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 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Burke, BA; Phone Number: 3172749047; Email: esburke@regenstrief.org
• Study Contact Backup: Name: Jennifer L Carnahan, MD; Email: jenncarn@iupui.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Regenstrief Institute, Inc.
      • Contact: Jennifer L Carnahan, MD
      • Principal Investigator: Jennifer L Carnahan, MD
      • Principal Investigator: Rafael Samper-Ternent, MD

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 (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.

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
Number of patients with documentation of Patient Priorities Care discussion in the electronic health record	We will use a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months pre and 2 months post baseline
Acceptability	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
Appropriateness	We will assess appropriateness via qualitative exit interviews with patients, care partners, and clinicians.	Baseline and up to 2 months post baseline
Potential for future adoption of Patient Priorities Care intervention	We will assess potential for future adoption of the intervention via qualitative exit interviews with patients, care partners, and clinicians.	Baseline and up to 2 months post baseline
Number of patient days at home	We will use the electronic health record to assess for hospital visits, emergency room visits, or nursing home admissions.	2 months pre and 2 months post baseline
Number of total medications	We will use the electronic health record to assess the medication list total at 2 months pre and post baseline.	2 months pre and 2 months post baseline
Number of new referrals to specialist physicians	We will use the electronic health record to assess referrals to specialists at 2 months pre and post baseline	2 months pre and 2 months post baseline
Feasibility of the intervention using Proctor et al as a guide	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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jennifer L Carnahan, MD, 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 (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

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 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: dementia; mild cognitive impairment; patient priorities care
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• 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