Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia

NCT ID: NCT06001775

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2025-02-15

Brief Summary

The goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and geriatrics clinics with patients living with dementia or mild cognitive impairment. This study aims are:

• demonstrate the feasibility of using the electronic health record to identify a diverse cohort of eligible patient and patient-care partner dyads who will engage in a Patient Priorities Care conversation with a trained facilitator.
• demonstrate feasibility of pragmatically assessing clinical outcomes using the electronic health record, including a) number of days at home, b) total medications, and c) new referrals to specialist physicians.
• examine key feasibility measures across racial, ethnic, and socioeconomic subgroups.

Participants will receive a packet of information about Patient Priorities Care from their primary care clinic, in advance of their next upcoming clinic appointment. Individuals who receive a packet will have the opportunity to engage in a conversation about what matters most to them and what their priorities are, with trained facilitators at the clinic.

Conditions

Dementia; Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment

Patients (and their care partners when available) will receive a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) will initiate a Patient Priorities Care conversation with the patient or patient care partner dyad. This conversation will be documented in the Electronic Health Record.

Group Type: EXPERIMENTAL

Patient Priorities Care

Intervention Type: BEHAVIORAL

According to patientprioritiescare.org a Patient Priorities Care conversation helps to align healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare.

Interventions

Patient Priorities Care

According to patientprioritiescare.org a Patient Priorities Care conversation helps to align healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patients must meet all of the following criteria to participate in this study:

• 40 years or older

• English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site
• Receiving care with a participating physician
• Has a scheduled outpatient care visit within 1-2 months (60 days)
• Individual has a diagnosis of MCI or dementia

Definition: To identify individuals with dementia and MCI, we will use two or more instances of use of an ICD-10 code for either diagnosis in the EHR within 24 months. Typically, we would include instances of these billing codes within a year of each other but, due to the COVID-19 pandemic, recognize that there may be less frequent clinical visits and less robust billing. Diagnostic codes include:

• F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, G31.01, G31.09, G31.1, G31.2, F41.81, G31.84 and F03.91.

Care partners must meet all of the following criteria to participate in the study:

• 18 years or older
• English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site

A note about inclusion of care partners: Clinician determination of a patient's capacity to participate in a visit independently is part of a pragmatic approach. This means that clinic staff will determine when a care partner is needed. Generally, we act under the assumption that patients who require a care partner will have already included them in previous visits and/or provider communications (and we anticipate that this will be documented in the EHR), whereas patients who attend clinic visits independently and have no documentation indicating the involvement of a care partner in their medical decisions, or a need for one, will be determined to have the capacity to also participate in a PPC visit.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from the study:

• Is not community-dwelling- e.g. lives in a nursing home
• Is enrolled in hospice
• Individuals who decline to receive the PPC intervention (i.e. decline to have the PPC conversation) will be excluded from the study.

• Note that declining to receive the PPC intervention will in no way impact the care that patients receive now or in the future.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer L Carnahan

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer L Carnahan, MD

Role: PRINCIPAL_INVESTIGATOR

Regenstrief Institute, Inc.

Locations

Eskenazi Health

Indianapolis, Indiana, United States

Indiana University Health Connected Care

Indianapolis, Indiana, United States

University of Texas Health- Houston

Houston, Texas, United States

Countries

United States

Related Links

http://patientprioritiescare.org

Patient Priorities Care homepage

Other Identifiers

15345

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00063400

Identifier Type: OTHER

Identifier Source: secondary_id

U54AG063546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FY22_Pilot1_Carnahan

Identifier Type: -

Identifier Source: org_study_id