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Multiple Chronic ConditionsPPC-HDNCT05303194

Patient Priorities Care for Hispanics With Dementia

A study testing Patient Priorities Care (PPC) Approach and Adapted PPC in people with Multiple Chronic Conditions and Dementia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Multiple Chronic Conditions, Dementia
What is being tested?
Patient Priorities Care (PPC) Approach and Adapted PPC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
31 May 2022to 30 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Texas Medical Branch in Galveston

    Galveston, Texas, 77555

Other trials in United States

About this study

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.

Read the detailed description

STUDY OBJECTIVES

  • Primary Objective Adapt PPC to be culturally appropriate for Hispanics with dementia and test its feasibility in an outpatient setting.
  • Secondary Objectives The adapted version of PPC will improve care by identifying the healthcare priorities of Hispanics with dementia and aligning these priorities with the care participants receive.

BACKGROUND AND RATIONALE

  • Background on Condition, Disease, or Other Primary Study Focus Most older adults with dementia have multiple chronic conditions (MCC), experience difficulty managing their MCC, and have poorer outcomes. Managing MCC typically involves adhering to single-disease clinical practice guidelines (CPG). This approach often results in burdensome care with outcomes that may not reflect what matters most to patients. To address the challenges for caring for patients with MCC, Patient Priorities Care (PPC) was developed - an approach that aligns disease management with patient priorities rather than CPG, to improve care. PPC is feasible and effective. Patients report less burdensome treatment and have fewer medications and referrals after going through PPC. PPC also helps clinicians recommend home and community services that are aligned with patient priorities. Focusing on patient priorities rather than CPG is a patient-centered approach that integrates well in routine clinic encounters.
  • Study Rationale Physical, emotional, and cognitive impairments related to dementia interfere with disease self-management. Persons living with dementia (PlwD) therefore rely on caregivers for care and decision-making. Caregivers may add complexity to the patient-clinician interaction but are essential for translating 'what matters most' for PlwD into healthcare decisions. Patient and caregiver involvement should include identifying outcome goals and care preferences (health priorities) as well as aligning care to meet those priorities. It is therefore important to integrate caregivers into the healthcare process to achieve high-quality, family-centered care.

PlwD from minority groups experience more difficulties and poorer outcomes compared to their Non-Hispanic White (NHW) counterparts. Hispanics are the fastest-growing underrepresented population in the USA and have 1.5 times higher risk of dementia compared to NHW. Hispanics rely heavily on their families and there is a cultural expectation of families to provide care to members in need. Recent data report older Hispanics prefer care at home rather than professional care. These cultural differences and language barriers play key roles in shaping healthcare priorities and how priorities impact outcomes among Hispanics.

STUDY DESIGN For the adaptation 5 Hispanic patients will be included and for the feasibility test 20 Hispanic patients will be included.

The process will be as follows:

  1. Eligible Hispanic patients will be identified through the patient roster of the Geriatrics Outpatient Clinic at UTMB.
  2. Primary care providers will be asked to select patients that would not be good candidates for the study.
  3. A research team member will contact the eligible patients and invite them to schedule the priority setting an appointment. For those that agree she will obtain assent and/or consent and schedule the session.
  4. On the day of the session, the facilitator will use the PPC materials and identify the patient priorities, and document them in the electronic health record (Step 1). The visit will be audio recorded.
  5. A research team member will schedule an appointment with the patient's primary care provider (PCP) within 2 weeks to conduct the alignment portion of the PPC approach (Step two).
  6. The primary care provider will discuss the patient priorities and the provider will align care to meet those priorities and document changes in care based on the discussion on the electronic health record.
  7. A research member will call the patient and assess their satisfaction with the PPC approach 2 weeks after the visit with the primary care provider.
  8. A research member will contact the primary care provider and assess their satisfaction with the PPC approach.
  9. The PI, Co-PI, and advisory team will review all the information and make adjustments to the protocol for the feasibility phase.
  10. Activities 1-8 will be repeated with 20 Hispanic patients to test the feasibility of the adapted PPC approach for Hispanics. Given the presence of cognitive impairment, consent from a family caregiver will be obtained.
Being tested
Patient Priorities Care (PPC) Approach, Adapted PPC
Keywords
multiple chronic conditions, dementia, Hispanic
Medical subject headings
Multiple Chronic Conditions, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Priorities Care (PPC) ApproachBehavioural

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

  • Adapted PPCBehavioural

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

Study groups in NCT05303194
Study groupRoleWhat they receive
Patient Priorities Care (PPC) AdaptationOther5 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.
Receives: Behavioral: Patient Priorities Care (PPC) Approach
PPC Feasibility TestingOther20 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.
Receives: Behavioral: Adapted PPC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: On average one month after baseline

Secondary outcomes (1)
  1. Number of Participants With Documented Changes in the Electronic Health Record That Indicate Care Alignment Was Done

    Dichotomous variable (yes vs no). Review of medical records to identify changes in care based on priorities identified by participants as a result of the Patient Priorities Care (PPC) approach. All medical charts were reviewed for language indicating that the primary care providers used the patient priorities to align the care provided to the patient. The default sentence provided to the providers was "Based on the patient's specific priorities, including outcome goals and care preferences, we decided to..." If information resembling this wording was found, then Care alignment was marked as positive. Otherwise, it was marked as negative.

    Measured: Approximately one month after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start31 May 2022
  3. Primary completion5 Mar 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05303194
Sponsor's protocol ID
21-0107
Acronym
PPC-HD
Status last verified
Jul 2025
First submitted
8 Mar 2022
Last updated
8 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data of participants and their caregivers will be made available to other researchers once results have been released to clinicaltrials.gov.

Publications

  • 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.

    PubMed 33760091
  • 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.

    PubMed 32687218
  • 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.

    PubMed 31589281
  • 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.

    PubMed 30281777
  • 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.

    PubMed 30281794

Questions about this trial

What is this clinical trial studying?

A study testing Patient Priorities Care (PPC) Approach and Adapted PPC in people with Multiple Chronic Conditions and Dementia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported Perceived Value of Patient Priorities Care (PPC) Approach (time frame: On average one month after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05303194, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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