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Open Access Study protocol

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

Konrad Schmidt15*, Paul Thiel15, Friederike Mueller15, Katja Schmuecker15, Susanne Worrack15, Juliane Mehlhorn15, Christoph Engel2, Katja Brenk-Franz1, Stephan Kausche1, Ursula Jakobi15, Anne Bindara-Klippel15, Nico Schneider1, Antje Freytag1, Dimitry Davydow6, Michel Wensing14, Frank Martin Brunkhorst35, Jochen Gensichen15 and Smooth Study Group

Author Affiliations

1 Institute of General Practice and Family Medicine, Jena University Hospital, Bachstrasse 18, 07743 Jena, Germany

2 Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Härtelstrasse 16-18, 04107 Leipzig, Germany

3 Center of Clinical Studies, Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Salvador-Allende-Platz 27, 07747 Jena, Germany

4 Radboud University Nijmegen Medical Centre, Geert Grooteplein 9, PO Box 9101 6500, HB Nijmegen, Netherlands

5 Center of Sepsis Control and Care (CSCC), Jena University Hospital, Erlanger Allee 101, 07747 Jena, Germany

6 Department of Psychiatry and Behavioral Sciences, University of Washington, School of Medicine, 325 Ninth Ave, WA 98104 Seattle, USA

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Trials 2014, 15:283  doi:10.1186/1745-6215-15-283

Published: 11 July 2014

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).

Keywords:
Severe sepsis; Sequelae; Critical illness; Primary health care; Aftercare