Back to resultsPriorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
Primary Purpose
Dementia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PPC
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia
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)
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PPC
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Number of medication changes
Type of medication changes
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
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05970315
First Posted
July 24, 2023
Last Updated
July 24, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05970315
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PPC
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
PPC
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of medication changes
Time Frame
Baseline, 3 month
Title
Type of medication changes
Time Frame
Baseline, 3 month
Title
Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)
Description
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
Time Frame
Baseline, 3 month
Title
Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale
Description
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.
Time Frame
3 months
Title
Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score
Description
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
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aanand D Naik, MD
Phone
713-500-9156
Email
Aanand.Naik@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erika F Patino
Phone
713-500-9000
Email
Erika.F.Patino@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aanand D Naik, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aanand Naik, MD
Phone
713-500-9156
Email
Aanand.Naik@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Erika Patino
Phone
713-500-9000
Email
Erika.F.Patino@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
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