Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05970315
Collaborator
(none)
50
1
2
10.8
4.6

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PPC
  • Behavioral: Usual care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
Actual Study Start Date :
Jul 6, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: PPC

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.

Active Comparator: Usual Care

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.

Outcome Measures

Primary Outcome Measures

  1. Number of medication changes [Baseline, 3 month]

  2. Type of medication changes [Baseline, 3 month]

  3. Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ) [Baseline, 3 month]

    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

  4. Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale [3 months]

    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.

  5. Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale [3 months]

    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

  1. Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score [Baseline, 3 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Aanand D Naik, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aanand Dinkar Naik, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05970315
Other Study ID Numbers:
  • HSC-SPH-22-0639
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023