RADAR: A Measure of the Sixth Vital Sign?

Transcription

1 603346CNRXXX / Clinical Nursing ResearchVoyer et al. research-article2015 Article RADAR: A Measure of the Sixth Vital Sign? Clinical Nursing Research 2016, Vol. 25(1) 9 29 The Author(s) 2015 Reprints and permissions: sagepub.com/journalspermissions.nav DOI: / cnr.sagepub.com Philippe Voyer, RN, PhD 1,2, Nathalie Champoux, MD, MSc 3, Johanne Desrosiers, OT, PhD 4, Philippe Landreville, PhD 1, Jane McCusker, MD, DrPH 5,6, Johanne Monette, MD, MSc 7,8, Maryse Savoie, RN, MSc 6, Pierre-Hugues Carmichael, MSc 2, Hélène Richard, MSc 2, and Sylvie Richard, OT, MSc 2 Abstract The objective of this study was to investigate the potential of RADAR (Recognizing Active Delirium As part of your Routine) as a measure of the sixth vital sign. This study was a secondary analysis of a study (N = 193) that took place in one acute care hospital and one long-term care facility. The primary outcome was a positive sixth vital sign, defined as the presence of both an altered level of consciousness and inattention. These indicators were assessed using the Confusion Assessment Method. RADAR identified 30 of the 43 participants as having a positive sixth vital sign and 58 of the 70 cases as not, yielding a sensitivity and specificity of 70% and 83%, respectively. Positive predictive value was 71%. RADAR s characteristics, including its brevity and 1 Laval University, Quebec City, Canada 2 Centre for Excellence in Aging-Research Unit, Quebec City, Canada 3 Montreal University, Quebec, Canada 4 Sherbrooke University, Quebec, Canada 5 St Mary s Hospital, Montreal, Quebec, Canada 6 McGill University, Montreal, Quebec, Canada 7 Jewish General Hospital, Montreal, Quebec, Canada 8 Donald Berman Maimonides Geriatric Center, Montreal, Quebec, Canada Corresponding Author: Philippe Voyer, Faculty of Nursing Sciences, Laval University, Pavillon Ferdinand-Vandry, Room 3445, 1050, rue de la Médecine, Quebec City, Quebec, Canada G1V 0A6. philippe.voyer@fsi.ulaval.ca

2 10 Clinical Nursing Research 25(1) acceptability by nursing staff, make this tool a good candidate as a measure of the sixth vital sign. Future studies should address the generalizability of RADAR among various populations and clinical settings. Keywords mental status, sixth vital sign, elderly, cognitive impairment Altered mental status generally refers to a range of symptoms that include disorders in cognition, level of consciousness, and attention (American College of Emergency Physicians, 1999). Just as an increased body temperature can be a sign of infection, an alteration in mental status can also be the only sign of an infection in older adults and not recognizing it could prove detrimental to the patient (Fick & Foreman, 2000; Inouye, Rushing, Foreman, Palmer, & Pompei, 1998; McAvay et al., 2006). For this reason, the Veterans Affairs (VA) Delirium Working Group recommended the addition of mental status to the five vital signs currently measured in most clinical settings: heart rate, blood pressure, respiratory rate, temperature, and pain (Flaherty et al., 2007). Other researchers also endorse adding mental status as the sixth vital sign (Bellelli & Trabucchi, 2008; Rosenbloom et al., 2012). Vital signs are measurements of the body s most basic physical functions, and mental status should also be seen as a vital sign (Inouye, Westendorp, & Saczynski, 2014). Common causes for an altered mental status include infection, drug toxicity, cardiac failure, metabolic disturbances, and cerebrovascular conditions (Xiao et al., 2012). In fact, the etiology is often multifactorial and may include a combination of predisposing and precipitating factors (Cole et al., 2011; Inouye & Charpentier, 1996). Screening for the sixth vital sign is therefore essential to rapidly identify and address the underlying problems and so limit its deleterious consequences. An altered mental status is usually secondary to delirium, stupor, and coma, all of which are associated with impaired consciousness (Han & Wilber, 2013). For this reason, some authors suggest using the clinical features of delirium to create the sixth vital sign because an altered level of consciousness is a key feature for delirium (Flaherty et al., 2009). In this regard, a study among 30 elderly patients who underwent hip surgery confirmed that altered level of consciousness was a strong indicator of delirium or subsyndromal delirium (Tieges, McGrath, Hall, & Maclullich, 2013), a condition in which patients have one or more symptoms of delirium without displaying its full clinical presentation (Cole, Ciampi, Belzile, & Dubuc-Sarrasin, 2013). Both delirium and subsyndromal delirium are associated with poor outcomes (Cole et al., 2013; McAvay et al., 2006).

3 Voyer et al. 11 Level of consciousness can be evaluated by observing the patient during routine care. It is reported as normal if the patient is alert. Conversely, level of consciousness is recognized as impaired if the patient is hyperalert (overly sensitive to environmental stimuli), lethargic (drowsy but arousal is possible by voice), stuporous (drowsy but arousal is possible through vigorous touching), or comatose (unarousable; Wilber, 2006). Patients with an altered level of consciousness often present signs of inattention, that is, difficulty in focusing, sustaining, and shifting attention appropriately. It should be noted that the alteration of mental status observed in delirium is characterized by the presence of both inattention and an altered level of consciousness (American Psychiatric Association [APA], 2013). For this reason, the literature underscores the importance of including both these symptoms in the measure of the sixth vital sign (Flaherty et al., 2009). In addition, the inclusion of these specific symptoms will aid in differentiating delirium from mental status alterations that occur as a result of chronic conditions, such as dementia. Patients with dementia show an abnormal level of consciousness and attention only in the later stages of the disease, or in Lewy body dementia. Consequently, including both of these two symptoms (level of consciousness and attention) will increase the sensitivity of the measure, and it will be defined as such in this study. A measure of the sixth vital sign must also overcome several challenges. As for the other vital signs, a positive result should trigger a search for potential underlying problems. Therefore, the measure has to be sensitive and relatively specific to a change in consciousness level and inattention. Measure of the sixth vital sign must also be reproducible among raters and valid for use across various clinical settings (e.g., acute and long-term care settings) and populations (e.g., individuals with dementia, cognitive impairment, communication problems, and so on; Boockvar et al., 2008; Flaherty et al., 2009). As vital signs are usually taken several times over a 24-hr period, bias due to repeated testing that could affect the validity of the measure should be avoided as well. In fact, measuring mental status is very different from measuring respiratory rate or blood pressure because it may actively involve the patients. For instance, although asking for a response such as Say the months of the year backwards is a very effective way to assess attention (O Regan et al., 2014), if the request is repeated several times throughout the day, practice rather than any real change in the patient s attention may result in their getting better at answering (Boockvar et al., 2008; Kolanowski et al., 2012). The nursing staff s acceptability of the measure and its recognition across disciplines are also crucial to its successful implementation. Therefore, the development of a mental status measure has to take into account the extent of the skills those usually responsible for taking vital signs, that is, nurses and licensed practical nurses (LPN). In addition, every effort should be made to

4 12 Clinical Nursing Research 25(1) avoid placing an additional burden on staff s already heavy workload. For this reason, the measure should not require the patient to answer a lot of questions or be a pen-and-paper test. RADAR (Recognizing Active Delirium As part of your Routine; is a new tool that was developed for use during routine practice to recognize the signs that are indicative of delirium (Voyer et al., 2015). Because RADAR meets most of the requirements mentioned, this tool would be suitable for measuring the sixth vital sign: (a) It includes a measure of level of consciousness and attention; (b) it is sensitive to delirium, a mental status change; (c) it has good interrater reliability; (d) it has been validated in acute and long-term care settings among older adults with and without cognitive impairment; (e) it is completed solely through observation of the patient during the distribution of medication, therefore no direct questioning or testing are necessary; (f) it is very well accepted by nursing staff (registered nurses [RN] and LPN); and (g) it takes only 7 s to complete. The aim of this study is to investigate the potential of RADAR as a measure of the sixth vital sign. We hypothesized that RADAR would be sensitive to a positive sixth vital sign (defined as the presence of both an altered level of consciousness and inattention) among older individuals, with or without cognitive impairment, in both acute and long-term care settings. Method Study Design and Settings The present study is a secondary analysis of data from a previously published study (Voyer et al., 2015) that took place from November 2012 to November 2013 on three units (medical, cardiology, and coronary care) of an acute care hospital (ACH) and four units of one long-term care facility (LTC). The Research Ethics Boards of each participating facility approved the study. Described method, as well as its sample, is from the original study; in this article, only the research questions and statistical plan are different. Selection of Participants Patients/residents enrollment. Patients (ACH)/residents (LTC), with or without a medical diagnosis of dementia in their medical chart, were included in the study if they were aged 65 years or older and were receiving medication on at least two occasions during the day. We excluded anyone with a history of psychiatric illness (specifically psychotic disorders, bipolar disorders, and major depressive disorders with psychotic features). A research assistant (RA) compiled weekly lists of all eligible patients/residents for each study site.

5 Voyer et al. 13 Recruitment procedures varied for individuals with and without cognitive impairment. Cognitive impairment was defined as the presence of any indicators (e.g., dementia, confusion, disorientation, etc.) in the medical chart or reported by the bedside nurse, which could affect the patient/resident s ability to make an informed decision regarding study participation. For individuals with cognitive impairment, the institution s staff sent out an information letter about the study to the legal guardians or, in the absence of such, to the family member designated as guardian and invited them to contact the RA for further information. Respondents who authorized participation on behalf of another were asked to sign proxy consent forms. For reasons related to workload, a maximum of six consenting patients/residents were randomly selected each week to participate in the study. Direct assent to participation was obtained from those individuals who are deemed to have mild or moderate cognitive impairment (according to the RA s clinical judgment). Potential participants among patients/residents without cognitive impairment were also randomly selected from the weekly list of all those eligible for the study. Their bedside nurse asked them whether they would agree to meet with the RA to learn about the project. Those who then agreed to take part were invited to sign the consent form. Nursing staff enrollment and training. Part-time and full-time RNs, LPNs, and candidates for the profession of nursing practice (CPNPs) who were working day and evening shifts, with at least 2 months of work experience in the selected facility and a minimum of 5 days on the targeted unit in the previous month, were invited to take part in the study. We then sought their informed consent. LPNs are nursing staff with 18 months of training who can provide certain basic nursing care (e.g., dressing changes, medication administration). CPNPs (candidate pending entry to nursing profession) have completed their 3-year training to become RN but still have to pass exams from the regulatory body. Training on the use of RADAR was given to all participating nursing staff. The training consisted of a 15-min PowerPoint presentation with instructions on how to administer and score the RADAR items. This presentation included four 1-min videos showing simulated nurse patient interactions during the medication distribution process. Following each viewing, and to ensure they correctly understood the information, all participants had to complete the RADAR. In addition, a RA gave at least two individual coaching sessions to the participating nurses. One such session was done at the patient s bedside during the participating nurse s first completion of RADAR and consisted of reviewing the completed items for validation. The second individual coaching session took place every 4 weeks, or as needed, with the sole objective of going over the instructions on how to complete each RADAR item.

6 14 Clinical Nursing Research 25(1) Data Collection and Measures The RADAR (see the appendix) was inserted into the folder containing the medication administration record for each participating patient/resident. Participating nursing staff were to complete the RADAR during every scheduled distribution of medication. Two RAs per study site were responsible for gathering data on each patient/resident over a 12-hr period that included all potential distributions of medication (8:00 a.m., 12:00 p.m., 17:00 p.m., and HS [at bedtime]). The first RA focused on the assessment of the sixth vital sign and the evaluation of the level of cognitive impairment. The second RA, blinded to the results of the sixth vital sign evaluation, was responsible for administering the RADAR at exactly the same time as the bedside nurse and for collecting the participant s baseline characteristics (age, sex, date of admission, level of functional autonomy, level of comorbidity, and type of dementia, if any). Operationalization of a positive sixth vital sign. As previously mentioned, a positive sixth vital sign was defined as the presence of both an altered level of consciousness (hyperalert, lethargic, stuporous, or comatose) and inattention over the course of the day. The Confusion Assessment Method (CAM) was used to measure these symptoms. The RA based the completion of the CAM on several data sources (medical chart, family members, if available, and nursing staff) and on observations made during three structured interviews in a 7-hr period. One such interview included administration of a cognitive test, the Hierarchic Dementia Scale (HDS; Cole & Dastoor, 1987). Instruments for Primary Measures The RADAR was used to screen for the sixth vital sign. RADAR is a screening instrument initially developed by our team to detect signs of delirium during routine practice. The different steps that led to its final version have been described elsewhere (Voyer et al., 2015). In essence, the RADAR scale consists of three items, each of which represents an observable sign for a specific symptom of delirium: That is, Item 1: Was the patient drowsy? a decreased level of consciousness (hypoalert); Item 2: Did the patient have trouble following your instructions? inattention, plus an increased level of consciousness (hyperalert) or psychomotor agitation; and Item 3: Were the patient s movements slowed down? psychomotor retardation. In a validation study conducted among 142 patients (acute care) and 51 residents (long-term care) aged 65 and older, with or without dementia, the RADAR was found to have high percentages of interrater agreement (82%-98%). When compared

7 Voyer et al. 15 with Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; DSM-IV-TR; APA, 2000) criterion-defined delirium, RADAR had a sensitivity of 73% and a specificity of 67%. Participating nursing staff took about 7 s on average to complete the tool and RADAR was very well received ( 98%) overall. The CAM (Inouye et al., 1990) was used to assess the presence of an altered level of consciousness and inattention (positive sixth vital sign). The CAM takes 10 min to complete and was designed to allow a nonpsychiatrist clinician to assess the nine criteria for delirium specified in the Diagnostic and Statistical Manual of Mental Disorders (3rd ed., rev.; DSM-III-R; APA, 1987), that is, (a) acute onset and fluctuation of symptoms over the course of the day, (b) inattention, (c) disorganized thinking, (d) altered level of consciousness, (e) disorientation, (f) memory impairment, (g) perceptual disturbances, (h) psychomotor agitation or retardation, and (i) altered sleep wake cycle. The CAM is an established and widely used instrument to help in the detection of delirium in both clinical and research settings and has been shown to be sensitive (94%-100%) and specific (90%-95%), when compared with the diagnosis of a psychiatrist (Inouye et al., 1990; Wei, Fearing, Sternberg, & Inouye, 2008). Instruments for Descriptive Measures Cognitive impairment severity was assessed using the HDS (Cole & Dastoor, 1987). Maximum score for the entire scale is 200 points. Older adults who are cognitively intact generally score the maximum number of points or close to it (Bickel, 1996). This scale displays almost no floor effect; that is, participants with severe dementia can respond correctly to some of the easiest items and obtain scores other than 0 (Ronnberg & Ericsson, 1994). The HDS has well established validity and reliability (Bickel, 1996). For example, Ronnberg and Ericsson (1994) reported a test retest reliability of.96 (Spearman s rho coefficients) and a concurrent validity coefficient of 0.86 between the HDS and the Mini-Mental Status Examination. Engelborghs and colleagues (2006) demonstrated a significant correlation between HDS scores and biological markers of Alzheimer s disease. Functional autonomy was measured according to the Functional Autonomy Measurement System (SMAF; Hebert, Carrier, & Bilodeau, 1988). This 29-item scale measures functional ability in five areas: activities of daily living (ADL; 7 items), mobility (6 items), communication (3 items), mental functions (5 items), and instrumental activities of daily living (IADL: 8 items). In this study, we used a modified 20-item version of the SMAF for institutionalized participants (excluding the 8 IADL items and 1 item related

8 16 Clinical Nursing Research 25(1) to exterior mobility). Disability for each item is scored on a 5-point scale: 0 = independent, 0.5 = with difficulty, 1 = with supervision, 2 = with help, and 3 = dependent. This version of the scale has shown good test retest and interrater reliability (intraclass correlation [ICC] of.95 and.96, respectively; Desrosiers, Bravo, Hebert, & Dubuc, 1995). A higher score is indicative of severe impairment of autonomy. Data extracted from the participants medical charts included demographic information (e.g., age, sex, and years since admission), diagnosis of dementia, and other medical diagnoses. Information on medical problems was used to compute the Charlson Comorbidity Index (Charlson, Pompei, Ales, & MacKenzie, 1987) which is validated as a predictive index for survival among older patients and nursing home residents (Bravo, Dubois, Hebert, De Wals, & Messier, 2002; Buntinx et al., 2002). The overall score ranges from 0 to 37, with higher scores indicating greater comorbidity. Data Analysis Plan To present the participants characteristics, researchers used means and standard deviations or frequencies and percentages to describe continuous and discrete variables, respectively. A RADAR screening was deemed positive if at least one of the three items was checked as present. Participants were said to be positive for RADAR if they received at least one positive RADAR screening during the day. First, we evaluated the convergent validity between the RADAR items and their corresponding symptoms (hypoalert, inattention and hyperalert/ agitation, and psychomotor retardation) as measured with the CAM. We also computed the proportion of agreement (percent agreement) and the kappa values with their confidence intervals. Second, using criterion-defined positive sixth vital sign as gold standard, we used sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively), and their confidence intervals to calculate the concurrent validity of each RADAR item and the RADAR scale as a whole. All analyses were carried out using SAS for Windows, version 9.3. Results Description of the Study Population Patients/residents. A total of 589 patients and 90 residents met the eligibility criteria. Of these, 267 (38%) were asked to participate in the study and 210 (79%) consented. Of those who consented, 17 (8.1%) were not evaluated

9 Voyer et al. 17 (7 withdrew their consent, 5 were discharged home, and 5 others were no longer eligible), which left a sample for analysis consisting of 142 (74%) patients and 51 (26%) residents. Table 1 shows the characteristics of these patients/residents. Mean age was 81 years, 37 (19%) had a high level of comorbidity (score 8 on the Charlson Comorbidity Index), and 24 (12%) showed substantial alteration in their functional autonomy (score 29 on the SMAF). For example, among this last group, 15 (63%) were completely dependent for personal hygiene, 17 (75%) were dependent for dressing, and 15 (63%) were unable to walk. The medical charts of 41 (21%) patients/ residents included a diagnosis of dementia. A total of 68 (35.2%) participants met the criteria for a positive sixth vital sign, meaning an alteration in the level of consciousness and inattention. Nursing staff. A total of 63 (45%) RNs, 70 (50%) LPNs, and 6 CPNPs (4%) consented to take part in the study, representing a recruitment rate of 96%. Mean number of years (SD) of experience in nursing and in geriatrics were 10.8 (10.3) and 9.7 (9.2), respectively. Detailed Descriptive Data on RADAR Descriptive results of the RADAR showed that 64 (33%) of 193 participants had a positive RADAR. A total of 541 RADAR screenings were administered to these 193 participants by bedside nursing staff or RA; 98 (18%) of the 541 RADAR administered were positive. More precisely, 40 (63%) participants had one positive RADAR, 16 (25%) had two positives, 6 (9%) had three positives, and 2 (3%) had four positive RADARs out of the four RADAR administrations. In all the RADAR screenings with a positive score, Item 3 (Were the patient s movements slowed down?) was checked as positive the most often (86; 88%), while Item 1 (Was the patient drowsy?) was positive the least often (25; 26%). More than half (57; 58%) of the RADAR screenings with a positive score had one item checked as present, 26 (27%) had two items checked, and 15 (15%) had three. Convergent Validity of RADAR With the Sixth Vital Sign The percentages of agreement between the RADAR items and their corresponding CAM symptom ranged from 36% to 85%. The lowest percentage of agreement was for RADAR Item 2... did the patient have trouble following your instructions? and inattention while the highest percentage was for the same RADAR item and hyperalert/agitation. Kappa values varied from 0.08 to 0.42.

10 Table 1. Characteristics of Patients/Residents. Total (N = 193) Patients = 142 (73.6%) Residents = 51 (26.4%) Variables [Missing] n % M SD n % M SD n % M SD Age (years) Female Diagnosis of dementia (yes) Types of dementia Unspecified Alzheimer s Vascular Mixed Korsakoff syndrome Positive sixth vital sign a Severity of cognitive impairment (HDS) [1] Mild ( 160) Moderate (between 40 and 160) Severe ( 40) Level of functional autonomy (SMAF) Mild (<29) Moderate (29-40) Severe (>40) Level of comorbidity: (CCI) Severe Number of medications/day Number of distributions of medications/day Note. HDS = Hierarchic Dementia Scale; SMAF = Functional Autonomy Measurement System; CCI = Charlson Comorbidity Index; [1] = Missing data. a Positive sixth vital sign was defined as the presence of both an altered level of consciousness (hyperalert, lethargic, stuporous, or comatose) and inattention over the course of the day, as measured with the Confusion Assessment Method. 18

11 Voyer et al. 19 Concurrent Validity of RADAR With the Sixth Vital Sign Table 2 presents the concurrent validity of RADAR items taken individually compared with a criterion-defined positive sixth vital sign. Item 3 (Were the patient s movements slowed down?) was the best performing item with a sensitivity of 54.4% and a specificity of 85.5%. The concurrent validity of the RADAR scale was optimal among participants who underwent three to four RADAR screenings in the day (Table 3). Among this group (n = 113), RADAR identified 30 of the 43 patients/residents with a positive sixth vital sign, yielding a sensitivity of 70%. Alternatively, RADAR identified 58 of the 70 cases without a positive sixth vital sign, which corresponds to a specificity of 83%. The PPV of RADAR was moderately high (71%), indicating that among the 42 patients/residents with a positive RADAR, 30 had a positive sixth vital sign. We undertook further analysis to determine the profile of the 12 participants who had both a positive RADAR and a negative sixth vital sign. We found that 8 of them had inattention, while 3 had an altered level of consciousness. In other words, 92% had a partial positive sixth vital sign. The concurrent validity of the RADAR scale was also examined according to the presence, or not, of cognitive impairment/dementia (Table 4). Although the sensitivity of the tool remained almost the same, the specificity decreased among participants with cognitive impairment or a diagnosis of dementia in their medical chart. Discussion Although RADAR was initially developed for delirium screening among elderly individuals, with or without dementia, in acute and long-term care settings, several of its features make it worthwhile to investigate using RADAR as a measure of the sixth vital sign. In this regard, RADAR can be administered quickly (7 s) by both RNs and LPNs without the need to question patients/residents, and RADAR can be administered several times during the day without incurring the possibility of patient-learned responses or increasing nursing staff workloads. RADAR also has a good interrater reliability and is well accepted by nursing staff (RN and LPN). Most importantly, it includes items that assess the presence of both an altered level of consciousness and inattention, two important features to include in a measure of mental status (Voyer et al., 2015). The results of this study show that RADAR is sensitive to a positive sixth vital sign among older patients, with or without cognitive impairment, in both acute and long-term care settings. This is the first study to propose a screening tool sensitive to a positive sixth vital sign among older individuals in acute and long-term care settings.

12 Table 2. Concurrent Validity of RADAR Items Compared With a Criterion-Defined Positive Sixth Vital Sign. Sensitivity Specificity Positive predictive value Negative predictive value RADAR items % 95% CI % 95% CI % 95% CI % 95% CI Item 1:... was the patient drowsy? 17.6 [9.5, 28.8] 96.8 [92.0, 99.1] 75.0 [47.6, 92.7] 68.4 [61.0, 75.1] Item 2:... trouble following instructions? 30.9 [20.2, 43.3] 94.4 [88.8, 97.7] 75.0 [55.1, 89.3] 71.5 [64.0, 78.3] Item 3:... movements slowed down? 54.4 [41.9, 66.5] 85.5 [78.0, 91.2] 67.3 [53.3, 79.3] 77.4 [69.4, 84.1] Note. Positive sixth vital sign was defined as the presence of both an altered level of consciousness (hyperalert, lethargic, stuporous, or comatose) and inattention over the course of the day, as measured with the Confusion Assessment Method. RADAR = Recognizing Active Delirium As part of your Routine; CI = confidence interval. 20

13 Table 3. Concurrent Validity of RADAR Compared With a Criterion-Defined Positive Sixth Vital Sign, According to the Number of Daily RADAR Administrations. Sensitivity Specificity Positive predictive value Negative predictive value Number of RADAR administrations (n) % 95% CI % 95% CI % 95% CI % 95% CI 1 to 4 (193) 63.2 [50.7, 74.6] 83.2 [75.5, 89.3] 67.2 [54.3, 78.4] 80.6 [72.7, 87.0] 1 to 2 (80) 52.0 [31.3, 72.2] 83.6 [71.2, 92.2] 59.1 [36.4, 79.3] 79.3 [66.6, 88.2] 3 to 4 (113) 69.8 [53.9, 82.8] 82.9 [72.0, 90.8] 71.4 [55.4, 84.3] 81.7 [70.7, 89.9] Note. Positive sixth vital sign was defined as the presence of both an altered level of consciousness (hyperalert, lethargic, stuporous, or comatose) and inattention over the course of the day, as measured with the Confusion Assessment Method. RADAR = Recognizing Active Delirium As part of your Routine; CI = confidence interval. 21

14 Table 4. Concurrent Validity of RADAR Compared With a Criterion-Defined Positive Sixth Vital Sign in Different Subsamples of Participants (Based on three to four RADAR Administrations, n = 113). Sensitivity Specificity Positive predictive value Negative predictive value Subsamples of participants (n) % 95% CI % 95% CI % 95% CI % 95% CI With cognitive impairment or dementia (42) 70.4 [49.8, 86.2] 60.0 [32.3, 83.7] 76.0 [54.9, 90.6] 52.9 [27.8, 77.0] Without cognitive impairment or dementia (71) 68.8 [41.3, 89.0] 89.1 [77.8, 95.9] 64.7 [38.3, 85.8] 90.7 [79.7, 96.9] Note. Positive sixth vital sign was defined as the presence of both an altered level of consciousness (hyperalert, lethargic, stuporous, or comatose) and inattention over the course of the day, as measured with the Confusion Assessment Method. RADAR = Recognizing Active Delirium As part of your Routine; CI = confidence interval. 22

15 Voyer et al. 23 The VA Delirium Working Group has presented their preliminary work on the development of a measure of the sixth vital sign (Flaherty et al., 2009). However, their tool, a pictorial visual scale, which included both the assessment of level of consciousness and attention, has yet to be validated. Furthermore, none of the existing tools reported in the literature appear to be a good candidate as a measure of the sixth vital sign. Indeed, some of these instruments target only one of the two features, that is, level of consciousness or attention. For instance, the Glasgow Coma Scale (Teasdale & Jennett, 1974) and the Alert/Verbal/Painful/Unresponsive Scale (American College of Surgeons Committee on Trauma, 1997) are the most commonly used tools to measure level of consciousness (Kelly, Upex, & Bateman, 2004). Those tools, which were initially developed for trauma assessment in the emergency department, have become useful as an indicator of illness severity (Kelly et al., 2004). With regard to attention, simple and quick tests are also available to assess this second feature. For example, two items of the Folstein s Mini Mental State Examination (Folstein, Folstein, & McHugh, 1975), serial sevens (counting down from 100 by sevens) and WORLD (spelling the word world backward), as well as reciting the months of the year in reverse order (O Regan et al., 2014) can be easily administered by any health care staff at bedside. However, the Folstein s items are particularly sensitive to the patient s educational level. Moreover, these tests cannot be used among patients who are unable to speak or those with severe dementia, and as mentioned previously, patients can learn these tests and so the test becomes less effective over time. Other tools including both measures of level of consciousness and attention are available and have been designed to screen for, or detect, delirium. However, their characteristics limit their use as a measure of the sixth vital sign. For instance, administration time is an important issue as vital signs are taken several times over the course of the day. For this reason, neither the CAM (Inouye et al., 1990), which takes 10 min to administer, nor the Delirium Observation Scale (Schuurmans, Shortridge-Baggett, & Duursma, 2003), which includes 13 items with an administration time of approximately 5 min, would be appropriate. The 4At (Bellelli et al., 2014), a recently developed delirium screening tool, could have been interesting as its administration time is less than 2 min. However, the item measuring attention is to recite the months of the year backward, the limitations of which we have already described. This item, together with the requirement to know the patient s mental functioning in the 2 weeks preceding hospitalization, constitute constraints that preclude use of the 4At as a measure of the sixth vital sign.

16 24 Clinical Nursing Research 25(1) Study Limitations Even though RADAR was found sensitive to a positive sixth vital sign in both acute and long-term care, further work is needed. First, because RADAR was designed to be completed during the medication administration process, the format of the tool and its training program would need to be modified accordingly. For instance, the sentence When you gave the patient his or her medication did... would be replaced by When you took the patient s vital signs did..., and similarly, the simulated nurse patient interactions in the training program would be adapted to the context of recording the vital signs. Second, although we have no reason to believe that the patient/nurse interaction involved during the measurement of vital signs would be less informative about the patient s functioning than that involved during the act of taking medication for example, is the patient following the instruction by opening the mouth for a glass of water (medication) or thermometer (vital sign) further studies are needed to verify this assumption. Third, contrary to the process of administering medication, the frequency at which vital signs are recorded can vary greatly, depending on the clinical settings (acute vs. longterm care), type of medical unit (orthopedic vs. intensive care), as well as the patient s medical status (stable vs. unstable). In our study, when RADAR was administered during the medication administration process, we found that RADAR sensitivity for a positive sixth vital sign was optimal when based on three to four RADAR administrations throughout the day. Future studies are necessary to assess whether this same result is also observed when RADAR is administered during measurement of vital signs. Fourth, RADAR was validated among a group of patients and residents aged 65 years and older. For RADAR to be used across a wider range of age groups and in other settings, such as intensive care and home care, necessitates further validation studies. Last, future research will also have to address the decreased specificity of the RADAR in participants with cognitive impairment. Despite these limitations, if a health professional is concerned about his or her patients mental status and wants to move forward with a measure of the sixth vital sign, then RADAR could be a valuable option to consider at this time. In conclusion, RADAR is sensitive to a positive sixth vital sign among patients and residents 65 years and older, with or without dementia. Its characteristics including its brevity and acceptability by nursing staff make this tool a good candidate as a measure of the sixth vital sign. Minor modifications to both the tool format and training will be necessary to adapt RADAR to the context of monitoring vital signs. Future studies should also address the generalizability of RADAR among different populations (younger adults) and clinical settings (intensive care, home care, etc.).

17 Voyer et al. 25 Appendix The RADAR form Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by a grant from the Canadian Institutes of Health Research (#221803) and the Réseau Québécois de Recherche sur le Vieillissement. Financial support was also received from the Saint- Sacrement Hospital Foundation. References American College of Emergency Physicians. (1999). Clinical policy for the initial approach to patients presenting with altered mental status. Annals of Emergency Medicine, 33,

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20 28 Clinical Nursing Research 25(1) Ronnberg, L., & Ericsson, K. (1994). Reliability and validity of the Hierarchic Dementia Scale. International Psychogeriatrics, 6, Rosenbloom, M., Barclay, T., Perfect, D., Pyle, M., Kiihn, M., Zahs, K.,... Hanson, L. (2012). The sixth vital sign project: Is cognitive screening in the elderly population clinically effective? Alzheimer s & Dementia, 8, P366-P367. Schuurmans, M. J., Shortridge-Baggett, L. M., & Duursma, S. A. (2003). The Delirium Observation Screening scale: A screening instrument for delirium. Research and Theory for Nursing Practice, 17, Teasdale, G., & Jennett, B. (1974). Assessment of coma and impaired consciousness: A practical scale. The Lancet, 2, Tieges, Z., McGrath, A., Hall, R. J., & Maclullich, A. M. (2013). Abnormal level of arousal as a predictor of delirium and inattention: An exploratory study. American Journal of Geriatric Psychiatry, 21, doi: /j.jagp Voyer, P., Champoux, N., Desrosiers, J., Landreville, P., McCusker, J., Monette, J.,... Carmichael, P. H. (2015). Recognizing acute delirium as part of your routine [RADAR]: A validation study. BMC Nursing, 14, 19. doi: /s Wei, L. A., Fearing, M. A., Sternberg, E. J., & Inouye, S. K. (2008). The confusion assessment method: A systematic review of current usage. Journal of the American Geriatrics Society, 56, doi: /j x Wilber, S. T. (2006). Altered mental status in older emergency department patients. Emergency Medicine Clinics of North America, 24, , vi. doi: / j.emc Xiao, H. Y., Wang, Y. X., Xu, T. D., Zhu, H. D., Guo, S. B., Wang, Z., & Yu, X. Z. (2012). Evaluation and treatment of altered mental status patients in the emergency department: Life in the fast lane. World Journal of Emergency Medicine, 3, doi: /wjem.j Author Biographies Philippe Voyer, RN, PhD, is full professor at the Faculty of Nursing Sciences, Laval University, and both researcher and clinician at Centre for Excellence in Aging- Research Unit, Quebec City, Quebec, Canada. Nathalie Champoux, MD, MSc, is full professor at the Faculty of Medicine, Montreal University, Montreal, Quebec, Canada. Johanne Desrosiers, OT, PhD, is full professor at the Faculty of Medicine and Health Sciences, Sherbrooke University, Sherbrooke, Quebec, Canada. Philippe Landreville, PhD is full professor at the Faculty of Social Sciences, Laval University Quebec City, Quebec, Canada. Jane McCusker, MD, DrPH is researcher at St. Mary s Research Centre, St Mary s Hospital, Montreal, and full professor at the Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.

21 Voyer et al. 29 Johanne Monette, MD, MSc, is geriatrician and researcher at Lady Davis Institute for Medical Research, Sir Mortimer B. Davis-Jewish General Hospital, McGill University, Montreal, Quebec, Canada. Maryse Savoie, RN, MSc, director of Nursing and Strategic Affairs, Ste-Anne Hospital, Montreal, Quebec, Canada. Pierre-Hugues Carmichael, MS is statistician at the Centre for Excellence in Aging- Research Unit, Quebec City, Quebec, Canada. Hélène Richard, MS is a research assistant at the Centre for Excellence in Aging- Research Unit, Quebec City, Quebec, Canada. Sylvie Richard, OT, MSc is a research assistant at the Centre for Excellence in Aging-Research Unit, Quebec City, Quebec, Canada.