Clinical trial NCT03442322: Optimizing Care for Patients With Dementia
Official title: Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: long term care residents
nursing home care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-02-22
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Primary outcomes:
measure: Dispensing of Psychotropic Medications
timeFrame: 6-month period (months 1-6)
measure: Dispensing of Psychotropic Medications
timeFrame: 12-month period (months 7-12)
measure: Dispensing of Psychotropic Medications
timeFrame: 18-month period (months 13-18)
measure: Behavioral Symptoms
timeFrame: 6-month period (months 1-6)
measure: Behavioral Symptoms
timeFrame: 12-month period (months 7-12)
measure: Behavioral Symptoms
timeFrame: 18-month period (months 13-18)
measure: Wandering
timeFrame: 6-month period (months 1-6)
measure: Wandering
timeFrame: 12-month period (months 7-12)
measure: Wandering
timeFrame: 18-month period (months 13-18)
measure: Rejection of Care
timeFrame: 6-month period (months 1-6)
measure: Rejection of Care
timeFrame: 12-month period (months 7-12)
measure: Rejection of Care
timeFrame: 18-month period (months 13-18)
Secondary outcomes:
measure: Unintended Weight Loss
timeFrame: 6-month period (months 1-6)
measure: Unintended Weight Loss
timeFrame: 12-month period (months 7-12)
measure: Unintended Weight Loss
timeFrame: 18-month period (months 13-18)
measure: Falls
timeFrame: 6-month period (months 1-6)
measure: Falls
timeFrame: 12-month period (months 7-12)
measure: Falls
timeFrame: 18-month period (months 13-18)
measure: Depressive Symptoms
timeFrame: 6-month period (months 1-6)
measure: Depressive Symptoms
timeFrame: 12-month period (months 7-12)
measure: Depressive Symptoms
timeFrame: 18-month period (months 13-18)
measure: Physical Restraints Use
timeFrame: 6-month period (months 1-6)
measure: Physical Restraints Use
timeFrame: 12-month period (months 7-12)
measure: Physical Restraints Use
timeFrame: 18-month period (months 13-18)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Natalie E Leland, PhD
role: PRINCIPAL_INVESTIGATOR
References: