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Patients who have survived sepsis or septic shock do not receive any significant benefit in the quality of their mental health by receiving primary care management intervention, according to a new study published by JAMA.
“Many survivors of sepsis have multiple medical comorbidities that are typically managed in primary care [but] interventions for managing sepsis sequelae in primary care have not been developed,” states the study, which was led by Jochen Gensichen, MD, of the Institute of General Practice & Family Medicine at Jena (Germany) University Hospital.
“To our knowledge, this is the first large-scale, randomized controlled clinical trial of an intervention to improve outcomes in survivors of sepsis in primary care,” Dr. Gensichen and his coinvestigators added.
The study recruited sepsis and septic shock survivors from nine ICUs across Germany between February 2011 and December 2014, excluding any patients with cognitive impairment, defined as a Telephone Interview of Cognitive Status score no greater than 27. Ultimately, 291 patients aged 18 years or older (mean age of 61.6 years) were selected for inclusion and randomized into cohorts receiving either primary care–based intervention (n = 148) or usual care (n = 143) (JAMA. 2016;315:2703-11. doi: 10.1001/jama.2016.7207).
Those assigned to the usual care cohort received the standard care that their primary care providers would normally carry out, which included “periodic contacts, referrals to specialists, and prescription of medication and therapeutic aids at quantities comparable with those for other populations with multiple chronic conditions.” Those in the other cohort were given active monitoring of symptoms from providers who had been given evidence-based care training and clinical decision support from nurses who underwent training to become case managers. Case managers would take patients through an hour-long face-to-face training on sepsis sequelae within 2-20 days of ICU discharge, along with subsequent follow-up conversations over the phone.
“Case managers monitored patients’ symptoms using validated screening tools to assess critical illness polyneuropathy/myopathy, wasting, neurocognitive deficits, [posttraumatic stress disorder], depressive and pain symptoms, as well as patient self-management behaviors focusing on physical activity and individual self-management goals,” the authors said, noting that case managers would report their results to a consulting physician who “supervised the case managers and provided clinical decision support to the [primary care physicians].”
Baseline Mental Component Summary (MCS) scores were taken for subjects in both cohorts to determine mental health-based quality of life, which averaged 49.1 for the intervention cohort and 49.3 for the control. MCS scores at 6 months’ follow-up were 52.9 for the intervention group (95% confidence interval, 1.05-6.54) and 51.0 for the control group (95% CI, –1.22-4.51), for a mean change of 3.8 in the intervention cohort and 1.6 for the control group. The mean treatment effect was 2.15 (95% CI, –1.79-6.09; P = .28), indicating no significant difference between the two.
“There was no evidence for a differential treatment effect on the study’s primary outcome, postsepsis MCS scores,” the authors concluded. “This finding is similar to those from previous trials of care management interventions following critical illness.”
The authors added that “further research is needed to determine if modified approaches to primary care management may be more effective.”
The study was funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from the Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
Patients who have survived sepsis or septic shock do not receive any significant benefit in the quality of their mental health by receiving primary care management intervention, according to a new study published by JAMA.
“Many survivors of sepsis have multiple medical comorbidities that are typically managed in primary care [but] interventions for managing sepsis sequelae in primary care have not been developed,” states the study, which was led by Jochen Gensichen, MD, of the Institute of General Practice & Family Medicine at Jena (Germany) University Hospital.
“To our knowledge, this is the first large-scale, randomized controlled clinical trial of an intervention to improve outcomes in survivors of sepsis in primary care,” Dr. Gensichen and his coinvestigators added.
The study recruited sepsis and septic shock survivors from nine ICUs across Germany between February 2011 and December 2014, excluding any patients with cognitive impairment, defined as a Telephone Interview of Cognitive Status score no greater than 27. Ultimately, 291 patients aged 18 years or older (mean age of 61.6 years) were selected for inclusion and randomized into cohorts receiving either primary care–based intervention (n = 148) or usual care (n = 143) (JAMA. 2016;315:2703-11. doi: 10.1001/jama.2016.7207).
Those assigned to the usual care cohort received the standard care that their primary care providers would normally carry out, which included “periodic contacts, referrals to specialists, and prescription of medication and therapeutic aids at quantities comparable with those for other populations with multiple chronic conditions.” Those in the other cohort were given active monitoring of symptoms from providers who had been given evidence-based care training and clinical decision support from nurses who underwent training to become case managers. Case managers would take patients through an hour-long face-to-face training on sepsis sequelae within 2-20 days of ICU discharge, along with subsequent follow-up conversations over the phone.
“Case managers monitored patients’ symptoms using validated screening tools to assess critical illness polyneuropathy/myopathy, wasting, neurocognitive deficits, [posttraumatic stress disorder], depressive and pain symptoms, as well as patient self-management behaviors focusing on physical activity and individual self-management goals,” the authors said, noting that case managers would report their results to a consulting physician who “supervised the case managers and provided clinical decision support to the [primary care physicians].”
Baseline Mental Component Summary (MCS) scores were taken for subjects in both cohorts to determine mental health-based quality of life, which averaged 49.1 for the intervention cohort and 49.3 for the control. MCS scores at 6 months’ follow-up were 52.9 for the intervention group (95% confidence interval, 1.05-6.54) and 51.0 for the control group (95% CI, –1.22-4.51), for a mean change of 3.8 in the intervention cohort and 1.6 for the control group. The mean treatment effect was 2.15 (95% CI, –1.79-6.09; P = .28), indicating no significant difference between the two.
“There was no evidence for a differential treatment effect on the study’s primary outcome, postsepsis MCS scores,” the authors concluded. “This finding is similar to those from previous trials of care management interventions following critical illness.”
The authors added that “further research is needed to determine if modified approaches to primary care management may be more effective.”
The study was funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from the Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
Patients who have survived sepsis or septic shock do not receive any significant benefit in the quality of their mental health by receiving primary care management intervention, according to a new study published by JAMA.
“Many survivors of sepsis have multiple medical comorbidities that are typically managed in primary care [but] interventions for managing sepsis sequelae in primary care have not been developed,” states the study, which was led by Jochen Gensichen, MD, of the Institute of General Practice & Family Medicine at Jena (Germany) University Hospital.
“To our knowledge, this is the first large-scale, randomized controlled clinical trial of an intervention to improve outcomes in survivors of sepsis in primary care,” Dr. Gensichen and his coinvestigators added.
The study recruited sepsis and septic shock survivors from nine ICUs across Germany between February 2011 and December 2014, excluding any patients with cognitive impairment, defined as a Telephone Interview of Cognitive Status score no greater than 27. Ultimately, 291 patients aged 18 years or older (mean age of 61.6 years) were selected for inclusion and randomized into cohorts receiving either primary care–based intervention (n = 148) or usual care (n = 143) (JAMA. 2016;315:2703-11. doi: 10.1001/jama.2016.7207).
Those assigned to the usual care cohort received the standard care that their primary care providers would normally carry out, which included “periodic contacts, referrals to specialists, and prescription of medication and therapeutic aids at quantities comparable with those for other populations with multiple chronic conditions.” Those in the other cohort were given active monitoring of symptoms from providers who had been given evidence-based care training and clinical decision support from nurses who underwent training to become case managers. Case managers would take patients through an hour-long face-to-face training on sepsis sequelae within 2-20 days of ICU discharge, along with subsequent follow-up conversations over the phone.
“Case managers monitored patients’ symptoms using validated screening tools to assess critical illness polyneuropathy/myopathy, wasting, neurocognitive deficits, [posttraumatic stress disorder], depressive and pain symptoms, as well as patient self-management behaviors focusing on physical activity and individual self-management goals,” the authors said, noting that case managers would report their results to a consulting physician who “supervised the case managers and provided clinical decision support to the [primary care physicians].”
Baseline Mental Component Summary (MCS) scores were taken for subjects in both cohorts to determine mental health-based quality of life, which averaged 49.1 for the intervention cohort and 49.3 for the control. MCS scores at 6 months’ follow-up were 52.9 for the intervention group (95% confidence interval, 1.05-6.54) and 51.0 for the control group (95% CI, –1.22-4.51), for a mean change of 3.8 in the intervention cohort and 1.6 for the control group. The mean treatment effect was 2.15 (95% CI, –1.79-6.09; P = .28), indicating no significant difference between the two.
“There was no evidence for a differential treatment effect on the study’s primary outcome, postsepsis MCS scores,” the authors concluded. “This finding is similar to those from previous trials of care management interventions following critical illness.”
The authors added that “further research is needed to determine if modified approaches to primary care management may be more effective.”
The study was funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from the Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
FROM JAMA
Key clinical point: Primary care intervention does not improve mental health–related quality of life in survivors of sepsis or septic shock.
Major finding: Mean Mental Component Summary (MCS) scores showed no significant change between the time of ICU discharge (49.1) versus at 6 months postdischarge (52.9) (95% CI, 1.05-6.54), compared with the control group: 49.3 at baseline vs. 51.0 at 6 months follow-up (95% CI, –1.22-4.51).
Data source: A multicenter, unblinded, two-group randomized clinical trial of 291 adult sepsis or septic shock survivors recruited from nine German ICUs from February 2011 through December 2014.
Disclosures: Study funded by the Center for Sepsis Control and Care, the German Federal Ministry of Education and Research, and the German Sepsis Society. Dr. Gensichen reported receiving personal fees from The Primary Health Care Foundation and receiving a grant from the German Federal Ministry of Education and Research.
