Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study.

OBJECTIVES Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials. DESIGN Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003. SETTING Randomized clinical trials involving patients in an acute or nonacute care setting. SUBJECTS AND INTERVENTIONS We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators. MEASUREMENTS AND MAIN RESULTS Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size. CONCLUSIONS Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.

Clinical and economic outcomes of serious postoperative infections following resection of common respiratory and gastrointestinal solid tumors

Unlike infections occurring during periods of chemotherapy-induced neutropenia, postoperative infections in patients with solid malignancy remain largely understudied. The purpose of this population-based study was to evaluate the clinical and economic burden, as well as the relationship of hospital surgical volume and outcomes associated with serious postoperative infection (SPI) – i.e., bacteremia/sepsis, pneumonia, and wound infection – following resection of common solid tumors.^ From the Texas Discharge Data Research File, we identified all Texas residents who underwent resection of cancer of the lung, esophagus, stomach, pancreas, colon, or rectum between 2002 and 2006. From their billing records, we identified ICD-9 codes indicating SPI and also subsequent SPI-related readmissions occurring within 30 days of surgery. Random-effects logistic regression was used to calculate the impact of SPI on mortality, as well as the association between surgical volume and SPI, adjusting for case-mix, hospital characteristics, and clustering of multiple surgical admissions within the same patient and patients within the same hospital. Excess bed days and costs were calculated by subtracting values for patients without infections from those with infections computed using multilevel mixed-effects generalized linear model by fitting a gamma distribution to the data using log link.^ Serious postoperative infection occurred following 9.4% of the 37,582 eligible tumor resections and was independently associated with an 11-fold increase in the odds of in-hospital mortality (95% Confidence Interval [95% CI], 6.7-18.5, P < 0.001). Patients with SPI required 6.3 additional hospital days (95% CI, 6.1 - 6.5) at an incremental cost of $16,396 (95% CI, $15,927–$16,875). There was a significant trend toward lower overall rates of SPI with higher surgical volume (P=0.037). ^ Due to the substantial morbidity, mortality, and excess costs associated with SPI following solid tumor resections and given that, under current reimbursement practices, most of this heavy burden is borne by acute care providers, it is imperative for hospitals to identify more effective prophylactic measures, so that these potentially preventable infections and their associated expenditures can be averted. Additional volume-outcomes research is also needed to identify infection prevention processes that can be transferred from higher- to lower-volume providers.^

COSTS AND EFFECTS OF ARKANSAS' LONG-TERM CARE DEMONSTRATION PROJECT (MEDICAID, CHANELLING, COMMUNITY ASSESSMENT)

The purpose of this study was to assess the impact of the Arkansas Long-Term Care Demonstration Project upon Arkansas' Medicaid expenditures and upon the clients it serves. A Retrospective Medicaid expenditure study component used analyses of variance techniques to test for the Project's effects upon aggregated expenditures for 28 demonstration and control counties representing 25 percent of the State's population over four years, 1979-1982.^ A second approach to the study question utilized a 1982 prospective sample of 458 demonstration and control clients from the same 28 counties. The disability level or need for care of each patient was established a priori. The extent to which an individual's variation in Medicaid utilization and costs was explained by patient need, presence or absence of the channeling project's placement decision or some other patient characteristic was examined by multiple regression analysis. Long-term and acute care Medicaid, Medicare, third party, self-pay and the grand total of all Medicaid claims were analyzed for project effects and explanatory relationships.^ The main project effect was to increase personal care costs without reducing nursing home or acute care costs (Prospective Study). Expansion of clients appeared to occur in personal care (Prospective Study) and minimum care nursing home (Retrospective Study) for the project areas. Cost-shifting between Medicaid and Medicare in the project areas and two different patterns of utilization in the North and South projects tended to offset each other such that no differences in total costs between the project areas and demonstration areas occurred. The project was significant ((beta) = .22, p < .001) only for personal care costs. The explanatory power of this personal care regression model (R('2) = .36) was comparable to other reported health services utilization models. Other variables (Medicare buy-in, level of disability, Social Security Supplemental Income (SSI), net monthly income, North/South areas and age) explained more variation in the other twelve cost regression models. ^

Conhecimentos sobre a RNCCI: um estudo exploratório sobre a perceção dos alunos do curso de enfermagem

A Rede Nacional de Cuidados Continuados (RNCCI) foi criada em 2006 pelo decreto-lei nº 101/2006, no âmbito do Ministério da Saúde e da Segurança Social. A RNCCI tem como missão prestar os cuidados adequados, de saúde e apoio social, a todas as pessoas que, independentemente da idade, se encontrem em situação de dependência, e articula-se com os serviços de saúde e sociais já existentes. Para cumprir a sua missão, a RNCCI, necessita de uma equipa multidisciplinar, na qual integram vários profissionais, tais como: médicos, enfermeiros, assistentes sociais, psicólogos, entre muitos outros, de entre estes os enfermeiros são os profissionais que maior percentagem detêm na constituição da mesma. Daí que seja pertinente a realização de estudos de investigação, com enfermeiros e estudantes de enfermagem, nesta nova valência de cuidados. O presente estudo incide sobre os conhecimentos dos estudantes de enfermagem sobre a RNCCI, que frequentam o terceiro e quarto ano na Escola Superior de Saúde do Instituto Politécnico de Bragança. Sendo a questão de investigação deste estudo: “Quais os conhecimentos dos alunos de enfermagem do terceiro e quarto ano da licenciatura em enfermagem sobre a RNCCI?”. Foi realizado um estudo de natureza quantitativa, descritivo, correlacional, num plano transversal. Optou-se por um processo de amostragem não probabilística de conveniência, que refletisse a distribuição da população por ano de escolaridade. Assim, considerou-se uma amostra de 120 alunos (75 % da população), selecionados acidentalmente, visando a disponibilidade, rapidez e o menor custo na recolha de dados. Concluiu-se que os alunos de enfermagem de uma forma geral apresentam conhecimentos sobre a RNCCI. Destacando-se uma percentagem de 90% de respostas corretas referentes sobre a RNCCI. No entanto 75% dos alunos responderam erradamente às afirmações relacionados com o processo de referenciação e tipologia das respostas da RNCCI. Comparando estes resultados com estudos realizados com enfermeiros que exercem funções na RNCCI, verifica-se que os alunos não apresentam conhecimentos suficientes para desencadear funções ou processos relacionados com a RNCCI, apesar de terem conhecimentos gerais da mesma, pois apresentam consideráveis falhas desde logo no processo de referenciação, assim como profissionais que já trabalham na área. Tais factos constatados salientam a importância de formação teórica e/ou prática, no plano curricular da licenciatura de enfermagem, preparando os futuros enfermeiros para exercerem as suas funções na RNCCI, e não só. Pois os enfermeiros que trabalham nos cuidados de saúde primários e secundários, também eles necessitam de ter conhecimentos sobre a RNCCI, verificando-se muito frequentemente é durante o internamento que se inicia o processo de referenciação. Sugerindo que o conhecimento dos alunos sobre a RNCCI, são adquiridos na sua maioria durante a realização do ensino clínico, onde acompanham este tipo de atividades. Embora a formação base da licenciatura, permita uma vasta aquisição de competências teórico-práticas, e a integração de formação sobre a RNCCI, seja considerada pelos alunos de enfermagem, como importante ou muito importante, a mesma pode considerar-se atualmente praticamente inexistente.

Simulating Nursing: Rhetoric, Materiality, and Disciplinary Learning

Thesis (Ph.D.)--University of Washington, 2016-06

Are diagnosis specific outcome indicators based on administrative data useful in assessing quality of hospital care?

Background: Hospital performance reports based on administrative data should distinguish differences in quality of care between hospitals from case mix related variation and random error effects. A study was undertaken to determine which of 12 diagnosis-outcome indicators measured across all hospitals in one state had significant risk adjusted systematic ( or special cause) variation (SV) suggesting differences in quality of care. For those that did, we determined whether SV persists within hospital peer groups, whether indicator results correlate at the individual hospital level, and how many adverse outcomes would be avoided if all hospitals achieved indicator values equal to the best performing 20% of hospitals. Methods: All patients admitted during a 12 month period to 180 acute care hospitals in Queensland, Australia with heart failure (n = 5745), acute myocardial infarction ( AMI) ( n = 3427), or stroke ( n = 2955) were entered into the study. Outcomes comprised in-hospital deaths, long hospital stays, and 30 day readmissions. Regression models produced standardised, risk adjusted diagnosis specific outcome event ratios for each hospital. Systematic and random variation in ratio distributions for each indicator were then apportioned using hierarchical statistical models. Results: Only five of 12 (42%) diagnosis-outcome indicators showed significant SV across all hospitals ( long stays and same diagnosis readmissions for heart failure; in-hospital deaths and same diagnosis readmissions for AMI; and in-hospital deaths for stroke). Significant SV was only seen for two indicators within hospital peer groups ( same diagnosis readmissions for heart failure in tertiary hospitals and inhospital mortality for AMI in community hospitals). Only two pairs of indicators showed significant correlation. If all hospitals emulated the best performers, at least 20% of AMI and stroke deaths, heart failure long stays, and heart failure and AMI readmissions could be avoided. Conclusions: Diagnosis-outcome indicators based on administrative data require validation as markers of significant risk adjusted SV. Validated indicators allow quantification of realisable outcome benefits if all hospitals achieved best performer levels. The overall level of quality of care within single institutions cannot be inferred from the results of one or a few indicators.

Clinical progression and outcome of dysphagia following paediatric traumatic brain injury: a prospective study

Objectives : To provide a preliminary clinical profile of the resolution and outcomes of oral-motor impairment and swallowing function in a group of paediatric dysphagia patients post-traumatic brain injury (TBI). To document the level of cognitive impairment parallel to the return to oral intake, and to investigate the correlation between the resolution of impaired swallow function versus the resolution of oral-motor impairment and cognitive impairment. Participants : Thirteen children admitted to an acute care setting for TBI. Main outcome measures : A series of oral-motor (Verbal Motor Production Assessment for Children, Frenchay Dysarthria Assessment, Schedule for Oral Motor Assessment) and swallowing (Paramatta Hospital's Assessment for Dysphagia) assessments, an outcome measure for swallowing (Royal Brisbane Hospital's Outcome Measure for Swallowing), and a cognitive rating scale (Rancho Level of Cognitive Functioning Scale). Results : Across the patient group, oral-motor deficits resolved to normal status between 3 and 11 weeks post-referral (and at an average of 12 weeks post-injury) and swallowing function and resolution to normal diet status were achieved by 3-11 weeks post-referral (and at an average of 12 weeks post-injury). The resolution of dysphagia and the resolution of oral-motor impairment and cognitive impairment were all highly correlated. Conclusion : The provision of a preliminary profile of oral-motor functioning and dysphagia resolution, and data on the linear relationship between swallowing impairment and cognition, will provide baseline information on the course of rehabilitation of dysphagia in the paediatric population post-TBI. Such data will contribute to more informed service provision and rehabilitation planning for paediatric patients post-TBI.

Evaluating the role of speech-language pathology with patients with communication disability in the acute hospital setting using the ICF

The practice of speech-language pathology in the acute care hospital setting has changed dramatically over the last 20 years. Speech-language pathologists now routinely assess and manage patients with dysphagia as well as patients with acquired communication disorders. In practice, clinicians have tended to direct their limited resources toward the assessment and management of patients with dysphagia before addressing the needs of patients with acquired communication disorders. This practice has resulted in a decline in speech-language pathology services for patients with communication disorders and has led some clinicians to question the role of the speech-language pathologist in the acute care hospital setting. This article continues this discussion by evaluating the role of the speech-language pathologist in the acute care hospital setting within the context of the World Health Organization's (WHO) International Classification of Functioning, Disability and Health (ICF; WHO, 2001). It argues that by adopting the ICF, speech-language pathologists have a sound rationale for broadening their role to identify the communication needs of all hospital inpatients who experience communication difficulties in the acute care hospital setting.

Experimental hand pain delays recognition of the contralateral hand: Evidence that acute and chronic pain have opposite effects on information processing?

Recognising the laterality of a pictured hand involves making an initial decision and confirming that choice by mentally moving one's own hand to match the picture. This depends on an intact body schema. Because patients with complex regional pain syndrome type 1 (CRPS1) take longer to recognise a hand's laterality when it corresponds to their affected hand, it has been proposed that nociceptive input disrupts the body schema. However, chronic pain is associated with physiological and psychosocial complexities that may also explain the results. In three studies, we investigated whether the effect is simply due to nociceptive input. Study one evaluated the temporal and perceptual characteristics of acute hand pain elicited by intramuscular injection of hypertonic saline into the thenar eminence. In studies two and three, subjects performed a hand laterality recognition task before, during, and after acute experimental hand pain, and experimental elbow pain, respectively. During hand pain and during elbow pain, when the laterality of the pictured hand corresponded to the painful side, there was no effect on response time (RT). That suggests that nociceptive input alone is not sufficient to disrupt the working body schema. Conversely to patients with CRPS1, when the laterality of the pictured hand corresponded to the non-painful hand, RT increased similar to 380 ms (95% confidence interval 190 ms-590 ms). The results highlight the differences between acute and chronic pain and may reflect a bias in information processing in acute pain toward the affected part.

A Comparison of Methodologies from Two Longitudinal Community-Based Randomized Controlled Trials of Similar Interventions in Palliative Care: What Worked and What Did Not

Background: Methodological challenges such as recruitment problems and participant burden make clinical trials in palliative care difficult. In 2001-2004, two community-based randomized controlled trials (RCTs) of case conferences in palliative care settings were independently conducted in Australia-the Queensland Case Conferences trial (QCC) and the Palliative Care Trial (PCT). Design: A structured comparative study of the QCC and PCT was conducted, organized by known practical and organizational barriers to clinical trials in palliative care. Results: Differences in funding dictated study designs and recruitment success; PCT had 6 times the budget of QCC. Sample size attainment. Only PCT achieved the sample size goal. QCC focused on reducing attrition through gatekeeping while PCT maximized participation through detailed recruitment strategies and planned for significant attrition. Testing sustainable interventions. QCC achieved a higher percentage of planned case conferences; the QCC strategy required minimal extra work for clinicians while PCT superimposed conferences on normal work schedules. Minimizing participant burden. Differing strategies of data collection were implemented to reduce participant burden. QCC had short survey instruments. PCT incorporated all data collection into normal clinical nursing encounters. Other. Both studies had acceptable withdrawal rates. Intention-to-treat analyses are planned. Both studies included substudies to validate new outcome measures. Conclusions: Health service interventions in palliative care can be studied using RCTs. Detailed comparative information of strategies, successes and challenges can inform the design of future trials. Key lessons include adequate funding, recruitment focus, sustainable interventions, and mechanisms to minimize participant burden.

Family centred care: a review of qualitative studies

Aim. To review systematically qualitative studies, which were found during a literature search for a Cochrane systematic review of the use of family centred care in children's hospitals. Background. Family centred care has become a cornerstone of paediatric practice, however, its effectiveness is not known. No single definition exists, rather a list of elements that constitute family centred care. However, it is recognized to involve the parents in care planning for a child in health services. A new definition is presented here. Methods. The papers were found in wide range of databases, by hand searching and by contacting the authors where necessary, using terms given in detail in the protocol in the Cochrane Library, in 2004. Qualitative studies could not be used for statistical analysis, but are still important to the review and so are described separately in this paper. Results. Negotiation between staff and families, perceptions held by both parents and staff roles influenced the delivery of family centred care. A sub-theme of cost of family centred care to families and staffs was discovered and this included both financial and emotional costs. Conclusion. Further research is needed to generate evidence about family centred care in situations arising from modern models of care in which family centred care is thought to be an inherent part, but which leave families with the care of sick children with little or no support. Relevance to clinical practice. Family centred care is said to be used widely in practice. More research is needed to ensure that is it being implemented correctly.

The antimicrobial efficacy of copper alloy furnishing in the clinical environment:a crossover study

Objective. To determine whether copper incorporated into hospital ward furnishings and equipment can reduce their surface microbial load. Design. A crossover study. Setting. Acute care medical ward with 19 beds at a large university hospital. Methods. Fourteen types of frequent-touch items made of copper alloy were installed in various locations on an acute care medical ward. These included door handles and push plates, toilet seats and flush handles, grab rails, light switches and pull cord toggles, sockets, overbed tables, dressing trolleys, commodes, taps, and sink fittings. Their surfaces and those of equivalent standard items on the same ward were sampled once weekly for 24 weeks. The copper and standard items were switched over after 12 weeks of sampling to reduce bias in usage patterns. The total aerobic microbial counts and the presence of indicator microorganisms were determined. Results. Eight of the 14 copper item types had microbial counts on their surfaces that were significantly lower than counts on standard materials. The other 6 copper item types had reduced microbial numbers on their surfaces, compared with microbial counts on standard items, but the reduction did not reach statistical significance. Indicator microorganisms were recovered from both types of surfaces; however, significantly fewer copper surfaces were contaminated with vancomycin-resistant enterococci, methicillin-susceptible Staphylococcus aureus, and coliforms, compared with standard surfaces. Conclusions. Copper alloys (greater than or equal to 58% copper), when incorporated into various hospital furnishings and fittings, reduce the surface microorganisms. The use of copper in combination with optimal infection-prevention strategies may therefore further reduce the risk that patients will acquire infection in healthcare environments.

The effects of advanced practice nurses (APNs) as intensivists in a surgical intensive care unit (SICU) on patient outcomes, healthcare charges, and apn intensivist services in the SICU

Intensive Care Units (ICUs) account for over 10 percent of all US hospital beds, have over 4.4 million patient admissions yearly, approximately 360,000 deaths, and account for close to 30% of acute care hospital costs. The need for critical care services has increased due to an aging population and medical advances that extend life. The result is efforts to improve patient outcomes, optimize financial performance, and implement models of ICU care that enhance quality of care and reduce health care costs. This retrospective chart review study examined the dose effect of APN Intensivists in a surgical intensive care unit (SICU) on differences in patient outcomes, healthcare charges, SICU length of stay, charges for APN intensivist services, and frequency of APNs special initiatives when the SICU was staffed by differing levels of APN Intensivist staffing over four time periods (T1-T4) between 2009 and 2011. The sample consisted of 816 randomly selected (204 per T1-T4) patient chart data. Study findings indicated reported ventilator associated pneumonia (VAP) rates, ventilator days, catheter days and catheter associated urinary tract infection (CAUTI) rates increased at T4 (when there was the lowest number of APN Intensivists), and there was increased pressure ulcer incidence in first two quarters of T4. There was no statistically significant difference in post-surgical glycemic control (M = 142.84, SD = 40.00), t (223) = 1.40, p = .17, and no statistically significant difference in the SICU length of stay among the time-periods (M = 3.27, SD = 3.32), t (202) = 1.02, p = .31. Charges for APN services increased over the 4 time periods from $11,268 at T1 to $51,727 at T4 when a system to capture APN billing was put into place. The number of new APN initiatives declined in T4 as the number of APN Intensivists declined. Study results suggest a dose effect of APN Intensivists on important patient health outcomes and on the number of APNs initiatives to prevent health complications in the SICU. ^

CAUTI prevention bundles: improving best practices within Western Health for continued success

Background: Persons in acute care settings who have indwelling urethral catheters are at higher risk of acquiring a urinary tract infection (UTI). Other complications related to prolonged indwelling urinary catheters include decreased mobility, damage to the meatus and/or urethra, increase use of antibiotics, increased length of stay, and pain. UTIs in acute care settings account for 30 to 40% of all health care associated infections (HAIs). Of these, 80% are catheter associated UTIs (CAUTIs). Purpose: To utilized the CDC (2009) bundle approach for CAUTI prevention and create a program which supports a multimodal method to improving urinary catheter use, maintenance, and removal, including a continuing competency program where role expansion is anticipated. Methods: A comprehensive review of the literature was conducted. Physicians were consulted through a power point presentation followed by a letter explaining the project, a questionnaire, and two selections of relevant literature. Nursing staff and allied health professionals from the target units of 3A and 3B medicine attended one of two lunch and learns. They were presented the project via a power point presentation and the same questionnaire as distributed to physicians. Results: Five e-learning modules, a revised policy, and clinical pathway have been developed to support staff with best practice knowledge transfer. Conclusion: Behaviour changes need to be approached with a framework, extensive consultation, and education. Sustainability of any practice change cannot occur without having completed the background work to ensure staff have access to tools to support the change.

Service users experiences of a therapeutic group programme in an acute psychiatric inpatient unit.

Psychiatric nurses have been facilitating therapeutic groups in acute psychiatric inpatient units for many years; however, there is a lack of nursing research related to this important aspect of care. This paper reports the findings of a study which aimed to gain an understanding of service users' experiences in relation to therapeutic group activities in an acute inpatient unit. A qualitative descriptive study was undertaken with eight service users in one acute psychiatric inpatient unit in Ireland. Data were collected using in-depth semi-structured interviews and analysed using Burnard's method of thematic content analysis. Several themes emerged from the findings which are presented in this paper.