Carie R. Kennedy

Tracheostomy protocol: experience with development and potential utility.

Objectives:To examine the feasibility and potential utility of a tracheostomy protocol based on a standardized approach to ventilator weaning. Design:Prospective, observational data collection. Setting:Academic medical center. Patients:Surgical intensive care unit patients requiring mechanical ventilatory support. Interventions:None. Measurements and Main Results:Tracheostomy practice in 200 patients was analyzed in relation to spontaneous breathing trial (SBT) weaning. Decision for, and performance of, tracheostomy occurred (median [interquartile range]) 5.0 (3.75–8.0) and 7.0 (5.0–10.0) days following initiation of mechanical ventilation, respectively. Duration of mechanical ventilation was greater in tracheostomy compared with nontracheostomy patients (15.0 [11.0–19.0] vs. 6.0 [4.0–8.0], p < .001). For patients requiring ventilatory support for ≥20 days, 100% of patients were maintained via tracheostomy. A protocol based on weaning performance, which included technical considerations, was developed. Individuals who failed preliminary weaning assessment or SBT for 3 successive days following 5 days (nonreintubated patients) or 3 days (reintubated patients) of ventilatory support met tracheostomy criteria. The protocol was implemented on a pilot basis in 125 individuals. Of the 55 (44.0%) patients undergoing tracheostomy, 25 (45.5%) did so consistent with criteria. Eighteen patients (32.7%) underwent tracheostomy before the time interval of data collection targeting weaning protocol performance, and 12 patients (21.8%) passed SBT on one or more occasions, were not extubated, and proceeded to tracheostomy. Conclusions:A standardized approach in which the decision for tracheostomy is based on objective measures of weaning performance may be a means of using this procedure more consistently and effectively.

Genetic research and testing in critical care: surrogates' perspective.

Objective:Genetic testing is increasingly a component of clinical research in critical illness and has potential for integration into routine care. This study explored the perspectives of surrogate decision-makers (SDMs) for acutely ill patients with respect to social, legal, and ethical aspects of genetic testing. Setting:Medical and surgical intensive care units in an urban tertiary care hospital. Intervention:Questionnaires administered to SDMs for critically ill patients over a 12-month period. Measurements and Main Results:A majority of eligible SDMs participated (117/146; 80.8%). SDMs were more likely to permit genetic testing for purposes of diagnosing a treatable life-threatening disease (114/117; 97.4%) or chronic disease (111/117; 94.9%) than for an untreatable life-threatening illness (95/117; 81.2%) (p < .001). SDMs were receptive to testing to explain familial traits (112/117; 95.7%) or ethnic traits (105/117; 89.7%) (p = .131). SDMs were concerned about potential for economic discrimination, with a majority expressing reluctance to permit testing if employers (93/117; 79.5%), health insurers (90/117; 76.9%), or life insurers (92/117; 78.6%) could access results. There was a greater willingness to allow participation in studies in which data were collected anonymously (90/117; 76.9%) vs. nonanonymously (75/117; 64.1%) (p = .04). Finally, SDMs placed greater trust in universities and nonprofit organizations (107/117; 91.4%) than either the federal government (75/117; 64.1%) or pharmaceutical companies (46/117; 39.3%) to perform genetic research (p < .01). Conclusions:SDMs expressed concerns regarding economic discrimination, confidentiality of data, and trust in entities conducting clinical investigation that may represent barriers both to performing studies in which genetic information is collected and to implementation of gene-based technologies in the critical care environment.

Examination of non-clinical factors affecting tracheostomy practice in an academic surgical intensive care unit

Objectives: To gain insight into nonclinical factors potentially influencing tracheostomy practice and determine whether a specialized consultation form impacts tracheostomy utilization. Design: Prospective, observational. Setting: Surgical intensive care unit (SICU). Patients: Patients requiring mechanical ventilatory support. Data abstracted from the Project Impact administrative database served as a practice benchmark. Interventions: Prospective data collection, completion of online survey, and implementation of specialized tracheostomy consultation form. Measurements and Main Results: Data were prospectively collected on 539 patients and 13 attending intensivists. Our SICU tracheostomy rate (54.2%) exceeded that of 18 comparable ICUs participating in Project Impact (13.9%, p < .001). We attempted to identify factors that might account for liberal tracheostomy use. In 41.5% (±0.6%) of patients undergoing tracheostomy, extubation had not occurred despite successful completion of spontaneous breathing trial on ≥1 occasion, a rate that varied significantly among attending intensivists responsible for decision making for this procedure (p < .001). Attending intensivists and postgraduate surgical trainees with SICU experience were surveyed to better understand perceptions of tracheostomy practice. Most respondents (96.1%) reported relying on spontaneous breathing trial to guide decision for extubation, 72.6% estimated that ≤25% of patients successfully completed spontaneous breathing trial but did not proceed to immediate extubation, 86.3% estimated that ≤25% of such patients undergo tracheostomy, and 58.8% felt an acceptable benchmark for this practice was ≤10%. In most survey domains, respondents’ perceptions underestimated actual practice. Implementation of a specialized tracheostomy consultation form did not impact tracheostomy utilization. Conclusions: We identified variation among clinicians with respect to tracheostomy practice as well as discrepancies between perceptions of this practice and actual utilization. These factors may underlie the liberal use of this procedure in our SICU. Processes for providing accurate physician feedback may assist in optimizing tracheostomy use.

Considerations in the construction of an instrument to assess attitudes regarding critical illness gene variation research.

Clinical studies conducted in intensive care units are associated with logistical and ethical challenges. Diseases investigated are precipitous and life-threatening, care is highly technological, and patients are often incapacitated and decision-making is provided by surrogates. These investigations increasingly involve collection of genetic data. The manner in which the exigencies of critical illness impact attitudes regarding genetic data collection is unstudied. Given interest in understanding stakeholder preferences as a foundation for the ethical conduct of research, filling this knowledge gap is timely. The conduct of opinion research in the critical care arena is novel. This brief report describes the development of parallel patient/surrogate decision-maker quantitative survey instruments for use in this environment. Future research employing this instrument or a variant of it with diverse populations promises to inform research practices in critical illness gene variation research.

Perspectives of surrogate decision makers for critically ill patients regarding gene variation research

Purpose:We undertook this investigation to explore the manner in which surrogate decision makers for critically ill patients perceived genetic data collected in the context of clinical investigation.Methods:Surrogate decision makers for critically ill patients cared for in intensive care units of two urban hospitals participated in focus groups designed to explore perceptions regarding gene variation research.Results:Surrogate decision makers were generally familiar with genetic concepts and reported that they could provide an informed opinion regarding permitting (or declining) the participation of their loved ones in gene variation research. Respondents perceived the risk associated with this type of research largely as the risk associated with acquiring the sample (i.e., whether it involved an invasive procedure or not) but appreciated that genetic samples could provide information not readily obtained from nongenetic sources. Concerns about potential misuse of genetic data largely centered on misconduct, paternity, forensic applications, and insurance and employment discrimination. Although surrogate decision makers expressed that their loved ones would have interest in return of results and being recontacted for future use, these interests were secondary to confidentiality concerns.Conclusion:Respondents perceived genetic and nongenetic data as comparable. Informed consent processes that provide clear information regarding confidentiality protections, specimen handling, and parameters for future use may enhance enrollment.Genet Med 2013:15(5):368–373

Critical illness research involving collection of genomic data: the conundrum posed by low levels of genomic literacy among surrogate decision makers for critically ill patients.

Critical illness clinical trials that entail genomic data collection pose unique challenges. In this qualitative study, we found that surrogate decision makers (SDMs) for critically ill individuals, such as those who would be approached for study participation, appeared to have a limited grasp of genomic principles. We argue that low levels of genomic literacy should neither preclude nor be in conflict with the conduct of ethically rigorous clinical trials.

Does difficulty functioning in the surrogate role equate to vulnerability in critical illness research? Use of path analysis to examine the relationship between difficulty providing substituted judgment and receptivity to critical illness research participation

PURPOSE Individuals who struggle to provide substitute judgment for the critically ill often find it challenging to engage in decision making for therapeutic interventions. Although essential to the conduct of research, how these individuals respond to requests for clinical trial participation is poorly understood. METHODS Survey data collected to examine surrogate attitudes toward research provided the conceptual framework to explore influences on decision making. Path analysis was used to derive the final model (nonlatent, fully recursive, 1 indicator/variable). RESULTS Surrogates with list-wise complete records (406) were analyzed. The following variables were not retained in the final model: education, income, religiosity, decision-making experience, discussion of patients wishes, number of individuals assisting with decision making, trust in care providers, difficulty making decisions, and responsibility for decision making. Being white and having experience making treatment decisions for the patient during the current intensive care unit encounter affected the likelihood the surrogate would permit participation in research positively (parameter estimates, 0.281 and 0.06, respectively). No variable reflecting difficulty functioning in the surrogate role was associated with permitting research participation. CONCLUSIONS We were unable to demonstrate a relationship between perceived difficulty in decision making in the surrogate role and receptivity to clinical trial participation.