SCCM Resource Library-43-Effect of a Navigator-Led Transition and Recovery Program on Mortality and Readmission After Sepsis

Video Transcription

Good afternoon. I'm Stephanie Taylor. I'm a physician-scientist at Atrium Health, and today I'm going to present the results of our IMPACTS clinical trial, which is a randomized  clinical trial evaluating the effectiveness of a nurse-navigator-led sepsis transition program. So we'll begin here. Although sepsis mortality has decreased over the past few  decades, the incidence of sepsis continues to be high, and this translates to a huge number of patients who survive the acute sepsis event, but who remain vulnerable to downstream  effects of that illness. More and more data are revealing that simply surviving sepsis is not the end of the road for these patients. Many sepsis survivors experience persistent  impairments in health status, such as impairments in physical or functional status, cognitive impairment, mental health challenges, and they have trouble returning to their social  roles, such as employment. These persistent difficulties translate into strikingly high rates of readmission and mortality following hospital discharge. There's data that show  that sepsis survivors are at increased risk of mortality for up to two years following the index sepsis event, and this data shown here on this slide shows you that one in three  sepsis survivors were readmitted within 90 days, and this amounts to a significant proportion of health care costs. So the readmission rate after sepsis is high, but how much of  this is preventable? These are sick patients, often to begin with, so how much modifiability  is there in their poor post-discharge outcomes? Well, this study by Dr. Prescott attempted to answer that question, and the findings were that almost a half of hospital readmissions  after sepsis were for conditions that were considered ambulatory sensitive conditions, and this means that, theoretically, these were conditions that could have been treated  in the outpatient world that would have prevented a hospital admission, and the most common reasons for readmission are things like new or worsening infection, heart failure, renal  failure, COPD exacerbation, and foreseeably, these are the types of things that you would  think might be able to be treated in the outpatient world to prevent a hospital readmission. So this made us realize that of all the great things we're doing for sepsis patients,  there's a gap in how we help them transition after the hospital discharge at a time where they've survived, but they're still quite vulnerable to ongoing and new threats to their  health status. Although there aren't a lot of data to guide how we should be managing post-sepsis patients, a reasonable place to start is this set of evidence-informed care  practices described by Prescott and Angus a couple years back, which include, one, screening for new impairments, two, careful attention to medication management, three, monitoring  and mitigating risk for health deterioration, and four, establishing goals of care or providing palliative care to appropriate patients.  In our preliminary data, we found that these care practices, these things that seem like common sense and we should be doing them for everybody, we found that these care practices  are inconsistently applied to our patients, and we found that there was an association between delivery of these care elements and risk of 90-day mortality or hospital readmission,  with the more the better. So if you had all four care elements, there was a dramatic reduction in the risk of 90-day mortality or readmission.  So building on all of that, we put together a transition program to be delivered through a nurse navigator that would implement these best practices for sepsis survivors following  hospital discharge. So to briefly walk through how the program works, our patients are identified as high-risk  using an electronic health record embedded algorithm that identifies eligibility criteria and then applies two risk models, risk for readmission and risk for mortality in 30 days,  and patients who are identified as high-risk for either of those get electronically sent to a list for the STAR navigator.  The STAR navigator makes contact with the patient while they're still inpatient, makes that relationship, and follows along during their hospital stay, makes sure that the best  practices for inpatient care are being followed, and if not, can sort of nudge the inpatient  team to do those things. In the peri-discharge period, the navigator focuses on sepsis education,  medication review, and then immediately after discharge, within 48 hours, regardless of whether they go home or have home health or skilled nursing facility, the navigator contacts  them via telephone and checks in on them, monitors for symptoms, makes sure they have their medications and know how to take them, and does screening for impairments and identifies  any barriers to their care. And that check-ins continue at close regular intervals up through 30 days.  So the question that we had was, does a nurse navigator program actually improve outcomes for sepsis survivors? And specifically, our research question was, does the STAR program  improve 30-day mortality and rehospitalization outcomes among our sepsis survivors? So we designed the IMPACTS trial, which is a two-arm, parallel-group, pragmatic, randomized  controlled trial. We enrolled patients from three hospitals across North Carolina. We enrolled patients from January 2019 through March of 2020, and we followed up for 30 days  after hospital discharge. So follow-up for everyone in the trial was completed in May of 2020.  The primary outcome was a binary composite of mortality or hospital readmission. We used an intention-to-treat approach, and we estimated the effect size by estimating conditional  odds ratios, adjusting for pre-specified covariates. These included age, comorbidity burden, and organ dysfunction at enrollment.  For sample size, we calculated to detect a 25% relative risk in the composite rate of 30-day readmission and mortality, based on prior literature suggesting between 2% of  deaths and between 22% and 42% of readmissions are preventable. Our historical data for these sites, the control group was estimated to have a 40% combined readmission and mortality  rate. So to achieve 80% power, we estimated a sample size of 354 patients per group, with a total number of patients, 708.  So how did it all work out? We screened 2,600 patients for eligibility. 1,900 or so were  excluded. 930 did not meet eligibility criteria. 988 were not randomized due to resource constraints,  which just means that we let the navigator have days off on the weekends. We ended up with 712 adults with suspected sepsis for randomization. They were allocated one-to-one  to either usual care or to the STAR program. Then we excluded a few patients who ended up not having an infection after all, because it didn't make sense to apply a sepsis-specific  transition program to people who didn't have sepsis. And we ended up with 691 adults hospitalized with sepsis for the IMPACS trial.  The baseline data, the groups were generally well-balanced. They were about 60 years old, half and half female, male. They had a smattering of comorbidities, an average of two organ  failures at the time of presentation. So primary outcome results are shown here. For the 30-day composite outcome, composite of mortality and readmission, that event occurred in 114  of the usual care patients versus 100 of the STAR patients. And this was a risk difference of 4.6% reduction associated with the STAR program. And the odds ratio worked out to  be 0.8, with a p-value of 0.03. When you look at the individual components of the primary outcomes, so mortality and  readmission separately, those were both lower in the STAR group compared to the usual care group. And briefly, we'll talk about some of the process measures, so things that happened  more frequently in the STAR group compared to the usual care group. Outpatient speech therapy was more frequent in the STAR group. Depression screening was more frequent in  the STAR group. Timely outpatient follow-up and medication review documentation was more common. Documentation of goals of care was more common in the STAR group. And this was  interesting. Of patients who died after hospitalization, patients in the STAR group were less frequently  died in the hospital compared to patients in the usual care group who more frequently died in the hospital.  So to put all that in context, back in 2017, the World Health Organization adopted a resolution  on improving the prevention, diagnosis, and management of sepsis, specifically calling on members to address the needs of sepsis survivors. And subsequently, experts have  gotten together to establish priorities for how we can accomplish those research and practice agendas. And in that setting, our study is the first that we're aware of to identify  an intervention that improves morbidity and mortality for sepsis survivors. Some strengths and weaknesses of our study. Some strengths are the rigorous design. A  lot of times, studies that evaluate these types of complex interventions end up being quasi-experimental or observational. And we were able to do a rigorous randomized trial  evaluating this intervention. We enrolled patients across three hospitals with ended  up with a diverse population. We used a electronic health record embedded recruitment and enrollment  process, which increased the reach and representativeness of our trial population. And the pragmatic  design of our study really optimized the real world context and our ability to apply these results to a practical setting. And finally, we used mortality and hospital readmission  as our outcomes, which are meaningful outcomes to both patients and healthcare systems.  A few limitations of the study. With any multi-component intervention, it's hard to disentangle the  effects of the different components. So from our study, we don't necessarily know which parts of the intervention were necessary, which parts could be dropped, which parts  were synergistic. We're not able to tease that out. In the grand scheme of sepsis survivorship,  30 days is actually a pretty short-term outcome. We know that patients typically experience long-term adverse outcomes, even up to two years for some of the mortality data. So in  some ways, 30 days is actually a pretty short-term outcome there. And then our study isn't able to really comment on implementation factors that may have enhanced or may be barriers  to the success of this type of program. So in conclusion, our multi-site randomized clinical trial of 691 adults hospitalized with sepsis, a multi-component transition  and recovery intervention compared with usual care, reduced 30-day mortality and re-hospitalizations.  Certainly, further research is needed to understand the generalizability of these findings to other healthcare settings and to identify implementation or contextual factors that  will be critical for implementation success. So I'd like to thank our study team and our Atrium Health Acorn Collaborative for supporting this research. I'd like to thank  the audience for attending and for allowing us to meet to present our results. Thank you.

Video Summary

The IMPACTS clinical trial evaluated the effectiveness of a nurse-navigator-led sepsis transition program. Sepsis survivors often face persistent health impairments and high rates of readmission and mortality after hospital discharge. The study found that almost half of hospital readmissions after sepsis were for conditions that could have been treated in an outpatient setting. To address this gap in care, a nurse navigator program was developed to implement evidence-informed care practices for sepsis survivors. The program improved 30-day mortality and rehospitalization outcomes, with a 4.6% reduction in risk. Further research is needed to understand implementation factors and generalizability.

Asset Subtitle

Sepsis, Quality and Patient Safety, 2021

Asset Caption

The Society of Critical Care Medicine's Critical Care Congress features internationally renowned faculty and content sessions highlighting the most up-to-date, evidence-based developments in critical care medicine. This is a presentation from the 2021 Critical Care Congress held virtually from January 31-February 12, 2021.

Stephanie Parks Taylor

Introduction/Hypothesis: Sepsis survivors experience high mortality and morbidity following hospital discharge. We hypothesized that a nurse navigator-led, telehealth-focused Sepsis Transition and Recovery (STAR) program would reduce 30-day mortality and readmission rates among high-risk sepsis survivors.

Methods: We conducted a pragmatic randomized trial from January 2019 to March 2020 at three urban academic hospitals in a single healthcare system. Adults who presented with suspected sepsis and deemed high risk for readmission or death by previously developed risk-stratification models were randomized 1:1 to either usual care (UC) or STAR. The STAR program comprised a nurse navigator using proactive follow-up to facilitate best-practice post-sepsis care strategies. STAR support began during index hospitalization and continued through 30â€‰days after discharge. Navigators reviewed medications, assessed for new impairments or symptoms, monitored existing comorbidities, and prompted palliative care referral as needed. Protocols guided escalation of support for identified problems. The primary outcome was a composite of all-cause hospital readmission or mortality within 30 days of discharge. Logistic regression models were constructed to evaluate marginal and conditional odds ratios (adjusted for prespecified covariates: age, comorbidity, and organ dysfunction at enrollment).

Results: We enrolled 691 patients with mean age of 63.7 years. 359 (52%) were female, and 448 (65%) were white. Among 349 patients randomized to STAR, 100 (28.7%) experienced the composite outcome of mortality or hospital readmission within 30 days, compared to 114 of 342 (33.3%) randomized to UC (difference: 4.6%; marginal odds ratio [OR]: 0.80, 95% confidence interval [CI] 0.58-1.11; conditional OR: 0.80, 95%CI: 0.64-0.98 p=0.03). There were 74 deaths (STAR: 33 [9.5%] vs UC: 41 [12.0%] and 155 rehospitalizations (STAR: 71 [20.3%] vs UC: 84 [24.6%]).

Conclusions: Among high-risk sepsis survivors, the use of a nurse navigator-led telehealthâ€“focused intervention, compared with usual care, reduced mortality and readmissions within 30 days after discharge when adjusting for covariates known a priori to be associated with the outcomes. Further research is needed to clarify contextual factors associated with successful implementation of this approach.

Meta Tag

Content Type Presentation

Knowledge Area Sepsis

Knowledge Area Quality and Patient Safety

Knowledge Level Advanced

Membership Level Select

Tag Mortality

Tag Length of Stay

Year 2021

Keywords

IMPACTS clinical trial

nurse-navigator-led sepsis transition program

sepsis survivors

hospital readmissions

outpatient setting

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