Real-time pharmacy surveillance and clinical decision support to reduce adverse drug events in acute kidney injury: a randomized, controlled trial

OBJECTIVES: Clinical decision support (CDS), such as computerized alerts, improves prescribing in the setting of acute kidney injury (AKI), but considerable opportunity remains to improve patient safety. The authors sought to determine whether pharmacy surveillance of AKI patients could detect and prevent medication errors that are not corrected by automated interventions. METHODS: The authors conducted a randomized clinical trial among 396 patients admitted to an academic, tertiary care hospital between June 1, 2010 and August 31, 2010 with an acute 0.5 mg/dl change in serum creatinine over 48 hours and a nephrotoxic or renally cleared medication order. Patients randomly assigned to the intervention group received surveillance from a clinical pharmacist using a web-based surveillance tool to monitor drug prescribing and kidney function trends. CDS alerting and standard pharmacy services were active in both study arms. Outcome measures included blinded adjudication of potential adverse drug events (pADEs), adverse drug events (ADEs) and time to provider modification or discontinuation of targeted nephrotoxic or renally cleared medications. RESULTS: Potential ADEs or ADEs occurred for 104 (8.0%) of control and 99 (7.1%) of intervention patient-medication pairs (p=0.4). Additionally, the time to provider modification or discontinuation of targeted nephrotoxic or renally cleared medications did not differ between control and intervention patients (33.4 hrs vs. 30.3 hrs, p=0.3). CONCLUSIONS: Pharmacy surveillance had no incremental benefit over previously implemented CDS alerts.     

Pharmacist- versus physician-initiated admission medication reconciliation: impact on adverse drug events

BackgroundMedication reconciliation (MR) has proven to be a problematic task for many hospitals to accomplish. It is important to know the clinical impact of physician- versus pharmacist-initiated MR in the resource-limited hospital environment.MethodsThis quasi-experimental study took place from December 2005 to February 2006 at an urban US Veterans Affairs hospital. MR was implemented on 2 similar general medical units: one received physician-initiated MR and the other received pharmacist-initiated MR. Adverse drug events (ADEs) and a 72-hour medication-prescribing risk score were ascertained by research pharmacists for all admitted patients by structured record review. Multivariable models were tested for intervention effect, accounting for quasi-experimental design and clustered observations, and were adjusted for patient and encounter covariates.ResultsPharmacists completed the MR process in 102 admissions and physicians completed the process in 116 admissions. In completing the MR process, pharmacists documented statistically more admission medication changes than physicians (3.6 vs 0.8; P < 0.001). The adjusted odds of an ADE caused by an admission prescribing change with pharmacist-initiated MR compared with a physician-initiated MR were 1.04 with a 95% CI of 0.53 to 2.0. The adjusted odds of an ADE caused by an admission prescribing change that was a prescribing error with pharmacist-initiated MR compared with a physician-initiated MR were 0.38 with a confidence interval of 0.14 to 1.05. No difference was observed in 72-hour prescribing risk score (coefficient = 0.10; 95% CI, ?0.54 to 0.75).ConclusionMR performed by pharmacists versus physicians was more comprehensive and was followed by lower odds of ADEs from admission prescribing errors but with similar odds of all types of ADEs. Further research is warranted to examine how MR tasks may be optimally divided among clinicians and the mechanisms by which MR affects the likelihood of subsequent ADEs. ClinicalTrials.gov identifier: NCT00370916.     

Improving the transition of highly complex patients into the community: impact of a pharmacist in an allogeneic stem cell transplant (SCT) outpatient clinic

Purpose

Patients having undergone allogeneic stem cell transplantation (SCT) require complex medication regimens. To ensure the safe and effective management of this patient group, specialised care in a centre with a dedicated and experienced healthcare team is essential. The aim of this study was to evaluate the effectiveness of a specialty clinical pharmacist working in an ambulatory SCT clinic.

Methods

A prospective cohort study was conducted on patients post SCT and discharged to the ambulatory setting. Patients were reviewed by a clinical pharmacist weekly for six visits. At these visits a medication review was undertaken. Interventions from these reviews were recorded. Interventions were then assigned a risk rating by a multidisciplinary panel. Adherence was also assessed by a Morisky questionnaire and review of dose administration aids. Comparison of data over the six-visit period was undertaken.

Results

In total 23 patients were enrolled in the study. All six visits were completed in 17 patients and 161 interventions were recorded at an average of 1.4 interventions per patient visit. The panel rated 40 % of interventions as high risk, 46 % as medium risk and 14 % as low risk. At all visit points high- and medium-risk interventions constituted >80 % of the total. Morisky scores improved by an average of 1.53 (p?<?0.0001) between visits 1 and 6. All patients were scored as highly adherent by visit 6.

Conclusions

A specialist clinical pharmacist in the SCT outpatient clinic resulted in regular and effective intervention contributing to improved medication management and adherence.     

The epidemiology of preventable adverse drug events: a review of the literature

BACKGROUND: A growing amount of data suggests that adverse drug events (ADEs) in hospital settings are frequent and result in substantial harm. Even though prevention is where efforts must be directed, only a few studies have reported on the preventability of these events. The objective of this article is to review the literature of ADEs and their preventability, and to report on their incidences, characteristics, risk factors, costs and prevention strategies. METHODS: We systematically searched Medline and Embase for literature published between 1980 and June 2002. All articles reporting primary data on the incidences of ADEs and their preventability in hospital settings were included. RESULTS: In the 8 articles retrieved the incidences of ADEs were between 0.7% and 6.5% of hospitalized patients; in up to 56.6% these events were judged to be preventable. Furthermore, ADEs accounted for 2.4% to 4.1% of admissions to inpatient facilities; preventability was stated in up to 69.0% of these events. A substantial body of preventable ADEs, the so-called medication errors, occur in the process of ordering, transcribing, dispensing and administrating the drugs. Further investigations into medication errors at the ordering stage reveal their occurrence in up to 57.0 per 1,000 orders. Between 18.7% and 57.7% of those errors have the potential for harm, but only in about 1% they result in preventable ADEs. IMPLICATIONS: The detection of errors having only the potential for harm by means of computerized surveillance has shown to be a useful technique in order to understand and prevent ADEs. Apart from the use of sophisticated computer techniques the participation of pharmacists in the drug prescribing process results in a tremendous error reduction. The greatest task in changing the health care system into a system with safety as its first priority is to create a culture of constant learning from mistakes among health care professionals. The appreciation of the health care teams' ideas and perceptions for improvement, and their implementation through small improvement cycles, may represent the leading strength in error reduction and health care improvement.     

Safety of nicotine replacement therapy in critically ill smokers: a retrospective cohort study

Purpose

Nicotine replacement therapy (NRT) has been used to ameliorate nicotine withdrawal in the intensive care unit (ICU). Previous cohort studies have suggested an increased mortality with NRT use: methodological problems may call into question the validity of these findings. We undertook a retrospective cohort study to determine if NRT use was associated with adverse outcomes.

Methods

This retrospective cohort study was conducted in a 30-bed, university affiliated, teaching hospital ICU.

Results

We identified 423 smokers admitted over 2?years, of whom 73 received transdermal NRT. Cox proportional hazard regression models, with NRT modelled as a time-varying covariate, were used to test the hypothesis that NRT was associated with an altered ICU or hospital mortality. A second analysis utilized propensity scores. The unadjusted ICU and hospital mortalities were lower for the NRT group; although both differences were non-significant. The Cox models showed that, after adjustment for APACHE risk, age, sex and alcohol use, risk associated with NRT administration was not statistically different than non-administration for both ICU (hazard ratio 0.50, [95?% CI 0.20–1.24], p?=?0.14) and hospital (hazard ratio 0.95, [95?% CI 0.52–1.75], p?=?0.88) mortality. Similar findings occurred with the propensity matched analysis.

Conclusion

We were unable to demonstrate any harm associated with NRT, with the ICU model actually trending towards benefit. We conclude that a randomised, blinded, placebo controlled trial is required to assess adequately the safety and efficacy of NRT as a treatment in critically ill smokers.     

Costs and cost-effectiveness of a telemedicine intensive care unit program in 6 intensive care units in a large health care system

Purpose

The purpose of this study is to estimate the costs and cost-effectiveness of a telemedicine intensive care unit (ICU) (tele-ICU) program.

Materials and Methods

We used an observational study with ICU patients cared for during the pre-tele-ICU period and ICU patients cared for during the post-tele-ICU period in 6 ICUs at 5 hospitals that are part of a large nonprofit health care system in the Gulf Coast region. We obtained data on a sample of 4142 ICU patients: 2034 in the pre-tele-ICU period and 2108 in the post-tele-ICU period. Economic outcomes were hospital costs, ICU costs and floor costs, measured for average daily costs, costs per case, and costs per patient.

Results

After the implementation of the tele-ICU, the hospital daily cost increased from $4302 to $5340 (24%); the hospital cost per case, from $21 967 to $31 318 (43%); and the cost per patient, from $20 231 to $25 846 (28%). Although the tele-ICU intervention was not cost-effective in patients with Simplified Acute Physiology Score II 50 or less, it was cost-effective in the sickest patients with Simplified Acute Physiology Score II more than 50 (17% of patients) because it decreased hospital mortality without increasing costs significantly.

Conclusions

Hospital administrators may conclude that a tele-ICU program aimed at the sickest patients is cost-effective.     

A study protocol to develop and test an e-health intervention in follow-up service for intensive care survivors' relatives

Background

The negative impact on long-term health-related outcomes among relatives of critically ill patients in the intensive care unit (ICU) has been well described. High-quality ICU specialized follow-up care, which is easily accessible with digital innovation and which is designed by and with relevant stakeholders (i.e., ICU patients' relatives and nurses), should be considered to reduce these impairments in the psychological and social domains.

Aim

The programme's aim is to develop and test an e-health intervention in a follow-up service to support ICU patients' relatives. Here, the protocol for the overall study programme will be described.

Study Design

The overall study comprises a mixed-methods, multicentre research design with qualitative and quantitative study parts. The study population is ICU patients' adult relatives and ICU nurses. The main outcomes are the experiences of these stakeholders with the newly developed e-health intervention. There will be no predefined selection based on age, gender, and level of education to maximize diversity throughout the study programme. After the participants provide informed consent, data will be gathered through focus groups (n = 5) among relatives and individual interviews (n = 20) among nurses exploring the needs and priorities of a digital follow-up service. The findings will be explored further for priority considerations among members of the patient/relative organization (aiming n = 150), which will serve as a basis for digital prototypes of the e-health intervention. Assessment of the intervention will be followed during an iterative process with investigator-developed questionnaires. Finally, symptoms of anxiety and depression will be measured with the 14-item Dutch version of the ‘Hospital Anxiety and Depression Scale’, and symptoms of posttraumatic stress will be measured with the 21-item Dutch version of the ‘Impact of Events Scale-Revised’ to indicate the effectiveness of digital support among ICU patients' relatives.

Relevance to Clinical Practice

The e-health intervention to be developed during this research programme can possibly bridge the gap in integrated ICU follow-up care by providing relevant information, self-monitoring and stimulating self-care among ICU patients' relatives.     

Exercise rehabilitation for patients with critical illness: a randomized controlled trial with 12 months of follow-up

Introduction

The purpose of this trial was to investigate the effectiveness of an exercise rehabilitation program commencing during ICU admission and continuing into the outpatient setting compared with usual care on physical function and health-related quality of life in ICU survivors.

Methods

We conducted a single-center, assessor-blinded, randomized controlled trial. One hundred and fifty participants were stratified and randomized to receive usual care or intervention if they were in the ICU for 5 days or more and had no permanent neurological insult. The intervention group received intensive exercises in the ICU and the ward and as outpatients. Participants were assessed at recruitment, ICU admission, hospital discharge and at 3-, 6- and 12-month follow-up. Physical function was evaluated using the Six-Minute Walk Test (6MWT) (primary outcome), the Timed Up and Go Test and the Physical Function in ICU Test. Patient-reported outcomes were measured using the Short Form 36 Health Survey, version 2 (SF-36v2) and Assessment of Quality of Life (AQoL) Instrument. Data were analyzed using mixed models.

Results

The a priori enrollment goal was not reached. There were no between-group differences in demographic and hospital data, including acuity and length of acute hospital stay (LOS) (Acute Physiology and Chronic Health Evaluation II score: 21 vs 19; hospital LOS: 20 vs 24 days). No significant differences were found for the primary outcome of 6MWT or any other outcomes at 12 months after ICU discharge. However, exploratory analyses showed the rate of change over time and mean between-group differences in 6MWT from first assessment were greater in the intervention group.

Conclusions

Further research examining the trajectory of improvement with rehabilitation is warranted in this population.

Trial registration

The trial was registered with the Australian New Zealand Clinical Trials Registry ACTRN12605000776606.     

Implementation and Preliminary Clinical Outcomes of a Pharmacist‐managed Venous Thromboembolism Clinic for Patients Treated With Rivaroxaban Post Emergency Department Discharge

Objective

The objective was to describe the implementation, work flow, and differences in outcomes between a pharmacist‐managed clinic for the outpatient treatment of venous thromboembolism (VTE) using a non‐vitamin K oral anticoagulant versus care by a primary care provider (PCP).

Methods

Patients in the studied health system that are diagnosed with low‐risk VTE in the emergency department are often discharged without hospital admission. These patients are treated with a non‐vitamin K oral anticoagulant and follow‐up either in a pharmacist‐managed VTE clinic or with their PCP. Pharmacists in the VTE clinic work independently under a collaborative practice agreement (CPA). An evaluation of 34 patients, 17 in each treatment arm, was conducted to compare the differences in treatment‐related outcomes of rivaroxaban when managed by a pharmacist versus a PCP.

Results

The primary endpoint was a 6‐month composite of anticoagulation treatment‐related complications that included a diagnosis of major bleeding, recurrent thromboembolism, or fatality due to either major bleeding or recurrent thromboembolism. Secondary endpoints included number of hospitalizations, adverse events, and medication adherence. There was no difference in the primary endpoint between groups with one occurrence of the composite endpoint in each treatment arm (p = 1.000), both of which were recurrent thromboembolic events. Medication adherence assessment was formally performed in eight patients in the pharmacist group versus no patients in the control group. No differences were seen among other secondary endpoints.

Conclusions

The pharmacist‐managed clinic is a novel expansion of clinical pharmacy services that treats patients with low‐risk VTEs with rivaroxaban in the outpatient setting. The evaluation of outcomes provides support that pharmacist‐managed care utilizing standardized protocols under a CPA may be as safe as care by a PCP.

     

Using NEWS2 to triage newly admitted patients with COVID-19

Background

The coronavirus disease 2019 (COVID-19) pandemic has spread globally and caused a major worldwide health crisis. Patients who are affected more seriously by COVID-19 usually deteriorate rapidly and need further intensive care.

Aim

We aimed to assess the performance of the National Early Warning Score 2 (NEWS2) as a risk stratification tool to discriminate newly admitted patients with COVID-19 at risk of serious events.

Design

We conducted a retrospective single-centre case-control study on 200 unselected patients consecutively admitted in March 2020 in a public general hospital in Wuhan, China.

Methods

The following serious events were considered: mortality, unplanned intensive care unit (ICU) admission, and non-invasive ventilation treatment. Receiver operating characteristic (ROC) analysis and logistic regression analysis were used to quantify the association between outcomes and NEWS2.

Results

There were 12 patients (6.0%) who had serious events, where 7 patients (3.5%) experienced unplanned ICU admissions. The area under the ROC curve (AUROC) and cut-off of NEWS2 for the composite outcome were 0.83 and 3, respectively. For patients with NEWS2 ≥ 4, the odds of being at risk for serious events was 16.4 (AUROC = 0.74), while for patients with NEWS2 ≥ 7, the odds of being at risk for serious events was 18.2 (AUROC = 0.71).

Conclusions

NEWS2 has an appropriate ability to triage newly admitted patients with COVID-19 into three levels of risk: low risk (NEWS2 = 0-3), medium risk (NEWS2 = 4-6), and high risk (NEWS2 ≥ 7).

Relevance to clinical practice

Using NEWS2 may help nurses in early identification of at-risk COVID-19 patients and clinical nursing decision-making. Using NEWS2 to triage new patients with COVID-19 may help nurses provide more appropriate level of care and medical resources allocation for patients safety.     

Non-pharmacological interventions to reduce the incidence and duration of delirium in critically ill patients: A systematic review and network meta-analysis

ObjectiveTo compare non-pharmacological interventions in their ability to prevent delirium in critically ill patients, and find the optimal regimen for treatment.MethodsLiterature searches were conducted using PubMed, Embase, CINAHL, and Cochrane Library databases until the end of June 2019. We estimated the risk ratios (RRs) for the incidence of delirium and in-hospital mortality and found the mean difference (MD) for delirium duration and the length of ICU stay. The probabilities of interventions were ranked based on clinical outcomes. The study was registered on PROSPERO (CRD42020160757).ResultsTwenty-six eligible studies were included in the network meta-analysis. Studies were grouped into seven intervention types: physical environment intervention (PEI), sedation reducing (SR), family participation (FP), exercise program (EP), cerebral hemodynamics improving (CHI), multi-component studies (MLT) and usual care (UC). In term of reducing the incidence of delirium, the two most effective interventions were FP (risk ratio (RR) 0.19, 95% confidence interval (CI) 0.08 to 0.44; surface under the cumulative ranking curve (SUCRA) = 94%) and MLT (RR 0.43, 95% CI 0.30 to 0.57; SUCRA = 68%) compared with observation. Although all interventions demonstrated nonsignificant efficacy in regards to delirium duration and the length of the patient's stay in the ICU, MLT (SUCRA = 78.6% and 71.2%, respectively) was found to be the most effective intervention strategy. In addition, EP (SUCRA = 97.2%) facilitated a significant reduction in hospital mortality, followed in efficacy by MLT (SUCRA = 73.2%), CHI (SUCRA = 35.8%), PEI (SUCRA = 34.8%), and SR (SUCRA = 31.8%).ConclusionsMulti-component strategies are overall the optimal intervention techniques for preventing delirium and reducing ICU length of stay in critically ill patients by way of utilizing several interventions simultaneously. Additionally, family participation as a method of patient-centered care resulted in better outcomes for reducing the incidence of delirium.     

Small increases in serum creatinine are associated with prolonged ICU stay and increased hospital mortality in critically ill patients with cancer

Purpose

Declining kidney function has been associated with adverse hospital outcome in cancer patients. ICU literature suggests that small changes in serum creatinine are associated with poor outcome. We hypothesized that reductions in renal function previously considered trivial would predict a poor outcome in critically ill patients with malignant disease. We evaluated the effects on hospital mortality and ICU length of stay of small changes in creatinine following admission to the intensive care unit.

Methods

We conducted a retrospective cohort study utilizing clinical, laboratory and pharmacy data collected from 3,795 patients admitted to the University of Texas M.D. Anderson Cancer Center's Intensive Care Unit. We conducted univariate and multivariate regression analysis to determine those factors associated with adverse ICU and hospital outcome.

Results

Increases in creatinine as small as 10% (0.2?mg/dl) were associated with prolonged ICU stay (5?days vs 6.6?days, p?<?0.001) and increased mortality (14.6% vs 25.5%, p?<?0.0001). Patients with a 25% rise in creatinine during the first 72?h of ICU admission were twice as likely to die in the hospital (14.3% vs 30.1%, p?<?0.001). RIFLE criteria were accurate predictors of outcome, though they missed much of the risk of even smaller increases in creatinine.

Conclusions

Even small rises in serum creatinine following admission to the ICU are associated with increased morbidity and mortality in oncologic patients. The poor outcome in those with rising creatinine could not be explained by severity of illness or other risk factors. These small changes in creatinine may not be trivial, and should be regarded as evidence of a decline in an individual patient's condition.     

A clinical information system reduces medication errors in paediatric intensive care

Purpose  

To determine the effect of electronic prescribing (EP) with a clinical information system (Intellivue Clinical Information Portfolio, Philips, UK) on prescribing errors and omitted doses in a paediatric intensive care unit (PICU).     

The effect of diabetes on mortality in critically ill patients: a systematic review and meta-analysis

Introduction  

Critically ill patients with diabetes are at increased risk for the development of complications, but the impact of diabetes on mortality is unclear. We conducted a systematic review and meta-analysis to determine the effect of diabetes on mortality in critically ill patients, making a distinction between different ICU types.