complex intervention in different acute care settings and to evaluate the intervention in an exploratory cluster-randomised controlled trial. Furthermore, the objective of this pilot study is to improve study procedures (e. g. recruitment strategy, data collection method) and collect data needed to determine a sample size in preparation of a future cluster-randomised controlled trial designed to evaluate the effectiveness of the intervention.
In a preparatory phase, focus groups and individual interviews with the target groups (e.g., nurses, physicians, physiotherapists, patients, and relatives) will be conducted to determine the need for improvement with regard to the intervention and the implementation strategies. Based on the results, the intervention and the study procedures will be revised. An exploratory cluster-randomised controlled trial with duration of six months will then be conducted. Six to eight hospitals in the region Halle (Saale) and Leipzig will be recruited, with 28 wards (approximately 924 patients per week) are expected to be randomly assigned to the intervention and control group (standard care). In addition, a comprehensive process evaluation will be conducted.
REHA-Post - Using care expertise to achieve access to medical rehabilitation treatment
- 01.03.2021 - 31.08.2022
Project team leader
Medical Advisory Service of the German Social Health Insurance (MDS)
- GKV Spitzenverband (Central Association of Statutory Health Insurances)
The Medical Advisory Service of Social Health Insurance is obliged to use care assessments to check whether there is an indication for rehabilitation treatment. If this is the case, a rehabilitation recommendation is made which activates simplified access to rehabilitation through the insured person’s consent. However, determining the indication for rehabilitation is preceded by a complex decision process, whereby in individual cases a clear decision for or against rehabilitation treatment can be associated with some uncertainty.
In a joint project between the Institute for Health and Nursing Science, the Institute for Rehabilitation Medicine and the Medical Advisory Service of Social Health Insurance, this area of uncertainty is to be described for the first time in terms of its quantitative scale and underlying causes. The aim is to reveal the complex process of decision-making that leads to a rehabilitation indication and to derive further optimization potentials.
The first methodical stage focuses on the experiences of the experts of the Medical Advisory Service of Social Health Insurance (MDS) relating to establishing the need for rehabilitation. Qualitative interviews will be conducted with experts who have nursing and medical backgrounds. The results from this stage will form the basis for a standardized survey with other MDS experts. In an expert workshop, the results of the qualitative and standardized survey will be used to derive recommendations for improving the reliability of the expert's assessment of the need for rehabilitation.
Piloting of a smart living space assessment to improve participation-oriented transfer from rehabilitation to own home
- November 2020 - April 2022
TDG Translationsregion für digitalisierte Gesundheitsversorgung über das Bundesministerium für Bildung und Forschung (...) (Translation region for digitalized healthcare – through the Federal Ministry for Education and Research)
Knowledge about the respective context for which participation is required is fundamental for participation orientation in medical rehabilitation. For older patients with chronic mobility restrictions the safe return to the domestic environment is generally foremost in the discharge management.
Within the frame of the discharge management the rehabilitation clinic examines the task (SGB V, §39 para. 1a,) of determining which follow-up measures are required after rehabilitation in order to ensure the success of the rehabilitation, advising the patients about suitable services and supporting them in their application. In this respect, an individual living space assessment can provide information about the environmental demands on the functional abilities needed by patients, thus contributing considerably to participation orientation by providing auxiliary aids and living space adjustments, and to the development of individually relevant participation-oriented training content and therapy goals.
A digitally supported, structured living space assessment (Smart Living Space Assessment) carried out by third parties can help reduce traveling times and additional burdens for rehabilitation patients and therapists during the stay in the clinic and give a concrete picture of the living environment. With the help of this information, a basis for a better participation-oriented therapy and timely preparation of the home environment can be created and contributed to by reducing resource consumption (misuse of auxiliary aids).
The scientific target of the project is to develop a complex intervention (modelling phase) that best integrates the smart living space assessment into clinical care, and to test this intervention for feasibility and acceptance among key user groups (feasibility and piloting phase). In addition, initial indications of potential care improvement effects should be gained and barriers to use and other influencing contextual factors of practice identified.
For this, an IT solution will be developed and piloted as a core element integrated into a clinical process pathway for discharge management. The IT solution will be modeled by means of a prototype and roughly subdivided into the parts for the acquisition of living space data, its structuring/processing and the use of the data in VR applications. The data collection of the living space is based on existing technical solutions and service providers.
"Development of a complex supportive intervention to promote physical functioning of older cancer patients, considering individual plasticity (SideKick)''.
Wilhelm Roux Programme FKZ: 28/20
July 2018 - June 2021
Composition of the working group:
- Principal Investigator: Dr. med. Heike Schmidt, Institute for Health and Nursing Science, Medical Faculty of the MLU Halle-Wittenberg
- Prof. Dr. phil. Anke Steckelberg Institute for Health and Nursing Science, Medical Faculty of the MLU Halle-Wittenberg
- Dr. med. Andrea Diestelhorst, University Hospital and Polyclinic for Radiotherapy
- M.A Eni Shehu
Older cancer patients are very heterogeneous with regard to physical and cognitive functioning and often burdened by multiple comorbidities. Therefore, prior to therapy, and in addition to clinical parameters, a geriatric assessment is recommended comprising assessments of physical and cognitive functioning, nutritional status, social support, self- care abilities and the patient's health- related quality of life in order to identify relevant risk factors and resources. During therapy, especially physical functions in particular may decline and thus endanger of self- independence and care abilities. However, prospective studies providing evidence-based recommendations regarding the promotion of physical functioning for order older cancer patients undergoing therapy are still sparsescarce.
This project aims to at developing and pilot- testing a multimodal intervention in order to promote the physical functioning of older cancer patients receiving outpatient radio-therapeutic radio-therapy treatment.
The project comprises three phases:
Phase 1: Development of the complex intervention
1.1 AsSystematic literature research will be conducted to identify existing training interventions for older patients (≥ 60 years) relevant to everyday life and addressing e.g. strength, endurance and coordination, and nutritional recommendations. In addition, a survey will identify the needs and preferences of the target group. The Rresults will be useds to conceptualize the modular intervention.
1.2 Consensus regarding all the components of the intervention will be obtained among from the clinical cooperation partners, the members of the scientific advisory board and the patient representatives. will be obrtained.
1.3 Creation of wWritten material and video-based instructions will be designed with the focus on comprehensibility, promotion of motivation and behavioral change.
Phase 2: Pretest, evaluation, optimization (if necessary) and preparation of materials
The pretest aims to at assessing the suitability for of the target group, the feasibility and the acceptance. The pre-test will be conducted with a convenience sample of older people aged >60 years who have a history of cancer (access SAKG, self-help groups). The evaluation will include defined outcomes (comprehensibility of the materials, adherence to the intervention, barriers and acceptance) by means of a semi- structured survey. After optimization, the content will be converted so as to be accessible via digital media.
Phase 3: Piloting
For piloting, the intervention will be randomized into two groups (paper-based and digitally supported). Inclusion: n=12 patients undergoing outpatient radio-therapeutic treatment per intervention arm; min. n=2 per age group ≥ 60, 70 and 80 years (preferably balanced gender distribution). The objectives of this pilot study are to test the recruitment strategy, randomisationrandomization, and implementation of the intervention. Process evaluation will include the feasibility from the patient’s‘- and study personnel’s perspective and an estimation of necessary resources regarding time and personnel. The Eevaluation of the endpoints, e.g. physical function scale (EORTC QLQ-C30), will also serve to estimate the sample size for the subsequent Phase III study.
Findings regarding feasibility and acceptance, potential benefits of intervention to promote physical function of older cancer patients undergoing outpatient therapy.
Scientific Advisory Board
Prof. Stangl, Prof. Hübner, Apl. Prof. Schwesig, Dr. med. Regenspurger, Dr. F. Jahn, Dr. P. Jahn, Dr. Neef, CA Meisel, CA Faber, MA Golla, Dr. Stoevesandt and Sven Weise, Sachsen-Anhaltische Krebsgesellschaft (SAKG), in order to establish access to representatives of cancer self-help.
Advance Care Planning for older people in need of care and living in their own home environment in Germany: a cluster-randomized study.
- August 2017 – September 2021
Project leader in Halle
Coordination of the joint project
- Prof. Falk Hoffmann, Carl von Ossietzky University Oldenburg, Faculty for Medicine and Health Sciences, Department for Healthcare Research
Cooperation partners in other locations
- Prof. Sascha Köpke (Lübeck), Institute for Social Medicine and Epidemiology, Section for Research and Teaching in Nursing;
- Prof. Juliane Köberlein-Neu (Wuppertal); Bergische University Wuppertal, Bergisches Competence Center for Health Economy and Healthcare Research
- Federal Ministry for Education and Research – Registration No.:01GL1707C
Self-determined decisions about therapies or life-prolonging measures are becoming more and more important in the context of today’s medical opportunities. In situations where the patient is unable to make decisions, the patient's will in written form is helpful. In order to be able to take this into account, the concept of "advance care planning" (ACP) was developed. The aim of this concept is to enable patients to make informed decisions and to document them. For a smooth process, it is necessary to anchor the ACP process into the health care system. In the international studies carried out so far, the focus was on patients in the final stage of life in hospitals or nursing homes. However, ACP commences at an earlier life stage.
The aim of this project is to develop an ACP program adapted specifically for use in Germany's outpatient care context. The effectiveness of this complex intervention will then be reviewed in comparison with previous practice.
A cluster-randomized controlled study will be carried out over a period of 12 months, involving an intervention group (training nurses in the ACP concept) and a control group (optimized normal care). A total of 32 ambulatory care services are to be recruited of which 16 care services will be randomly assigned to each of the intervention or control groups. We aim to include 30 participants from each care service, resulting in a total sample of 960 people. In the intervention group, nursing staff will be trained as facilitators to initiate and accompany the reflection and discussion process regarding treatment decisions that are planned in advance. The aim is to integrate the ACP in everyday care and for this the various stages and findings of the continuous communication process will be documented.
The primary outcome measure will be the extent to which the intervention changes the proportion of people who have a greater awareness of their own active role in managing their own health. The presence of valid patient’s wills, quality of life, anxiety and depression as well as the number of hospitalizations or institutionalizations are further end points.
Three study centers (Oldenburg, Lübeck, Halle) will be participating in the study and in addition an extensive evaluation of the process and of the health-economic aspects (Wuppertal) will be carried out.
- Evaluation study / Investigation of the effectivity
- Advance Care Planning
- Outpatient care
- Patient’s wills
- Self-determined decision-making
Transnational Care Innovation in Senior Citizens
- Trans-Senior (Link to research portal Sachsen-Anhalt)
- 01.10.2018 - 30.09.2022
- European Commission, Horizon 2020, Call: H2020-MSCA-ITN-2018, Marie Skłodowska-Curie Innovative Training Networks
- Katholieke Universiteit Leuven, Belgium
- Curaviva, Switzerland, Basel University
- Uniwersytet Jagiellonski, Poland
- State University for Applied Sciences for Health Professions, Claudiana, Italy
- Maastricht University, Netherlands
- Federatie van Wit-Gele Kruisverenigingen van Vlaa, Belgium
- Rabin Medical Center, Beilinson Hospital, Petah-Tiqva, Israel
TRANS-SENIOR trains young researchers who are dedicated to finding innovative solutions for the care and health of older citizens. The TRANS-SENIOR promotion projects have two perspectives:
- The avoiding of unnecessary transitions between care settings in the trajectory of illness, care, and treatment, such as unscheduled hospital or nursing home admissions
- The optimization of transitions if these are inevitable.
With TRANS-SENIOR it is intended to gain scientific insights
- about where transitions are avoidable,
- on the advantages of innovative transition models,
- on methods of involving senior citizens actively in nursing/care innovations and of implementing interventions sustainably to avoid unnecessary transitions as well as methods of optimizing the transitions.
TRANS-SENIOR includes 13 young researchers. Each doctoral student will be supervised by two universities, both of which will award the PhD. Contacts to praxis partners in the projects are contractually secured.