Copyright 1996 by The Gerontological Society of America Journal of Gerontology: PSYCHOLOGICAL SCIENCES 1996, Vol. 51B, No. 6, P364-P373 Environmental "White Noise": An Intervention for Verbally Agitated Nursing Home Residents Louis Burgio, Kay Scilley, J. Michael Hardin, C. Hsu, and Jeannie Yancey University of Alabama at Birmingham. This study presents preliminary data on the efficacy of two environmental "white noise" audiotapes for the treatment of verbal agitation in severely demented nursing home residents. The researchers employed a computer-assisted realtime observational system to assess both the frequency of verbal agitation and the actual use of the intervention on the nursing units (treatment fidelity). Intervention by nurse aides (NAs) on the unit was preceded by a researchercontrolled functional analysis phase that provided information regarding which of the two audiotapes would be most effective for individual residents. Results indicate a 23% reduction in verbal agitation with this individualized treatment strategy on the nursing units. These results were obtained even though treatment fidelity data showed that the audiotapes were used during only 51% of the observations. The authors discuss the need for formal staff management procedures for increasing staff compliance with treatment regimens. agitation is a prevalent form of behavioral VERBAL disturbance, in nursing homes with 11% (Cariaga, Burgio, Flynn, & Martin, 1991) to 28% (Ryan, Tanish, Kolodny, Lendrum, & Fischer, 1988) of residents exhibiting some form of this problem. As used by most researchers, this term includes an array of vocal behaviors including screaming, calling out, repetitive statements, and moaning. Verbal agitation can be stressful to other residents and to direct care staff. Over time, the occurrence of this and other disruptive behaviors can adversely affect the morale of nursing staff. This, in turn, can impact the quality of care provided to all residents. Historically, residents displaying clinically significant verbal agitation have received pharmacotherapy, with psychotropic drugs used most frequently (Billig, CohenMansfield, & Lipson, 1991). Unfortunately, pharmacotherapy has been shown to be, at best, only moderately effective (Devanand, Sackheim, & Mayeux, 1988; Sunderland & Silver, 1988). In fact, a meta-analysis examining the efficacy of pharmacotherapy with patients diagnosed with Alzheimer's disease, found that only 1 out of every 5 patients responded favorably to this type of intervention (Schneider, Pollock, & Lyness, 1990). Moreover, pharmacotherapy can produce serious side effects, including, but not limited to, memory impairment (Larson, Kukill, Buchner, & Reifler, 1987), sedation (Allen, 1986), and tardive dyskinesia (Thompson, Moran, & Nies, 1983). Recognizing these therapeutic limitations, the Health Care Finance Administration (HCFA) passed guidelines (OBRA-87) which restrict the conditions under which nursing homes may administer psychotropic medications (American Health Care Association, 1990). According to these guidelines, residents displaying a behavioral disturbance must also exhibit psychotic symptoms or be a danger to themselves or others before neuroleptic medication can be prescribed. As an alternative to medication, the guidelines specifically recommend that nursing homes utilize behavioral interventions and staff training as an initial approach to managing behavior problems. P364 Behavioral and environmental interventions have shown promise in ameliorating the behavioral complications of dementia in nursing home residents (Burgio & Bourgeois, 1992). Preliminary data suggest that these interventions can be used effectively to treat behavioral excesses such as physical aggression (Vacarro, 1988, 1990) and wandering (Hussian, 1981; Hussian & Brown, 1987); and behavioral deficits in such areas as ambulation (Burgio, Burgio, Engel, & Tice, 1986) and communication skills (Bourgeois, 1991). Researchers have reported limited success in decreasing verbal agitation using behavioral treatments such as differential reinforcement procedures (Birchmore & Clague, 1983), aversive conditioning and time-out (Matheson, Mian, MacPherson, & Anthony, 1976), and positive reinforcement combined with a modified time-out procedure (Baltes & Lascomb, 1975). More recently, researchers have investigated auditory stimulation as an intervention for verbal agitation. One rationale offered for using this type of intervention is that verbal agitation may be an attempt by some residents to provide auditory stimulation in an environment that supplies inadequate stimulation across all modalities. In one study, an inexpensive amplification device was used to decrease yelling in a hearing-impaired elderly nursing home resident (Leverett, 1991). Researchers have also begun to examine the effects of music on verbal agitation. Goddaer and Abraham (1994) used relaxing music during mealtime to decrease verbal agitation in 29 nursing home residents. Gerdner and Swanson (1993) also reported reductions in verbal agitation when music therapy was used with five residents with Alzheimer's disease. Interestingly, in the Gerdner and Swanson study, observations taken during the hour directly following the music intervention continued to show reduced rates of verbal agitation. Finally, Casby and Holm (1994) used classical and favorite music selections to decrease disruptive vocalization in two of the three nursing home residents they treated. Unfortunately, the majority of intervention research with older adults, including the aforementioned studies, have ENVIRONMENTAL ' 'WHITE NOISE'' serious methodological weaknesses. To date, studies have relied heavily on behavioral rating scales as their primary outcome measure (Burgio, 1996). Although rating scales are an excellent resource for gathering information on a rater's current impression of resident behavioral status, they can be insensitive to behavioral change because they are dependent on an individual's ability to recall occurrences of behavior over time (Bellack & Hersen, 1988). More sensitive behavioral data can be gathered through the use of direct observational techniques, with continuous (nonsampled) observation being the most sensitive procedure for recording low rate behaviors (Mudford, Beale, & Singh, 1990). Past studies have also tended to neglect the importance of assessing treatment fidelity (Moncher & Prinz, 1991). Failure to reliably assess the correct application of interventions can compromise the researcher's ability to draw conclusions regarding treatment efficacy. Also, intervention researchers must consider the practicality of implementing any intervention in a naturalistic setting with indigenous staff (e.g., nurse aides) employed as the primary interventionists. Due to the financial constraints and staff shortages that are commonplace in most nursing homes, interventions must be both easy to use and inexpensive (Burgio & Bourgeois, 1992; Burgio & Burgio, 1986). Finally, nursing home intervention research has yet to capitalize on the utility and explanatory power of a behavioral assessment technique termed functional analysis (Neef, 1994). Functional analysis involves the introduction of a brief assessment phase prior to intervention in an effort to generate information on the relationship between environmental events and the behavioral disturbance. Information about this relationship can help inform the therapist about potentially effective environmental interventions. During a functional analysis, environmental stimuli are introduced and withdrawn systematically, while any effects on the behavioral disturbance are examined (Horner, 1994). This assessment strategy has been used extensively in intervention research with developmentally disabled individuals to identify potential individual treatment approaches prior to intervention (Iwata, Dorsey, Slifer, Bauman, & Richman, 1994). The purpose of the present study was to use precise, direct observation assessment techniques to examine the efficacy of an auditory stimulation intervention. Our choice of intervention was based on a serendipitous finding from our prior research. In a pilot study examining the relationship between verbal agitation and environmental contextual variables, our results suggest that residents displayed briefer duration verbal agitation while they were with the nursing home hairdresser (Burgio et al., 1994). Our field notes documented statements from the hairdresser that verbally agitated residents rarely displayed agitation while under a hairdryer. From this we hypothesized that "white noise," produced by the hairdryer, might, through some unknown mechanism, be related to the reduction in verbal agitation. In the present study, we tested this hypothesis by using environmental "white noise" audiotapes (gentle ocean and mountain stream). Recently, environmental "white noise" has been combined with music therapy in the treatment of depression with elderly P365 individuals living in the community (Hanser & Thompson, 1994). Researchers have not previously examined environmental ' 'white noise'' as an intervention for verbal agitation. More specifically, this study examined the efficacy of environmental "white noise" as an intervention for verbal agitation in demented nursing home residents. A functional analysis phase was initiated by research staff, and the resulting information was used by the researchers for planning interventions on the nursing units. Using a computerassisted, real-time observational system, we sampled whether the intervention was in use on the nursing units (treatment fidelity) and measured precise rates of verbal agitation under various conditions. Finally, we assessed the social validity of the intervention (Wolf, 1978), as viewed by the nurse aides (NAs). METHOD Setting and Participants This study was conducted in two Birmingham area nursing homes. A census count at the beginning of the study indicated Nursing Home 1, a county-run facility, had a total of 306 residents residing within the facility; Nursing Home 2, a corporate owned, for-profit facility, had 232 residents. The average nurse-to-resident ratios were similar in both nursing homes. On the day shift, average ratios for NAs, LPNS, and RNs were 1:8, 1:27, and 1:67, respectively. Average staffing ratios for the evening shift were 1:12, 1:27, 1:156 for NAs, LPNS, and RNs, respectively. Neither facility was unionized. Fifteen of the 16 subjects entered into the study had participated in an earlier observational study of verbal agitation. In the earlier study, the nursing staff referred residents who were at least 65 years of age, were expected to remain in the facility for at least 3 months, and exhibited verbal agitation at least once a week; all subjects were judged by the Medical Director to be in stable medical condition. Between the two facilities, 213 residents met the entry criteria. Our consent rate was 54%. Residents in this earlier study were observed for an average of 2.52 hours. The average percentage of total observation time that the residents exhibited verbal agitation was 35% (range = 7%-79%). Prior to the start of the current study, the nursing staff were asked to update the list of verbally agitated residents using the same entry criteria used in the earlier observational study. In an effort to maximize the likelihood of detecting any reduction in verbal agitation due to the interventions, the researchers chose to target only residents displaying severe verbal agitation. To identify these residents, a group of unit charge nurses from each facility was asked to identify the 8 residents displaying the most severe and highest frequency verbal agitation. Also, in preparation for the audiotape intervention, the researchers identified residents with hearing impairments based on medical record review and staff report. Residents with severe hearing impairments were excluded from the study. Although 16 subjects entered the study, not all subjects completed this four-phase study. Figure 1 shows the sequencing of the four phases (baseline, functional analysis, staff training, and intervention). During functional analysis, BURGIOETAL. P366 Sequence of Study Phases Staff Training (2 days) Intervention (10 days) Naturalistic Observations (10 sessions) NO OBSERVATIONAL DATA COLLECTED - 1 5 min — samples Figure 1. Sequence and duration in days of the four study phases. the researchers systematically introduced and withdrew the audiotaped stimuli in a controlled setting to assess the effects of these tapes on rates of verbal agitation. This information was then used by the researchers for' 'prescribing" a specific environmental sound tape for use on the nursing unit (see below for a more detailed description). Three of the 16 residents did not complete the functional analysis phase and were dropped from the study. One of these residents was excluded by the researchers because she displayed a very low rate of verbal agitation during all trials of the functional analysis phase, making it impossible to acquire meaningful assessment data. One resident refused to wear the tape player headphones, and a third resident died prior to functional analysis. The mean age of the 13 residents completing this functional analysis phase was 83.08 years (range = 67-99). Twelve residents were women. Only one resident was reported by staff to have a marked hearing impairment; however, the researchers assumed some level of hearing impairment for the remaining 12 residents. We attempted to assess the residents' cognitive and functional status with the MiniMental State Exam (MMSE; Folstein, Folstein, & McHugh, 1975) and the Barthel Self-Care Rating Scale (Sherwood, Morris, Mor, & Gutkin, 1977). The range of possible scores on the Barthel items is 1-4, with 4 denoting total assistance on the care activity. One resident could not be assessed with the MMSE because of severe agitation. The average MMSE score for the 12 assessed residents was 1.66 (range = 0— 12), indicating severe cognitive impairment. Residents had a mean Barthel item score of 3.44 (range = 1.38—4.0), signifying that this group required near total assistance with activities of daily living. Medical record review showed that 12 of the 13 residents had received a diagnosis of dementia, with 4 of these diagnosed with probable Alzheimer's disease. The resident without a dementia diagnosis presented with symptoms strongly suggestive of dementia. Eight of the 13 residents received psychotropic medications for agitation on a routine basis, with 3 of the 8 residents also prescribed a psychotropic on an "as needed" (PRN) dosage schedule. Only one resident was recorded as having received a PRN psychotropic during the sampled times. Of the 13 residents completing the functional analysis phase, 9 residents displayed reliably lower verbal agitation while exposed to an environmental "white noise" audiotape as compared to the no-audiotape condition. These 9 subjects were considered responders and only they were provided an environmental "white noise" intervention on the nursing unit. The mean age of these 9 residents was 83.89 (range = 67-99); 8 were women. The average MMSE and Barthel scores for this group were 1.00 (range = 0-5) and 3.32 (range = 1.38-4.0), respectively. Eight residents had a dementia diagnosis, with 2 diagnosed with probable Alzheimer's disease. Six of these 9 responders were prescribed psychotropic medication on a routine basis, and 3 prescribed psychotropic medication on a PRN basis. The Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield, Marx, & Rosenthal, 1989) and the Survey of Disruptive Vocal Behavior (SDVB; Cariaga et al., 1991) were administered to NAs to provide a more complete description of the residents' behavioral disturbances. For the 13 residents completing the functional analysis phase, NAs reported that the most common forms of verbal agitation were (the number of residents displaying the behavior is in parentheses): moans/groans (8), self-talk (7), screaming (6), and calling out for assistance (6). The situations reported by NAs where verbal agitation was most likely to occur were: after grooming/bathroom use (5), during grooming/ bathroom use (4), during meals (4), upon awakening in the morning (4), and before evening bedtime (4). Five residents were reported to display verbal agitation constantly. On the CMAI, NAs reported that all 13 residents displayed behavior problems other than verbal agitation (e.g., physical aggression, wandering), with a mean of 3.1 additional problems. Eight residents displayed 1 to 3 and 5 residents displayed 4 to 6 additional behavior problems. Functional Analysis and Treatment Conditions On-unit baseline. — Prior to exposure to the functional analysis procedures, naturalistic observations were conducted with all subjects during a 10-day baseline phase on the nursing units. Behavioral observations were conducted during the 2-5 p.m. and 6-8 p.m. time periods (the dinner period was excluded). Our prior research (Burgio et al., 1994) suggested that verbal agitation was most likely to occur during the late afternoon and early evening hours. Each resident was observed for two continuous 15-minute intervals during each of the 5 hourly blocks of time, for a total of 2.5 hours of observation per resident during the baseline phase. Functional analysis. — Immediately following baseline assessment, the 16 identified residents were exposed to a functional assessment of the mountain stream and gentle ocean audiotapes (13 residents completed the phase). These audiotapes are part of an environmental sounds series and were purchased from the Nature Company® (Berkeley, CA; $9.95 each). Both of the tapes presented a type of environmental "white noise," although the sound profile on the two audiotapes was different. The mountain stream audiotape presented a continuous sound of water rushing over rocks in a stream bed, whereas the gentle ocean audiotape presented the sound of crashing waves interspersed with the more ENVIRONMENTAL ' 'WHITE NOISE'' muffled sound of receding waves. Both sounds are considered by the manufacturer and the researchers to be soothing and monotonous. The audiotapes were played through a portable cassette player with an auto-reverse function and were equipped with headphones; (Gerrard® Personal AM/FM Cassette Stereo, Model 5, $24.95). Over this 10-day phase, each resident was targeted to receive a maximum of four trials (exposures) with each of the two audiotapes (total of eight trials). Each trial lasted 20 minutes, and consisted of four sequential 5-minute segments wherein the therapist alternated "audiotape-on" and "audiotape-off" conditions. The order of audiotape presentation was counterbalanced across trials to control for potential order effects. One requirement of functional analysis is that the subject must either be naturally exhibiting the target behavior during the assessment, or the behavior must be elicited by the researcher so that the effects of the experimental stimuli can be assessed. We preferred to not exercise the latter option; thus, observers were required to be available during lengthy periods of time on the units so that functional assessment could be conducted in response to naturally occurring episodes of verbal agitation. Specifically, research staff made observational "rounds" with participating residents recurrently from 11 a.m. to 5 p.m. (a high probability period for agitation). Although this was the general observational procedure, some residents were agitated more reliably during the morning hours, and these few residents were observed at that time. Within a trial, observations and experimental manipulations (i.e., audiotape on and off) were completed by the same individual, although the role of experimenter/ observer was alternated among a Project Manager and two research assistants. Most of the 13 residents who completed the functional analysis phase displayed verbal agitation at lower rates than predicted by the charge nurses during the initial referral. Consequently, regardless of our frequent availability on the units for observations, only one resident received the complete set of eight trials; 5 residents received six trials; 5 received five trials; one received three trials, and one received two trials. A secondary reason for residents not completing the maximum of 8 trials was refusal to wear the headphones during a trial. Our data show that 14% of the trials were refused by the residents; 8 out of 13 residents (62%) refused at least one trial. Some resistance was expected by the researchers, and our intention was to oversample the functional analysis with eight trials. We believe that sufficient functional analysis data were generated for all residents, including the resident who received only two trials (i.e., 40 min of continuous direct observation). During this phase, the occurrence (i.e., percentage of observations) per trial of verbal agitation during ' 'audiotapeoff" and "audiotape-on" conditions with each of the two audiotapes was graphed for each resident. At the end of the phase, the research team examined the residents' graphs and classified residents as "responders" if verbal agitation occurred reliably less often during the "audiotape-on" conditions than during the "audiotape-off" conditions. Nine residents were considered responders based on this criterion and were entered into the intervention phase of the study. P367 Residents were assigned to receive the audiotape (i.e., either ocean or stream) that produced the largest decrease in verbal agitation during functional analysis. Staff training. — All NA training was conducted on the nursing units. The Project Manager (PM) met with the NAs in small groups, and occasionally one-on-one, to provide the initial rationale and description of the intervention. The NAs were told that we wanted to try a new intervention that might help verbally agitated residents. The PM described the audiotape intervention and explained that environmental sounds could have a calming effect on these residents. NAs were instructed how to use the tape player and the appropriate procedures for placing the headphones on the resident. A formal program was written for each resident, in nontechnical language, that included a definition of the resident's verbal agitation, a description of each step of the intervention, and the proper volume setting for the resident. The volume was set at the medium volume point of the tape player for all residents except for the one resident with a marked hearing impairment. For this resident, the volume level was set slightly above medium volume. The NAs were cautioned to check the volume level frequently to ensure that the optimal volume was used. They were told that the tape players would be available between 2 p.m. and 8 p.m. NAs were provided with a list of residents who were to receive the intervention on their unit. They were asked to approach the residents during the targeted time and say that they would like them to listen to an audiotape. If the resident did not resist, the NA was to place the headphones on the resident as instructed. If the resident resisted placement of the headphones, the NA was instructed to try again at a later time. The audiotapes were to be used "as much as possible" during this 6-hour period; however, NAs were asked not to apply the intervention during personal care or group activities, mealtimes, when the resident was sleeping, or when visitors were present. NAs were also told to use the intervention in response to specific occurrences of verbal agitation during this 6-hour time period, if the audiotape was not already in use. During the 2-day training phase, research staff provided on-the-job instruction and performance feedback to the NAs. Data on verbal agitation were not collected during this time. Intervention on the unit. — A copy of the behavioral program was placed on the resident's bedroom wall and in the medical record. The researchers distributed the tape players and audiotapes prior to 2 p.m., and collected them for safe storage at 8 p.m. At the beginning of this time period NAs were informed that the audiotapes were now available for the assigned residents. When a tape player was not in use during time periods between 2 p.m. and 8 p.m., it was kept on top of the bedside table in the resident's room. The observation schedule used during intervention was identical to the baseline phase. Observations were scheduled between 2-5 p.m. and 6-8 p.m., with specific times of observation distributed randomly across residents. Observations were completed by the PM and two research assistants. However, during these half-hourly observational rounds, the P368 BURGIOETAL. observers were allowed to prompt the NAs to use the audiotape intervention if the headphones were not in place and the resident was not engaged in any activity that conflicted with use of the intervention (e.g., group or care activity). Research staff did not prompt the NAs systematically; prompting was estimated to have occurred one to two times per shift. The NAs were aware that the project was important to the nursing home administrative staff; however, NAs' performance of the intervention was not tracked nor were there any specific consequences for performance or nonperformance of the intervention. A total of 22.8 hours of observation was collected during the intervention phase. Measures Mini-Mental State Examination. — The MMSE (Folstein et al., 1975) was administered to all participants within 2 weeks prior to the start of the baseline phase. The test-retest and inter-evaluator reliabilities for the MMSE are .89 and .83, respectively. Three research assistants were trained to administer this measure by a neuropsychologist with expertise in geriatric cognitive assessment. Barthel Self-Care Rating Scale. — The Barthel (Sherwood et al., 1977) is a 17-item assessment of activities of daily living tailored specifically to inpatients in chronic care settings. Sherwood et al. reported alpha reliabilities ranging from .95 to .96 for this measure. An NA who was familiar with the resident was asked to rate his/her ability to complete self-care on activities that included feeding, dressing, hygiene, bathing, mobility, and toileting. Items are rated on a 4-point (1-4) Likert-type scale with higher numbers signifying greater dependence on staff. Two of the items, use of prosthesis and wheelchair, are not applicable to all participants. Thus, a mean score for the applicable items was generated for each subject. The Barthel was administered during the baseline phase. Cohen-Mansfield Agitation Inventory (CMAI). — This measure consists of 29 behavior problems which were identified from the literature and NAs' perceptions. NAs rate each specific agitated behavior on a 7-point frequency scale with " 7 " indicating that the resident manifests the behavior on an average of several times an hour. Inter-rater agreement rates for each behavior on the CMAI averaged between .88 and .92 (Cohen-Mansfield et al., 1989). Medication tracking form. — This form was developed by the researchers to provide a structured format for recording resident medications. Medication names, strength, number of pills taken in the last 24 hours (or doses if liquid or parenteral), and duration the resident has taken the medication are catalogued for each medication from the nursing medicine administration records. This form was completed at the end of the baseline, functional analysis, and intervention phases. The form is limited in its ability to track administration of PRN medications in that only PRNs received by the resident within the 24-hour period preceding the assessment are reported. Survey of Disruptive Vocal Behavior (SDVB). — This measure is a modification of a staff questionnaire used in our earlier study of verbal agitation in the nursing home (Cariaga et al., 1991). It was designed to gather information on verbal agitation from the NA that was not obtainable from our computer-assisted data collection system. The survey elicited staff's impressions of the type and severity of verbal agitation, possible antecedent conditions, and interventions that had been used previously with the residents. Social validity item. — A social validity item was designed by researchers to assess the primary NA's impressions of the environmental "white noise" intervention. This item was administered at the end of the intervention phase. The resident's primary NA was asked: "Since we started using the behavioral intervention, how would you describe the resident's verbal agitation?" The NA rated the effectiveness of the intervention on a scale from 1 to 5, with 1 signifying that the resident was a lot worse, 5 a lot better, and 3 denoting no change. Computer-assisted data collection system: hardware and software. — Three Panasonic CF170 laptop computers were used to collect observational data in this study. The computers have 80286 microprocessors, 20 megabyte hard drives, and internal 3.5 floppy disc drives. The Portable Computer Systems for Observational Research software programs from Communitech International (DeKalb, IL) were chosen for this project (Repp, Karsh, van Acker, Felce, & Harman, 1989). These programs allowed researchers to assign keys on the laptop computer to various behavioral and environmental events. One set of keys was assigned to code the resident's social environment, which included information on whether the resident was alone or in the presence of a staff member. Another group of keys recorded one-to-one verbal and tactual interaction; yet another group recorded behavioral disturbance. During the intervention phase, two keys recorded resident contact or no contact with the tape player headphones. These keys provided a measure of treatment fidelity. Another pair of keys allowed researchers to track the assessment conditions (i.e., "audiotape-on," "audiotape-off") during the functional analysis phase (a detailed description of this computer-assisted observational system can be found in Burgio et al. [1994]). Detailed operational definitions were generated for all codes. Verbal agitation was defined as screaming, cursing, complaining, negativism, moaning, paranoid verbalization, repeated requests for attention, repetitious words or sentences, singing outside of an organized activity, and self-talk regardless of volume. Additional detail was provided on each resident's idiosyncratic verbal agitation to assist observers in coding. Interobserver reliability was assessed independently among three observers during 13% (12.6 hours) of the total observation time. Observer agreement was calculated using Cohen's Kappa, which controls for chance agreement (Cohen, 1968). A computer program was written by the researchers to calculate Kappas through a second-by-second comparison of the observational files. The Kappas for verbal ENVIRONMENTAL ' 'WHITE NOISE'' P369 agitation and contact with headphones were .90 and .95, respectively. All other Kappas were .70 or higher. RESULTS A total of 75.15 hours of observation was completed across the study phases. Due to the complexity of the data base, results were analyzed for only the most relevant variables. Because the sample size was small and not randomly sampled, all data were analyzed using paired Mests with a random sampling test procedure, or randomization test, as it is commonly called. This is a permutation test that allows the researcher to use standard test statistics even when random sampling or other distribution assumptions have been violated (Edgington, 1987). In the randomization test, statistical significance is assessed by using a probability distribution generated by the researcher instead of the standard significance tables most commonly employed. The probability distribution is created by repeatedly computing the test statistic, in this case a ttest, on all permutations of the experimental data. All the permuted data /-values that are as large or larger than the tvalue obtained from the original data set are totaled and divided by the total number of permuted data t-values calculated to produce the overall p-value. The " R T " software program (Western Ecosystems, Inc., 1991) was employed to analyze the data. Our data set allowed a total of 120 different data permutations. As suggested by Edgington (1987), 5,000 random samples of the 120 different possible data permutations were tested. Examination of the functional analysis phase data for the 13 available subjects indicated a significant decrease in the amount of verbal agitation exhibited when an environmental "white noise" audiotape was on (M = 51.70%) compared to when it was off (M = 57.61%, p < .001, see Figure 2). Nine residents were considered responders to the intervention based on graphic analysis of "audiotape-on" and "audiotape-off" conditions. Both responders and nonresponders were included in the analysis. When examined separately, both the ocean (p — .002) and stream (p = .06) audiotapes were associated with decreases in verbal agitation. All 13 subjects received both the ocean and stream audiotapes. These results can be found in graphic form in Figure 3. Because of the small sample involved, informal comparisons were made between responders (n = 9) and nonresponders (n = 4) to the audiotape intervention. Results from the CMAI show that nonresponders displayed fewer additional nonverbal behavior problems than responders (M = 2.0 and 3.6, respectively). Results from the SDVB also suggest differences between nonresponders and responders. Staff reported that more nonresponders displayed moaning and groaning (100%) and crying (75%) than responders (44% and 11%, respectively). Also, more nonresponders (75%) than responders (22%) were described as displaying constant verbal agitation. Comparisons on these characteristics between ocean and stream audiotape responders were not attempted either in the functional analysis or intervention phases because of sample size limitations. The percentage of verbal agitation during on-unit observations of responders (n = 9) was aggregated into an environ- Audiotape Off Audiotape On Treatment Condition Figure 2. Mean percentage of verbal agitation during the functional analysis phase for combined environmental "white noise." All subjects exposed to this phase (N = 13) were included in the analysis. The vertical lines denote the standard error. II O 4J1 I! OH r? Ocean Audiotape Stream Audiotape Treatment Condition Figure 3. Mean percentage of verbal agitation during the functional analysis phase analyzed by type of audiotape (N = 13 for both ocean and stream audiotapes). All subjects exposed to this phase were included in the analysis. The vertical lines denote the standard error. mental "white noise" condition (5 residents received the ocean tape and 4 residents received the stream tape). Results show a statistically significant decrease in verbal agitation from baseline (M = 50.02%) to intervention (M = 38.78%, p = .001). These results can be found in graphic form in Figure 4. Treatment fidelity data indicate that residents were wearing headphones during 51% of the observations on the nursing unit. Results from the social validity item were aggregated over the 9 residents who received the intervention on the nursing unit. Their mean score on the item was P370 BURGIOETAL. Sa 60 O < 3 15 £ u. on <U XI > O OJ . 5 ^ OH C Q Intervention Baseline Study Phase Figure 4. Mean percentage of verbal agitation during baseline and intervention phases. Due to the small sample (n = 9), results for the two audiotapes are presented in combination as environmental "white noise." The vertical lines denote the standard error. 3.78. Thus, on average, NAs reported that the residents' verbal agitation was somewhat better after the intervention. DISCUSSION The results of this preliminary study suggest that the use of environmental "white noise" audiotapes may be an effective treatment for reducing the frequency of verbal agitation in demented nursing home residents. These residents were severely cognitively impaired (mean MMSE = 1.66) and required almost total assistance to complete activities of daily living. It has been hypothesized that patients with this level of impairment are not good candidates for environmental/behavioral treatments due to their purported insensitivity to environmental stimuli. Moreover, these residents were severely agitated, with verbal agitation recorded during more than 50% of the observation intervals. This level of agitation was observed in spite of the majority of residents (8 out of 13) receiving psychotropic medications for agitation. Using a highly precise and reliable direct observational system, environmental "white noise" was associated with a decrease in verbal agitation during both the researchercontrolled functional analysis phase and during the on-unit nurse aide-managed intervention. During the functional analysis phase we observed an 11 % mean decrease in verbal agitation, with 9 of 13 subjects considered responders to the intervention (a 69% response rate). This compares favorably to the 20% response rate to pharmacotherapy reported by Schneider et al. (1990). Data from the functional analysis suggest that residents were responsive to both the ocean and stream audiotapes. Although Figure 3 indicates somewhat greater responsivity to the ocean audiotape, it would be premature to form a conclusion regarding the comparative efficacy of these two environmental sound audiotapes considering the small subject sample in this study. The results also suggest that the functional analysis proce- dure is an effective means of identifying geriatric patients who are probable responders to environmental/behavioral interventions. The procedure not only identified responders, but also provided information on which of the two audiotapes might be most effective for individual residents when used on the nursing unit. By including only the 9 functional analysis responders for intervention on the units, the percentage mean decrease in verbal agitation more than doubled to 23%. This decrease in verbal agitation was recorded even though our treatment fidelity data indicated that residents were using the audiotapes during only 51% of the observations. The social validity data suggest that this decrease in verbal agitation was noticed by the NAs. Specifically, NAs reported that these 9 residents were "somewhat better" due to the intervention. In the nursing home, the practicability of environmental/ behavioral interventions is of critical importance. Our choice of environmental "white noise" audiotapes was based, in part, on the ease of obtaining these audiotapes and the relative affordability of the intervention ($34.90 for the audiotape and tape player, combined). In addition, the purpose of employing a functional analysis to identify probable responders was to allow staff to devote their valuable time only to the residents who were most likely to benefit from their efforts. A similar strategy has been used by Schnelle and colleagues to identify probable responders to a prompted voiding procedure. Prompted voiding is a behavioral intervention used by NAs in the treatment of urinary incontinence (Schnelle et al., 1989). Specifically, research staff employ prompted voiding for incontinent residents during a 3-day period. Nurse aides are asked to use prompted voiding on the nursing units only for those residents who were responsive to this prompted voiding pre-trial conducted by research staff. Although in our study the functional analysis was conducted by research staff, we believe that the procedure can be more easily employed by nursing home staff. As described above, functional analysis requires that the intervention be applied while the resident is displaying disruptive behavior. One option is to elicit the behavior problem; an alternative is to apply the intervention while the behavior is occurring naturally. To complete the latter option with research staff, we were required to make frequent, researchstaff-intensive "rounds" in an attempt to "catch" the residents while they were displaying the target behavior. Still, only 1 of 13 residents received the maximum number (8) of functional analysis trials. Research has shown that NAs spend over 50% of their time engaged in direct care activities with residents (Burgio, Engel, Hawkins, McCormick, & Scheve, 1990). This high rate of resident contact should allow ample opportunities for the NAs to apply the intervention while the disruptive behavior is occurring, and to conduct the brief (5-minute) observations of resident verbal agitation with and without the audiotape. In spite of the substantial workload of NAs, research has shown that direct care staff in institutional settings are capable of observing and recording resident behavior reliably (Burgio et al., 1992). We are not recommending at this time that NAs use a computer-assisted data collection system for observing resident behaviors. However, partial-interval ENVIRONMENTAL ' 'WHITE NOISE'' time sampling (Kazdin, 1982) or even frequency recording by NAs is feasible, particularly when only one behavior is being observed. Particularly noteworthy is the finding that residents were observed using the audiotapes during only 51% of the observational samples. It is likely that a better response to the intervention would have been observed with more frequent use of the audiotape. This observed rate of use could be related to resident resistance to the intervention (e.g., wearing the headphones), NA resistance to employing the intervention, or both. Unfortunately, we did not collect specific data on resident or staff resistance during the intervention phase. Nevertheless, the impression of the research team is that resident resistance was a factor influencing audiotape use on the nursing unit. It should be noted, however, that residents who frequently resisted the intervention would have been excluded during the functional analysis phase (one resident was excluded for this reason). It is our belief that NA noncompliance with the intervention protocol was a more potent factor affecting intervention use. Schnelle, Newman, and Fogarty (1990) found that using state-of-the-art instructional techniques and on-the-job training was not adequate for maintaining NAs' use of a prompted voiding procedure. In the current study, we attempted to invest the NAs in the study by emphasizing their importance in making the intervention a success. We structured their assignments by providing explicit instructions and written, individualized therapeutic programs. Finally, we occasionally prompted the NAs verbally to use the audiotape intervention. Research has shown that staff compliance with therapeutic procedures can be improved through the use of more formal staff management procedures (see Burgio & Burgio, 1990, and Burgio & Scilley, 1994, for reviews of this literature). Total Quality Management (Schnelle, Ouslander, Osterweil, & Blumenthal, 1993) and Behavioral Supervision (Burgio & Burgio, 1990) are two staff management systems that have been used in nursing homes. These systems are similar in that they both employ systematic staff monitoring and performance feedback by the supervisor. In addition, Behavioral Supervision uses simple incentives for staff who reach performance criteria. Both systems have been used effectively to increase NAs' use of prompted voiding (Burgio, Engel, Hawkins, McCormick, Scheve, & Jones, 1990; Schnelle et al., 1989). Our research group is currently using Behavioral Supervision to increase NAs' use of behavior management procedures in the nursing home (Burgio et al., 1996). We believe that the procedure could easily be adapted to increase staff's compliance with an environmental "white noise" intervention. There are a number of limitations to this preliminary study. The results are based on a small sample of highly agitated nursing home residents. Replication is needed on a larger sample of residents with varying levels of agitation (e.g., mild, moderate, and severe). Testing the intervention on a larger sample would also allow investigation of resident characteristics which may predict responsiveness to the intervention. One potentially important resident characteristic is the presence of a hearing impairment. Although we attempted to modulate the sound volume of the audiotape to P371 each resident's hearing acuity, the information from the medical record and staff report suggested that only 1 of the 13 residents suffered from a hearing impairment. Findings from an audiologist's evaluation would provide more accurate information for individualized treatment plans. Also, although the data show the effects of the intervention on the rate of verbal agitation, we do not know if the intervention affected the volume of vocal outbursts, or if certain types of verbal agitation are more amenable to treatment than others. For example, the very preliminary data from the NAcompleted SDVB suggest that the nonresponders in this study were more likely to display constant verbal agitation, consisting of moans/groans and crying. These types of verbal agitation may have occurred in response to pain and/ or depression. Agitation associated with these factors may be less responsive to environmental interventions. It should be noted that the observers and NAs were not blinded to the intervention. Researchers have acknowledged the inherent difficulties of blinding individuals to the application of behavioral interventions (Teri et al., 1992). We have argued elsewhere (Burgio et al., 1994) that real-time observational recording systems are much less vulnerable to rater bias than other types of measurement. Our system involves frequent independent interobserver reliability assessments. The observational records are compared on a second-by-second basis. Thus, if observers were biased, in order to obtain high interobserver reliability scores they would not only need to be biased in the same direction, the bias would need to affect their ratings at the precise second of recording. In other words, the bias would need to affect the two observers in such a way that they would agree that a certain behavior not only occurred, but that it occurred during the same 1-second intervals. Although it is certainly possible that bias affected the NAs' social validity ratings reported in this study, it is unlikely that observer bias affected the observational data, considering the excellent Kappa reliabilities reported herein. In conclusion, this study presents preliminary results suggesting that environmental "white noise" audiotapes are effective for decreasing verbal agitation in demented nursing home residents. Although the intervention produced only a 23% reduction in this behavior on the nursing units, it should be noted that verbal agitation has been reported to be a notoriously intractable behavior problem. We have argued that the effectiveness of the intervention could be improved through the identification of patient characteristics associated with responsiveness, and the use of formal staff management procedures to increase staff's compliance with the therapeutic protocol. Perhaps most importantly, this study presents data suggesting that, contrary to common belief, severely demented individuals can be responsive to environmental/behavioral interventions. ACKNOWLEDGMENTS This study was supported through grants from the Retirement Research Foundation (#91-74), the National Institute for Nursing Research (R01NR02988), and a SERCA award (1K01AG00491) to L. Burgio from the National Institute on Aging. 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Social validity: The case for subjective measurement, or how behavior analysis is finding its heart. Journal of Applied Behavior Analysis, 11, 203-214. Received January 26, 1996 Accepted June 5, 1996 ADVANCE DIRECTIVES Videotapes in Spanish and Hmong These videotapes may be used to educate non-English speaking Hispanic or Hmong elderly about the Living Will and Power of Attorney for Health Care. The information is presented in a non-state specific manner. Topics discussed include: • The right to make one's own medical decisions • Medical technology • The concept of advance medical decision-making • The Living Will • The Power of Attorney for Health Care English and Hmong or Spanish scripts are included. Playing time: Spanish - 16 minutes; Hmong - 18 minutes Format: VHS Cost: $75 (Includes shipping and handling) For more information, please contact: Wisconsin Geriatric Education Center Marquette University P.O. Box 1881 Milwaukee, Wl 53201-1881 Phone: (414)288-3712 Toll-free: 1-800-799-7878 FAX: (414)288-1973 isconsw
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