CompletedNCT05303194PPC-HDUpdated Aug 8, 2025Results posted

Patient Priorities Care for Hispanics With Dementia

An interventional study of Patient Priorities Care (PPC) Approach and Adapted PPC in Multiple Chronic Conditions and Dementia, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 21
Allocation: Non-randomized
Ages: 60 Years and older
Sex: All

Study 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.

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:

Eligible Hispanic patients will be identified through the patient roster of the Geriatrics Outpatient Clinic at UTMB.
Primary care providers will be asked to select patients that would not be good candidates for the study.
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.
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.
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).
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.
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.
A research member will contact the primary care provider and assess their satisfaction with the PPC approach.
The PI, Co-PI, and advisory team will review all the information and make adjustments to the protocol for the feasibility phase.
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.

Conditions studied

Multiple Chronic Conditions
Dementia

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Keywords

multiple chronic conditions
dementia
Hispanic

In context

Multiple Chronic Conditions

89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.

This study's enrollment of 21 is below the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.

Browse Multiple Chronic Conditions studies →

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 257 studies on the registry; 38 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.

Browse The University of Texas Medical Branch, Galveston studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 60 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 21 participants (actual)

Study arms

Other
Patient Priorities Care (PPC) Adaptation
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
Other
PPC Feasibility Testing
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

BehavioralPatient Priorities Care (PPC) Approach
First, identify patient priorities, and second align care received with those priorities.
BehavioralAdapted PPC
First, identify patient priorities, and second align care received with those priorities.

What researchers measure

Primary outcomes

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".
Time frame: On average one month after baseline

Secondary outcomes

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.
Time frame: Approximately one month after baseline

Results

Posted Aug 8, 2025

Participant flow

Participants were recruited based on Hispanic ethnicity from a UTMB Galveston outpatient clinic, participants without cognitive impairment, and with cognitive impairment. The first participant was enrolled on May 31st, 2022 and the last participant was enrolled in January 2024.

Participant flow — Overall Study
Milestone	Patient Priorities Care (PPC) Adaptation	PPC Feasibility Testing
Started	5	16
Completed	4	14
Not completed	1	2
Withdrew: Lost to follow-up	1	1
Withdrew: Withdrawal by subject	0	1

Outcome measures

PrimarySelf-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".

Time frame:: On average one month after baseline
Reported as:: Number · percentage of participants

Self-reported Perceived Value of Patient Priorities Care (PPC) Approach
percentage of participants	Patient Priorities Care (PPC) Adaptation	PPC Feasibility Testing
Self-reported Perceived Value of Patient Priorities Care (PPC) Approach	75	85.7

SecondaryNumber 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.

Time frame:: Approximately one month after baseline
Reported as:: Count of participants · Participants

Number of Participants With Documented Changes in the Electronic Health Record That Indicate Care Alignment Was Done
Participants	Patient Priorities Care (PPC) Adaptation	PPC Feasibility Testing
Number of Participants With Documented Changes in the Electronic Health Record That Indicate Care Alignment Was Done	4	15

Adverse events

Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Patient Priorities Care (PPC) Adaptation	0/4 (0%)	0/4 (0%)	0/4 (0%)
PPC Feasibility Testing	0/15 (0%)	0/15 (0%)	0/15 (0%)

Baseline characteristics

Participants from the adaptation phase were different from those in the feasibility phase. Baseline Characteristics were not collected for caregivers.

Age, Categorical
Age, Categorical(Participants)	PPC Adaptation	PPC Feasibility	Total
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	5	16	21

Sex: Female, Male
Sex: Female, Male(Participants)	PPC Adaptation	PPC Feasibility	Total
Female	2	5	7
Male	3	11	14

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	PPC Adaptation	PPC Feasibility	Total
Hispanic or Latino	5	16	21
Not Hispanic or Latino	0	0	0
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	PPC Adaptation	PPC Feasibility	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	0	0	0
More than one race	0	0	0
Unknown or Not Reported	5	16	21

Cognitive impairment
Cognitive impairment(Participants)	PPC Adaptation	PPC Feasibility	Total
Count of participants	0	16	16

Multiple Chronic Conditions
Multiple Chronic Conditions(Participants)	PPC Adaptation	PPC Feasibility	Total
Count of participants	5	16	21

Study locations

1 site

The University of Texas Medical Branch in Galveston
Galveston, Texas 77555, United States

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan ↗ · Feb 24, 2025

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05303194
Lead sponsor: The University of Texas Medical Branch, Galveston
Collaborators: The University of Texas Health Science Center, Houston
Responsible party: Sponsor
First posted: Mar 31, 2022
Start date: May 31, 2022
Primary completion: Mar 5, 2024
Completion: Oct 30, 2024
Results posted: Aug 8, 2025
Last update: Aug 8, 2025

Study contacts

Aanand D Naik, MD

principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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