Long-Term Courses of Sepsis Survivors: Effects of a Primary Care Management Intervention.

BACKGROUND: Sepsis survivors face mental and physical sequelae even years after discharge from the intensive care unit. The aim of this study was to evaluate the long-term courses of sepsis survivors and the effects of a primary care management intervention in sepsis aftercare. METHODS: This study presents a 24-month follow-up of a randomized controlled trial that recruited 291 patients who survived sepsis (including septic shock) from nine German intensive care units. Participants were randomized to usual care (n=143) or to a 12-month-intervention (n=148). The intervention included training of patients and their primary care physicians (PCP) in evidence-based post-sepsis care, case management provided by trained nurses, and clinical decision support for PCPs by consulting physicians. Usual care was provided by PCPs in the control group. At the 24-month follow-up, 12 months after the 1-year-intervention, survival and measures of mental and physical health were collected by telephone interviews. RESULTS: One hundred eighty-six (63.9%, 98 intervention, 88 control) of 291 patients completed the 24-month follow-up, showing both increased mortality and recovery from functional impairment. Unlike the intervention group, the control group showed a significant increase of posttraumatic stress symptoms according to the Posttraumatic Symptom Scale (difference between baseline and 24-months follow-up values, mean [standard deviation] 3.7 [11.8] control vs -0.7 [12.1] intervention; P = .016). There were no significant differences in all other outcomes between the intervention and control groups. CONCLUSIONS: Twelve months after completion, a primary care management intervention among survivors of sepsis did not improve mental health-related quality of life. Patients in the intervention group showed less posttraumatic stress symptoms.

Quantification of nonverbal synchrony using linear time series analysis methods: Lack of convergent validity and evidence for facets of synchrony.

Nonverbal synchrony describes coordination of the nonverbal behavior of two interacting partners. Additionally, it seems to be important in human interactions, such as during psychotherapy. Currently, there are several options for the automated determination of synchrony based on linear time series analysis methods (TSAMs). However, investigations into whether the different methods measure the same construct have been missing. In this study, N = 84 patient-therapist dyads were videotaped during psychotherapy sessions. Motion energy analysis was used to assess body movements. We applied seven different TSAMs and recorded multiple output scores (average synchrony, maximum synchrony, and frequency of synchrony; in total, N = 16 scores). Convergent validity was examined using correlations of the output scores and exploratory factor analysis. Additionally, two criterion-based validations were conducted: investigations of concordant validity with a more generalized nonlinear method, and of the predictive validity of the synchrony scores for improvement in interpersonal problems at the end of therapy. We found that the synchrony measures only partially correlated with each other. The factor analysis did not support a common-factor model. A three-factor model with a second-order synchrony variable showed the best fit for eight of the selected synchrony scores. Only some synchrony scores were able to predict improvement at the end of therapy. We concluded that the considered TSAMs do not measure the same synchrony construct, but different facets of synchrony: the strength of synchrony of the total interaction, the strength of synchrony during synchronization intervals, and the frequency of synchrony.

[Restricted sleep as a secondary psychosocial consequence of facial palsy]. / Eingeschränkte Schlafqualität als indirekte psychosoziale Folge einer Fazialisparese.

BACKGROUND: Facial palsy (FP) is a paralysis of facial muscles and one of the most common motor failures. It is associated with intense impairment of health related quality of life and depressive symptoms. Sleep disorders as a result of FP are often attributed to illness-related impairments, although psychosocial problems might also be the cause. This study examined the direct and indirect effects of FP on sleep quality. METHODS: The sample of this cross-sectional study included N = 81 patients with FP. Symptoms of FP (FACE), sleep quality (PSQI), quality of life (SF36), depression (PHQ9) and social anxiety (LSAS) were measured. Mediation models were used to investigate the relationship between symptoms of FP, social anxiety, depression and sleep quality. RESULTS: Sleep quality was decreased in 33.3 % of patients. The subjective severity of the FP correlated significantly with sleep quality. Mediation analyses suggest a causal link between the severity of FP, symptoms of social anxiety, depressive symptoms and restricted sleep quality. However, including social anxiety and depression as mediators resulted in no direct effects of FP on sleep quality. CONCLUSION: Sleep problems related to FP seem to be caused less by physical than by an indirect consequence of psychosocial impairment. The change in the face associated with FP causes psychological problems which in turn lead to reduced sleep quality. The medical care of FP patients should therefore also consider the psychosocial consequences in order to prevent the onset of mental disorders (such as depression) and sleep disorders.

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).