title: Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Bachstrasse 18, 07743 Jena, Germany. Konrad.Schmidt@med.uni-jena.de.
authors.forename: Konrad
authors.initials: K
authors.lastname: Schmidt
authors.forename: Paul
authors.initials: P
authors.lastname: Thiel
authors.forename: Friederike
authors.initials: F
authors.lastname: Mueller
authors.forename: Katja
authors.initials: K
authors.lastname: Schmuecker
authors.forename: Susanne
authors.initials: S
authors.lastname: Worrack
authors.forename: Juliane
authors.initials: J
authors.lastname: Mehlhorn
authors.forename: Christoph
authors.initials: C
authors.lastname: Engel
authors.forename: Katja
authors.initials: K
authors.lastname: Brenk-Franz
authors.forename: Stephan
authors.initials: S
authors.lastname: Kausche
authors.forename: Ursula
authors.initials: U
authors.lastname: Jakobi
authors.forename: Anne
authors.initials: A
authors.lastname: Bindara-Klippel
authors.forename: Nico
authors.initials: N
authors.lastname: Schneider
authors.forename: Antje
authors.initials: A
authors.lastname: Freytag
authors.forename: Dimitry
authors.initials: D
authors.lastname: Davydow
authors.forename: Michel
authors.initials: M
authors.lastname: Wensing
authors.forename: Frank Martin
authors.initials: FM
authors.lastname: Brunkhorst
authors.forename: Jochen
authors.initials: J
authors.lastname: Gensichen
mesh_terms: D000553:Ambulatory Care; D002985:Clinical Protocols; D006801:Humans; D017063:Outcome Assessment, Health Care; D011320:Primary Health Care; D011446:Prospective Studies; D011788:Quality of Life; D018805:Sepsis / Q000401:mortality* / Q000523:psychology; D017741:Survivors