NCT05303194

Brief Summary

Most persons living with dementia (PlwD) have multiple chronic conditions (MCC). Managing MCC typically involves adhering to clinical practice guidelines for single diseases. This approach often results in burdensome care that usually does not reflect what matters most to patients. To address the challenges of caring for patients with MCC, Patient Priorities Care (PPC) was developed - a process that aligns treatment recommendations with patient priorities rather than single-disease guidelines, to improve care. Successful completion of this pragmatic pilot project will help determine how to best embedded PPC in a Healthcare system that serves a large Hispanic population. The investigators will determine if the benefits previously reported with the use of PPC hold in Hispanics with dementia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

March 8, 2022

Results QC Date

February 26, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

multiple chronic conditionsdementiaHispanic

Outcome Measures

Primary Outcomes (1)

  • Self-reported Perceived Value of Patient Priorities Care (PPC) Approach

    Participants were asked to grade how valuable they thought the PPC approach was. We report the percentage of participants who responded "valuable" or "very valuable" on a scale from 1 to 5 with 1 representing "not valuable" and 5 representing "very valuable".

    On average one month after baseline

Secondary Outcomes (1)

  • Number of Participants With Documented Changes in the Electronic Health Record That Indicate Care Alignment Was Done

    Approximately one month after baseline

Study Arms (2)

Patient Priorities Care (PPC) Adaptation

OTHER

5 Hispanic patients with multiple chronic conditions (MCC) and no dementia. In order to adapt PPC for Hispanics with MCC, five Hispanics with MCC will go through the 2 parts of the PPC approach: 1) Priority setting; and 2) Care alignment.

Behavioral: Patient Priorities Care (PPC) Approach

PPC Feasibility Testing

OTHER

20 Hispanic patients with multiple chronic conditions (MCC), including dementia. In order to adapt PPC for Hispanics with MCC and dementia, twenty Hispanics with MCC and dementia will go through the 2 parts of the PPC approach: 1) Priority setting; and 2) Care alignment.

Behavioral: Adapted PPC

Interventions

First, identify patient priorities, and second align care received with those priorities.

Patient Priorities Care (PPC) Adaptation
Adapted PPCBEHAVIORAL

First, identify patient priorities, and second align care received with those priorities.

PPC Feasibility Testing

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A) For adaptation (n=5)
  • Patient's primary care provider is located in the UTMB Geriatrics Outpatient Clinic in Galveston.
  • Patient identifies as Hispanic.
  • Patient speaks English or Spanish.
  • Patient has multiple chronic conditions listed as diagnoses in their electronic health record (3 or more chronic conditions).
  • Consent to participate in all parts of the study.
  • Primary care provider agrees with participation. B) For feasibility testing (n=20)
  • Patient's primary care provider is located in the UTMB Geriatrics Outpatient Clinic in Galveston.
  • Patient identifies as Hispanic.
  • Patient speaks English or Spanish.
  • Patient has multiple chronic conditions listed as diagnoses in their electronic health record (3 or more chronic conditions).
  • Patient has diagnosis of dementia.
  • Have a caregiver willing to participate in the study.
  • Patient consent if he/she has capacity as deemed by their primary care provider or assent if he/she doesn't have capacity.
  • Caregiver consent.

You may not qualify if:

  • A) For adaptation (n=5)
  • Patient's primary care provider located at UTMB but not in the Geriatrics Outpatient Clinic.
  • Non-Hispanic patients.
  • Speaks language other than English or Spanish.
  • Patient does not have multiple chronic conditions.
  • Deemed ineligible by primary care provider.
  • Patient has diagnosis of dementia. B) For feasibility testing (n=20)
  • Patient's primary care provider located at UTMB but not in the Geriatrics Outpatient Clinic.
  • Non-Hispanic patients.
  • Speaks language other than English or Spanish.
  • Patient does not have multiple chronic conditions.
  • Patient doesn't have diagnosis of dementia.
  • Patient deemed ineligible by primary care provider.
  • Patient doesn't provide consent or assent based on capacity.
  • Caregiver doesn't provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Medical Branch in Galveston

Galveston, Texas, 77555, United States

Location

Related Publications (5)

  • Tinetti ME, Costello DM, Naik AD, Davenport C, Hernandez-Bigos K, Van Liew JR, Esterson J, Kiwak E, Dindo L. Outcome Goals and Health Care Preferences of Older Adults With Multiple Chronic Conditions. JAMA Netw Open. 2021 Mar 1;4(3):e211271. doi: 10.1001/jamanetworkopen.2021.1271.

    PMID: 33760091BACKGROUND
  • Freytag J, Dindo L, Catic A, Johnson AL, Bush Amspoker A, Gravier A, Dawson DB, Tinetti ME, Naik AD. Feasibility of Clinicians Aligning Health Care with Patient Priorities in Geriatrics Ambulatory Care. J Am Geriatr Soc. 2020 Sep;68(9):2112-2116. doi: 10.1111/jgs.16662. Epub 2020 Jul 20.

    PMID: 32687218BACKGROUND
  • Tinetti ME, Naik AD, Dindo L, Costello DM, Esterson J, Geda M, Rosen J, Hernandez-Bigos K, Smith CD, Ouellet GM, Kang G, Lee Y, Blaum C. Association of Patient Priorities-Aligned Decision-Making With Patient Outcomes and Ambulatory Health Care Burden Among Older Adults With Multiple Chronic Conditions: A Nonrandomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1688-1697. doi: 10.1001/jamainternmed.2019.4235.

    PMID: 31589281BACKGROUND
  • Blaum CS, Rosen J, Naik AD, Smith CD, Dindo L, Vo L, Hernandez-Bigos K, Esterson J, Geda M, Ferris R, Costello D, Acampora D, Meehan T, Tinetti ME. Feasibility of Implementing Patient Priorities Care for Older Adults with Multiple Chronic Conditions. J Am Geriatr Soc. 2018 Oct;66(10):2009-2016. doi: 10.1111/jgs.15465. Epub 2018 Oct 3.

    PMID: 30281777BACKGROUND
  • Naik AD, Dindo LN, Van Liew JR, Hundt NE, Vo L, Hernandez-Bigos K, Esterson J, Geda M, Rosen J, Blaum CS, Tinetti ME. Development of a Clinically Feasible Process for Identifying Individual Health Priorities. J Am Geriatr Soc. 2018 Oct;66(10):1872-1879. doi: 10.1111/jgs.15437. Epub 2018 Oct 3.

    PMID: 30281794BACKGROUND

MeSH Terms

Conditions

Multiple Chronic ConditionsDementia

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Rafael Samper-Ternent
Organization
The University of Texas Medical Branch

Study Officials

  • Aanand D Naik, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: The study has two phases: 1) an initial adaptation phase; and 2) a feasibility testing phase. For the adaptation phase 5 Hispanics with multiple chronic condition and without dementia will be invited to participate. These participants will need to consent to be part of the study. For the second phase, the investigators will determine if participants with dementia have capacity by asking their primary care providers or by administering the telephone version of the Montreal Cognitive Assessment. If a score of less than 12 is obtained, the caregiver will be asked to consent for both participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 31, 2022

Study Start

May 31, 2022

Primary Completion

March 5, 2024

Study Completion

October 30, 2024

Last Updated

August 8, 2025

Results First Posted

August 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified data of participants and their caregivers will be made available to other researchers once results have been released to clinicaltrials.gov.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Once results have been submitted to clinicaltrials.gov the listed materials will be available to share with other researchers.
Access Criteria
Data will be shared with researchers upon request to the Pi or Co-PI of the study.

Locations