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N/A N=4,497 Randomized Double-blind Health Services Research

Optimizing Care for Patients With Dementia

Alzheimer Disease

Enrolled (actual)
4,497
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Dispensing of Psychotropic Medications — 161; 315 Participants — p=0.492

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
transdisciplinary approach (Other); multidisciplinary approach (Other)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
University of Pittsburgh
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Dispensing of Psychotropic Medications
107; 227 0.808
PRIMARY
Dispensing of Psychotropic Medications
107; 227 0.808
PRIMARY
Dispensing of Psychotropic Medications
107; 227 0.808
PRIMARY
Behavioral Symptoms
68; 232 0.981
PRIMARY
Behavioral Symptoms
68; 232 0.981
PRIMARY
Behavioral Symptoms
68; 232 0.981
PRIMARY
Wandering
38; 98 0.389
PRIMARY
Wandering
38; 98 0.389
PRIMARY
Wandering
38; 98 0.389
PRIMARY
Rejection of Care
59; 217 0.279
PRIMARY
Rejection of Care
59; 217 0.279
PRIMARY
Rejection of Care
59; 217 0.279
SECONDARY
Unintended Weight Loss
137; 294 0.232
SECONDARY
Unintended Weight Loss
137; 294 0.232
SECONDARY
Unintended Weight Loss
137; 294 0.232
SECONDARY
Falls
246; 614 0.584
SECONDARY
Falls
246; 614 0.584
SECONDARY
Falls
246; 614 0.584
SECONDARY
Depressive Symptoms
20; 59 0.560
SECONDARY
Depressive Symptoms
20; 59 0.560
SECONDARY
Depressive Symptoms
20; 59 0.560
SECONDARY
Physical Restraints Use
0; 70 0.303
SECONDARY
Physical Restraints Use
0; 70 0.303
SECONDARY
Physical Restraints Use
0; 70 0.303

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03442322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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