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

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 prima...

Full description

Saved in:

Bibliographic Details
Published in:	Trials Vol. 15; no. 1; p. 283
Main Authors:	Schmidt, Konrad, Thiel, Paul, Mueller, Friederike, Schmuecker, Katja, Worrack, Susanne, Mehlhorn, Juliane, Engel, Christoph, Brenk-Franz, Katja, Kausche, Stephan, Jakobi, Ursula, Bindara-Klippel, Anne, Schneider, Nico, Freytag, Antje, Davydow, Dimitry, Wensing, Michel, Brunkhorst, Frank Martin, Gensichen, Jochen
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 11-07-2014 BioMed Central
Subjects:	Ambulatory Care Case studies Clinical Protocols Humans Medical research Medicine, Experimental Outcome Assessment (Health Care) Primary Health Care Prospective Studies Quality of Life Sepsis - mortality Sepsis - psychology Study Protocol Survivors Germany
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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. 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. 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. U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 ObjectType-Feature-2
ISSN:	1745-6215 1745-6215
DOI:	10.1186/1745-6215-15-283