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

NCT06001775 | Completed Results

• 4 other identifiers: FY22_Pilot1_Carnahan15345Pro00063400U54AG063546
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

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 patients 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

Keywords

dementia; mild cognitive impairment; patient priorities care

Outcome Measures

Primary Outcomes (1)

• Documentation of PPC Discussion

  Review of the electronic health record will be used to assess for the presence of documentation of patient priorities care for each enrolled patient. Documentation can occur from enrollment through enrolled patient's visit with the participating physician in clinic. Enrollment (mailing of packet) occurred from two months prior to scheduled appointment with participating physician to clinic appointment. Documentation of discussion could occur from two months prior up to within 24 hours of clinic appointment with participating physician.

  From enrollment to participating clinic visit

Secondary Outcomes (12)

• Identification of a Care Partner

  Baseline and up to 2 months post baseline

• Acceptability

  Baseline and up to 2 months post baseline

• Appropriateness

  Baseline and up to 2 months post baseline

• Feasibility of the Intervention

  Baseline and up to 2 months post baseline

• Fidelity to the Intervention

  Baseline and up to 2 months post baseline

Other Outcomes (1)

• Number of Enrolled Eligible Patients Across Racial, Ethnic and Socioeconomic Subgroups

  2 months pre and 2 months post baseline

Study Arms (1)

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

EXPERIMENTAL

Patients 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. This conversation will be documented in the Electronic Health Record.

Behavioral: Patient Priorities Care

Interventions

Patient Priorities Care 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.

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to participate in this study:
• 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:
• years or older
• English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Connected Care

Indianapolis, Indiana, 46219, United States

Location

University of Texas Health- Houston

Houston, Texas, 77030, United States

Location

Related Links

• Patient Priorities Care homepage

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Katie Allen
• Organization: Regenstrief Institute

allenkat@regenstrief.org

317-874-9202

Study Officials

• Katie Allen, PhD

  Regenstrief Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 21, 2023
• Study Start: August 31, 2023
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: April 2, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)