Structured Abstract
Objective
The objective of this research was to determine if a personalized music intervention reduced the frequency of agitated behaviors as measured by structured observations of nursing home (NH) residents with dementia.
Design
The design was a parallel, cluster-randomized, controlled trial.
Setting
The setting was 54 NH (27 intervention, 27 control) from four geographically-diverse, multi-facility NH corporations.
Participants
The participants were 976 NH residents (483 intervention, 493 control) with Alzheimer’s disease or related dementias (66% with moderate to severe symptoms); average age 80.3 years (SD: 12.3) and 25.1% were Black.
Intervention
The intervention was individuals’ preferred music delivered via a personalized music device.
Measurement
The measurement tool was the Agitated Behavior Mapping Instrument, which captures the frequency of 13 agitated behaviors and five mood states during three-minute observations.
Results
The results show that no verbally agitated behaviors were reported in a higher proportion of observations among residents in NHs randomized to receive the intervention compared to similar residents in NHs randomized to usual care (marginal interaction effect (MIE): 0.061, 95% CI: 0.028 to 0.061). Residents in NHs randomized to receive the intervention were also more likely to be observed experiencing pleasure compared to residents in usual care NHs (MIE: 0.038; 95% CI: 0.008 to 0.073)). There was no significant effect of the intervention on physically agitated behaviors, anger, fear, alertness, or sadness.
Conclusions
The conclusions are that personalized music may be effective at reducing verbally-agitated behaviors. Using structured observations to measure behaviors may avoid biases of staff-reported measures.
Keywords: Agitated Behaviors, Dementia, Nursing Home, Structured Observations
Objective
Almost half of all nursing home (NH) residents living with moderate or severe Alzheimer’s disease and related dementias (ADRD) experience clinically meaningful agitation.(1) Agitation is a difficult to manage neurological symptom of ADRD. Pharmaceutical management with antipsychotic agents increases the probability of falls(2) and mortality(3) in NH residents with ADRD. Non-pharmaceutical options for managing agitation, including sensory(4) and reminiscence(5) therapies, are difficult to implement in NHs, which are resource-constrained.(6)
Music & Memory (M&M) is a personalized intervention in which the music residents preferred early in life is provided at initial signs of agitation or at times when behaviors are likely.(7) In this trial, personalized music is conceptualized as a reminiscence therapy, meaning the purpose of personalizing the playlists is to evoke memories.(8) Evidence for the benefits of preferred music over “relaxing” music for management of agitated behaviors in ADRD has been demonstrated in small, randomized studies(9, 10) and larger, nonrandomized studies(11, 12) but more rigorous evidence is needed.(13) While the mechanisms through which personalized music affects behaviors are not completely understood, we leverage literature which suggests musical memories may be relatively spared into late dementia,(14, 15) and eliciting positive memories may improve resident mood or distract from pain, two common causes of agitated behaviors in NH residents with ADRD.(16)
One barrier to establishing real-world effectiveness of non-pharmaceutical interventions is the measurement of agitation in NH residents with ADRD. Pragmatic trials generally rely on routinely-collected, standardized data, such as data from electronic health records (EHRs), to evaluate study outcomes.(17, 18) Unfortunately, routinely-collected data on agitated behaviors in NH residents with ADRD tend to under-detect prevalence,(19) particularly for non-aggressive behaviors.(20) On the other hand, the currently-accepted gold standard measure for assessing resident behaviors, the Cohen-Mansfield Agitation Inventory (CMAI),(21) requires 15-20 minutes to complete for each resident, a major barrier to implementation in understaffed NHs.
Independently-conducted, structured observations may address some limitations of existing methods for capturing agitation in NH residents with ADRD. (22) We report the results of structured observations conducted as part of an embedded pragmatic trial (ePCT) of M&M in 54 NHs (27 treatment, 27 usual care) from four corporations. We found no significant effect of the intervention on the frequency of agitated behaviors, as measured by administrative data or the CMAI.(23) As a pre-specified, secondary analysis, we now examine the effects of a personalized music intervention on the frequency of agitated behaviors based on structured observations conducted in treatment and control NHs. To the best of our knowledge, this is the first, large, US-based trial of personalized music which used structured observations to assess the effect of the intervention agitated behaviors in NH residents with ADRD.
Methods
Music & MEmory: A Pragmatic TRial for NH Residents with ALzheimer’s Disease (METRIcAL) was an embedded, pragmatic, randomized controlled trial (ePCT) of M&M in 54 NHs (27 treatment, 27 control) (ClinicalTrials.gov Identifier: NCT03821844). The Brown University Institutional Review Board issued a waiver of individual consent (#1705001793).(24)
Recruitment and enrollment.
We recruited four multi-facility, multi-state NH corporations to participate: two for-profit corporations [one with fewer than 25 eligible NHs (small), one with more than 50 eligible NHs (large)], and two non-profit corporations (one small, one large). One corporation was located in the Southeast US; one in East Central, and two in the Midwest. When we recruited NHs within these four corporations, we prioritized homes that were near each other to minimize travel for data collectors. NHs were eligible if they had at least 20 residents who: were long-stay (90 of the last 100 days spent in the NH); had an ADRD diagnosis; and, were not completely deaf. Eligible residents were identified using the Minimum Data Set (MDS).(25) MDS data are derived from routine, standardized assessments of residents, and include information on resident cognitive and physical functioning, comorbid conditions, medications, and care preferences.(26) After research staff identified NHs that met the inclusion criteria, corporate leadership removed NHs with competing priorities that may affect implementation, such as a recent poor inspection or leadership change. They also removed NHs using M&M. We enrolled NHs when they returned their letters of commitment until capacity was reached.
Staff in treatment and control facilities were asked to choose 15 long-stay (90 of the last 100 days spent in the NH) residents with ADRD who were not completely deaf, and who had an agitated behaviors that might be partially managed by the intervention. Specific behaviors were not specified, as there is not enough evidence to support recommendations, but examples were given during the training sessions included using music to distract residents from repetitive verbal or physical behaviors. Residents who died or were discharged before their 4-month follow-up was complete were excluded from the analytic sample.
Data and Measures.
Research staff used the Agitated Behavior Mapping Instrument (ABMI) tool, a previously validated instrument, to systematically observe resident behaviors.(21, 27) The ABMI assesses the frequency of 13 behaviors over a three-minute period. For each behavior, the observer counts how many times the behavior occurred (up to ten times) over the observation period resulting in a score that ranges between 0 and 130, with higher scores indicating more frequent agitated behaviors. Prior work has defined two behavior domains within the ABMI: verbal (attention-seeking, repetition, complaining, screaming, groaning, nonsense, unwarranted laughter, singing) and physical (hitting, kicking, pushing, scratching, tearing, cursing, grabbing, pacing, disrobing, exiting, handling things inappropriately, restlessness, repetitive mannerisms).(21) The ABMI has previously been used in research to assess behaviors in NH residents with advanced ADRD(22, 28) and has demonstrated high interrater reliability (0.88 to 0.93).(29, 30) We omitted repetitive mannerisms from the physical domain because it was difficult for raters to recognize and count the behavior consistently. This did not change the results (Appendix A).
The ABMI includes an embedded version of the Observed Emotion Rating Scale (OERS), a validated tool used to quantify the amount of time patients spent displaying different moods (pleasure, anxiety, anger, attentiveness, sadness) during each observation period.(31) The duration of these moods during the three-minute observation is described by one of five response categories: never, less than 16 seconds, less than half the time, more than half the time, or all/nearly all the time. The OERS has high demonstrated interrater reliability when administered by a trained observer.(32)
We obtained baseline characteristics from an MDS assessment occurring up to 90 days before or up to 30 days after their initial baseline observations. Demographic data included patient age, sex, and race/ethnicity. Medications included antianxietal or antidepressant use in past week. We defined ADRD using active diagnoses checkboxes (items I4200, I4800, or their corresponding ICD-10 codes in I8000). Similarly, we defined depression, anxiety, and psychotic disorder using checkboxes (items I5800, I5700, and I5950 respectively). We used the MDS Activities of Daily Living scale (ADL) to quantify functional status,(33) and the Agitated and Reactive Behavior Score (ABS) to quantify resident agitation.(20) We evaluated severity of depression using the Patient Health Questionnaire-9 (PHQ-9).(34)
Intervention, training, and fidelity.
M&M is a personalized music program in which NH staff load music a resident with ADRD liked as a young adult, (approximately 16-26 year of age), onto a personal music device (iPods), and provide the music to residents using earphones to reduce agitation.(7) NH staff are instructed to use the music at times of day when behaviors were likely or at early signs of agitation. The control condition was usual care, which may include use of ambient or group music.
Only 19% of participants were able to self-report their music preferences, 30% had a family member who provided musical preferences, and 51% of residents had staff identify their preferred music through trial and error.(35) There is no established efficacious dose of daily personalized music for agitation in NH residents. Based on feedback from M&M, we advised the NH champions to deliver 30 minutes of music per day, at times when behaviors were likely to occur. The training has been described in detail elsewhere.(29) Briefly, research consultants familiar M&M conducted a half-day, in-person training session at each participating NH with a multidisciplinary team. In addition, the NH champion, typically an activities or social work staff member, completed the official, four-hour Music & Memory online certification process.
Data collection protocol.
We relied on professional data collectors to conduct the resident observations using the ABMI. There were three training sessions, at baseline (20 hours), four months (midpoint, 20 hours), and eight months (endpoint, 16 hours). The baseline and midpoint trainings were conducted in-person over a three-day period; the endpoint training was conducted virtually using video conferencing, due to budgetary constraints. Research team members with experience in NH data collection and clinical care led these training sessions. The training sessions included: an introduction to the clinical features of ADRD and NH setting; an overview of the technical aspects of the data collection procedures; instruction on survey tools used to conduct staff interviews and structured observations of resident behaviors; definitions of captured behaviors; partner and small group practice sessions; and evaluation and feedback of observer performance. The training is further detailed elsewhere.(24) High interrater reliability across the ten data collectors was achieved using these methods. (29)
At baseline, 4 months, and 8 months, ten data collectors visited the 54 NHs for three days. Data collectors were instructed to conduct four, three-minute, observations for each resident over the three-day period: 7-10 am, 11 am-2 pm, 4 pm-7 pm, and during a meal. The times chosen for data collection were based on the waking and active hours of residents, and the times when behaviors were likely to be observed. For each two-hour block, residents were observed during usual activities on the unit. Residents were not observed when bathing, dressing, using the bathroom, or other situations in which privacy was compromised. During each block, residents were observed in the same order. If residents were skipped, due to privacy concerns, the data collectors attempted to complete those observations at the end of the window. However, this was not always possible.
Analyses.
For each observation, the number of verbal agitated behaviors and physical agitated behaviors were obtained by computing the total number of recorded behaviors in the verbal domain and physical domain of the ABMI, respectively. Each observation was then categorized as having none (0), some (1-3) or many (4 or more) physical agitated behaviors and verbal agitated behaviors. The reference category for the multinomial model for each outcome is “none”. The “some” and “many” categories of the outcome were defined to ensure that at least 10% of observations were classified as having “some” behaviors and at least 2% of observations were classified as having “many” behaviors (distribution in Appendix B). The levels used to quantify the amount of time a patient spent displaying different moods (pleasure, anxiety, anger, attentiveness, sadness) were aggregated into not observed or observed because of the relatively low frequency of observations with any observed anger (3.8% of observations) or sadness (7% of observations).
Intention to treat (ITT) analyses used Bayesian hierarchical multinomial logit models (36) to estimate the effect that being in a treatment versus control NH had on the observed behaviors and mood of residents. Models were implemented separately for the physical and verbal behavior domains, as well as each mood. Analyses were done in R version 4.0.1. To sample from the posterior distributions, we used the JAGS software and the corresponding rjags package.(37, 38)
All models adjust for residents’ baseline covariates and activity status during an observation (eating, sleeping, social, entertainment, M&M iPod use, other or none). Observations occurring during M&M iPod use happened while the intervention was being delivered. In addition, all models include an individual-level effect to account for multiple observations for the same resident, and a facility-level effect to account for variability in the outcomes for individuals residing in the same NHs. To address baseline differences in the proportion of individuals at each level of the outcomes between treatment and control groups, we report the marginal time by intervention interaction. We will refer to this estimand as the marginal interaction effect (MIE), also known as the Difference in Differences estimand. Formally, MIE estimates the marginal difference between the difference in proportions of individuals at each level of the ordinal outcome after and before the implementation of the intervention in the treatment arm, and the difference in the proportions of individuals at each level of the ordinal outcome at follow up and baseline in the control arm. We report point estimates of the MIEs with 95% credible intervals. Significance is defined at the 5% level.
To check the sensitivity of the results to choice of outcome thresholds, the analysis was also conducted when defining “some” as 1-4 behaviors and “many” as 5 or more behaviors, as well as defining “some” as 1-2 behaviors and “many” as 3 or more behaviors. To assess the sensitivity of the results to the inclusion observations that occurred during M&M iPod use, we also conduct the analysis for the behavioral and emotional outcomes with these observations removed.
Results
The analytic sample included 976 NH residents (483 intervention, 493 control, Figure 1). Selected residents were similar in treatment and control NHs with respect to age (treatment: 79.8, SD: 12.2; control: 80.8, SD: 12.4), gender (treatment: 67.7% female; control: 70.8% female) and race (treatment: 25.7% Black; control: 24.3% Black) (Table 1). Approximately two-thirds of selected residents in both arms had moderate or severe ADRD (66.6% treatment vs 65.5% control). However, residents in the treatment NHs were more likely to have severe ADL dependencies (treatment: 33.5%; control: 24.1%) and to have an agitated behavior documented in their chart in the past week (treatment 23.4%; control 17.9%). Residents in the treatment NHs were less likely than residents in control NHs to use antipsychotics (treatment 25.3%; control 33.9%) at baseline.
Figure 1.
CONSORT diagram of Metrical nursing homes (NHs) and residents
Table 1.
Baseline of residents in nursing homes randomized to the intervention and control conditions
| Total, n=976 | Treatment, n=483 | Control, n=493 | p-values | |
|---|---|---|---|---|
| Demographics | ||||
| Age, mean (SD) | 80.3 (12.3) | 79.8 (12.2) | 80.8 (12.3) | 0.19 |
| Females, n (%) | 676 (69.3) | 327 (67.7) | 349 (70.8) | 0.30 |
| Race, n (%) | ||||
| White | 708 (72.8) | 345 (71.7) | 363 (73.9) | 0.54 |
| Black | 244 (25.1) | 124 (25.8) | 120 (24.4) | |
| Others | 20 (2.1) | 12 (2.5) | 8 (1.6) | |
| Missing values, n | 4 | 2 | 2 | |
| Function | ||||
| Activities of Daily Living*, n (%) | ||||
| Severely impaired (≥21) | 281 (28.8) | 162 (33.5) | 119 (24.2) | <0.01 |
| Mild-moderately impaired (<21) | 694 (71.2) | 321 (66.5) | 373 (75.8) | |
| Missing values, n | 1 | 0 | 1 | |
| Cognitive function**, n (%) | ||||
| Cognitively intact | 113 (11.6) | 52 (10.8) | 61 (12.4) | 0.82 |
| Mildly impaired | 206 (21.1) | 102 (21.1) | 104 (21.1) | |
| Moderately impaired | 509 (52.1) | 252 (52.2) | 257 (52.1) | |
| Severely impaired | 148 (15.2) | 77 (15.9) | 71 (14.4) | |
| CHESS Score, n (%) | ||||
| No health instability, 0 | 494 (52.6) | 240 (51.6) | 254 (53.6) | 0.26 |
| Minimal/low instability, 1-2 | 424 (45.2) | 211 (45.4) | 213 (44.9) | |
| Moderate/high instability, 3+ | 21 (2.2) | 14 (3.0) | 7 (1.5) | |
| Missing values, n | 37 | 18 | 19 | |
| Presence of comorbidities, n (%) | ||||
| Dementia | 780 (79.9) | 394 (81.6) | 386 (78.3) | 0.20 |
| Heart failure | 165 (16.9) | 74 (15.3) | 91 (18.5) | 0.19 |
| Hypertension | 781 (80.0) | 383 (79.3) | 398 (80.7) | 0.58 |
| Anxiety disorder | 394 (40.4) | 203 (42.0) | 191 (38.7) | 0.29 |
| Depression | 559 (57.3) | 264 (54.7) | 295 (59.8) | 0.10 |
| Bipolar disease | 61 (6.3) | 27 (5.6) | 34 (6.9) | 0.40 |
| Psychotic disorder | 123 (12.6) | 62 (12.8) | 61 (12.4) | 0.83 |
| Asthma / COPD | 134 (13.7) | 57 (11.8) | 77 (15.6) | 0.08 |
| Medication use, n (%) | ||||
| Any antipsychotics in past week | 289 (29.6) | 122 (25.3) | 167 (33.9) | <0.01 |
| Any antianxietals in past week | 207 (21.2) | 99 (20.5) | 108 (21.9) | 0.59 |
| Any antidepressants in past week | 573 (58.7) | 272 (56.3) | 301 (61.1) | 0.13 |
| Baseline Observations | ||||
| Total Number | 3974 | 1838 | 2136 | |
| Activities,*** n (%) | ||||
| Eating | 763 (19.2) | 350 (19.0) | 413 (19.3) | 0.81 |
| Sleeping | 899 (22.6) | 435 (23.6) | 464 (21.7) | 0.15 |
| Entertainment | 940 (23.7) | 414 (22.5) | 526 (24.6) | 0.12 |
| Social Activity | 843 (21.2) | 309 (16.8) | 534 (25.0) | <0.01 |
| Other | 371 (9.3) | 208 (11.3) | 163 (7.6) | <0.01 |
| None | 916 (23.0) | 456 (24.8) | 460 (21.5) | 0.01 |
Abbreviations: CHESS, Changes in Health, End-Stage Disease and Symptoms and Signs Scale; COPD, chronic obstructive pulmonary disease; SD, standard deviation
The ADL is derived from Activities of Daily Living section of the MDS (section G), summing scores on bed mobility, self-transfer, locomotion on unit, dressing, eating, toileting, and personal hygiene.
The Cognitive Function Score is derived from the Brief Interview for Mental Status (BIMS) and Cognitive Performance Score (CPS) items of the MDS. See Thomas et. al. 2018.
Multiple Activities can be observed during the same observation
Each resident had between 0 and 6 ABMI observations at baseline (treatment: 4.10, SD: 0.96; control: 4.36, SD: 0.72) and 0 and 6 ABMI observations at follow up (treatment: 4.01, SD: 0.92; control: 4.39, SD: 0.72). Of the 483 residents in facilities assigned to treatment, 344 (71%) had their preferred music identified and the music player used at least once, with an average of 12.7 exposed residents (SD: 3.6) per intervention NH. Among those exposed, the median minutes of M&M iPod use per day exposed was 22.1 (SD 27.1).(23) The most common activities during structured observations at baseline were sleeping (22.6% of observations) and entertainment (23.7%).(Table 1) No activity was recorded for 23.0% of baseline observations. The distributions of activities in the treatment and control groups at baseline differed for social activity (treatment: 15.4%; control: 23.6%), none (treatment: 24.8%; control: 21.5%) and other (treatment: 11.3%; control: 7.6%). For observations conducted on residents in intervention NHs, 9.8% of observations were conducted during M&M iPod use (Table 2).
Table 2.
Distribution and Characteristics of observations at Baseline and Follow up.
| Observations Characteristics | Total, m=7799 | Treatment, m=3660 | Control, m=4139 | p-values |
|---|---|---|---|---|
| Baseline, m (%) | 3974 (51.0) | 1838 (50.2) | 2136 (51.6) | |
| Follow up, m (%) | 3825 (49.0) | 1822 (49.8) | 2003 (48.4) | |
| Activities | ||||
| Eating, m (%) | ||||
| All | 1488 (19.1) | 697 (19.0) | 791 (19.1) | 0.92 |
| Baseline | 763 (19.2) | 350 (19.0) | 413 (19.3) | 0.81 |
| Follow up | 725 (19.0) | 347 (19.0) | 378 (18,9) | 0.94 |
| Sleeping, m (%) | ||||
| All | 1826 (23.4) | 859 (23.5) | 967 (23.3) | 0.84 |
| Baseline | 899 (22.6) | 435 (23.6) | 464 (21.7) | 0.15 |
| Follow up | 927 (24.2) | 424 (23.2) | 503 (25.1) | 0.17 |
| Entertainment, m (%) | ||||
| All | 1776 (22.8) | 771 (21.1) | 1005 (24.3) | <0.01 |
| Baseline | 940 (23.7) | 414 (22.5) | 526 (24.6) | 0.12 |
| Follow up | 836 (21.9) | 357 (19.6) | 479 (23.9) | <0.01 |
| Social Activity, m (%) | ||||
| All | 1542 (19.8) | 563 (15.4) | 979 (23.6) | <0.01 |
| Baseline | 843 (21.2) | 309 (16.8) | 534 (25.0) | <0.01 |
| Follow up | 699 (18.3) | 254 (13.9) | 445 (22.2) | <0.01 |
| Other, m (%) | ||||
| All | 745 (9.6) | 382 (10.4) | 363 (8.8) | 0.02 |
| Baseline | 371 (9.3) | 208 (11.3) | 163 (7.6) | <0.01 |
| Follow up | 374 (9.8) | 174 (9.5) | 200 (9.9) | 0.68 |
| None, m (%) | ||||
| All | 1666 (21.4) | 782 (21.3) | 884 (21.4) | 0.91 |
| Baseline | 916 (23.0) | 456 (24.8) | 460 (21.5) | 0.01 |
| Follow up | 750 (19.6) | 332 (18.2) | 424 (21.2) | 0.02 |
| M&M iPod, m (%) | ||||
| All | - | 359 (9.8) | - | |
| Baseline | - | - | - | |
| Follow up | - | 359 (9.8) | - |
Behavioral outcome.
We observe a significant increase in the proportion of observations displaying no verbal agitated behaviors in the intervention group when compared to the control group after adjustment for baseline characteristics (MIE: 0.061, 95% CI: 0.028 to 0.061) (Table 3A). There is a significant decrease in the proportion of observations displaying some (1-3) verbally agitated behaviors in the intervention group compared to the control group (MIE: −0.044, 95% CI: −0.071 to −0.017). We do not observe a significant difference in the proportion of observations displaying many (4+) verbal agitated behaviors (MIE: −0.008, 95% CI: −0.042 to 0.010).
Table 3.
Adjusted proportion of people with observed verbal and physical behaviors at baseline and 4-month follow-up
| 3.A. Adjusted proportion of people with observed verbal behaviors at baseline and 4-month follow-up | |||||
|---|---|---|---|---|---|
| Behavior Category | Treatment Baseline | Treatment Follow Up | Control Baseline | Control Follow Up | Change Attributed to Treatment (MIE, 95% CI) |
| None | 0.75 [0.68, 0.80] |
0.80 [0.74, 0.85] |
0.81 [0.74, 0.86] |
0.80 [0.74, 0.85] |
0.06* [0.03, 0.09] |
| Some (1-3 instances) |
0.16 [0.12, 0.21] |
0.13 [0.09, 0.17] |
0.13 [0.09, 0.17] |
0.13 [0.10, 0.17] |
−0.04* [−0.07, −0.02] |
| Many (4+ instances) |
0.09 [0.07, 0.12] |
0.08 [0.06, 0.10] |
0.06 [0.05, 0.09] |
0.07 [0.03, 0.09] |
−0.01 [−0.04, 0.01] |
| 3.B. Adjusted proportion of people with observed physical behaviors at baseline and 4-month follow-up | |||||
| Behavior Category | Treatment Baseline | Treatment Follow Up | Control Baseline | Control Follow Up | Change Attributed to Treatment (MIE, 95% CI) |
| None | 0.85 [0.79, 0.90] |
0.85 [0.80, 0.90] |
0.89 [0.84, 0.93] |
0.90 [0.85, 0.94] |
0.00 [−0.03, 0.02] |
| Some (1-3 instances) |
0.12 [0.08, 0.17] |
0.12 [0.08, 0.17] |
0.09 [0.06, 0.13] |
0.09 [0.06, 0.13] |
0.00 [−0.02, 0.03] |
| Many (4 +instances) |
0.03 [0.02, 0.04] |
0.03 [0.02, 0.04] |
0.02 [0.01, 0.03] |
0.01 [0.01, 0.02] |
0.00 [−0.01, 0.01] |
Verbal behaviors include: attention-seeking, repetition, complaining, screaming, groaning, nonsense, unwarranted laughter, singing. Model Adjusted for Agitated and Reactive Behavior Score (ABS), Activities of Daily Living Scale (ADL), Patient Health Questionaire-9 (PHQ-9) severity score, age, psychotic diagnosis, depression diagnosis, anxiety diagnosis, dementia diagnosis, sex, race (white/ non-white), anti-depressant use, anti-anxiety use, activities during observation, treatment group, baseline or follow up, and included effects to account for observations within the same person and within the same facility.
Physical behaviors include: hitting, kicking, pushing, scratching, tearing, cursing, grabbing, pacing, disrobing, exiting, handling things inappropriately and restlessness. Model Adjusted for Agitated and Reactive Behavior Score (ABS), Activities of Daily Living Scale (ADL), Patient Health Questionaire-9 (PHQ-9) severity score, age, psychotic diagnosis, depression diagnosis, anxiety diagnosis, dementia diagnosis, sex, race (white/ non-white), anti-depressant use, anti-anxiety use, activity type during observation, treatment group, baseline or follow up, and included effects to account for observations within the same person and within the same facility.
We do not observe significant differences between the intervention and control arms in the proportion of observations displaying no physical behaviors (MIE: −0.001; 95% CI: −0.030 to 0.024), some physical behaviors (MIE: 0.001; 95% CI: −0.022 to 0.032), or many physical behaviors (MIE: 0.000; 95% CI: −0.013 to −0.014) (Table 3B). These results were unchanged in sensitivity analysis that utilized different thresholds for recorded behaviors during the observation (Appendix C), and the sensitivity analysis that removed follow-up observations that occurred during M&M iPod use among residents assigned to receive the intervention (Appendix D).
Emotional outcome.
We observe a significant increase in the proportion of observations displaying pleasure in the intervention arm when compared to control (MIE: 0.038; 95% CI: 0.008 to 0.073) after adjustment for baseline characteristics (Table 4). We do not observe significant differences between the treated and control arm with respect to the proportion of observations displaying anger (MIE: - 0.012; 95% CI: −0.031 to 0.007), anxiety (MIE: −0.021; 95% CI: −0.050 to 0.005), sadness (MIE: −0.013; 95% CI: −0.035 to 0.008), and attentiveness (MIE: 0.006; 95% CI: −0.019 to 0.030). In the sensitivity analysis that removed follow-up observations that included use of the intervention, we do not observe a significant difference between the treatment and control arms for the proportion of observations displaying pleasure (MIE −0.020; 95% CI: - 0.052 to 0.012) (Appendix D). Results for the other emotional outcomes were unchanged.
Table 4.
Adjusted proportion of people with observed pleasure, anger, anxiety, attentiveness, and sadness at baseline and 4-month follow-up
| Emotional State | Treatment Baseline | Treatment Follow Up | Control Baseline | Control Follow Up | Change Attributed to Treatment (MIE, 95% CI) |
|---|---|---|---|---|---|
| Pleasure1 observed |
0.37 [0.31, 0.44] |
0.36 [0.30, 0.43] |
0.34 [0.28, 0.40] |
0.29 [0.24, 0.35] |
0.04* [0.01, 0.07] |
| Anger2 observed |
0.06 [0.04, 0.08] |
0.04 [0.03, 0.06] |
0.03 [0.02, 0.05] |
0.03 [0.02, 0.04] |
−0.01 [−0.03, 0.01] |
| Anxiety3 observed |
0.13 [0.09, 0.18] |
0.12 [0.08, 0.17] |
0.12 [0.08, 0.17] |
0.13 [0.08, 0.18] |
−0.02 [−0.05, 0.01] |
| Attentiveness4 observed |
0.77 [0.72, 0.81] |
0.78 [0.74, 0.82] |
0.76 [0.71, 0.79] |
0.76 [0.72, 0.80] |
0.01 [−0.02, 0.03] |
| Saddness5 observed |
0.09 [0.07, 0.14] |
0.07 [0.05, 0.11] |
0.07 [0.05, 0.10] |
0.06 [0.04, 0.10] |
−0.01 [−0.04, 0.01] |
Model Adjusted for Agitated and Reactive Behavior Score (ABS), Activities of Daily Living Scale (ADL), Patient Health Questionaire-9 (PHQ-9) severity score, age, psychotic diagnosis, depression diagnosis, anxiety diagnosis, dementia diagnosis, sex, race (white/ non-white), anti-depressant use, anti-anxiety use, activity type during observation, treatment group, baseline or follow up, and included effects to account for observations within the same person and within the same facility.
Laughing; singing; smiling; kissing; stroking; or gently touching other; reaching out warmly to other; responding to music (only counts as pleasure if in combination with another sign)
Physical aggression; yelling; cursing; berating; shaking fist; drawing eyebrows together; clenching teeth; pursing lips; narrowing eyes; making distancing gesture
Shrieking; repetitive calling out; restlessness; wincing/grimacing; repeated or agitated movement; line between eyebrows; lines across forehead; hand wringing; tremor; leg jiggling; rapid breathing; eyes wide; tight facial muscles
Crying; frowning; eyes drooping; moaning; sighing; head in hand; eyes/head turned down and face expressionless (only counts as sadness if paired with another sign)
Participating in a task; maintaining eye contact; eyes following object or person; looking around room; responding by moving or saying something; turning body or moving toward person or object
Discussion
In this prespecified secondary analysis of observational data from METRIcAL, we find that residents in NHs randomized to receive this personalized music intervention were observed to have fewer verbally-agitated behaviors after four months of follow-up compared to residents in NHs randomized to standard care. This difference is primarily due to the decrease in the proportion of observations with a small number of verbally-agitated behaviors (between 1-4) and a corresponding increase in the proportion of observations with no verbally-agitated behaviors. We adjusted these findings for baseline differences in the treatment and control populations, the activities that residents were participating in during the observations, idiosyncratic facility effects, and repeated observations per resident. We also find an effect of the intervention on observed pleasure, but do not find any effects on physically-agitated behaviors or other observed mood states. Removing direct observations of intervention use from the analyses did not change the estimated effect of the intervention on verbally-agitated behaviors, but it did attenuate the effect of the intervention on observed pleasure.
These results differ from our previously reported findings from the same trial which found no effect of the intervention on agitated behaviors, as measured by the ARBS, a four-item measure of agitation reported quarterly for all US NH residents, or the CMAI, the gold-standard tool for measuring behaviors in NH residents living with ADRD.(23) Both the ARBS and the CMAI require NH staff to report on the frequency of observed behaviors in the past week(s). A smaller ePCT of M&M similarly found no effect of the intervention on staff-reported agitated behaviors, as measured by the ARBS or the CMAI.(39) Observational measures of agitation may avoid some of the barriers of staff report measures, including recall bias and normalization of aberrant behavior in the NH setting.(40) A recently completed RCT, which enrolled 90 NH residents with ADRD in Germany, used structured observations to detect a reduction in agitated behaviors during individualized personalized music sessions compared to usual care, but behaviors returned to pre-exposure levels when the music stopped.(41) Similarly, a recent observational study used structured observations to detect reductions in sundowning behaviors in response to a personalized music intervention, particularly among NH residents who were most engaged with the music.(42) Trials of other nonpharmaceutical interventions which have used the ABMI to assess frequency of agitated behaviors have also found positive effects during and immediate following the interventions.(22, 28) Finally, our findings that the intervention was effective at reducing verbally, but not physically, agitated behaviors highlights the need for more careful alignment of treatments with hypothesized etiologies of behaviors using Treatment Routes for Exploring Agitation (TREA)(22) or similar tools.
Due to the detrimental effects of antipsychotic use in residents with ADRD, most trials of nonpharmaceutical interventions have focused on reducing the frequency and severity of agitated behaviors.(43) While important, these trials often fail to quantitatively consider the positive impacts of these types of interventions on resident well-being and momentary quality of life. NH residents spend most of their days not engaged in any activity,(44) and, while quality of life is difficult to measure in this population,(45) NH residents with ADRD report worse quality of life than similarly impaired community-dwelling adults.(46) Consistent with previous work, we find that personalized music increased momentary pleasure,(28) and recent evidence suggests residents with positive reactions to music-based interventions may experience more behavioral benefits.(42) The research community needs to engage patients, families and professional caregivers to understand the value of prioritizing momentary quality of life outcomes in ePCTs of nonpharmaceutical interventions.
We note several limitations. The ABMI is traditionally used to observe residents at each half hour over a three-day visit, (21) but it was too expensive to scale this approach to almost 1,000 from 54 NHs. However, we were able to detect an effect of the intervention with a standardized, but less rigorous, observation schedule. We did not have the resources to conduct inter-rater reliability checks in the field. However, we conducted three training sessions (baseline, 4 months, and 8 months) and IRR increased over time, indicating consistency in scoring across raters. We also consistently assigned raters to NHs to increase reliability of scores. Another limitation is that observers were not blinded to the intervention, and intervention use was observed directly in 10% of treatment observations. Our verbally agitated results hold when observations of treatment are removed. Finally, activity status differed between treatment and control groups. We controlled for observed activity at both baseline and follow-up.
Conclusion
One of the tenets of ePCTs is that they attempt to leverage existing data to evaluate study outcomes efficiently.(47) However, pragmatic trials using routinely-collected agitation data have failed to demonstrate an effect of personalized music interventions on behaviors or related medication use.(23, 39) Future work needs to assess the value of providing residents moments of pleasure, connectedness, and reprieve from behaviors, in the absence of measurable long-term effects on clinical outcomes and in the context of ongoing neurodegeneration.(48) Important outcomes for future trials of similar interventions may include resident quality of life measures or staff burnout measures.
Supplementary Material
Highlights:
What is the primary question addressed by this study?
Does a personalized music intervention decrease the frequency of agitated behaviors in nursing home residents with dementia, as measured using structured observations conducted as part of a randomized controlled trial design.
What is the main finding of this study?
Personalized music decreased the frequency of verbally agitated behaviors in residents randomized to receive the treatment compared to residents randomized to a usual care control. No effect of the intervention was found on physically agitated behaviors. THe intervention also increased observed pleasure.
What is the meaning of the finding?
This study provides evidence for the effectiveness of a non-pharmacological intervention for temporary relief in verbal behaviors in nursing home residents with dementia.
Acknowledgements:
This work is supported by the National Institute on Aging (Grant #: R33AG057451). The sponsor did not have a role in the study design, collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication. The authors have the ultimate authority over these activities.
Collaborators:
We would like to acknowledge the efforts of nursing home staff who care for residents every day: regardless of resident mood, weather or pandemic. They still found enthusiasm to engage residents with music. We would also like to acknowledge the study staff and data collectors who made the analyses possible.
Footnotes
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Disclosure / conflict of interest: “The authors report no conflicts with any product mentioned or concept discussed in this article.”
Data Sharing Statement:
The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data is not available. This research was presented at the Academy Health Annual Research Meeting to attendees of the “Caring for People Living with Dementia” session on June 24, 2023.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data is not available. This research was presented at the Academy Health Annual Research Meeting to attendees of the “Caring for People Living with Dementia” session on June 24, 2023.