Alba Sánchez, Christine Thomas, Friederike Deeken, Sören Wagner, Stefan Klöppel, Felix Kentischer, Chrstine A. F. von Arnim, Michael Denkinger, Lars O. Conzelmann, Janine Biermann-Stallwitz, Stefanie Joos, Heidrun Sturm, Brigitte Metz, Ramona Auer, Yoanna Skrobik, Gerhard W. Eschweiler, Michael A. Rapp
- Background
Postoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients’ age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective.
Methods
The study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design withBackground
Postoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients’ age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective.
Methods
The study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design with cluster randomization of the medical centers. Measurements are performed at six consecutive points: preadmission, preoperative, and postoperative with daily delirium screening up to day 7 and POCD evaluations at 2, 6, and 12 months after surgery. Recruitment goals are to enroll 1500 patients older than 70 years undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures.
Discussion
Results of the trial should form the basis of future standards for preventing delirium and POCD in surgical wards. Key aims are the improvement of patient safety and quality of life, as well as the reduction of the long-term risk of conversion to dementia. Furthermore, from an economic perspective, we expect benefits and decreased costs for hospitals, patients, and healthcare insurances.
Trial registration
German Clinical Trials Register, DRKS00013311. Registered on 10 November 2017.…
MetadatenAuthor details: | Alba Sánchez, Christine Thomas, Friederike DeekenGND, Sören Wagner, Stefan Klöppel, Felix Kentischer, Chrstine A. F. von Arnim, Michael Denkinger, Lars O. Conzelmann, Janine Biermann-Stallwitz, Stefanie Joos, Heidrun Sturm, Brigitte Metz, Ramona Auer, Yoanna Skrobik, Gerhard W. Eschweiler, Michael A. RappORCiDGND |
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DOI: | https://doi.org/10.1186/s13063-018-3148-8 |
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ISSN: | 1468-6694 |
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ISSN: | 1745-6215 |
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ISSN: | 1468-6708 |
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Title of parent work (English): | Trials |
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Subtitle (English): | reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults—study protocol for a stepped-wedge cluster randomized trial (PAWEL Study) |
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Publisher: | BioMed Central |
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Place of publishing: | London |
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Publication type: | Article |
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Language: | English |
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Date of first publication: | 2019/01/21 |
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Publication year: | 2019 |
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Release date: | 2019/02/20 |
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Tag: | Cost-effectiveness; Cross-sectoral care; Delirium prevention; Dementia; Elective surgery; Older patients; Postoperative cognitive dysfunction; Quality of life |
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Volume: | 20 |
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Issue: | 71 |
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Number of pages: | 15 |
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Funding institution: | Universität Potsdam |
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Funding number: | PA 2019_13 |
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Organizational units: | Humanwissenschaftliche Fakultät / Strukturbereich Kognitionswissenschaften |
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DDC classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Peer review: | Referiert |
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Grantor: | Publikationsfonds der Universität Potsdam |
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Publishing method: | Open Access |
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License (German): | CC-BY - Namensnennung 4.0 International |
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External remark: | Zweitveröffentlichung in der Schriftenreihe Postprints der Universität Potsdam : Humanwissenschaftliche Reihe ; 535 |
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