EGDT provided no benefit compared to usual septic shock care
Early goal-directed therapy (EGDT) did not improve mortality or other outcomes in septic shock compared to current usual care, another study has found.
The Protocolised Management in Sepsis (ProMISe) trial included 1,260 patients treated at 56 hospitals in England who were randomized to either the 6-hour EGDT protocol or usual care. At 90 days, 29.5% of the EGDT patients had died compared to 29.2% of the usual care group (P=0.90). The EGDT patients received more intravenous fluids, vasoactive drugs, and red-cell transfusions. They also had significantly worse organ-failure scores, more days receiving advanced cardiovascular life support, and longer stays in the ICU than the usual care group.
The study, which was published in the April 2 New England Journal of Medicine, found no significant differences between the groups on any other secondary outcomes, including health-related quality of life or serious adverse events. None of the prespecified subgroups showed significant differences in response to EGDT. Use of EGDT increased costs, and the researchers calculated that there was less than a 20% probability that it was cost-effective.
This real-world trial confirms that usual sepsis care has changed since the 2001 Rivers study showed benefits from EGDT, the authors said. The results are similar to the recent ProCESS and ARISE trials, showing that continuous central venous saturation monitoring and strict protocolization do not improve outcomes. “Our results complete the planned trio of studies of EGDT, all of which showed that EGDT was not superior to usual care,” the authors concluded.
EHR access for inpatients shows promise in small trial
Giving inpatients access to their electronic health records (EHRs) during hospitalization appeared to improve empowerment and did not seem to affect clinician or nurse workload, according to a small study.
Researchers at an academic tertiary care hospital in Colorado performed a prospective cohort study to examine the experience of patients, clinicians, and nurses when patients were provided with immediate release of medications, test results, and other EHR data during hospitalization. Patients used an electronic tablet provided by the study to access EHR data. Surveys that evaluated caregiver workload, patient confusion and worry, patient empowerment, detection of errors, and discharge planning were completed by patients, clinicians, and nurses before and after the intervention. The study results were published in the May JAMA Internal Medicine.
Pre- and postintervention surveys were completed by all 50 of the included patients, 28 of 30 clinicians, and 14 of 16 nurses (response rates, 100%, 93%, and 88%, respectively). Before the intervention, 75% of clinicians and 100% of nurses felt that open access would cause patients to ask for the nurse more often; 68% of clinicians and 85% of nurses felt that it would cause patients to ask for the physician more often. After the intervention, these percentages decreased to 54% and 50% and 36% and 54%, respectively. Concern about patient worry was also high for both clinicians and nurses before the intervention but decreased after the intervention. Patients indicated that they expected open access to increase their control, understanding, reassurance, and ability to follow recommendations both before and after the intervention. Before the intervention, 44% of patients, 96% of clinicians, and 93% of nurses said that they thought patient access to medication lists would help find errors; after the intervention, these percentages decreased to 6%, 65%, and 50%, respectively (P<0.001, P=0.008, and P=0.03, respectively). More patients expected better understanding of their discharge timing before the intervention than after it (67% vs. 24%; P<0.001).
The authors concluded that giving inpatients access to their EHRs increased empowerment and that concern about any potential risks, such as increased patient worry or increased clinician or nurse workload, appeared to be unwarranted. “Federal programs recommend that patients be able to access results from their hospitalization within 36 hours of discharge,” the authors wrote. “Based on our results, we believe that this requirement still misses an opportunity for patient engagement through better transparency, and future policies should consider real-time EHR access for inpatients.”
Using a threshold of 2 SIRS criteria to define severe sepsis may not be adequate, study finds
Requiring 2 or more systemic inflammatory response syndrome (SIRS) criteria to define severe sepsis may result in exclusion of seriously ill patients, according to a recent study.
Researchers used data from 172 ICUs in Australia and New Zealand to test the sensitivity, face validity, and construct validity of the consensus definition of severe sepsis: suspected or proven infection, organ failure, and the presence of 2 or more SIRS criteria. Patients with infection and organ failure were categorized according to number of SIRS criteria met (≥2 was SIRS-positive severe sepsis, while <2 was SIRS-negative severe sepsis) and were then assessed for increased risk for death. Characteristics and outcomes were also compared. The study results were published in the April 23 New England Journal of Medicine.
A total of 109,663 patients had infection and organ failure, and of these, 96, 385 (87.9%) had SIRS-positive severe sepsis while 13, 278 (12.1%) had SIRS-negative severe sepsis. Twenty percent of those in the SIRS-negative category fulfilled no SIRS criteria and 80% fulfilled 1 criterion. Over the study period, from 2000 through 2013, changes in mortality rates were similar in both groups (36.1% to 18.3% in the SIRS-positive group and 27.7% to 9.3% in the SIRS-negative group; P<0.001 for both comparisons). After adjustment for baseline characteristics, the annual odds ratios for death were 0.96 (95% CI, 0.96 to 0.97) and 0.96 (95% CI, 0.94 to 0.98), respectively (P=0.12 for the between-group difference). Each additional SIRS criterion was associated with a linear increase in mortality (odds ratio for each additional criterion, 1.13; 95% CI, 1.11 to 1.15; P<0.001). The threshold of 2 SIRS criteria was not associated with a transitional increase in risk.
The authors noted that their study used data that were collected for quality-control purposes and that SIRS criteria could be assessed only during the first 24 hours a patient spent in the ICU, among other limitations. However, they concluded that using a SIRS criteria cutoff of 2 or more to define severe sepsis missed the diagnosis in 1 in 8 patients. Mortality rates were lower but still substantial in patients with SIRS-negative infection. Patients with SIRS-negative severe sepsis also saw decreases in incidence, proportion, and mortality over time similar to those seen with SIRS-positive severe sepsis.
In addition, the authors said that a SIRS criteria cutoff of 2 or more does not seem to indicate a risk transition point. “Our findings challenge the sensitivity, face validity, and construct validity of the rule regarding two or more SIRS criteria in diagnosing or defining severe sepsis in patients in the ICU,” they concluded.
PCMH model slowed growth in ED visits, but not hospitalizations
Patient-centered medical homes (PCMH) showed slower growth in expenditures for outpatient ED visits than non-PCMH practices, but the model wasn't associated with any decrease in hospitalizations, a recent study found.
Researchers analyzed a sample of Medicare beneficiaries treated at U.S. primary care practices from 2008 to 2010: 308 practices that were designated as PCMHs by the National Committee for Quality Assurance and 1,906 that weren't. At baseline, even before designation, the practices that would become PCMHs had healthier patients and lower ED and hospitalization costs and utilization, noted the authors, who adjusted for this variation in their analysis. Results were published by Annals of Emergency Medicine on March 10.
The practices that became PCMHs by 2009 had $54 less growth in their ED expenditures per patient than the non-PCMHs between 2008 and 2010, and the practices that became PCMHs in 2010 reduced growth by $48 during the time period compared to the non-PCMHs. Both differences were statistically significant. The PCMH practices also had slower growth in their ED visits per beneficiary, both for conditions that were judged ambulatory-care-sensitive and overall.
However, rates and costs of hospitalizations were not significantly affected by whether practices were PCMHs, the study found. These findings—both the lack of difference in hospitalization and the reduction in ED visit growth regardless of whether the condition was judged sensitive to ambulatory care—suggest that the PCMH model may substitute for some outpatient ED care, perhaps by expanding access, the authors wrote. “By comparison, becoming a patient-centered medical home did not appear to prevent more costly hospitalizations through improved communication, information sharing, and care coordination,” they added.
The study authors called for additional research into the effects of PCMH, especially on specific populations such as those with multiple comorbidities or social issues. An accompanying editorial suggested a rethinking of the whole concept that outpatient care can and should prevent ED use to reduce health care costs. The study didn't determine whether the ED savings exceeded the costs of PCMH care, providing net savings, the editorialist noted. Reducing the more costly category of ED visits that lead to admissions may prove more difficult, she said, concluding “perhaps policymakers should consider that the provision of acute, ‘outpatient’ type care in EDs may not be an anathema after all.”
Face-to-face handoffs didn't reduce adverse events
Patients whose hospitalists handed them off to another clinician in a face-to-face meeting had similar rates of adverse events and length of stay as those who didn't get face-to-face handoffs, a recent study found.
The retrospective cohort study at an academic medical center compared outcomes between 305 low-acuity patients who were admitted at night and handed off without face-to-face communication between clinicians and 500 similar patients who were also admitted at night and transferred face-to-face in 2011 and 2012. Results were published in the March Journal of Hospital Medicine.
In the 12 hours after the studied handoff, the 2 groups showed no difference in the frequency of rapid response team calls, code team calls, transfers to a higher level of care, deaths in hospital, or adverse events. They also had similar lengths of stay and 30-day readmission rates, leading study authors to conclude that face-to-face handoffs were not associated with any significant difference in the measured outcomes.
The study was limited by its size, the authors noted, with only about 3% of all patients suffering an adverse event, as well as the possibility that events occurred after the studied time frame. However, they speculated that the lack of effect with face-to-face handoffs could suggest that clinicians were more vigilant in gathering data when they didn't receive a face-to-face handoff, spending more time reviewing the medical record, speaking with the patients, and communicating with other clinicians.
The results suggest that, as long as key information is communicated by other means (such as electronic tools, e-mail, or phone), a face-to-face handoff is “not vital to ensure a safe care transition,” the authors wrote. Future investigations should look for other strategies or qualities that affect the safety of handoffs, they suggested.