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临床试验/NCT03865602
NCT03865602已完成不适用

Improving Morbidity During Post-Acute Care Transitions for Sepsis (IMPACTS): A Pragmatic Randomized Evaluation of Implementing Best Practice Care for Sepsis Survivors to Reduce Morbidity and Mortality

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 712 人开始时间: 2019年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
712
试验地点
2
主要终点
Combined all-cause mortality or unplanned hospital readmission

研究概览

简要总结

The purpose of this study is to improve transitions of care for the highest risk, complex patients with suspected sepsis. Atrium Health has developed a nurse-navigator facilitated care transition strategy, called the Sepsis Transition and Recovery (STAR) program, to improve the implementation of recommended care practices and bridge care gaps for patients in the post-sepsis transition period. During their hospitalization, STAR program patients enter into a transition pathway facilitated by a centrally located nurse navigator and including the following evidence-based post-sepsis care components: i) review and recommendation for adjustment of medications; ii) identification of and referral for new physical, mental, and cognitive deficits; iii) surveillance for treatable conditions that commonly lead to poor outcomes; and iv) referral to palliative care when appropriate. IMPACTS (Improving Morbidity during Post-Acute Care Transitions for Sepsis) is a pragmatic, randomized program evaluation to compare clinical outcomes between sepsis survivors who receive usual care versus care delivered through the STAR program following hospitalization. IMPACTS will test the hypothesis that patients that receive care through STAR will have decreased composite all cause, 30-day hospital readmission and mortality compared to patients that receive usual care.

详细描述

BACKGROUND

Sepsis is a common and life-threatening condition defined by organ dysfunction due to a dysregulated response to infection (Fleischmann, 2016). Aggressive early sepsis identification and treatment initiatives have decreased hospital mortality for patients with sepsis (Rhodes, 2017). As mortality rates have improved, there has been a growing recognition of the downstream effects of sepsis for the approximately 14 million annual sepsis survivors who encounter increased long-term mortality and morbidity across functional, cognitive, and psychological domains (Iwashyna, 2010; Shah, 2013; Schuler, 2018; Borges, 2015; Annane, 2015; Prescott, 2015). Currently, there is a disconnect between the post-acute care needs of sepsis survivors and the resources available to these patients (Huang, 2016; Ortego, 2015; Winters, 2010; Nesseler, 2013). Inadequate post-sepsis care strategies are reflected by adverse outcomes post-sepsis including increased mortality risk and strikingly high rates of healthcare utilization, including a 90-day hospital readmission rate of 40% and over 3 billion dollars in preventable costs (Prescott, 2016; Goodwin, 2015; Prescott, 2014; Jones, 2015). To address the specific gaps in treatment for sepsis survivors, international experts developed best-practice recommendations to guide delivery of post-sepsis care (Prescott, 2018). These best-practice recommendations are directed towards the specific challenges and sequelae following a sepsis hospitalization and include: i) identification and treatment of new physical, mental, and cognitive deficits; ii) review and adjustment of medications; iii) surveillance of treatable conditions that commonly lead to poor outcomes; and iv) focus on palliative care when appropriate. However, implementation of recommended post-sepsis practices is hindered by a gap in understanding how to best integrate interventions into the complex and fragmented post discharge setting (e.g., lack of provider time and patient engagement, limited access to care management, and insufficient institutional support) (Taylor, 2019; Brownson, 2012; Bodenheimer, 2008; Coleman, 2004).

RATIONALE

In randomized controlled trials (RCTs), including our previous work, successfully implemented care transition programs using nurse navigators have been shown to reduce hospital readmissions and costs. To better enhance transitions of care for the highest risk, complex patients with suspected sepsis, we propose extending this evidence using a nurse-facilitated care transition program for patients in the post-sepsis transition period to improve the implementation of recommended care practices and bridge care gaps. This approach, called the Sepsis Transition and Recovery (STAR) program, is the next step in the progression of our group's work on improving discharge transitions and sepsis processes of care. A key aspect of this initiative includes the ability to identify sepsis survivors at the greatest risk for poor outcomes. For example, one-quarter of sepsis survivors account for three-quarters of hospital readmissions and costs, indicating that identifying high-risk sepsis patients for targeted facilitation of best-practice care could efficiently impact quality and cost.

Our STAR program uses near real-time risk modeling to identify high-risk patients and a centrally located nurse, virtually connected to participating hospitals, to coordinate the application of evidence-based recommendations for post-sepsis care, overcome barriers to recommended care, and bridge gaps in service that can serve as points of failure for complex patients. During their hospitalization, high-risk patients enter into a transition pathway integrated within Atrium Health Hospital Medicine's Transition Services program and includes the following core components: i) Introduction to STAR process prior to discharge (confirm provider consults e.g., PT, ID, palliative); ii) Disease-specific education and discharge "playbook"; iii) Virtual hospital follow-up evaluation within 48 hours including medication reconciliation; iv) Second, post-acute virtual follow-up within 72 hours (symptom monitoring, confirm provider follow-up); v) Weekly contact with care management team; vi) Referral to provider follow-up (e.g., primary care provider, transition clinic) as appropriate; vii) Coordinated transition to the next appropriate care location after 30 days from time of discharge. The STAR navigator also meets weekly with the Medical Director of the Atrium Health Transition Services program who provides additional clinical oversight of ongoing cases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted from the emergency department to inpatient or observation status at one of: Carolinas Medical Center, Carolinas Medical Center - Mercy, or Atrium Health Northeast;
  • ≥18 years of age upon admission;
  • oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation and
  • culture drawn first, antibiotics ordered within 48 hours or
  • antibiotics ordered first, culture ordered within 48 hours (adapted from criteria applied in development of the Third International Consensus Definitions for Sepsis and Septic Shock)
  • deemed as high-risk for 30-day readmission (i.e., ≥ 20%) or 30-day mortality (i.e., ≥ 10%) using risk-scoring models
  • not discharged at the time of patient list generation

排除标准

  • prior randomization to either STAR or usual care study arms;
  • not a North Carolina resident or residence >2.5-hour drive time from treating hospital;
  • the only antibiotic associated with patient is administered in the operating room as this likely represents pre-operative infection prophylaxis and not presumed infection;
  • patients transferred from other acute care hospitals;
  • patients with a change in code status (i.e., do not resuscitate, do not intubate) within 24 hours after admission due to the general assumption of increased risk of exposure to less aggressive treatment;
  • patients with infection ruled out during the index hospitalization.

结局指标

主要结局

Combined all-cause mortality or unplanned hospital readmission

时间窗: 30 days from index visit

Hospital readmission will be captured from healthcare utilization data in the Atrium Health enterprise data warehouse. Index visit is defined by the Centers for Medicaid and Medicare Services (CMS) with additional inclusion of observation patients at any Atrium Health facility. Vital status verification data is ascertained via monthly Social Security Administration Limited Access Death Master File (DMF) data feed and validated record linkage process into the Atrium Health data warehouse. For the composite primary outcome, we will capture all patients with either date of death or eligible hospital readmission prior to 30 days post discharge as event-positive.

次要结局

  • Acute care costs(90 days from index visit)
  • All-cause mortality(90 days from index visit)
  • Acute kidney injury-related unplanned hospital readmission(90 days from index visit)
  • All-cause emergency department visits(90 days from index visit)
  • Total healthcare costs(90 days from index visit)
  • Acute care-free days alive(90 days from index visit)
  • All-cause unplanned hospital readmission(90 days from index visit)
  • Infection-related unplanned hospital readmission(90 days from index visit)
  • Chronic lung disease-related unplanned hospital readmission(90 days from index visit)
  • Heart failure-related unplanned hospital readmission(90 days from index visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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