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

Abstract

BackgroundSepsis 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/DesignIn 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.DiscussionThis 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 registrationU1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).

Ambulatory and stationary healthcare use in survivors of ARDS during the first year after discharge from ICU: findings from the DACAPO cohort

“…Overall, the median number of outpatient visits during the first year after discharge from ICU was 15, with a high variability between participants (IQR [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]. The median number of outpatient visits to a general practitioner was 7 (IQR 4-12), and the median number for visits to physicians from any other specialty was 8 (IQR [4][5][6][7][8][9][10][11][12][13][14].…”

“…The SMOOTH study included 291 survivors of sepsis and investigated the effects of a primary-care-based intervention [23]. A variety of secondary outcomes were assessed, among others measures of healthcare utilization.…”

Effect of a Primary Care Management Intervention on Mental Health–Related Quality of Life Among Survivors of Sepsis

“…Initially, the MCS as well as the Physical Component Summary score (PCS) of the SF-36 were chosen for primary outcome to provide a multicomponent score reflecting HRQoL (as noted in the study protocol 13 and the ISRCTN registration). However, based on review of the literature 12 highlighting the importance of mental health outcomes in post-ICU care, the primary outcome was specified to the MCS.…”

“…The purpose of this randomized clinical trial was to assess whether a primary care-based intervention 13 would improve mental-health-related quality of life among survivors of sepsis compared with usual care.…”

From self-awareness to self-actualization: empowering sepsis survivors to a meaningful and enduring recovery

“…The intervention involved three components: (I) discharge management with structured information between the inpatient and outpatient providers; (II) training patients and primary care physicians in sepsis sequelae and selfmonitoring of PICS-related symptoms and functional abilities, nutrition, sleep habits, and pain; and (III) telephone monitoring of patients for 12 months (11)…”