Effect of a Primary Care Management Intervention on Mental Health-Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial.

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.

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

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).

Rehabilitation interventions for postintensive care syndrome: a systematic review.

OBJECTIVE: An increasing number of ICU patients survive and develop mental, cognitive, or physical impairments. Various interventions support recovery from this postintensive care syndrome. Physicians in charge of post-ICU patients need to know which interventions are effective. DATA SOURCES: Systematic literature search in databases (MEDLINE, EMBASE, Cochrane CENTRAL, PsycInfo, CINAHL; 1991-2012), reference lists, and hand search. STUDY SELECTION: We included comparative studies of rehabilitation interventions in adult post-ICU patients if they considered health-related quality of life, frequency/severity of postintensive care syndrome symptoms, functional recovery, need for care, autonomy in activities of daily living, mortality, or hospital readmissions. DATA EXTRACTION: Two reviewers extracted data and assessed risk of bias independently. DATA SYNTHESIS: From 4,761 publications, 18 studies with 2,510 patients were included. Studies addressed 20 outcomes, using 45 measures, covering inpatient (n = 4 trials), outpatient (n = 9), and mixed (n = 5) healthcare settings. Eight controlled trials with moderate to high quality were considered for evaluation of effectiveness. They investigated inpatient geriatric rehabilitation, ICU follow-up clinic, outpatient rehabilitation, disease management, and ICU diaries. Five of these trials assessed posttraumatic stress disorder, with four trials showing positive effects: first, ICU diaries reduced new-onset posttraumatic stress disorder (5% vs 13%, p = 0.02) after 3 months and second showed a lower mean Impact of Event Scale-Revised score (21.0 vs 32.1, p = 0.03) after 12 months. Third, aftercare by ICU follow-up clinic reduced Impact of Event Scale for women (20 vs 31; p < 0.01). Fourth, a self-help manual led to fewer patients scoring high in the Impact of Event Scale after 8 weeks (p = 0.026) but not after 6 months. For none of the other outcomes did more than one study report positive impacts. CONCLUSION: Interventions which have substantial effects in post-ICU patients are rare. Positive effects were seen for ICU-diary interventions for posttraumatic stress disorder. More interventions for the growing number of ICU survivors are needed.