Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches
Phase: NA
Conditions: Alzheimer Disease
Sponsor: University of Pittsburgh

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Study Protocol  
 
 
 
 
 
 
Official Title: Optimizing Care for Patients with Dementia: A 
Comparison of Two Non-Pharmacological Treatment Approaches 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT03442322 
 
 
 
Protocol Date: December 2017, revised August 2021 due to COVID-19 
pandemic 
 
 
 
 

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Scientific Background 
More than half of the 1.4 million long-term care nursing home (NH) residents have a 
diagnosis of Alzheimer’s Disease and Related Dementias (ADRD), which we will refer to as 
dementia throughout this report. 1 Residents living with dementia experience devastating 
negative effects associated with these progressive, irreversible conditions that result in loss of 
independence and subsequent long-term institutionalization. As the disease progresses, 
disruptions in the resident’s daily routine, difficulty communicating personal needs, and 
environmental overstimulation or sensory deprivation often trigger the behavioral and 
psychological symptoms of dementia (e.g., agitation). 2-4 If untreated, these symptoms result in 
negative side effects such as self-inflicted pain, limited food/liquid intake, accidental falls, and 
injuries to self or others (e.g., residents, NH staff), increasing the risk of hospitalization and 
death. 4  
In the early 2010s, more than 30% of NH residents were taking antipsychotic 
medication. 5 To reduce this antipsychotic medication use in NH residents, the Centers for 
Medicare & Medicaid Services (CMS) championed a national initiative to enhance NH dementia 
care, starting in 2012. This comprehensive program, which had a goal of reducing national NH 
resident antipsychotic medication use, included NH staff and state surveyor training, 
established minimum standards for dementia care, and introduced a new quality measure (i.e., 
the percent of long-stay residents who received an antipsychotic medication) that all CMS 
certified NHs were mandated to report. 6 
Off-label antipsychotic medications, while commonly used to address the behavioral 
and psychological symptoms of dementia, have been shown to be ineffective and cause harm 
to the person living with dementia, 7 including an elevated risk of death. 8 By 2019, 
approximately 23% of NH residents living with dementia were administered off-label 
antipsychotics. 5,9 However, these off-label medications have significant negative impacts on the 
resident’s mortality and quality of life, primarily due to inducing withdrawal and lethargy. 10-12  
Given these poor outcomes, families, ADRD and resident advocates, and recent national 
initiatives have prioritized the reduction of antipsychotic medication use and shifted attention 
to increased use of non-pharmacological interventions in the NH context. 6,13-15 In particular, 
CMS has recommended NHs reduce antipsychotic medication use to improve the quality of 
dementia care. 6 Further, based on our preliminary data, family members and NH providers 
strongly support the use of non-pharmacological approaches for dementia care.  
Common features of such approaches include training staff to understand the disease 
process of dementia and equip them with strategies to address triggers for negative resident 
behaviors, such as disruptions in routine or communication difficulties. 15 Given the multi-
faceted nature of triggers, evidence suggests that non-pharmacological treatments must 
incorporate a wide range of NH staff, such as professional healthcare providers and direct care 
providers. 13,16 First, professional healthcare providers (e.g., include registered nurses, licensed 
practical nurses, social services, and rehabilitation practitioners/therapists) collaborate to 
develop a comprehensive, multi-dimensional plan of care to address factors that precipitate 

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behavioral and psychological symptoms of dementia (e.g., triggers). Second, NH direct care 
providers (e.g., certified nursing assistants [CNAs], dietary staff, social services, activities 
department staff), ancillary support staff (e.g., housekeeping), as well as family, are trained by 
the professional healthcare providers with strategies to support the customized plan of care. 4,17 
Collaboration across these individuals ensures maximum support to minimize episodes of 
extreme behavioral and psychological symptoms of dementia, thereby promoting optimal 
function, enhancing quality of life for the resident, and improving safety of all individuals.  
Two leading approaches (team- and problem-based) to dementia care, prioritized by our 
community-partners, help staff implement non-pharmacological, resident-centered dementia 
care. Both approaches have randomized control trial (RCT)-level evidence to support efficacy 
and integration into clinical practice. 4,11,18-23 The NHs using the team-based (TB) approach to 
integrated dementia care provide core training to all professional healthcare providers, direct 
care providers, ancillary support staff, and administrators, using a common language across 
disciplines to support continuity and sustainability. Results of randomized trials have indicated 
that the collaborative TB approach decreases the use of medications as well as the frequency 
and severity of resident agitation, pacing, and repetitive vocalization, compared to the 
minimum mandated usual care. 19,24-26 In contrast, the multidisciplinary approach for problem-
based (PB) dementia care draws on the expertise of the individual professional healthcare 
providers (e.g., speech language pathology, occupational therapy, nursing) to target issues that 
arise. For example, when residents have a change in status (e.g., weight loss, accidental fall 
event, change in self-care or mobility, emergence of behaviors during morning care routine), 
the nurses request a screen to be conducted by the relevant healthcare providers to determine 
the need for a resident evaluation by the respective discipline(s), revision to care plan, and 
treatment to address the emergent issue (i.e., change in status). These providers then train all 
other staff and family in resident-specific strategies and adjust the care plan as needed. In 
randomized trials, the PB approach has been found to decrease the frequency and severity of 
challenging behaviors (including aggression and calling out), as well as reduce the use of 
antipsychotic medications, when compared to usual care. 25,27  
Despite evidence supporting TB and PB approaches to dementia care, clear gaps in 
evidence limiting implementation exist. Guided by our community-partners, our team identified 
the following gaps in evidence and variability in practice patterns that require urgent attention:   
First, although efficacy studies support both approaches, 4,11,18-23 the underlying studies 
have only compared the two approaches to individual, discipline-specific interventions or usual 
care. 19,24,25,27 These two interventions have not been compared to each other; thus, it is not 
clear which approach is most effective given the varied resident and NH contexts across the US.  
Second, prior studies have been limited by small samples of residents living with 
dementia (Ns=4 to 250) and use of researchers as opposed to NH personnel for intervention 
delivery.17-19 Although supportive of feasibility and general efficacy, previous studies have not 
provided professional healthcare providers, other NH staff, or NH administrators with the 
evidence to support widespread implementation, due to the above-noted problems.  

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Third, there is currently no standardized way in which professional healthcare providers 
and other NH staff communicate their efforts to ensure that residents living with dementia 
receive appropriate daily care. Although all NHs provide specialized services (e.g., occupational 
therapy, recreation therapy, nursing), few NHs support the coordination of care in a 
predetermined manner, resulting in NH staff often receiving training or information to support 
their interactions with a resident only after an incident of extreme behavioral and psychological 
symptoms of dementia occurs.  
Although these care approaches are currently used in care delivery, there is significant 
variability in practical implementation. This variability is primarily due to wide differences in 
education and dementia-specific training across the numerous NH staff involved in dementia 
care. Efforts to minimize behavioral and psychological symptoms of dementia through non-
pharmacological approaches must better account for the diverse education and training needs 
of the collective NH staff who all contribute to the care for residents on a day-to-day basis. 
The COVID-19 pandemic altered NH care delivery and further exacerbated existing 
factors that contribute to aggression, agitation, and behavioral and psychological symptoms of 
dementia among residents. The pandemic policies put in place to minimize viral spread further 
perpetuated the challenges associated with caring for this vulnerable population. 28-30 This new 
“normal” created a tension between life safety and an individual’s quality of life. For example, 
NHs had to restrict family visitation per CMS guidance, eliminate all resident group activities 
and congregate meals, and constrain resident access to limited areas of the NH campus to 
mitigate spread. 31,32 These examples reflect disruptions in the resident’s routine and changes in 
the environment, all of which contributed to potential exacerbation of behavioral and 
psychological symptoms associated with dementia. As a result, these COVID-19 policies 
fostered social isolation and environmental under-stimulation among residents, 32 increasing 
the likelihood of a resident living with dementia experiencing behavioral and psychological 
symptoms and expanding the risk of adverse events (e.g., functional decline). These infection 
control policies had a cascade of negative effects on mood, cognitive status, physical function, 
and quality of life among NH residents and staff; and were emotionally traumatic for families 
and others who could not visit their family member living with dementia in person. 32-38 Yet, 
there is a need to evaluate the best approaches to provide dementia care, given heightened 
infection control policies. 
Despite national initiatives (pre-COVID-19) to reduce off-label medication for these 
residents, 4,6,11,18-23,39 there is growing concern that the use of off-label antipsychotics may yet 
again be on the rise to manage behavioral and psychological symptoms of dementia. Strategies 
that are used in NHs as part of a non-pharmacological comprehensive, multi-dimensional plan 
(e.g., group activities, consistent routine) may be hindered due to COVID-19-related infection 
control policies and staffing shortages. Thus, given the multiple challenges NHs face in trying to 
care for residents, manage behavioral and psychological symptoms among residents living with 
dementia, and control the spread of COVID-19, NHs may rely more heavily on pharmacological 
strategies. 

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Study Objectives 
The initial study protocol was designed and initiated prior to the emergence of the 
COVID-19 pandemic. However, with the emergence of the COVID-19 pandemic, our study was 
modified to also include looking at the impact of the pandemic. Thus, two questions were 
addressed by this study: (a) is there a statistically significant difference in resident outcomes 
among NH residents living with dementia based on the non-pharmacological approach to 
dementia care? And (b) How did these non-pharmacological approaches compare after the 
emergence of COVID-19 when residents and staff faced social isolation, infection control 
policies, and staffing shortages? These questions were addressed via three aims:  
Aim 1: Compare the effectiveness of two non-pharmacological approaches for dementia 
care (TB and PB) in reducing the use of antipsychotic medications and behavioral and 
psychological symptoms in NH residents living with dementia.  
Aim 2: Determine the effectiveness of the two non-pharmacological approaches on NH 
residents living with dementia and staff safety and wellness.  
Aim 3: Identify benefits, limitations, barriers, and facilitators of each approach from the 
perspectives of the NH staff and NH residents’ families. This qualitative data will augment the 
resident-level quantitative data by more fully capturing the impact of the two approaches on 
resident outcomes; resident-staff, staff-family, and resident-family interactions; and staff job 
roles before and after the emergence of COVID-19, which will guide future implementation. 
 
Study Design & Methods 
The study was initiated in January 2018. As of March 2020, 80 NHs had been recruited, 
randomized and staff training delivered. The COVID-19 pandemic emerged in early March 2020. 
Subsequent national lockdown of NHs and leadership requests to not communicate with the 
NHs as they navigate the early days of the pandemic resulted in a pause on all research related 
communication between the study team and study sites. 
As the pandemic evolved, the study team developed a plan for moving forward, which 
included assessing the ability for NHs to re-engage in the study. Due to the negative impact of 
the pandemic, 27 of the 80 NHs were unable to re-engage. The remaining 53 NHs were included 
in the revised study protocol. This change resulted in the original cluster randomized control 
trial becoming two sets of exploratory analyses differentiated by the emergence of the COVID-
19 pandemic. 
Exploratory quantitative analyses were conducted for 53 NHs (TB n=17, PB n=36 NHs). 
Primary resident-level outcomes included antipsychotic medication use, behavioral symptoms, 
wandering, and rejection of care, which were extracted from the Minimum Data Set and 

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electronic medical records. Six-month outcomes were captured prior to the emergence of 
COVID-19, while 12- and 18-month outcomes were after the start of the pandemic.  
As a result of the COVID-19 pandemic and the significant impact it had on the study, the 
team bolstered the scope of the qualitative interviews from those that were originally planned. 
Qualitative data was collected via individual interviews with 327 NH staff (TB n=168, PB n=159) 
and 30 family caregivers (TB n= 13, PB n= 17) to explore their perspective of the two 
approaches as it relates to resident outcomes and training. Using mixed methods, quantitative 
and qualitative data were integrated to determine whether these sources confirm each other, 
provide emergent, or conflicting information. 
 
 
Eligibility Criteria  
Facility-level inclusion criteria required eligible NHs to (a) not have an existing dementia 
program targeting reduction of off-label antipsychotic medication use, (b) serve an average of 
>60 long-term care residents living with dementia, (c) be a CMS certified NH (e.g., conduct 
regularly scheduled resident assessments), and (d) comply with CMS’s annual staff dementia 
care training requirement (i.e., 4 hours). Exclusion criteria included (a) NHs located in states 
that require more than four hours of dementia-specific training annually were excluded, (b) 
NHs that had existing dementia care programs which required staff to engage in additional 
training beyond the CMS minimum training requirements and more than the four hours 
required by the state. 
 
Eligible NH residents included those that (a) have an existing diagnosis of ADRD or a 
Cognitive Function Scale score indicating Mild, Moderate, or Severe Cognitive Impairment, (b) 
are 65 years of age or older, and (c) are long-stay residents (>100 days). Post-acute care 
patients admitted for a brief stay (<100 days) and respite stay patients were excluded. 
 
Eligible staff were employed by a participating NH and included all staff categories, (a) 
professional healthcare providers, including licensed staff with professional degrees, such as 
registered nurses, licensed practical nurses, rehabilitation practitioners (e.g., occupational [OT], 
physical [PT], speech therapists [SLP]), certified therapeutic recreation specialist, dieticians, (b) 
direct care providers such as certified nursing assistants [CNA], activities department staff, 
nutrition services personnel (e.g., dining services/aids); (c) ancillary support staff, including 
environmental services workers (e.g., maintenance, housekeeping, kitchen staff) and 
administrative staff (e.g., reception, billing department, medical records); and (d) 
administrators, including executive directors, directors of nursing.  
 
Eligible family caregivers were the primary contact for a resident living with dementia in 
a participating NH (e.g., relative, spouse, partner, friend, per neighbor). 
 
Statistical Considerations 

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Descriptive analyses included calculating appropriate central tendencies (e.g., mean) for 
each outcome variable. We examined outcomes separately before and after the emergence of 
COVID-19. To assess validity of randomization, we compared resident characteristics and 
outcomes and NH characteristics by arm for the six-month baseline period prior to training 
(December 16, 2018 to June 15, 2019). 
 
We used the intention-to-treat analytic approach to conduct the exploratory 
quantitative analysis.  A difference-in-differences analytic model was used, rather than 
comparing outcomes across the arms during each six-month period after the training, to 
account for baseline differences in resident characteristics and outcomes. The estimating 
equation is as follows: 
𝑂𝑢𝑡𝑐𝑜𝑚𝑒𝑖𝑗𝑡= 𝛽𝑜+ 𝑝𝑜𝑠𝑡𝑡𝛽1 + (𝑝𝑜𝑠𝑡𝑡𝑥𝑇𝐵𝑖)𝛽2 + 𝑋𝑖𝑗𝛿+ 𝑁𝐻𝑖+ 𝑢𝑖𝑗𝑡 
where 𝑂𝑢𝑡𝑐𝑜𝑚𝑒𝑖𝑗𝑡 is a binary variable of having the outcome measure of interest for resident j 
residing in NH i at time t. Post is an indicator for being in the follow-up period after 
implementation of approaches, which would be 1 for t=1 and 0 for t=0. TB is an indicator for NH 
i, which would be 1 if assigned to team-based approach arm and 0 if assigned to problem-based 
approach arm. The comparative effectiveness (treatment effect) of the team-based approach 
relative to the problem-based approach would be estimated with B2, which is the coefficient 
estimate of postt x TBi representing residents in team-based approach NHs during the 
respective follow-up period while accounting secular time trends (postt) and time invariant 
characteristics of NH using nursing home fixed effects (NHi). In addition, the model accounts for 
a set of individual resident characteristics including age, sex, race/ethnicity, Cognitive Function 
Scale, number of valid assessments resident had for outcome during period (Xij). Models were 
analyzed using complete case analysis. Standard errors were clustered at the NH level. Linear 
probability models were implemented for ease of interpretation; regression coefficients and 
standard errors are presented in percentage point units. Robustness checks were conducted by 
implementing logistic regression difference-in-differences models with NH characteristics 
rather than NH-level fixed-effects to estimate the treatment effect. Marginal effects from the 
logistic models were computed to complement the linear probability regression models.40 
Finally, stratified analyses were conducted to examine whether treatment effects were 
different among residents with moderate to severe dementia vs. mild dementia. All analyses 
were conducted using Stata 14.0 (Stata, College Station, TX). 
For resident-level primary and secondary outcomes, we conducted difference-in-
differences analyses using baseline data and the first six months of post-implementation data 
(six-month outcomes; September 15, 2019 to March 14, 2020) to compare outcomes across the 
two study arms, prior to the emergence of the pandemic. Next, we conducted analyses of 
resident outcomes after the emergence of pandemic spanning post-implementation months (a) 
7-12 (March 15, 2020-September 14, 2020) and (b) 13-18 (September 15, 2020-March 14, 2021) 
(12-month and 18-month outcomes analyses, respectively). Observations with missing resident 
covariates were excluded from the analyses. 
For staff and resident secondary safety outcomes, we calculated the monthly rate (per 
100 residents) of each outcome for each NH that submitted data each month. We averaged the 

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monthly measures available for each NH and then examined descriptive statistics (e.g., mean) 
to compare the outcomes across two arms during the first five months of implementation. 
 
Qualitative Analysis 
The objectives of the staff analyses were to explore (a) perceived barriers and 
facilitators surrounding the intervention approach, (b) perspectives on the training modules 
(e.g., adequacy, acceptability, satisfaction, burden), (c) the quality of resident-staff interactions 
(i.e., how staff training contributed to patient outcomes) and (d) training program 
recommendations for modifications (i.e., sustainability, scalability). We used a three-phase 
team-based rapid qualitative analysis approach. 41,42 In phase one, interview transcripts were 
reviewed and summarized by domains (based on interview questions) and categories (emerging 
inductively) into a coding template. Phase two required reviewers to reduce, synthesize, and 
look for similarities and differences in the data through the use of matrices. In phase three, 
summary tabulation procedures occurred in which reviewers combined data (e.g., NH cases, 
care approaches), developing themes. 42 We explored patterns and variations in themes within 
and across cases and care approaches. 43,44 
We identified themes, patterns, and relationships that emerged from family caregivers 
that contextualized quantitative and qualitative staff findings. 45 Given the paucity of knowledge 
regarding the experiences of family caregivers of NH residents living with dementia, we used 
qualitative analysis, specifically a grounded theory approach, to further analyze caregiver 
interviews. 46-48 We employed open, axial, and selective coding to understand the perceptions 
of family caregivers and create a data-driven conceptual model of family caregiver experiences. 
41,42,43,44 
 
 
 
 

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