Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

NCT05970315 | Completed

• 2 other identifiers: HSC-SPH-22-06395R24AG064025-05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare patient priorities care (PPC) and usual care (UC) patients to identify differences in post-encounter medication changes, treatment burden (TBQ), and shared decision making in Older Patient Assessment of Chronic Illness Care (OPACIC), to understand PPC participant's sense-making and communication approaches related to deprescribing decisions in relation to the identified health priorities and to identify and categorize adverse drug withdrawal events (ADWEs)

Conditions

Dementia

Outcome Measures

Primary Outcomes (5)

• Number of medication changes

  Baseline, 3 month

• Type of medication changes

  Baseline, 3 month

• Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)

  This is a 15 item questionnaire and each is scored from 0(not a problem) to 10(big problem) for a maximum score of 150, higher number indicating more burden

  Baseline, 3 month

• Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale

  Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.

  3 months

• Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale

  Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.

  3 months

Secondary Outcomes (1)

• Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score

  Baseline, 3 months

Study Arms (2)

PPC

EXPERIMENTAL

Behavioral: PPC

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual care

Interventions

PPC BEHAVIORAL

Participants will have an encounter with a facilitator who will identify priorities (outcome goals and care preferences) from the dyads and transmits them in the electronic health records (EHR), and a follow-up encounter with their usual geriatric care provider to decide upon changes in their care that align with the identified priorities.

PPC

Usual care BEHAVIORAL

Participants will have a geriatric clinic visit with a geriatrician that acts as their primary care provider (PCP) , in which the dyads will be encouraged by an unblinded study coordinator to ask about reducing medication burden.

Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dementia listed as an active problem in the medical record, including Alzheimer's disease, vascular dementia, frontotemporal dementia, Parkinson's dementia, Lewy body disease.
• The functional assessment staging tool (FAST) score of 5 or lower (This will be established by the patient's clinician).
• or more additional chronic conditions
• Takes 5 or more regular medications and
• A caregiver present during visits. Caregivers may include family members or unrelated caregivers and will be identified through chart review and confirmed by clinician, patient, and surrogate decision maker if necessary. Identified caregivers must be involved in decisions and care of People living with dementia (PLWD) and routinely attend clinic visits with patient

You may not qualify if:

• FAST score of 6 or more (This will be established by the patient's clinician).
• Significant hearing, vision, or advanced cognitive impairment that limits ability to participate in PPC encounters,
• Caregiver is unwilling or able to participate in visits, or
• Deemed ineligible by their Primary care physician (PCP)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, 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

• Aanand D Naik, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: July 6, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)