Optimizing Care for Patients With Dementia

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442322
• Other study ID #: STUDY19090117
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: July 26, 2022

Study information

• Verified date: June 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• transdisciplinary approach
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;
• multidisciplinary approach
This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Behavioral and psychological symptoms of dementia	percent of residents with behavioral symptoms, rejection of care, or wandering	18 month window
Secondary	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
Secondary	Falls	percent of residents who experienced an accidental fall since last assessment	6 month window
Secondary	Depressive symptoms	percent of residents who had moderate or severe depressive symptoms	6 month window
Secondary	Physical restraints use	percent of residents who were physically restrained	6 month window
Secondary	Resident to resident altercations	monthly rate (per 100 residents) of resident-to-resident altercations	6 month window
Secondary	Resident to staff altercations	monthly rate (per 100 residents) of resident-to-staff altercations	6 month window
Secondary	Nursing staff days out of work	monthly rate (per 100 residents) of nursing staff days out of work due to injury	6 month window
Secondary	Nursing days on light duty	monthly rate (per 100 residents) of nursing days on light duty	6 month window