Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia (IN-TX-PPC)

Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Patient Priorities Care

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health
    • Indianapolis, Indiana, United States, 46219
      • Indiana University Health Connected Care
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health- Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patient 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 Partner Inclusion Criteria

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability will be assessed using Sekhon's Theoretical Framework of Acceptability (TFA) to qualitatively assess acceptability, which includes meeting definitions outlined within the framework, represented by seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.	Baseline and up to 2 months post baseline
Appropriateness	Appropriateness will be assessed via qualitative exit interviews with patients, care partners, and clinicians.	Baseline and up to 2 months post baseline
Identification of a Care Partner	Identification of a care partner for 50% of eligible persons living with dementia and mild cognitive impairment. Care partners will be identified based on information provided by the patient, the electronic health record, and the clinical team.	Baseline and up to 2 months post baseline
Feasibility of the Intervention	Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide.	Baseline and up to 2 months post baseline
Fidelity to the Intervention	Fidelity will be assessed when select charts are reviewed for adherence to the protocol.	Baseline and up to 2 months post baseline
Potential for Future Adoption of Patient Priorities Care Intervention	Assessment of potential for future adoption of the intervention will be conducted via qualitative exit interviews with patients, care partners, and clinicians.	Baseline and up to 2 months post baseline
Number of Patient Days at Home	Review of the electronic health record will be used to assess for hospital visits, emergency room visits, or nursing home admissions. Number of patient days at home will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences.	2 months pre and 2 months post baseline
Number of Total Medications	Review of the electronic health record will be used to assess the medication list total at 2 months pre and post baseline. Number of total medications will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences.	2 months pre and 2 months post baseline
Number of New Referrals to Specialist Physicians	Review of the electronic health record to identify the number of referrals to specialists at 2 months pre and post baseline. Number of new referrals to specialist physicians will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences.	2 months pre and 2 months post baseline
Number of Patients Across Racial, Ethnic, and Socioeconomic Subgroups With Documentation of Patient Priorities Care Discussion in the Electronic Health Record	Evaluation will occur using a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded.	2 months pre and 2 months post baseline
Acceptability Across Racial, Ethnic, and Socioeconomic Subgroups.	Acceptability effects will be further evaluated across racial, ethnic, and socioeconomic subgroups. We will utilize Sekhon et al's Theoretical Framework of Acceptability (TFA) to qualitatively assess acceptability, which includes meeting definitions outlined within the framework, represented by seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.	Baseline and up to 2 months post baseline
Number of Patients With Social Factors Indicated in the Electronic Health Record	Established algorithms for detecting social factors that may influence patient care priorities, such as housing instability, financial insecurity, or transportation concerns will be deployed. These algorithms have been previously created and validated across the care spectrum and will be deployed at the primary site in current form on the established natural language processing platform at Regenstrief Institute. Similar data will be manually extracted using keywords from the primary site for the secondary site. All available clinical notes for the recruited cohort will be annotated by the software as either positive or negative for the social factors. This can then be incorporated into analyses.	Baseline and up to 2 months post baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Enrolled Eligible Patients Across Racial, Ethnic and Socioeconomic Subgroups	Number of eligible patients enrolled across racial, ethnic and socioeconomic subgroups.	2 months pre and 2 months post baseline

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Katie Allen, PhD, Regenstrief Institute, Inc.

Publications and helpful links

Helpful Links

• Patient Priorities Care homepage

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): February 15, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: dementia; mild cognitive impairment; patient priorities care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: FY22_Pilot1_Carnahan; U54AG063546 (U.S. NIH Grant/Contract); 15345 (Other Identifier: Indiana University Institutional Review Board); Pro00063400 (Other Identifier: Advarra (CIRBI) External Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since this study is a pragmatic trial in a clinical environment, the majority of our outcomes will be determined via data that is already held in the EHR. Therefore a plan for sharing IPD seems unnecessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No