Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

NCT ID: NCT05970315

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2024-05-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

PPC

Group Type: EXPERIMENTAL

PPC

Intervention Type: 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.

Usual Care

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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.

Interventions

PPC

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.

Intervention Type: BEHAVIORAL

Usual care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).
• 2 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Aanand Dinkar Naik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aanand D Naik, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aanand D Naik, MD

Role: CONTACT

Aanand.Naik@uth.tmc.edu

713-500-9156

Erika F Patino

Role: CONTACT

Erika.F.Patino@uth.tmc.edu

713-500-9000

Facility Contacts

Aanand Naik, MD

Role: primary

Aanand.Naik@uth.tmc.edu

713-500-9156

Erika Patino

Role: backup

Erika.F.Patino@uth.tmc.edu

713-500-9000

Other Identifiers

HSC-SPH-22-0639

Identifier Type: -

Identifier Source: org_study_id