Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

Dementia Clinical Trial

Official title:

Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970315
• Other study ID #: HSC-SPH-22-0639
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: July 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Aanand D Naik, MD
• Phone: 713-500-9156
• Email: Aanand.Naik[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of medication changes		Baseline, 3 month
Primary	Type of medication changes		Baseline, 3 month
Primary	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
Primary	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
Primary	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	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