Clinical trial NCT05970315: Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
Official title: Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


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)

Primary outcomes:
measure: Number of medication changes
timeFrame: Baseline, 3 month
measure: Type of medication changes
timeFrame: Baseline, 3 month
measure: Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)
timeFrame: Baseline, 3 month
measure: Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale
timeFrame: 3 months
measure: Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale
timeFrame: 3 months
Secondary outcomes:
measure: Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Aanand D Naik, MD
role: PRINCIPAL_INVESTIGATOR
References: