title: Effect of a Primary Care Management Intervention on Mental Health-Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Survivors of sepsis face long-term sequelae that diminish health-related quality of life and result in increased care needs in the primary care setting, such as medication, physiotherapy, or mental health care.
  
  
  OBJECTIVE
  To examine if a primary care-based intervention improves mental health-related quality of life.
  
  
  METHODS
  Randomized clinical trial conducted between February 2011 and December 2014, enrolling 291 patients 18 years or older who survived sepsis (including septic shock), recruited from 9 intensive care units (ICUs) across Germany.
  
  
  METHODS
  Participants were randomized to usual care (n = 143) or to a 12-month intervention (n = 148). Usual care was provided by their primary care physician (PCP) and included periodic contacts, referrals to specialists, and prescription of medication, other treatment, or both. The intervention additionally included PCP and patient training, case management provided by trained nurses, and clinical decision support for PCPs by consulting physicians.
  
  
  METHODS
  The primary outcome was change in mental health-related quality of life between ICU discharge and 6 months after ICU discharge using the Mental Component Summary (MCS) of the 36-Item Short-Form Health Survey (SF-36 [range, 0-100; higher ratings indicate lower impairment; minimal clinically important difference, 5 score points]).
  
  
  RESULTS
  The mean age of the 291 patients was 61.6 years (SD, 14.4); 66.2% (n = 192) were men, and 84.4% (n = 244) required mechanical ventilation during their ICU stay (median duration of ventilation, 12 days [range, 0-134]). At 6 and 12 months after ICU discharge, 75.3% (n = 219 [112 intervention, 107 control]) and 69.4% (n = 202 [107 intervention, 95 control]), respectively, completed follow-up. Overall mortality was 13.7% at 6 months (40 deaths [21 intervention, 19 control]) and 18.2% at 12 months (53 deaths [27 intervention, 26 control]). Among patients in the intervention group, 104 (70.3%) received the intervention at high levels of integrity. There was no significant difference in change of mean MCS scores (intervention group mean at baseline, 49.1; at 6 months, 52.9; change, 3.79 score points [95% CI, 1.05 to 6.54] vs control group mean at baseline, 49.3; at 6 months, 51.0; change, 1.64 score points [95% CI, -1.22 to 4.51]; mean treatment effect, 2.15 [95% CI, -1.79 to 6.09]; P = .28).
  
  
  CONCLUSIONS
  Among survivors of sepsis and septic shock, the use of a primary care-focused team-based intervention, compared with usual care, did not improve mental health-related quality of life 6 months after ICU discharge. Further research is needed to determine if modified approaches to primary care management may be more effective.
  
  
  BACKGROUND
  isrctn.org Identifier: ISRCTN61744782.
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany2Center of Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany.
authors.forename: Konrad
authors.initials: K
authors.lastname: Schmidt
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany2Center of Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Worrack
authors.affiliation: Group Health Research Institute, Group Health Cooperative, Seattle, Washington.
authors.forename: Michael
authors.initials: M
authors.lastname: Von Korff
authors.affiliation: Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.
authors.forename: Dimitry
authors.initials: D
authors.lastname: Davydow
authors.affiliation: Center of Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany5Center of Clinical Studies, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Brunkhorst
authors.affiliation: Department of Psychology, University of Zuerich, Zuerich, Switzerland.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Ehlert
authors.affiliation: Center of Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany7Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Pausch
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany.
authors.forename: Juliane
authors.initials: J
authors.lastname: Mehlhorn
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany.
authors.forename: Nico
authors.initials: N
authors.lastname: Schneider
authors.affiliation: Center of Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany.
authors.forename: André
authors.initials: A
authors.lastname: Scherag
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany.
authors.forename: Antje
authors.initials: A
authors.lastname: Freytag
authors.affiliation: Center of Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany8Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.
authors.forename: Konrad
authors.initials: K
authors.lastname: Reinhart
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany9Department of General Practice and Health Services, University of Heidelberg Hospital, Heidelberg, Germany.
authors.forename: Michel
authors.initials: M
authors.lastname: Wensing
authors.affiliation: Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany2Center of Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Gensichen
mesh_terms: D000328:Adult; D000368:Aged; D019090:Case Management; D020000:Decision Support Systems, Clinical; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D010351:Patient Discharge; D058007:Physicians, Primary Care; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D012017:Referral and Consultation; D018805:Sepsis / Q000523:psychology* / Q000534:rehabilitation; D017741:Survivors