Reducing Inappropriate Medication Use for BPSD

NCT06040502 | Completed

• 3 other identifiers: 2017468FY22_Pilot2_KalesDBSR-10721
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators previously developed a low-cost, practical, patient- and care partner-centric, evidence-informed systematic approach (the "DICE Approach" or DICE), to assess and manage behavioral and psychological symptoms of dementia (BPSD). The goals of this proposal are to refine and test the application of DICE in primary care clinics by: (a) using existing clinic staff to deliver DICE; and (b) using the electronic medical record to identify and recruit PLWD (persons living with dementia) and their care partners (n=100) based on criteria that are clinically meaningful and inclusive of the maximum number of participants in the most equitable way. Clinic-based social workers in four primary care practices at University of California Davis (UCD) will coordinate behavioral management using DICE with care partners, PLWD and other clinic providers. Outcomes will include: 1) feasibility/ability to carry out the approach; 2) acceptability to PLWD and their care partners; and 3) the ability to measure psychiatric medication use and health care use in the electronic medical record. Findings from this study will guide the design of a much larger future study using the DICE Approach to improve outcomes for PLWD and their care partners.

Conditions

Dementia

Outcome Measures

Primary Outcomes (4)

• Operationalization -- Feasibility of using the DICE Approach #1

  Rate of enrollment of PLWD-care partner dyads

  6 months

• Ease of Use -- Feasibility of using the DICE Approach #2

  Number of contacts between Onsite DICE Champions (ODCs) and dyads

  6 months

• Time required to implement -- Feasibility of using the DICE Approach #3

  Time requirements for ODCs implementing DICE (as estimated by the ODCs and corroborated by clinic notes).This information will be obtained through chart abstractions within the EMR.

  6 months

• Acceptability

  Acceptability will be measured by the implementation rates of the ODC's recommendations of strategies for BPSD (generated by use of DICE) among dyads, as well as by other providers within the primary care practice. This information will be obtained through chart abstractions within the EMR. Exit interviews of participants (ODCs, other providers and care partners) will be conducted to further deepen the knowledge of intervention acceptability and implementation challenges

  6 months

Secondary Outcomes (2)

• Measurement of Psychotropic Medication use

  6 months

• Measurement of Health care use

  6 months

Study Arms (1)

The DICE Approach

EXPERIMENTAL

Training of clinic staff to work with caregivers in the approach.

Behavioral: The DICE Approach

Interventions

The DICE Approach BEHAVIORAL

Systematic guidance for care partners through assessment and management of the behavioral and psychological symptoms of dementia

The DICE Approach

Eligibility Criteria

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

You may qualify if:

• Person living with dementia (as defined by chart diagnosis) and their care partner
• Care partner age \>18 as defined in the EMR
• Care partner English speaking
• Historical controls
• Person living with dementia (as defined by chart diagnosis)

You may not qualify if:

• Age of care partner \<18 (this age group is rarely the responsible or legal party for PLWD)
• Non-English speaking

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 48169, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Helen C Kales, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Joshua Chodosh, MD

  New York University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: September 15, 2023
• Study Start: July 12, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)