Effect of a Primary Care Management Intervention on Mental Health–Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial
Open accessAbstract
IMPORTANCE: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOMES AND MEASURES: 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 AND RELEVANCE: 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. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN61744782.
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We identified six RCTs that evaluated educational interventions for critically ill patients and their families.
“We identified six RCTs that evaluated educational interventions for critically ill patients and their families (583-588).”
From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [585]
The incidence of DVT acquired in the ICU may be as high as 10%, and the incidence of acquired PE may be 2%-4%.
“The incidence of DVT acquired in the ICU may be as high as 10% (497), the incidence of acquired PE may be 2%-4% (498, 499).”
From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [499]
The Methods (Study design and population; page unavailable) describe a trial of primary care management for sepsis survivors, and the Results (Secondary outcomes; page unavailable) report follow-up outcomes rather than ICU-acquired thrombosis. Searches for ICU-acquired DVT and PE incidence found no passage supporting the 10% or 2%–4% figures. (LLM, conf=0.76)
Experimental — accuracy not yet measuredICU education did not appear to impact patients' anxiety and depression but did improve families' satisfaction with care.
“ICU education did not appear to impact patients’ anxiety and depression [584, 586, 588], but did improve families’ satisfaction with care [583].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [588]
Only one of the six RCTs specifically studied patients with sepsis, evaluating a complex intervention including education, primary care follow-up, and post-discharge monitoring.
“Only one specifically studied patients with sepsis [588], evaluating a complex intervention, which included education along with primary care follow-up and post-discharge monitoring.”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [588]
Six RCTs evaluated educational interventions for critically ill patients and their families.
“We identified six RCTs that evaluated educational interventions for critically ill patients and their families [583–588].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [588]
Few randomised studies have assessed post-critical illness clinics, and meta-analysis found no differences from usual care in mortality, quality of life, physical function, or cognition, with possible small improvements in psychological symptoms.
“Few randomised studies have assessed post-critical illness clinics [588, 628, 638, 639], and—consistent with a recent Cochrane review [640]—our meta-analysis found no differences from usual care in terms of mortality, QoL, physical function, or cognition, with possible small improvements in psychological symptoms (anxiety, depression, PTSD).”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [588]
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- Authors
- Schmidt, K., Worrack, S., Von Korff, M., Davydow, D., Brunkhorst, F., Ehlert, U., Pausch, C., Mehlhorn, J., Schneider, N., Scherag, A., Freytag, A., Reinhart, K., Wensing, M., Gensichen, J., & for the SMOOTH Study Group
- Affiliations
- Jena University Hospital (DE)
- Group Health Research Institute, Group Health Cooperative, Seattle, Washington
- University of Washington (US)
- University of Zurich (CH)
- Heidelberg University (DE)
- Corresponding author
- Gensichen, Jochen
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2016-06-28
- Volume
- 315
- Issue
- 24
- Pages
- 2703
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5122319
- OpenAlex
- W2472420050
- Semantic Scholar
- 9f4e26fd4b9ac677a1fc329bac87dd35cda72fb5
- Cited by
- 179
- References
- 63
- Citations by year
- 2026: 15 · 2025: 21 · 2024: 20 · 2023: 19 · 2022: 13 · 2021: 18 · 2020: 18 · 2019: 22 · 2018: 15 · 2017: 14 · 2016: 4
- FWCI
- 17.16
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- PubMed Central (acceptedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- National Institutes of Health (KL2TR000421, KL2TR002317)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Intensive Care Unit Cognitive Disorders
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- sepsis survivors, septic shock, mental health-related quality of life, primary care intervention, case management, clinical decision support, patient training, post-intensive care syndrome, intensive care unit discharge, SF-36 mental component summary, mortality, anxiety, post-traumatic stress disorder
- MeSH terms
- Adult, Aged, Female, Humans, Intensive Care Units, Male, Mental Health, Middle Aged, Patient Discharge, Primary Health Care, Quality of Life, Referral and Consultation, Survivors, Sepsis, Case Management, Decision Support Systems, Clinical, Physicians, Primary Care
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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