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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial

Authors: 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, Smooth Study Group

Published in: Trials | Issue 1/2014

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Abstract

Background

Sepsis 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/Design

In 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.

Discussion

This 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 registration

U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).
Appendix
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Metadata
Title
Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial
Authors
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
Smooth Study Group
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-283

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