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

ABSTRACT: 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.

SUBMITTER: Schmidt K

PROVIDER: S-EPMC5122319 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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

Schmidt Konrad K Worrack Susanne S Von Korff Michael M Davydow Dimitry D Brunkhorst Frank F Ehlert Ulrike U Pausch Christine C Mehlhorn Juliane J Schneider Nico N Scherag André A Freytag Antje A Reinhart Konrad K Wensing Michel M Gensichen Jochen J

JAMA 20160601 24

<h4>Importance</h4>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.<h4>Objective</h4>To examine if a primary care-based intervention improves mental health-related quality of life.<h4>Design, setting, and participants</h4>Randomized clinical trial conducted between February 2011 and December 2014, enrolling 291 patients 18 years or olde ...[more]

PMID: 27367877

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Project description:OBJECTIVES:Mortality from pediatric sepsis has steadily declined over the past several decades; however, little is known about morbidity among survivors. We aimed to determine the prevalence of and risk factors for failure to recover to baseline health-related quality of life following community-acquired pediatric sepsis. DESIGN:Retrospective cohort study. SETTING:Seattle Children's Hospital. PATIENTS:Children aged 1 month to 21 years admitted to the inpatient wards or ICUs from 2012 to 2015 who met 2005 consensus sepsis criteria within 4 hours of hospitalization and were enrolled in the hospital's Outcomes Assessment Program with baseline, admission, and post-discharge health-related quality of life data available. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:We assessed health-related quality of life with the Pediatric Quality of Life Inventory for pre-admission baseline, admission, and post-discharge (median, 31 d) status. We determined associations between patient and illness characteristics with failure to recover within 4.5 points of baseline at follow-up (the minimum clinically significant difference between two scores). Of 790 patients, 23.8% failed to recover to baseline health-related quality of life at follow-up. Factors associated with failure to recover were septic shock, older age, private insurance, complex chronic disease, immune compromise, CNS infection or bacteremia, ICU admission, and longer length of stay. On multivariable analysis controlling for time to follow-up, failure to recover was independently associated with septic shock (relative risk, 1.79; 95% CI, 1.24-2.58), older age (relative risk, 1.02/yr; 95% CI, 1.01-1.05), immune compromise (relative risk, 1.83; 95% CI, 1.40-2.40), and length of stay (relative risk, 1.03/d; 95% CI, 1.01-1.04). CONCLUSIONS:Nearly one-quarter of children surviving hospitalization for community-acquired sepsis experienced a clinically significant deterioration in health-related quality of life. We identify risk factors for poor outcomes following sepsis and highlight the need for ongoing evaluation and treatment by primary and specialty care providers for pediatric sepsis survivors after hospital discharge.

Project description:BACKGROUND:Due to the rise in incidence, the long term effect of sepsis are becoming more evident. There is increasing evidence that sepsis may result in an impaired health related quality of life. The aim of this study was to investigate whether health related quality of life is impaired in sepsis survivors and which clinical parameters are associated with the affected health related quality of life. METHODS:We analyzed 880 Short Form 36 (SF-36) questionnaires that were sent to sepsis survivors who participated in the Prehospital Antibiotics Against Sepsis (PHANTASi) trial. These questionnaires were sent by email, 28 days after discharge. Data entry and statistical analyses were performed in SPSS. The data from the general Dutch population, was obtained from the Netherlands Cancer Institute (NKI-AVL) and served as a control group. Subsequently, 567 sepsis survivors were matched to 567 controls. Non-parametric Wilcoxon signed-rank test was performed to compare these two groups. Within the group, we sought to explain the diminished health related quality of life by factor analysis. RESULTS:We found that sepsis survivors have a worse health related quality of life compared to the general Dutch population. This negative effect was more evident for the physical component than the mental component of health related quality of life. We found that health related quality of life was significantly altered by advancing age and female sex. We also found that the total length of stay (in the hospital) and (previous) comorbidity negatively affect the physical component of health related quality of life. CONCLUSION:In our study we found that health related quality of life in sepsis survivors, 28 days after discharge, is severely diminished in comparison with the general Dutch population. The physical domain is severely affected, whereas the mental domain is less influenced. The length of stay, comorbidity, advancing age and female sex all have a negative effect on the Physical Component Scale of the health related quality of life.

Project description:OBJECTIVES:To identify a generic set of face valid quality indicators for primary care mental health services which reflect a multi-stakeholder perspective and can be used for facilitating quality improvement. DESIGN:Modified two-round postal Delphi questionnaire. SETTING:Geographical spread across Great Britain. PARTICIPANTS:One hundred and fifteen panellists representing 11 different stakeholder groups within primary care mental health services (clinical psychologist, health and social care commissioner, community psychiatric nurse, counsellor, general practitioner, practice nurse/district nurse/health visitor, psychiatrist, social worker, carer, patient and voluntary organisations). MAIN OUTCOME MEASURES:Face validity (median rating of 8 or 9 on a nine point scale with agreement by all panels) for assessing quality of care. RESULTS:A maximum of 334 indicators were rated by panels in the second round; 26% were rated valid by all panels. These indicators were categorised into 21 aspects of care, 11 relating to general practices and 10 relating to health authorities or primary care groups/trusts. There was variation in the total number of indicators rated valid across the different panels. Overall, GPs rated the lowest number of indicators as valid (41%, n=138) and carers rated the highest number valid (91%, n=304). CONCLUSIONS:The quality indicators represent consensus among key stakeholder groups in defining quality of care within primary care mental health services. These indicators could provide a guide for primary care organisations embarking on quality improvement initiatives in mental health care when addressing national targets and standards relating to primary care set out in the National Service Framework for Mental Health for England. Although many of the indicators relate to parochial issues in UK service delivery, the methodology used in the development of the indicators could be applied in other settings to produce locally relevant indicators.

Project description:BackgroundAs a major public health issue in China and worldwide, late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Like other chronic diseases in elders such as hypertension and diabetes, depression is a chronic disease that the new National Health Policy of China indicates should be managed in primary care settings. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management (DCM) intervention, and examine its effectiveness on the depressive symptoms of older patients in Chinese primary care settings.Methods/designThe trial is a multi-site, primary clinic based randomized controlled trial design in Hangzhou, China. Sixteen primary care clinics will be enrolled in and randomly assigned to deliver either DCM or care as usual (CAU) (8 clinics each) to 320 patients (aged ≥ 60 years) with major depression (20/clinic; n = 160 in each treatment condition). In the DCM arm, primary care physicians (PCPs) will prescribe 16 weeks of antidepressant medication according to the treatment guideline protocol. Care managers monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. Depressive symptoms, functional status, treatment stigma and clients' satisfaction will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.DiscussionThis will be the first trial of the effectiveness of a collaborative care intervention aiming to the management of late-life depression in China primary care. If effective, its finding will have relevance to policy makers who wish to scale up DCM treatments for late-life depression in national wide primary care across China.Study registrationThe DCM project is registered through the National Institutes of Health sponsored by clinical trials registry and has been assigned the identifier: NCT01287494.

Project description:OBJECTIVES:To describe the quality of life among sepsis survivors. DESIGN:Secondary analyses of two international, randomized clinical trials (A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis [derivation cohort] and PROWESS-SHOCK [validation cohort]). SETTING:ICUs in North and South America, Europe, Africa, Asia, and Australia. PATIENTS:Adults with severe sepsis. We analyzed only patients who were functional and living at home without help before sepsis hospitalization (n = 1,143 and 987 from A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis and PROWESS-SHOCK, respectively). INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:In A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis and PROWESS-SHOCK, the average age of patients living at home independently was 63 and 61 years; 400 (34.9%) and 298 (30.2%) died by 6 months. In A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis, 580 patients had a quality of life measured using EQ-5D at 6 months. Of these, 41.6% could not live independently (22.7% were home but required help, 5.1% were in nursing home or rehabilitation facilities, and 5.3% were in acute care hospitals). Poor quality of life at 6 months, as evidenced by problems in mobility, usual activities, and self-care domains were reported in 37.4%, 43.7%, and 20.5%, respectively, and the high incidence of poor quality of life was also seen in patients in PROWESS-SHOCK. Over 45% of patients with mobility and self-care problems at 6 months in A Controlled Comparison of Eritoran and placebo in patients with Severe Sepsis died or reported persistent problems at 1 year. CONCLUSIONS:Among individuals enrolled in a clinical trial who lived independently prior to severe sepsis, one third had died and of those who survived, a further one third had not returned to independent living by 6 months. Both mortality and quality of life should be considered when designing new interventions and considering endpoints for sepsis trials.

Dataset Information

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

Publications

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

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