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Optimizing Care for Patients With Dementia

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transdisciplinary approach
multidisciplinary approach
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer Disease focused on measuring long term care residents, nursing home care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

transdisciplinary approach

multidisciplinary approach

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Behavioral and psychological symptoms of dementia
percent of residents with behavioral symptoms, rejection of care, or wandering

Secondary Outcome Measures

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.
Falls
percent of residents who experienced an accidental fall since last assessment
Depressive symptoms
percent of residents who had moderate or severe depressive symptoms
Physical restraints use
percent of residents who were physically restrained
Resident to resident altercations
monthly rate (per 100 residents) of resident-to-resident altercations
Resident to staff altercations
monthly rate (per 100 residents) of resident-to-staff altercations
Nursing staff days out of work
monthly rate (per 100 residents) of nursing staff days out of work due to injury
Nursing days on light duty
monthly rate (per 100 residents) of nursing days on light duty

Full Information

First Posted
January 31, 2018
Last Updated
June 13, 2023
Sponsor
University of Pittsburgh
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03442322
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
long term care residents, nursing home care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcome assessors will be blinded to the treatment arm the facility is randomly assigned to.
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transdisciplinary approach
Arm Type
Active Comparator
Arm Description
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
Arm Title
multidisciplinary approach
Arm Type
Active Comparator
Arm Description
The multidisciplinary approach that is problem-based and draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.
Intervention Type
Other
Intervention Name(s)
transdisciplinary approach
Intervention Description
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;
Intervention Type
Other
Intervention Name(s)
multidisciplinary approach
Intervention Description
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 Measure Information:
Title
Dispensing of psychotropic medications
Description
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
Time Frame
18 month window
Title
Behavioral and psychological symptoms of dementia
Description
percent of residents with behavioral symptoms, rejection of care, or wandering
Time Frame
18 month window
Secondary Outcome Measure Information:
Title
Unintended weight loss
Description
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.
Time Frame
6 month window
Title
Falls
Description
percent of residents who experienced an accidental fall since last assessment
Time Frame
6 month window
Title
Depressive symptoms
Description
percent of residents who had moderate or severe depressive symptoms
Time Frame
6 month window
Title
Physical restraints use
Description
percent of residents who were physically restrained
Time Frame
6 month window
Title
Resident to resident altercations
Description
monthly rate (per 100 residents) of resident-to-resident altercations
Time Frame
6 month window
Title
Resident to staff altercations
Description
monthly rate (per 100 residents) of resident-to-staff altercations
Time Frame
6 month window
Title
Nursing staff days out of work
Description
monthly rate (per 100 residents) of nursing staff days out of work due to injury
Time Frame
6 month window
Title
Nursing days on light duty
Description
monthly rate (per 100 residents) of nursing days on light duty
Time Frame
6 month window

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie E Leland, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Care for Patients With Dementia

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