Optimizing Care for Patients With Dementia

NCT03442322 | Completed Results

• 1 other identifier: STUDY19090117
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

long term care residents; nursing home care

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (12)

• Unintended Weight Loss

  6-month period (months 1-6)

• Unintended Weight Loss

  12-month period (months 7-12)

• Unintended Weight Loss

  18-month period (months 13-18)

• Falls

  6-month period (months 1-6)

• Falls

  12-month period (months 7-12)

Study Arms (2)

transdisciplinary approach

ACTIVE COMPARATOR

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

multidisciplinary approach

ACTIVE COMPARATOR

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

Interventions

transdisciplinary approach OTHER

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;

transdisciplinary approach

multidisciplinary approach OTHER

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

multidisciplinary approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Piersol CV, Martinez J, Chew F, Perry B, Leland NE. Understanding the Experiences of Family Caregivers of Nursing Home Residents With Dementia: A Grounded Theory Study. Gerontologist. 2024 Apr 1;64(4):gnad102. doi: 10.1093/geront/gnad102.

  PMID: 37501632 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

We were only able to assess post-training outcomes for 6 months prior to COVID-19 and it is possible that nursing homes would have achieved different outcomes after this initial start-up period. Similarly, the comparative effectiveness of the care approaches in 12- and 18-month follow-up period were confounded by the effects of COVID-19. Finally, the use of antipsychotic medication outcome was collected with a 7-day look back period, which may have resulted in underreporting.

Results Point of Contact

• Title: Natalie Leland
• Organization: University of Pittsburgh

NEL24@pitt.edu

(412) 383-3405

Study Officials

• Natalie E Leland, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the treatment arm the facility is randomly assigned to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 22, 2018
• Study Start: March 15, 2018
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)