Effect of a primary care management intervention on mental-health-related quality of life among survivors of sepsis: a randomized clinical trial
Importance: Sepsis survivors face long-term sequelae which diminish health-related quality of life (HRQoL) and result in increased care needs in the primary care setting as medication, physiotherapy or mental health care. Objective: To examine if a primary care-based intervention improves mental HRQ...
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| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2016 December 28
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| In: |
The journal of the American Medical Association
Year: 2016, Jahrgang: 315, Heft: 24, Pages: 2703-2711 |
| ISSN: | 1538-3598 |
| DOI: | 10.1001/jama.2016.7207 |
| Online-Zugang: | Verlag, Volltext: http://dx.doi.org/10.1001/jama.2016.7207 Verlag, Volltext: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5122319/ 
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| Verfasserangaben: | Konrad Schmidt MD, Susanne Worrack MSc, Michael Von Korff ScD, Dimitry Davydow MD, MPH, Frank Brunkhorst MD, Ulrike Ehlert PhD, Christine Pausch PhD, Juliane Mehlhorn MD, Nico Schneider MSc, André Scherag MSc, PhD, Antje Freytag ScD, Konrad Reinhart MD, Michel Wensing PhD, Jochen Gensichen MD, MSc, MPH, and for the SMOOTH Study Group Institute |
MARC
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| 245 | 1 | 0 | |a Effect of a primary care management intervention on mental-health-related quality of life among survivors of sepsis |b a randomized clinical trial |c Konrad Schmidt MD, Susanne Worrack MSc, Michael Von Korff ScD, Dimitry Davydow MD, MPH, Frank Brunkhorst MD, Ulrike Ehlert PhD, Christine Pausch PhD, Juliane Mehlhorn MD, Nico Schneider MSc, André Scherag MSc, PhD, Antje Freytag ScD, Konrad Reinhart MD, Michel Wensing PhD, Jochen Gensichen MD, MSc, MPH, and for the SMOOTH Study Group Institute |
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| 520 | |a Importance: Sepsis survivors face long-term sequelae which diminish health-related quality of life (HRQoL) and result in increased care needs in the primary care setting as medication, physiotherapy or mental health care. Objective: To examine if a primary care-based intervention improves mental HRQoL. Design, Setting and Participants: A randomized clinical trial was conducted between February 2011 and December 2014. 291 patients ≥18 years who survived sepsis (including septic shock) were recruited from nine intensive care units (ICU) across Germany. Intervention: 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 and/or other treatment. The intervention additionally included PCP and patient training, case management provided by trained nurses and clinical decision support for PCPs by consulting physicians. Main outcome: The primary outcome was change in mental HRQoL between ICU discharge and six months post-ICU using the Mental Component Summary (MCS) of the Short-Form Health Survey 36 (SF-36; range 0-100; higher ratings indicating lower impairment, minimal clinically important difference five score points). Results: The mean age of the 291 patients was 61.6 years (SD 14.4), 66.2% (n=192) were male, and 84.4% (n=244) required mechanical ventilation during their ICU stay (median 12 days, range 0-134). At six and 12 months post-ICU, 75.3% (n=219, 112 intervention, 107 control) and 69.4% (n=202, 107 intervention, 95 control) completed follow-up, respectively. Overall mortality was 13.7% at six months (40 deaths, 21 intervention, 19 control) and 18.2% at 12 months (53 deaths, 27 intervention, 26 control). Among intervention group patients, 104 (70.3%) received the intervention at high levels of integrity. There was neither a significant difference in change of MCS scores (intervention group baseline, mean=49.1, six months=52.9, change=3.79 score points (95%CI 1.05; 6.54) vs. control group baseline, mean =49.3, six months=51.0, change=1.64 score points (95%CI -1.22; 4.51) mean treatment effect=2.15 (95%CI -1.79; 6.09); p=0.28), nor in PCP care delivered between both groups. Conclusions and relevance: Among sepsis survivors, a primary-care-focused team-based intervention did not improve mental HRQoL or impact PCP care compared with usual care. Trial Registration: ISRCTN registry; http://www.isrctn.com/ISRCTN61744782 | ||
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