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Optimizing Care for Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03442322
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : January 21, 2020
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Natalie Leland, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: transdisciplinary approach Other: multidisciplinary approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The nursing facilities are randomized and assigned prospectively to one of the two interventions according to the predetermined protocol to evaluate the effect of the facility-based intervention(s) on medication dispensing in the facility.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blinded to the treatment arm the facility is randomly assigned to.
Primary Purpose: Health Services Research
Official Title: Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

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.

Primary Outcome Measures :
  1. Dispensing of psychotropic medications [ Time Frame: 18 month window ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03442322

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Contact: Natalie E Leland, PhD 412-383-3405

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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Natalie E Leland, PhD    412-383-3405   
Sponsors and Collaborators
University of Pittsburgh
Patient-Centered Outcomes Research Institute
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Principal Investigator: Natalie E Leland, PhD University of Pittsburgh
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Responsible Party: Natalie Leland, Associate Professor, University of Pittsburgh Identifier: NCT03442322    
Other Study ID Numbers: PRO17100544
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natalie Leland, University of Pittsburgh:
long term care residents
nursing home care
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders