• Konrad Schmidt, Paul Thiel, Friederike Mueller, Katja Schmuecker, Susanne Worrack, Juliane Mehlhorn, Christoph Engel, Katja Brenk-Franz, Stephan Kausche, Ursula Jakobi, Anne Bindara-Klippel, Nico Schneider, Antje Freytag, Dimitry Davydow, Michel Wensing, Frank Martin Brunkhorst, Jochen Gensichen, and Smooth Study Group.
• Institute of General Practice and Family Medicine, Jena University Hospital, Bachstrasse 18, 07743 Jena, Germany. Konrad.Schmidt@med.uni-jena.de.
• Trials. 2014 Jan 1;15:283.

BackgroundSepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following hospital discharge are treated. The aim of our study is to determine the effect of a primary care-based, long-term program on health-related quality of life in sepsis survivors.Methods/DesignIn a two-armed randomized multicenter interventional study, patients after sepsis (n = 290) will be assessed at 6, 12 and 24 months. Patients are eligible if severe sepsis or septic shock (ICD-10), at least two criteria of systemic inflammatory response syndrome (SIRS), at least one organ dysfunction and sufficient cognitive capacity are present. The intervention comprises 1) discharge management, 2) training of general practitioners and patients in evidence-based care for sepsis sequelae and 3) telephone monitoring of patients. At six months, we expect an improved primary outcome (health-related quality of life/SF-36) and improved secondary outcomes such as costs, mortality, clinical-, psycho-social- and process-of-care measures in the intervention group compared to the control group.DiscussionThis study evaluates a primary care-based, long-term program for patients after severe sepsis. Study results may add evidence for improved sepsis care management. General practitioners may contribute efficiently to sepsis aftercare.Trial RegistrationU1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).

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