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Completed

NCT Number: NCT03442322

Optimizing Care for Patients With Dementia

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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;

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.

Primary outcomes

  1. Dispensing of Psychotropic Medications

    Time frame: 6-month period (months 1-6)

    Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 1-6 of Intervention.

  2. Dispensing of Psychotropic Medications

    Time frame: 12-month period (months 7-12)

    Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 7-12 of Intervention.

  3. Dispensing of Psychotropic Medications

    Time frame: 18-month period (months 13-18)

    Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention.

  4. Behavioral Symptoms

    Time frame: 6-month period (months 1-6)

    Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention.

  5. Behavioral Symptoms

    Time frame: 12-month period (months 7-12)

    Percentage of nursing home residents with dementia who had behavioral symptoms over Months 7-12 of Intervention.

  6. Behavioral Symptoms

    Time frame: 18-month period (months 13-18)

    Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention.

  7. Wandering

    Time frame: 6-month period (months 1-6)

    Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention.

  8. Wandering

    Time frame: 12-month period (months 7-12)

    Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention.

  9. Wandering

    Time frame: 18-month period (months 13-18)

    Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention.

  10. Rejection of Care

    Time frame: 6-month period (months 1-6)

    Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention.

  11. Rejection of Care

    Time frame: 12-month period (months 7-12)

    Percentage of nursing home residents with dementia who had rejection of care over Months 7-12 of Intervention.

  12. Rejection of Care

    Time frame: 18-month period (months 13-18)

    Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention.

Secondary outcomes

  1. Unintended Weight Loss

    Time frame: 6-month period (months 1-6)

    Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention.

  2. Unintended Weight Loss

    Time frame: 12-month period (months 7-12)

    Percentage of nursing home residents with dementia who had unintended weight loss over Months 7-12 of Intervention.

  3. Unintended Weight Loss

    Time frame: 18-month period (months 13-18)

    Percentage of nursing home residents with dementia who had unintended weight loss over Months 13-18 of Intervention.

  4. Falls

    Time frame: 6-month period (months 1-6)

    Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention.

  5. Falls

    Time frame: 12-month period (months 7-12)

    Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention.

  6. Falls

    Time frame: 18-month period (months 13-18)

    Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention.

  7. Depressive Symptoms

    Time frame: 6-month period (months 1-6)

    Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention

  8. Depressive Symptoms

    Time frame: 12-month period (months 7-12)

    Percent of nursing home residents with dementia who had depressive symptoms over Months 7-12 of Intervention.

  9. Depressive Symptoms

    Time frame: 18-month period (months 13-18)

    Percent of nursing home residents with dementia who had depressive symptoms over Months 13-18 of Intervention.

  10. Physical Restraints Use

    Time frame: 6-month period (months 1-6)

    Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention.

  11. Physical Restraints Use

    Time frame: 12-month period (months 7-12)

    Percent of nursing home residents with dementia who had physical restraint use over Months 7-12 of Intervention.

  12. Physical Restraints Use

    Time frame: 18-month period (months 13-18)

    Percent of nursing home residents with dementia who had physical restraint use over Months 13-18 of Intervention.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2018
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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