- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05303194
Patient Priorities Care for Hispanics With Dementia (PPC-HD)
Study Overview
Status
Conditions
Intervention / Treatment
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.
4 STUDY DESIGN For the adaptation 5 Hispanic patients will be included and for the feasibility test 20 Hispanic patient-caregiver dyads 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 patient-caregiver dyads to test the feasibility of the adapted PPC approach for Hispanics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77555
- The University of Texas Medical Branch in Galveston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
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 dyads)
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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First, identify patient priorities, and second align care received with those priorities.
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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.
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First, identify patient priorities, and second align care received with those priorities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with changes in medications documented in the electronic health record based on participants' health priorities
Time Frame: After 1 month from participant visit to primary care provider
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Determine if primary care providers changes medications on the electronic health to align management to patient priorities
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After 1 month from participant visit to primary care provider
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Aanand D Naik, MD, The University of Texas Health Science Center, Houston
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-0107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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