Optimizing Care for Patients With Dementia

• ClinicalTrials.gov Identifier: NCT03442322
• Recruitment Status: Recruiting
• First Posted: February 22, 2018
• Last Update Posted: November 24, 2021
• Sponsor: University of Pittsburgh
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Natalie Leland, University of Pittsburgh

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.

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

Study Design

• 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 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Natalie E Leland, PhD; 412-383-3405; NEL24@pitt.edu

Locations

United States, Pennsylvania

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Natalie E Leland, PhD 412-383-3405 NEL24@pitt.edu

Sponsors and Collaborators

University of Pittsburgh

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Natalie E Leland, PhD; University of Pittsburgh

More Information

• Responsible Party: Natalie Leland, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03442322
• Other Study ID Numbers: STUDY19090117
• First Posted: February 22, 2018
• Last Update Posted: November 24, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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