Optimizing Care for Patients With Dementia

Study Overview
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Brief Summary
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Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. Medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. Therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. Two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all NH staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. While prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. This project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach. This study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident. This project is important because it will address a key clinical dilemma NH staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. Transforming the quality of dementia care in NHs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.

Official Title
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Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: transdisciplinary approach
* Other: multidisciplinary approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible nursing home facilities will lack any existing dementia program targeting reduction of off-label psychotropic medication use each serve >60 long-term care residents with Alzheimer's or dementia meet Center for Medicare & Medicaid Services' minimum requirements for NHs (e.g., meeting the mandated number of hours of staff training on dementia care, performing regularly scheduled resident assessments). Exclusion Criteria: Facilities will be excluded if they have less than 60 long-stay residents an existing formal dementia care program in place an off-label psychotropic medication reduction program is located in a state that requires more than the Center for Medicare & Medicaid Services' minimum for staff training requirements on the topic of dementia care
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This cluster pragmatic trial randomized eligible nursing homes to one of the two intervention arms according to the predetermined protocol to evaluate the effect of the facility-level intervention on resident (i.e. long term care residents living with Alzheimer's Disease or Related Dementia) and staff outcomes.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transdisciplinary approach<br>The transdisciplinary approach that is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability | Other: transdisciplinary approach<br>* This approach is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability;<br>|
| Active Comparator: multidisciplinary approach<br>The multidisciplinary approach that is problem-based and draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. | Other: multidisciplinary approach<br>* This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dispensing of psychotropic medications | percent of NH residents with dementia who received one or more off-label psychotropic medications in the past 30-days, over each of the 18 months of the intervention | 18 month window | 
| Behavioral and psychological symptoms of dementia | percent of residents with behavioral symptoms, rejection of care, or wandering | 18 month window | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unintended weight loss | percent of residents who experienced unintended (≥ 5% in the last month or ≥10% in the last 6 months) weight loss, while accounting for the resident not being on a physician-prescribed weight-loss program. | 6 month window | 
| Falls | percent of residents who experienced an accidental fall since last assessment | 6 month window | 
| Depressive symptoms | percent of residents who had moderate or severe depressive symptoms | 6 month window | 
| Physical restraints use | percent of residents who were physically restrained | 6 month window | 
| Resident to resident altercations | monthly rate (per 100 residents) of resident-to-resident altercations | 6 month window | 
| Resident to staff altercations | monthly rate (per 100 residents) of resident-to-staff altercations | 6 month window | 
| Nursing staff days out of work | monthly rate (per 100 residents) of nursing staff days out of work due to injury | 6 month window | 
| Nursing days on light duty | monthly rate (per 100 residents) of nursing days on light duty | 6 month window | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long term care residents, nursing home care