Optimizing Care for Patients With Dementia

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: transdisciplinary approach; Other: multidisciplinary approach

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transdisciplinary approach; 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; 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;
Active Comparator: multidisciplinary approach; 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; This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dispensing of Psychotropic Medications	Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 1-6 of Intervention.	6-month period (months 1-6)
Dispensing of Psychotropic Medications	Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 7-12 of Intervention.	12-month period (months 7-12)
Dispensing of Psychotropic Medications	Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention.	18-month period (months 13-18)
Behavioral Symptoms	Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention.	6-month period (months 1-6)
Behavioral Symptoms	Percentage of nursing home residents with dementia who had behavioral symptoms over Months 7-12 of Intervention.	12-month period (months 7-12)
Behavioral Symptoms	Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention.	18-month period (months 13-18)
Wandering	Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention.	6-month period (months 1-6)
Wandering	Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention.	12-month period (months 7-12)
Wandering	Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention.	18-month period (months 13-18)
Rejection of Care	Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention.	6-month period (months 1-6)
Rejection of Care	Percentage of nursing home residents with dementia who had rejection of care over Months 7-12 of Intervention.	12-month period (months 7-12)
Rejection of Care	Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention.	18-month period (months 13-18)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unintended Weight Loss	Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention.	6-month period (months 1-6)
Unintended Weight Loss	Percentage of nursing home residents with dementia who had unintended weight loss over Months 7-12 of Intervention.	12-month period (months 7-12)
Unintended Weight Loss	Percentage of nursing home residents with dementia who had unintended weight loss over Months 13-18 of Intervention.	18-month period (months 13-18)
Falls	Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention.	6-month period (months 1-6)
Falls	Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention.	12-month period (months 7-12)
Falls	Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention.	18-month period (months 13-18)
Depressive Symptoms	Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention	6-month period (months 1-6)
Depressive Symptoms	Percent of nursing home residents with dementia who had depressive symptoms over Months 7-12 of Intervention.	12-month period (months 7-12)
Depressive Symptoms	Percent of nursing home residents with dementia who had depressive symptoms over Months 13-18 of Intervention.	18-month period (months 13-18)
Physical Restraints Use	Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention.	6-month period (months 1-6)
Physical Restraints Use	Percent of nursing home residents with dementia who had physical restraint use over Months 7-12 of Intervention.	12-month period (months 7-12)
Physical Restraints Use	Percent of nursing home residents with dementia who had physical restraint use over Months 13-18 of Intervention.	18-month period (months 13-18)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Natalie E Leland, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: nursing home care; long term care residents
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: STUDY19090117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No