Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

Study Overview
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Brief Summary
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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)

Official Title
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Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: PPC
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPC<br> | Behavioral: PPC<br>* 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.<br>|
| Active Comparator: Usual Care<br> | Behavioral: Usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score | This is a 10 item questionnaire and each is scored from 1(almost never) to 5(almost always),for a maximum score of 50 ,higher scores indicate better perceived chronic disease care | Baseline, 3 months |